LICENSE AGREEMENT
CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED WITH RESPECT TO CERTAIN INFORMATION IN THIS
AGREEMENT. THIS INFORMATION HAS BEEN REDACTED AND DENOTED BY ASTERISKS [***].
THIS
LICENSE AGREEMENT
(the
“Agreement”)
is
effective as of November 22, 2006 (the “Effective
Date”),
between WYETH, acting through its Wyeth Pharmaceuticals division, a Delaware
corporation with offices located at 000 Xxxxxx Xxxx, Xxxxxxxxxxxx, XX 00000
(“WYETH”),
and
NEUROGEN CORPORATION, a Delaware corporation with offices located at 00 XX
Xxxxxxxxxx Xx., Xxxxxxxx, XX 00000 (“NEUROGEN”).
Background:
|
X.
|
XXXXX
has undertaken research and development of a compound commonly referred
to
as Aplindore. WYETH and its Affiliates are the owners of certain
patents,
know-how and other intellectual property rights relating to such
compound.
WYETH desires to license such patents, know-how and other intellectual
property rights to NEUROGEN according to the terms and conditions
set
forth below.
|
|
B.
|
NEUROGEN
is in the business of drug discovery and development. NEUROGEN desires
to
license from WYETH such patents, know-how and other intellectual
property
rights, subject to the terms and conditions set forth below.
|
NOW,
THEREFORE, WYETH and NEUROGEN (hereafter “Party,”
if
singular or “Parties,”
if
plural) agree as follows:
ARTICLE
I DEFINITIONS
The
following terms shall have the respective meanings set forth below:
1.1 “Affiliate”
means as
of any point in time and for so long as such relationship continues to exist
with respect to any entity (a) any corporation or business entity of which
more
than fifty percent (50%) or more of the securities or other ownership interests
representing the equity or voting interest are owned, controlled or held,
directly or indirectly, by WYETH or NEUROGEN; or (b) any corporation or business
entity which, directly or indirectly, owns, controls or holds more than fifty
percent (50%) (or the maximum ownership interest permitted by law) or more
of
the securities or other ownership interests representing the equity or voting
interest of WYETH or NEUROGEN; or (c) any corporation or business entity of
which more than fifty percent (50%) or more of the securities or other ownership
interests representing the equity or voting interest are owned, controlled
or
held, directly or indirectly, by a corporation or business entity described
in
(a) or (b).
1.2 “Aplindore”
means
the compound having CAS Registry Number 189681-71-8 and known as aplindore;
aplindorum; aplindor; palindore; palindorum; palindor;
8H-1,4-dioxino[2,3-e]indol-8-one,
2,3,7,9-tetrahydro-2-[[(phenymethyl)amino]methyl]-,2(S)-,(2E)-2-butenedioate;
(2S)-2-[(benzylamino)methyl]-2,3,7,9-tetrahydro-8H-1,4-dioxino[2,3-e]indol-8-one
(E)-butenedioate; or DAB-452.
1.3 “Aplindore
Licensed Know-How”
means
the following: (a)the
complete IND file for Aplindore, (b) the existing pre-clinical and clinical
data
relating exclusively to the Compounds, and (c) synthesis processes related
exclusively to the Compounds.
1.4 “Compounds”
means
Aplindore and pharmaceutically acceptable salts or complexes thereof, and all
salts, solvates, crystal forms, polymorphs, chelates, non-covalent complexes,
hydrates, enantiomers, and racemates thereof.
1
1.5 “Commercially
Reasonable Efforts”
means,
with respect to NEUROGEN and its Affiliates’ obligations, that effort
customarily exerted by NEUROGEN with respect to its own products of similar
scientific merit and commercial potential, taking into account, by example
and
without limitation, such factors as intellectual property position, the cost
and
length of development, regulatory risk, safety (including any adverse condition
or event relating to safety) and efficacy, projected sales, reimbursement
factors, parallel importation considerations, pricing, product life cycle and
cost of sales and marketing, and also including the timing and promptness with
which such efforts and resources would be applied.
1.6 “Control”
or“Controlled”
means
the
possession of the right to grant the license, sublicense or access hereunder
to,
intangible or intellectual property rights (including patent rights, trademarks,
know-how, trade secrets and rights to access or cross-reference regulatory
filings) without (i) violating the terms of any agreement or other arrangement
with any Third Party existing at the time such Party would be first required
hereunder to grant the other Party such access or license or sublicense, or
(ii)
requiring the Party required hereunder to grant the other Party such access
or
license or sublicense to pay any consideration to any Third Party.
1.7 “Effective
Date”
means
the date first written above.
1.8 “EMEA”
means
the
European Medicines Agency and the Committee for Proprietary Medicinal Products
or any successor agency thereof performing similar functions.
1.9 “FDA”
means
the Food and Drug Administration of the United States Department of Health
and
Human Services or any successor agency thereof performing similar
functions.
1.10 “Field”
means
the treatment and/or prevention of human disease or medical conditions.
1.11 “Filing”
of
an NDA
means the acceptance by a Regulatory Authority of an NDA for
filing.
1.12 “First
Commercial Sale”
means,
with respect to any Product, the first sale by NEUROGEN, its Affiliates or
Sublicensees for end use or consumption of such Product in a country after
all
required approvals, including NDA Approvals, have been granted by the Regulatory
Authority of such country.
1.13 “Xxxxx-Xxxxxx
Act” means
the
United States Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. Law 98-471), or any successor thereto, and any equivalent legal
requirements in other countries, as in effect from time to time during the
term
of this Agreement.
1.14 “HSR
Act”
means
the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended from time
to time.
1.15 “IND”
means
an
investigational new drug application (together with all subsequent submissions,
supplements and amendments thereto) filed with the FDA in conformance with
applicable laws and regulations, for approval to conduct human clinical
investigations, and the equivalent thereof, as applicable, in jurisdictions
outside the United States.
1.16 “Information”
means
(i) all information, materials and data, including Licensed Know-How and all
other scientific, preclinical, gene sequence, chemical structure, clinical,
regulatory, manufacturing, marketing, financial, or patent information, and
commercial information and data, whether communicated in writing or orally
or by
any other method, which is provided by one Party to the other Party in
connection with this Agreement or (ii) existing Know-How, and that is identified
as confidential or is customarily regarded as confidential within the
pharmaceutical industry.
2
1.17 “Know-How”
means
any and all know-how and data, proprietary methods, devices, written
information, materials, regulatory filings, INDs and related documentation
and
data, manufacturing methods, technology, trade secrets, inventions,
compositions, designs, formulae, discoveries, improvements, documentation,
research and development reports, information, processes, protocols, clinical
and safety data, statistical programs, preclinical data, research data,
manufacturing data, analytical data, assays, batch records and standard
operating procedures, in each case to the extent: (i) Controlled by WYETH or
its
Affiliates, (ii) existing as of the Effective Date, and (iii) that has actually
been used by or on behalf of WYETH or its Affiliates in connection with, and
is
reasonably necessary, for the research, development, formulation, registration,
manufacture, sale or use of Compound.
1.18 “Licensed
Know-How”
means
any and all Know-How other than the Aplindore Licensed Know-How.
1.19 “Licensed
Patent Rights”
means
all Patents owned or Controlled by Wyeth or any of its Affiliates during the
term of this Agreement that would, but for the license granted under this
Agreement, be infringed by the research, development, manufacture, use, offer
for sale, sale, import or export of Compounds, including the Licensed Patent
Rights listed on Schedule 1.19.
1.20 “NDA”
means a
new drug application, biologic license application, marketing application
authorization, or similar application or submission for Regulatory Approval
of a
Product
filed with a Regulatory Authority to obtain approval to sell commercially the
Product in that country or in that group of countries, together with all
subsequent submissions, supplements and amendments thereto.
1.21 “NDA
Approval”
means
approval of an NDA by the FDA, EMEA or other applicable Regulatory
Authority.
1.22 “Net
Sales”
with
respect to the sale of any Product means the gross amount invoiced by NEUROGEN,
its Affiliates, licensees or Sublicensees (including any co-marketing partners),
to Third Parties less, the following reasonable and customary deductions, in
each case to the extent specifically relating to the Product for: (i) trade,
quantity and cash discounts and allowances actually allowed or given; (ii)
to
the extent included in the invoice amount, freight, shipping insurance and
other
transportation expenses incurred in transporting such Product in final form
to
such customers; (iii) credits or refunds actually allowed for rejections,
defects or recalls of such Products, outdated or returned Products, or
retroactive price reductions; (iv) sales, value-added, excise taxes, tariffs
and
duties, and other taxes directly related to the sale (but not including taxes
assessed against the income derived from such sale); (v) chargebacks granted
to
wholesalers; and (vi) rebates, including managed care, Medicaid and other
governmental rebates, in respect of the sales of the Products. The transfer
of
Products by NEUROGEN or one of its Affiliates to either (a) another Affiliate
of
NEUROGEN or (b) a licensee or Sublicensee of NEUROGEN, shall not be considered
a
sale; in such cases, Net Sales shall be determined based on the invoiced sales
price by the Affiliate, licensee or Sublicensee to an unrelated Third Party,
less the deductions allowed under this Section 1.22. Every other commercial
use or disposition of a Product by NEUROGEN or its Affiliates, licensees or
Sublicensees in barter or other transactions (other than dispensing of
reasonable and customary quantities of promotional samples) shall be considered
a sale of such Product at the weighted average Net Sales price for such Product
during the preceding quarter.
With
respect to sales of a combination product (a Product containing as its active
ingredients Product and one or more other therapeutically or prophylactically
active ingredients priced in a single package), for the purpose of determining
Royalties, Net Sales shall be calculated by multiplying the total Net Sales
of
such combination product by the fraction A/A+B where A is the actual invoice
price of the Product in the same dosage amount in the applicable country if
sold
separately and B is the sum of the actual invoice prices of all other active
ingredients or products in the same dosage amount in the combination product
in
the applicable country if sold separately during the applicable quarter. If
A or
B cannot be determined because values for the Product or the other active
ingredients sold alone are not available in a particular country then WYETH
and
NEUROGEN will discuss an appropriate allocation for the fair market value of
the
Product and other active ingredients in the combination product to determine
Net
Sales for such combination product. The deductions set out in the paragraph
above in this Section 1.22 will be applied in calculating Net Sales for a
combination product.
1.23 “Patents”
means
patent applications (including provisional applications, certificates of
invention and applications for certificates of invention, continuations,
divisionals and continuations-in-part), and all patents issuing therefrom and
foreign equivalents thereof (including
all substitutions, reissues, renewals, reexaminations, supplementary protection
certificates, extensions, registrations and confirmations of any of the
foregoing patents and the like).
3
1.24 “Phase
II Clinical Trial”
means a
human clinical trial that is intended to gain evidence of the efficacy of a
Product for a particular indication or indications in human subjects with the
disease or indication under study including a trial that would satisfy the
requirements of 21 C.F.R. 312.21(b), as may be amended or the foreign equivalent
thereof.
1.25 “Phase
III Clinical Trial”
means a
pivotal human clinical trial that is intended to gain evidence to establish
the
efficacy and safety of a Product as a basis for an NDA including a trial that
would satisfy the requirements of 21 C.F.R. 312.21(c), as may be amended or
the
foreign equivalent thereof.
1.26 “Product”
means
a
pharmaceutical product, formulation or preparation for sale and therapeutic
use
in humans containing one or more Compounds as a pharmaceutically active
ingredient(s).
1.27 “Regulatory
Approval”
means
any NDA Approvals and other approvals, licenses, registrations, or
authorizations granted or issued by any national, regional, state or local
governmental entities and agencies, necessary for the development, registration,
manufacture, packaging, labeling, use, storage, transport, export, import,
clinical testing, promotion or sale of the Products in a country, including
pricing and reimbursement approvals to the extent the applicable Regulatory
Authorities in such country require a pricing or reimbursement approval prior
to
commercialization of a Product in such country.
1.28 “Regulatory
Authority”
means
any applicable government regulatory authority involved in granting approvals
for the manufacturing, marketing, reimbursement and/or pricing of a Product
in
the Territory, including, in the United States, the FDA.
1.29 “Sublicensee”
means a
Third Party to whom NEUROGEN grants a license or sublicense to develop, make,
use, or sell the Compounds or Products.
1.30 “Territory”
means
worldwide (all of the countries in the world, and their territories and
possessions of any nature or category).
1.31 “Third
Party”
means an
entity other than WYETH and its Affiliates, or NEUROGEN and its
Affiliates.
1.32 “U.S.
GAAP”
means
generally-accepted accounting principles in the United States.
1.33 “Valid
Claim”
means an
issued claim within the scope of the Licensed Patent Rights, including any
extensions thereof and supplemental protection certificates, to the extent
such
claims have not been disclaimed, revoked or held invalid by a final unappealable
decision of a court or governmental agency of competent jurisdiction, and which
claims are otherwiseenforceable.
“Valid Claim” also means any claim within a pending application for a Patent
included within the scope of the Licensed Patent Rights to the extent the
invention(s) described in the claims of such application have not been abandoned
without being refiled in another application or finally rejected by an
administrative agency action from which no appeal can be taken, such that the
claim at issue has been pending for less than five (5) years. If a claim of
a
patent application that ceased to be a Valid Claim due to the passage of time
set forth in the preceding sentence later issues as a part of a Patent described
above, then it will again be considered a Valid Claim effective as of the
issuance of such patent.
1.34 Interpretation.
(a) Whenever
any provision of this Agreement uses the term “including” (or “includes”), such
term shall be deemed to mean “including without limitation” and “including but
not limited to” (or “includes without limitations” and “includes but is not
limited to”) regardless of whether the words “without limitation” or “but not
limited to” actually follow the term “including” (or “includes”);
(b) “Herein,”
“hereby,” “hereunder,” “hereof” and other equivalent words shall refer to this
Agreement in its entirety and not solely to the particular portion of this
Agreement in which any such word is used;
4
(c) All
definitions set forth herein shall be deemed applicable whether the words
defined are used herein in the singular or the plural;
(d) Wherever
used herein, any pronoun or pronouns shall be deemed to include both the
singular and plural and to cover all genders;
(e) The
recitals set forth at the start of this Agreement, along with the Attachments
to
this Agreement, and the terms and conditions incorporated in such recitals
and
Attachments shall be deemed integral parts of this Agreement and all references
in this Agreement to this Agreement shall encompass such recitals and
Attachments and the terms and conditions incorporated in such recitals and
Attachments; provided, that in the event of any conflict between the terms
and
conditions of this Agreement and any terms and conditions set forth in the
recitals or Attachments, the terms of this Agreement shall control;
(f) In
the
event of any conflict between the terms and conditions of this Agreement and
any
terms and conditions that may be set forth on any order, invoice, verbal
agreement or otherwise, the terms and conditions of this Agreement shall
govern;
(g) The
Agreement shall be construed as if both Parties drafted it jointly, and shall
not be construed against either Party as principal drafter;
(h) Unless
otherwise provided, all references to Sections, Articles and Attachments in
this
Agreement are to Sections, Articles and Attachments of and to this
Agreement;
(i) All
references to days, months, quarters or years are references to calendar days,
calendar months, calendar quarters or calendar years;
(j) Any
reference to any federal, national, state, local or foreign statute or law
shall
be deemed to also refer to all rules and regulations promulgated thereunder,
unless the context requires otherwise; and
(k) Wherever
used, the word “shall” and the word “will” are each understood to be imperative
or mandatory in nature and are interchangeable with one another.
ARTICLE
II LICENSES
2.1 License
Grant. (a)
WYETH
hereby grants to NEUROGEN and its Affiliates an exclusive license (including
as
to WYETH), with the right to grant sublicenses, under the Licensed Patent Rights
(subject to WYETH’s retained right set forth below), solely for the purposes of
research, making, having made, using, developing, registering, offering to
sell,
selling, importing and exporting and distributing Products and Compounds in
the
Field in the Territory. WYETH retains the nonexclusive right to make and use
Compounds for internal research purposes only, provided, however, under no
circumstances shall WYETH’s retained right be used for administering the
Compounds to animals or humans, nor to provide Compounds to Third
Parties.
(b) WYETH
hereby grants to NEUROGEN and its Affiliates a nonexclusive license, with the
right to grant sublicenses, to the Licensed Know-How solely for the purposes
of
research, making, having made, using, developing, registering, offering to
sell,
selling, importing and exporting and distributing Products and Compounds in
the
Field in the Territory.
(c) WYETH
hereby grants to NEUROGEN and its Affiliates an exclusive license (including
as
to WYETH), with the right to grant sublicenses, under the Aplindore Licensed
Know-How (subject to WYETH’s retained right set forth below) solely for the
purposes of research, making, having made, using, developing, registering,
offering to sell, selling, importing and exporting and distributing Products
and
Compounds in the Field in the Territory. Wyeth retains the nonexclusive right
to
make and use Compounds for internal research purposes only, provided, however,
under no circumstances shall WYETH’s retained right be used for administering
the Compounds to animals or humans, nor to provide Compounds to Third
Parties.
5
ARTICLE
III IND
AND TECHNOLOGY TRANSFER; COMPOUND SUPPLY
3.1 Access
to Regulatory Filings.
Consistent
with the requirements of 00 XXX 000, XXXXX will provide to NEUROGEN the complete
IND file for Aplindore (“Original
IND”)
including all supplements to the Original IND, all regulatory files and FDA
correspondence related thereto, and all records and reports required to be
kept
that are necessary to effect the transfer of the IND and allow NEUROGEN to
pursue development of the Compound (but excluding, for the avoidance of doubt,
records of WYETH that are not necessary for such purposes such as confidential
personnel records or facility design records). Within ten (10) days after
NEUROGEN confirms in writing the receipt of the Original IND from WYETH, WYETH
will execute and deliver a letter to the FDA authorizing the transfer of
ownership of the Original IND to NEUROGEN. NEUROGEN will promptly thereafter
take all further actions that are necessary to transfer ownership of the
Original IND for Aplindore to NEUROGEN. WYETH
shall use reasonable and diligent efforts to ensure that it has located and
provided to NEUROGEN all such documentation related to the Original IND and
all
other Licensed Know-How and Aplindore Licensed Know-How and WYETH shall promptly
convey to NEUROGEN any such documentation or other Licensed Know-How, or
Aplindore Licensed Know-How that WYETH locates after the Effective Date. WYETH
also agrees to provide reasonable assistance to ensure a prompt and complete
transfer by the FDA of ownership of the IND to NEUROGEN. Following the effective
transfer of ownership of the IND to
NEUROGEN, NEUROGEN will assume sole regulatory responsibility for development
of
Aplindore,
3.2 Technology
Transfer.
(a) WYETH
shall use reasonably diligent efforts to transfer the Aplindore Know-How and
all
Licensed Know-How within
ninety (90) days of the Effective Date. The later of the date on which WYETH
has
made such transfer or the date of the transfer of the Compound Inventory
pursuant to Section 3.3 is hereinafter referred to as the “Transfer
Completion Date”.
(b) In
addition, (i) [***],
upon NEUROGEN’s request, WYETH shall provide other reasonable assistance to
NEUROGEN [***] in NEUROGEN’s Compound manufacturing and development activities
which assistance shall include [***] (ii) [***] regulatory filings or CMC
(Chemistry, Manufacturing and Controls) related issues [***]. NEUROGEN shall
pay
WYETH for such assistance based on [***] days of receipt of WYETH’s invoice.
3.3 Supply
of Existing Compound. Within
forty five (45) days after the Effective Date, WYETH shall re-test, re-certify
(to standards acceptable for human testing in Phase II Clinical Trials) and
ship
to Neurogen or Neurogen’s designee all of its existing inventory of cGMP
Compound, and formulated clinical supplies of Compound (if any) (collectively,
the “Compound
Inventory”).
Within
thirty (30) days of receipt from WYETH of the Compound Inventory, NEUROGEN
shall
pay WYETH four hundred thousand dollars ($400,000) based on an estimated
quantity of at least 1.5 kilograms.
If the
Compound Inventory is less than 1.5 kilograms, NEUROGEN’s payment shall be
prorated based on the actual amount transferred.
ARTICLE
IV RESEARCH
AND DEVELOPMENT; DILIGENCE
4.1 Research
and Development Obligations
(a) NEUROGEN
shall be solely responsible for all future research and development and
regulatory activities with respect to Compounds and Products, including adverse
event reporting to the appropriate Regulatory Authorities in the countries
in
the Territory, in accordance with the appropriate laws and regulations of
the
relevant countries.
(b) NEUROGEN
shall use Commercially Reasonable Efforts to commence a Phase II Clinical
Trial
within eighteen (18) months of the Transfer Completion Date and to further
develop, manufacture and commercialize Products in the Field in the
Territory.
[***]
Confidential
treatment requested by Neurogen Corporation.
6
(c) If
NEUROGEN does not commence a Phase II Clinical Trial within eighteen (18)
months
of the Transfer Completion Date, NEUROGEN shall make a one time payment
to WYETH
of [***] ($[***]), and thereafter, shall pay WYETH [***] ($[***]) on each
anniversary of such date until a Phase II Clinical Trial is
commenced.
4.2 Reports.
NEUROGEN
will keep WYETH reasonably apprised of its and its Sublicensees’ development,
regulatory and commercialization activities related to Compounds or Products
by
providing WYETH with summary reports on or about June 30 and December 31 of
each
year, following the year in which the Effective Date occurs.
4.3 Manufacture.
Other
than as set forth in Section 3.3,
WYETH
shall have no responsibility for the manufacture of Compounds and Products
for
development, use and sale by NEUROGEN and its Sublicensees in the
Territory.
ARTICLE
V CONFIDENTIALITY
5.1
All
Information disclosed by a Party (the “Disclosing Party”_) to the other Party
(the “Receiving Party”) under this Agreement, shall, for the term of this
Agreement and for five (5) years thereafter, be maintained in confidence by
the
Receiving Party and, without the prior written consent of the Disclosing Party,
shall not be disclosed to any Third Party or used for any purpose except as
expressly permitted in this Agreement including this Article V. This
nondisclosure and non-use obligation shall not apply to Information that:
(a) is
known
by the Receiving Party at the time of its receipt, as documented by business
records, and not through a prior disclosure by the Disclosing Party;
(b) is
properly in the public domain;
(c)
is
subsequently disclosed to the Receiving Party by a Third Party who may lawfully
do so and is not under an obligation of confidentiality to the Disclosing Party;
(d) is
developed by the Receiving Party independently of Information received from
the
Disclosing Party, as documented by business records; or
(e) is
required to be disclosed by law or court order; provided that notice is promptly
delivered to the Disclosing Party in order to provide an opportunity to
challenge or limit the disclosure obligation; and provided further that the
Receiving Party cooperates with the Disclosing Party in limiting disclosure
to
the extent so required. Information that is disclosed by judicial or
administrative process shall remain otherwise subject to the confidentiality
and
non-use provisions of this Section 5.1 and the Receiving Party shall take
all
steps reasonably necessary, including compliance with any order of
confidentiality, to ensure the continued confidential treatment of such
Information.
(f) Any
combination of features or disclosures as set forth in Subsections (a)
through
(e) above shall not be deemed to fall within the foregoing exclusions merely
because individual features are published or available to the general public
or
in the rightful possession of the Receiving Party unless the combination
itself
and principle of operation are published or available to the general public
or
in the rightful possession of the Receiving Party.
5.2 Permitted
Disclosure of Information.
Notwithstanding anything to the contrary contained in Section 5.1, NEUROGEN
may
disclose such Information:
[***]
Confidential
treatment requested by Neurogen Corporation.
7
(a)
required
to be submitted to governmental or other Regulatory Authorities to obtain
Patents (including disclosure to U.S. and foreign patent offices and patent
counsel for purposes of patent prosecution) or to facilitate the issuance
of any
necessary registrations or filings in connection with conducting clinical
trials
for a Product or Compound, or developing, manufacturing or commercializing
a
Product, provided
that
such disclosure may be made only to the extent reasonably necessary to obtain
Patents or authorizations and that reasonable steps shall be taken to assure
confidential treatment of such Information; or
(b) to
its
permitted Sublicensees, agents, consultants, Affiliates and/or other Third
Parties to the extent reasonably necessary for the research and development,
manufacturing, registration and/or marketing of a Product or Compound (or
for
such parties to determine their interest in performing such activities) in
accordance with this Agreement on the condition that such disclosure may
be only
to the extent reasonably necessary for such activities and that such Third
Parties agree to be bound by confidentiality and non-use obligations at least
as
restrictive as those contained within this Agreement; provided
that the
term of confidentiality for such Third Parties shall be no less than five
(5)
years.
5.3 Publication.
The
Parties may each have an interest from time to time in publishing clinical
results or other research or development advancements involving Compounds or
Products to obtain recognition within the scientific community and to advance
the state of scientific knowledge. Consequently, except for disclosures
permitted pursuant to Sections 5.2 and 5.4, a Party, its employees, agents
or
consultants wishing to make a publication disclosing any of the Aplindore
Licensed Know-How shall deliver to the other Party a copy of the proposed
written publication at least sixty (60) days prior to submission for publication
and a copy of the proposed outline of an oral disclosure or presentation at
least forty-five (45) days prior to presentation. The non-disclosing Party
shall have the right to propose reasonable modifications to the publication
for
Patent reasons, trade secret reasons or proprietary business Information
reasons. Upon expiration of such sixty (60) day or forty-five (45) day period,
the disclosing Party shall be free to proceed with the publication or
presentation. If the non-disclosing Party has requested modifications to the
publication or presentation,
the disclosing Party shall give due consideration to such modifications and
edit
such publication or presentation if necessary to prevent disclosure of trade
secret or proprietary business Information prior to submission of the
publication or presentation.
5.4 Financial
Terms and Other Disclosures. Except
as
otherwise provided in this Article, the Parties agree that the material terms
of
this Agreement will be considered confidential Information of both Parties
and
neither Party may disclose the terms of this Agreement; provided,
however, on
or
promptly
after the Effective Date, each Party may, or the Parties collectively will,
issue a press release reasonably acceptable to each Party describing the
Agreement. Notwithstanding
the foregoing: (a) either Party may disclose such terms as are required to
be
disclosed by applicable laws, regulations or stock market or stock exchange
rules of a governing authority such as the U.S. Securities and Exchange
Commission, the Federal Trade Commission, the NASDAQ or the NYSE (including
securities laws, and relevant regulations, guidelines, orders or directives
of
any such governing authority), including in its publicly-filed financial
statements, reports or other filings, pursuant to applicable laws, regulations
and stock market or stock exchange rules (e.g.,
the
U.S. Securities and Exchange Commission, NASDAQ, NYSE, or any other stock market
or stock exchange on which securities or debt instruments issued by WYETH or
NEUROGEN may be issued or traded); provided,
to the
extent reasonably practicable, such Party shall provide the other Party with
a
copy of the proposed text of such statements or disclosure (including any
exhibits containing this Agreement) sufficiently in advance of the scheduled
release or publication thereof to afford such other Party a reasonable
opportunity to review and comment upon the proposed text (including redacted
versions of this Agreement), (b) either Party shall have the further right
to
disclose the material financial terms of this Agreement under a confidentiality
agreement consistent with the terms set forth in this Article to any bona fide
potential acquirer, merger partner, potential providers of financing and their
advisors, or for similar purposes, and (c) NEUROGEN shall have the further
right
to disclose Information regarding events relating to matters covered by the
terms of this Agreement to the extent NEUROGEN reasonably believes such
disclosure is (i) significant to its investors, prospective investors or
otherwise consistent with the types of releases generally made regarding similar
programs by biotech or pharmaceutical companies, or (ii) required by, or is
necessary to be consistent with the disclosure requirements of any applicable
laws, regulations or stock market or stock exchange rules (including securities
laws, and relevant regulations, guidelines, orders or directives of any such
governing authority). NEUROGEN shall use good faith efforts to have any
disclosure made relating to the filing of this Agreement, including the terms
of
this Agreement, treated as confidential by the U.S. Securities and Exchange
Commission, NASDAQ, NYSE, or any other stock market or stock exchange on which
securities issued by NEUROGEN may be issued.
ARTICLE
VI PAYMENTS
AND ROYALTIES
8
6.1 License
Fee. On
the
Effective Date, NEUROGEN shall pay WYETH a non-refundable payment of Three
Million Dollars ($3,000,000) payable by wire transfer of immediately available
funds to an account designated in writing by WYETH.
6.2 Milestone
Payments.
Subject
to the terms and conditions of this Agreement, within thirty (30) days after
the
first occurrence of each of the following events, NEUROGEN shall
make each of the following one-time non-refundable and non-creditable payments
to WYETH:
|
Milestone
|
Payment
|
||
|
Initiation
of First Phase II Clinical Trial of Compound
|
$[***]
|
||
|
Initiation
of First Phase III Clinical Trial of Compound
|
$[***]
|
||
|
First
NDA Filing in the US for Compound
|
$[***]
|
||
|
First
EMEA Filing for Compound:
|
$[***],
or if
|
||
|
filed
for individual or less
than
all member countries,
$[***]
for each of
United
Kingdom,
Germany,
France, Italy
|
|||
|
First
NDA Approval in US of Compound:
|
$[***]
|
||
|
First
NDA Approval in Europe of Compound:
|
$[***],
or if
|
||
|
approved
for individual or
less
than all member
countries,
$[***]
for
each
of United Kingdom,
Germany,
France, Italy
|
|||
Thereafter,
no additional milestone payments would be due or payable by NEUROGEN to
WYETH.
6.3 Annual
Maintenance Fee.
NEUROGEN
shall pay to WYETH an annual maintenance fee of two
hundred fifty thousand dollars ($250,000) per year on each annual anniversary
of
the Effective Date of the Agreement until a NDA Approval of a Product in one
of
the following countries: United States, United Kingdom, France, Germany, Italy
or Japan.
6.4 Royalties
Payable by NEUROGEN.
(a)
NEUROGEN
shall pay to WYETH royalties based on annual Net Sales by NEUROGEN, its
Affiliates and Sublicensees of Products in the Territory as follows (the
“Royalties”):
[***]
Confidential
treatment requested by Neurogen Corporation.
9
|
On
that Portion of
Annual
Net Sales in the Territory:
|
Marginal
Royalty Rate
(%
of Annual Net Sales)
|
|
|
Less
than $150 million
|
[***]%
|
|
|
Over
$150 million to $300 million
|
[***]%
|
|
|
Over
$300 million to $900 million
|
[***]%
|
|
|
Over
$900 million to $1.5 billion
|
[***]%
|
|
|
Over
$1.5 billion
|
[***]%
|
|
For
the
avoidance of doubt, the marginal royalty rates set forth above shall apply
only
to that portion of Net Sales within the applicable tier of Net
Sales.
(b) Royalties
shall be payable on a country-by-country and Product-by-Product basis, for
the
“Royalty Term”, which shall be the longer of (i) ten (10) years after the date
of First Commercial Sale of such Product in such country, and (ii) expiration
of
the last to expire claim of the Valid Claims in such country. At the end of
the
Royalty Term, Neurogen would have an exclusive fully paid-up, royalty free,
exclusive perpetual license for such Product in such country.
6.5 Royalty
Reports.
Royalty
payments shall be paid after the First Commercial Sale of a Product for each
calendar quarter within forty five (45) days after the end of the calendar
quarter. In addition, on such dates NEUROGEN, or a Third Party on behalf of
NEUROGEN, shall provide a written report with respect to the preceding quarter
(the “Payment
Report”)
stating: (a) the total gross sales and the total deductions used in arriving
at
Net Sales of the Product sold by NEUROGEN, its Affiliates and Sublicensees,
during such quarter on a country-by-country basis; (b) the date of any First
Commercial Sale of the Product in each country during such quarter, and (c)
a
calculation of the Royalties due to WYETH.
6.6 Audits.
(a)
Upon the
written request of WYETH and not more than once per year, NEUROGEN shall permit
an independent certified public accounting firm of nationally recognized
standing selected by WYETH and reasonably acceptable to NEUROGEN, at WYETH’s
expense, to have access during normal business hours to such of the records
of
NEUROGEN as may be reasonably necessary to verify the accuracy of the Payment
Reports hereunder for any year ending not more than thirty-six (36) months
prior
to the date of such request,
including currency exchange rates. The accounting firm shall disclose to
NEUROGEN and WYETH the details of the audit and the specific amount of any
discrepancies found.
(b)
If such
accounting firm correctly identifies a discrepancy during such period, NEUROGEN
shall issue to WYETH an objection to the auditor’s findings, or a payment or an
invoice to correct such discrepancy within sixty (60) days of the date of such
accounting firm’s written report. Any objections to the auditor’s findings shall
be resolved through the dispute resolution procedures set forth in Section
12.8.
The fees charged by such an accounting firm shall be reimbursed by NEUROGEN
if
the Royalty payments made were at least ten percent (10%) different than the
amount that should have been paid during the period in question.
(c)
Upon the
expiration of thirty-six (36) months following the end of any year for which
WYETH has not contested, pursuant to this Section 6.6, the amount of Royalties
due WYETH, then calculation of Royalties payable with respect to such year
shall
be binding and conclusive upon WYETH, and NEUROGEN, its Affiliates and its
Sublicensees shall be released from any liability or accountability with respect
to Royalties for such year.
[***]
Confidential
treatment requested by Neurogen Corporation.
10
(d)
WYETH
shall treat all Information subject to review under this Section 6.6 in
accordance with the confidentiality and non-use provisions of Article V of
this
Agreement, and shall cause its accounting firm to enter into an acceptable
confidentiality agreement with NEUROGEN (and its applicable Affiliates and
Sublicensees) obligating such firm to retain all such Information in confidence
pursuant to such confidentiality agreement.
6.7 Payment
Exchange Rate. All
payments to be made by NEUROGEN to WYETH under this Agreement shall be made
in
United States dollars and may be paid by bank wire transfer in immediately
available funds to such bank account in the United States designated in writing
by WYETH from time to time. In the case of sales invoiced in currencies other
than United States dollars, the exchange conversions of such sales into United
States dollars shall be made based on the daily average as published in The
Wall
Street Journal (or such other publication as the Parties may mutually agree
upon
from time to time) for the last month of the quarter preceding such
payment.
6.8
Income Tax Withholding.
If
laws, rules or regulations require withholding of income taxes or other taxes
imposed upon payments set forth in this Article VI, NEUROGEN shall make such
withholding payments as required and subtract such withholding payments from
the
payments set forth in this Article VI. NEUROGEN shall submit appropriate proof
of payment of the withholding taxes to WYETH within a reasonable period of
time.
|
ARTICLE
VII
|
[***]
|
||
|
7.1
|
[***]
|
||
|
7.2
|
[***]
|
||
ARTICLE
VIII REPRESENTATIONS
AND WARRANTIES
8.1
Mutual Representations and Warranties of WYETH and
NEUROGEN.
Each of
WYETH and NEUROGEN hereby represents and warrants to the other Party as of
the
Effective Date as follows:
(a) It
is
duly organized, validly existing and in good standing under the laws of the
jurisdiction of incorporation. It has the requisite legal and company power
and
authority to conduct its business as presently being conducted and as proposed
to be conducted by it and is duly qualified to do business in those
jurisdictions where its ownership of property or the conduct of its business
requires.
(b) It
has
all requisite legal and company power and authority to enter into this Agreement
and to perform its obligations hereunder. All company actions on its part,
its
boards of directors or managers, or similar governing body and its equity
holders necessary for (i) the authorization, execution, delivery and performance
by it of this Agreement, and (ii) the consummation of the transactions
contemplated hereby, have been duly taken.
(c) This
Agreement is a legally valid and binding obligation of it, enforceable against
it in accordance with its terms (except in all cases as such enforceability
may
be limited by applicable bankruptcy, insolvency, reorganization, moratorium,
or
similar laws affecting the enforcement of creditors’ rights generally and except
that the availability of the equitable remedy of specific performance or
injunctive relief is subject to the discretion of the court or other tribunal
before which any proceeding may be brought).
8.2 WYETH
Representations and Warranties.
WYETH
represents and warrants to NEUROGEN that as of the Effective Date:
[***]
Confidential
treatment requested by Neurogen Corporation.
11
(a) To
the
knowledge of WYETH, there are no existing or threatened Third Party actions,
suits or other proceedings pending against it with respect to the Licensed
Patent Rights, Licensed Know-How or Aplindore Licensed Know-How;
(b) To
the
knowledge of WYETH, the issued Patents on Schedule 1.19 are not invalid;
(c) WYETH
has
the right to grant the licenses to the extent set forth in this Agreement;
(d) Subject
to Section 5.3, WYETH and its Affiliates will take reasonable measures to
protect the confidentiality of the Aplindore Licensed Know-How during the term
of this Agreement; and
(e)
WYETH
and its Affiliates are not developing, manufacturing or commercializing, alone
or with any Third Party, any dopamine modulator for Xxxxxxxxx’x Disease or
Restless Leg Syndrome.
8.3 HSR
Act.
NEUROGEN represents and warrants to WYETH that as of the Effective Date,
NEUROGEN has determined in good faith that a filing under the HSR Act is not
required in connection with the transactions contemplated hereby.
8.4 Disclaimer
of Warranties.
EXCEPT
AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT OR MANDATED BY APPLICABLE
LAW
(WITHOUT THE RIGHT TO WAIVE OR DISCLAIM), NEITHER PARTY MAKES ANY REPRESENTATION
OR WARRANTY WITH RESPECT TO ANY COMPOUND, PRODUCT, ANY KNOW-HOW, GOODS,
SERVICES, RIGHTS, OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS
ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED
WARRANTIES OF NONINFRINGEMENT, PERFORMANCE, MERCHANTABILITY, OR FITNESS FOR
A
PARTICULAR PURPOSE.
ARTICLE
IX
INTELLECTUAL PROPERTY
9.1 Filing,
Prosecution and Maintenance of Patents.
(a) Except
as
set forth in (b) and (c) below, WYETH shall be responsible and bear the costs to
file, prosecute and maintain (including filing and/or defending interferences,
oppositions, reexaminations and reissues) in the Territory, the Licensed Patent
Rights. In the event WYETH elects not to prosecute or maintain any of the
Licensed Patent Rights, WYETH shall grant NEUROGEN the timely opportunity to
prosecute and maintain such Licensed Patent Rights at NEUROGEN’s expense. Each
Party shall keep the other advised of the status of the Licensed Patent Right
filings for which it receives notice and upon the request of the other Party,
provide copies of any papers related to the filing, prosecution and maintenance
of such filings. Each Party shall cooperate fully and shall cause its employees
to cooperate fully, on the filing and prosecution of such Licensed Patent
Rights. Each Party shall promptly give notice to the other of the grant, lapse,
revocation, surrender, invalidation or abandonment of any Licensed Patent Rights
in the Field for which the Party receives notice.
(b) As
of the
Effective Date, NEUROGEN shall have the first right, and shall bear the costs,
to file Patents in Europe including any continuation or divisional of any prior
Licensed Patent Right and WYETH shall provide reasonable assistance as may
be
requested by NEUROGEN to complete such filings and prosecution for Licensed
Patent Rights, at NEUROGEN’s expense. NEUROGEN shall provide to WYETH copies of
all communications sent to and received from any patent office pertaining to
Licensed Patent Rights being prosecuted under this Section 9.1(b) by NEUROGEN
including, but not limited to, draft patent applications, filing receipts,
office actions, responses and/or amendments, and notices of allowance. WYETH
shall be given reasonable opportunity prior to the earlier of the expiration
of
any shortened statutory period for response or anticipated filing to review
and
comment upon the text of any such communication. In the event that the Parties,
after good faith discussions, cannot agree with respect to any decision to
be
made with respect to the preparation, filing, prosecution and maintenance of
the
Licensed Patent Rights being prosecuted by NEUROGEN under this Section 9.1(b)
(including decisions relating to interference, opposition,
12
revocation,
reexamination and similar proceedings related to the Licensed Patent Rights),
NEUROGEN shall make such decision, provided that such decision shall not
have a
material adverse effect on the scope and/or validity of the Licensed Patent
Rights. In the event NEUROGEN elects not to prosecute or maintain any of
the
Licensed Patent Rights it files and prosecutes under this Section 9.1(b),
NEUROGEN shall xxxxx XXXXX the timely opportunity to prosecute and maintain
such
Licensed Patent Rights at WYETH’s expense.
(c) As
of the
Effective Date, NEUROGEN shall have the first right, and shall bear the costs,
to file Patents for additional formulations of Compound or Product including
sustained release formulations including any continuation or divisional of
any
prior Licensed Patent Right, and WYETH shall provide reasonable assistance
as
may be requested by NEUROGEN to complete such filings and prosecution for
Licensed Patent Rights, at NEUROGEN’s expense. NEUROGEN shall provide to WYETH
copies of all communications sent to and received from any patent office
pertaining to Licensed Patent Rights being prosecuted under this Section 9.1(c)
by NEUROGEN including, but not limited to, draft patent applications, filing
receipts, office actions, responses and/or amendments, and notices of allowance.
WYETH shall be given reasonable opportunity prior to the earlier of the
expiration of any shortened statutory period for response or anticipated filing
to review and comment upon the text of any such communication. In the event
that
the Parties, after good faith discussions, cannot agree with respect to any
decision to be made with respect to the preparation, filing, prosecution and
maintenance of the Licensed Patent Rights being prosecuted by NEUROGEN under
this Section 9.1(c) (including decisions relating to interference, opposition,
revocation, reexamination and similar proceedings related to the Licensed Patent
Rights), NEUROGEN shall make such decision, provided that such decision shall
not have a material adverse effect on the scope and/or validity of the Licensed
Patent Rights. In the event NEUROGEN elects not to prosecute or maintain any
of
the Patents it files and prosecutes under this Section 9.1(c), NEUROGEN shall
xxxxx XXXXX the timely opportunity to prosecute and maintain such Licensed
Patent Rights at WYETH’s expense
9.2 Enforcement
and Defense.
(a) If
either
Party learns of any infringement of Licensed Patent Rights, such Party shall
promptly notify the other Party of such infringement. NEUROGEN (or its
Sublicensee) shall have the first right to initiate and prosecute any legal
action for infringement of Licensed Patent Rights at its own expense and in
the
name of NEUROGEN (and, if appropriate, WYETH), or to control the defense of
any
declaratory judgment action relating to Licensed Patent Rights. NEUROGEN shall
inform WYETH if it elects not to exercise such first right within 180 days,
and
WYETH thereafter shall have the right either to initiate and prosecute such
action or to control the defense of such declaratory judgment action at its
own
expense in the name of WYETH and, if necessary, in the name of NEUROGEN. Each
Party shall be entitled to be represented by counsel of its own choice at its
own expense.
(b) For
any
such action, if either Party is unable to initiate or prosecute such action
solely in its own name or if desired to obtain a more effective remedy, the
other Party will join such action voluntarily and will execute all documents
necessary to initiate litigation to prosecute and maintain such action with
the
other Party’s expenses paid for by the Party bringing such action. In connection
with any such action, WYETH and NEUROGEN will cooperate fully and will provide
each other with any information or assistance that either reasonably requests.
Each Party shall keep the other informed of developments in any
such action
or
proceeding, including, to the extent permissible by law, the consultation and
approval of any offer related thereto.
(c) Any
recovery obtained by either or both WYETH and NEUROGEN in connection with or
as
a result of any action contemplated by this Section, whether by settlement
or
otherwise, shall be used to first reimburse the Party bringing such action
for
its reasonable attorney’s fees and other expenses in making such recovery.
Any
amount that remains after reimbursement of the Party bringing such
action (“Remaining
Proceeds”)
shall
be used to reimburse the other Party for its reasonable expenses not previously
reimbursed and incurred as a necessary cost in support of the legal proceedings,
if any. Finally, the Remaining Proceeds, if any, after reimbursement of the
expenses described above shall: (i) if NEUROGEN has brought the action NEUROGEN
shall retain 100% of the Remaining Proceeds but the Remaining Proceeds shall
be
treated as Net Sales subject to the payment of royalty to WYETH, and (ii) if
WYETH has brought the action, WYETH shall retain 100% of the Remaining
Proceeds.
13
(d) Each
Party shall inform the other Party of any certification regarding any Patents
comprising any of the Licensed Patents Rights it has received pursuant to either
21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions
or any similar provisions in a country in the Territory other than the United
States. WYETH shall provide to NEUROGEN a copy of such certification within
five
(5) days of receipt by WYETH. NEUROGEN’s and WYETH’s rights with respect to the
initiation and prosecution of any legal action as a result of such certification
or any recovery obtained as a result of such legal action shall be as defined
for Patents above; provided, that NEUROGEN shall determine whether to exercise
its first right to initiate and prosecute any action regarding applicable
Patents and shall inform WYETH of such decision within ten (10) days of
NEUROGEN’s receipt of the certification, after which time WYETH shall have the
right to initiate and prosecute such action.
9.3
Patent Term Extensions.
NEUROGEN
shall have the first right, and shall bear the costs, to file for or otherwise
pursue the issuance of each Patent term extension, adjustment or restoration,
or
supplementary protection certificate or their equivalents (together with Patent
term extensions, adjustments and restorations, “Patent
Term Extensions”)
for
Patents comprising the Licensed Patent Rights. NEUROGEN shall provide notice
to
WYETH of each such Patent Term Extension obtained giving the date of issue
and
patent number for each such Patent. WYETH shall not seek or request
any Patent Term Extensions on Licensed Patent Rights without the prior written
consent of NEUROGEN. WYETH shall execute such authorizations and other documents
and take such other actions as may be reasonably requested by NEUROGEN to obtain
such Patent Term Extensions, including designation as its agent for such purpose
as provided in 35 U.S.C. Section 156. The Parties shall cooperate with each
other in gaining Patent Term Extensions wherever applicable to such Patents
within the scope of this Agreement.
9.4 Trademark.
Any
trademark or tradename for any Product or Compound shall be selected and owned
by NEUROGEN in the Territory, provided however, that if WYETH and NEUROGEN
should enter into an agreement pursuant to WYETH’s right of exclusive
negotiation described above in Article VII, pursuant to which WYETH and NEUROGEN
co-develop and co-promote a Product, the relevant trademarks would have to
be
reasonably mutually acceptable to the Parties; and if WYETH and NEUROGEN enter
into an agreement
9.5 pursuant
to WYETH’s right of exclusive negotiation described above, pursuant to which
WYETH obtains exclusive rights to commercialize a Product, the relevant
trademarks would be selected and owned by WYETH.
ARTICLE
X TERM
AND TERMINATION
10.1 Term
and Expiration.
This
Agreement shall be effective as of the Effective Date and, unless earlier
terminated pursuant to the provisions of this Article 10, shall continue in
full
force and effect until the expiration of all Royalty Terms. Upon the expiration
of the Royalty Term for a Product in a country, WYETH’s licenses granted to
NEUROGEN herein for that Product in that country shall become fully paid-up,
royalty-free, exclusive perpetual licenses as provided in Section 6.4(b).
10.2 Termination.
(a)
NEUROGEN
shall be entitled to terminate the Agreement, at will, upon ninety (90) days
written notice to WYETH.
(b)
WYETH
shall be entitled to terminate the Agreement, in whole or in part, on a
Product-by-Product or Product formulation-by-Product formulation basis, or
with
respect to the entire license granted in the Territory or on a
country-by-country basis, on sixty (60) days prior written notice, for any
uncured material breach by NEUROGEN or its Sublicensees, provided,
however;
(i) such
notice shall not be effective if NEUROGEN cures any such existing breach within
sixty (60) days after receiving notice of such breach from WYETH; (ii) such
notice shall not be effective if NEUROGEN has commenced and continues diligent
efforts to cure such breach but more time is reasonably necessary for the cure,
then for such longer reasonable period of time until the completion of the
cure
of the breach but not to exceed a maximum of one hundred eighty (180 ) days;
(iii) any such
termination pursuant to this subsection (b) shall be applicable only to the
country, Product and/or formulation that is the subject of the breach; and
(iv)
WYETH’s sole remedy for a breach of NEUROGEN’s obligation to use Commercially
Reasonable Efforts to market Products in a specific country or region shall
be a
termination of the license in such specific country or region.
14
(c)
If the
Agreement is terminated at will by NEUROGEN or terminated by WYETH (in all
or
part) due to an uncured material breach by NEUROGEN, all rights granted by
WYETH
to NEUROGEN, in the terminated country and for the terminated Product or
terminated formulation would revert to WYETH, and upon WYETH’s written request,
NEUROGEN would (i) xxxxx XXXXX a royalty-free exclusive license to NEUROGEN
know-how and patents and trademarks to the extent the know-how, patents and
trademarks relate exclusively to the Compound, terminated Product or the
terminated formulation of Product in the terminated country, including the
transfer of all data, documentation, regulatory filings and registrations,
and
full rights therein, free of cost to WYETH; and (ii) to sublicense or assign
any
terminated Product-related Third Party agreements to WYETH. In the event
NEUROGEN elects not to prosecute or maintain any of the NEUROGEN patents and
trademarks pertaining to the Compound, terminated Product or the terminated
formulation of Product, NEUROGEN shall xxxxx XXXXX the timely opportunity to
prosecute and maintain such patents and trademarks at WYETH’s
expense
(d) Notwithstanding
anything to the contrary in this Article 10, if any license granted to NEUROGEN
under this Agreement is terminated, any sublicense under such license granted
prior to termination of said license shall remain in full force and effect,
provided
that:
(i) the
Sublicensee is not then in breach of its sublicense agreement; (ii) the
Sublicensee agrees to be bound to WYETH as the licensor under the terms and
conditions of the applicable sublicense agreement, as modified by the provisions
of this Section 10.2(d);
(iii)
the Sublicensee, at WYETH’s written request, assumes in a signed writing, the
same obligations to WYETH as those assumed by NEUROGEN under the terms of
this
Agreement; and (iv) WYETH shall have the right to receive any payments payable
to NEUROGEN under such sublicense agreement to the extent they are reasonably
and equitably attributable to such Sublicensee’s rights under such sublicense to
use and exploit Licensed Patent Rights and Licensed Know-How.
10.3 Effect
of Expiration or Termination.
Expiration or termination of this Agreement shall not relieve the Parties of
any
obligations accruing prior to such expiration or termination, including payment
obligations. Except as otherwise specifically provided above, all of the
Parties’ rights and obligations under the provisions of Section 2.2, Article V,
Section 6.4 (b) and Article XI shall survive the termination or expiration
of
the Agreement.
10.4 Remedies.
In the
event of any breach of any provision of this Agreement, in addition to the
termination rights set forth herein, unless otherwise set forth herein each
Party shall have all other rights and remedies at law or in equity to enforce
this Agreement.
10.5 [****]
ARTICLE
XI INDEMNIFICATION
11.1 Mutual
Indemnification.
Each
Party shall defend, indemnify and hold the other Party and its Affiliates,
and
their respective directors, officers, employees and agents, harmless from
and
against any and all liabilities, losses, damages, settlements, claims, actions,
suits, penalties, fines, costs or expenses (including reasonable attorneys’ fees
and other expenses of litigation actually incurred) arising out of any claim,
lawsuit, demand, assessment, proceeding or action (“Claim”)
brought by a Third Party (any of the foregoing, a “Loss”)
arising out of or resulting from:
(a)
the
gross negligence, recklessness or intentional acts or omissions of the
indemnifying Party and its Affiliates, and their respective directors, officers,
employees and agents with respect to this Agreement and the transactions
contemplated hereby;
(b)
any
breach of any representation or warranty made by the indemnifying Party
hereunder; and
(c) Any
breach or violation of any covenant in or pursuant to this
Agreement.
(a) NEUROGEN
shall indemnify and hold harmless WYETH and its Affiliates and their respective
directors, officers, employees and agents, from, against and in respect of
any
and all liabilities, losses, damages, settlements, claims, actions, suits,
penalties, fees, costs or expenses (including reasonable attorney’s fees and
other expenses of litigation actually incurred) involving a Third Party products
liability claim or action directly or indirectly relating to development
performed by or on behalf of NEUROGEN, commercialization, manufacturing,
use,
offer for sale or sale of any Compound or Product in the Territory.
(b) WYETH
shall indemnify and hold harmless NEUROGEN and its Affiliates and their
respective directors, officers, employees and agents, from, against and in
respect of any and all liabilities, losses, damages, settlements, claims,
actions, suits, penalties, fees, costs or expenses (including reasonable
attorney’s fees and other expenses of litigation actually incurred) involving a
Third Party products liability claim or action directly or indirectly relating
to development, clinical trials or other work performed by or on behalf of
WYETH
of any Compound or Product in the Territory prior to the Effective Date.
11.3 [****]
11.4 Notice
of Claim.
Upon
receipt of notice of any Claim which may give rise to a right of indemnity
from
the other Party hereto, the Party seeking indemnification (the “Indemnified
Party”)
shall
give written notice thereof to the other Party (the “Indemnifying
Party”)
with a
Claim for indemnity. Such Claim for indemnity shall indicate the nature of
the
Claim and the basis therefor. Promptly after a claim is made for which the
Indemnified Party seeks indemnity, the Indemnified Party shall permit the
Indemnifying Party, at its option and expense, to assume the complete defense
of
such Claim, provided that (i) the Indemnified Party will have the right to
participate in the defense of any such Claim at its own cost and expense,
(ii)
the Indemnifying Party will conduct the defense of any such Claim with due
regard for the business interests and potential related liabilities of the
Indemnified Party, and (iii) the Indemnifying Party will not agree to any
settlement that would admit liability on the part of the Indemnified Party
or
involve relief other than payment of money, without the approval of the
Indemnified Party, such consent not to be unreasonably withheld; and provided,
further, that if it is reasonably likely that the Parties may have conflicting
interests or if it is otherwise not advisable under applicable legal and
ethical
requirements for the Indemnifying Party’s defense counsel to represent both
Parties, separate independent counsel shall be retained for each Party at
the
Indemnifying Party’s expense. The Indemnified Party shall have the right, at its
election, to release and hold harmless the Indemnifying Party from its
obligations hereunder with respect to such Claim and assume the complete
defense
of the same in return for payment by the Indemnifying Party to the Indemnified
Party of the amount of the Indemnifying Party’s settlement offer. The
Indemnifying Party will not, in defense of any such Claim, except with the
consent of the Indemnified Party, consent to the entry of any judgment or
enter
into any settlement which does not include, as an unconditional term thereof,
the giving by the claimant or plaintiff to the Indemnified Party of a release
from all liability in respect thereof. After notice to the Indemnified Party
of
the Indemnifying Party’s election to assume the defense of such Claim, the
Indemnifying Party shall be liable to the Indemnified Party for such legal
or
other expenses subsequently incurred by the Indemnified Party in connection
with
the defense thereof at the request of the Indemnifying Party. As to those
Claims
with respect to which the Indemnifying Party does not elect to assume control
of
the defense, the Indemnified Party will afford the Indemnifying Party an
opportunity to participate in such defense at the Indemnifying Party’s own cost
and expense, and will not settle or otherwise dispose of any of the same
without
the consent of the Indemnifying Party, such consent not to be unreasonably
withheld.
ARTICLE
XII
ADDITIONAL TERMS
12.1 Consequential
Damages.
IN NO
EVENT SHALL EITHER PARTY OR THEIR AFFILIATES BE LIABLE FOR SPECIAL, PUNITIVE,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT
OR ANY OTHER LEGAL THEORY AND IRRESPECTIVE OF WHETHER SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF ANY SUCH LOSS OR DAMAGE; PROVIDED, THAT THIS
LIMITATION SHALL NOT LIMIT THE INDEMNIFICATION OBLIGATION OF SUCH PARTY UNDER
THE PROVISIONS OF ARTICLE XI FOR SUCH DAMAGES CLAIMED BY A THIRD
PARTY.
(a)
Except
as provided in this Section, neither Party shall have the right to assign or
otherwise transfer this Agreement, nor any of its rights hereunder, nor delegate
any of its obligations hereunder, without the prior written consent of the
other
Party which consent shall not be unreasonably withheld.
(b)
Either
Party may assign this Agreement and its rights and obligations hereunder to
one
or more of its Affiliates, or to a Third Party in connection with a sale of
all
or substantially all of the Party’s assets, voting stock or securities or
business relating to this Agreement or a merger, reorganization or
consolidation; provided, that the provisions of Section 10.5 shall apply to
such
an assignment by Wyeth to a Third Party that controls rights to a dopamine
agonist in a Phase III clinical trial or a similar or subsequent stage of
development or commercialization.
(c)
This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and each of their successors and permitted assigns. Any attempted or purported
assignment in violation of this Section 12.2 shall be void.
12.3 Force
Majeure.
Neither
Party shall be held liable or responsible to the other Party nor be deemed
to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement when such failure or delay
is caused by or results from causes beyond the reasonable control of the
affected Party including fire, floods, mudslides, earthquakes, embargoes, war,
acts of war (whether war be declared or not), insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or the other Party,
or any other events or circumstances beyond the reasonable control of the Party
claiming force majeure.
The affected Party shall notify the other Party of such force majeure
circumstances as soon as reasonably practicable, and shall promptly undertake
all reasonable efforts necessary to cure such force majeure
circumstances.
12.4 Severability.
If one
or more of the provisions contained in this Agreement are held invalid, illegal
or unenforceable in any respect, the validity, legality and enforceability
of
the remaining provisions shall not be affected or impaired, unless the absence
of the invalidated provision(s) adversely affects the substantive rights of
the
Parties. The Parties shall in such case use their best efforts to replace the
invalid, illegal or unenforceable provision(s) with valid, legal and enforceable
provision(s) which, insofar as practical, implement the purposes of this
Agreement.
12.5 Publicity/Use
of Names.
Neither
Party may use the names of the other Party or those of its Affiliates,
Sublicensees, employees, agents or consultants or any of their trademarks,
trade
names, logos or symbols without the prior written consent of the other Party.
12.6 Notices.
All
notices or other communications which are required or permitted hereunder shall
be in writing and sufficient if delivered personally, sent by telecopier (and
promptly confirmed by personal delivery, registered or certified mail or
overnight courier), sent by nationally recognized overnight courier or sent
by
registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:
if
to
NEUROGEN:
at
the
address set out for NEUROGEN on page 1
Attn:
President, Chief Executive Officer
Facsimile
No.:
203-483-8651
with
copy
to: Legal
Department
Facsimile
No: 000-000-0000
17
if
to WYETH:
000
Xxxxxx Xxxx
Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000
Attn:
Senior Vice President, Corporate Development
Facsimile
No.: 000-000-0000
Wyeth
0
Xxxxxxx
Xxxxx
Xxxxxxx,
Xxx Xxxxxx 00000
Attn:
General Counsel
with
copy
to:
Facsimile
No: (000) 000-0000
or
to
such other address as the Party to whom notice is to be given may have furnished
to the other
Party in writing in accordance herewith. Any such communication shall be deemed
to have been given when delivered if personally delivered or sent by telecopier
on a business day, on the business day after dispatch if sent by nationally
recognized overnight courier and on the fifth business day following the date
of
mailing if sent by mail.
12.7 Applicable
Law and Jurisdiction.
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of Delaware without reference to any rules of conflict of laws that would
require the application of the laws of a different jurisdiction. The Parties
irrevocably submit to the jurisdiction of any Delaware State or Federal Court
sitting in the State of Delaware over any suit, action or proceeding arising
out
of or relating to this Agreement that are not otherwise covered by Section
12.8.
The Parties waive any objection which they may now or hereafter have to the
venue of any such suit, action or proceeding brought in such court and any
claim
that any such suit, action or proceeding brought in such a court has been
brought in an inconvenient forum. The Parties agree that a final judgment in
any
such suit, action, or proceeding brought in such a court shall be conclusive
and
binding on the Parties, and may be enforced in any court of the jurisdiction
of
which any Party is or may be subject by a suit upon such judgment; provided
that
service of process is effected upon the Party as permitted by applicable law.
12.8 Dispute
Resolution.
(a)
The
Parties recognize that a bona fide dispute as to certain matters may from time
to time arise during the term of this Agreement that relate to a party’s rights
or obligations hereunder. In the event of the occurrence of any dispute arising
out of or relating to this Agreement, either party may, by written notice to
the
other, have such dispute referred to its respective officer designated below
or
their successors, for attempted resolution by good faith negotiations within
thirty (30) days after such notice is received. Said designated officers are
as
follows:
For
NEUROGEN: Chief Executive Officer or Executive Vice President
For
WYETH: Senior Vice President, Wyeth Pharmaceuticals
(b)
If they
are unable to resolve the dispute by executive mediation within such sixty
(60)
day period, then WYETH or NEUROGEN, as the case may be, may pursue whatever
measures legally available to resolve the dispute.
18
(c) The
executive mediation process described above in (a) and (b) shall toll any
applicable statute of limitation that would expire during the mediation process
for any claim. The executive mediation process described above in (a) and (b)
shall not apply in the event either Party seeks immediate injunctive or other
emergency relief.
12.9 Entire
Agreement.
This
Agreement contains the entire understanding of the Parties with respect to
the
subject matter hereof. All express or implied agreements and understandings,
either oral or written, heretofore made relating to the subject matter hereof
are expressly superceded. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by both Parties.
12.10 Headings.
The
captions to the Articles, Sections and Subsections of this Agreement are
not a
part of the Agreement, but are merely guides or labels to assist in locating
and
reading the Articles, Sections and Subsections.
12.11 Independent
Contractors.
NEUROGEN
and WYETH shall be independent contractors and the relationship between them
shall not constitute a partnership, joint venture or agency. Neither Party
shall
have the authority to make any statements, representations or commitments of
any
kind, or to take any action, which shall be binding on the other, without the
prior written consent of the other Party.
12.12 Waiver.
The
waiver by a Party of any right under this Agreement or of the other Party’s
failure to perform or breach shall not be a waiver of any other right, failure
or breach whether of a similar nature or otherwise.
12.13 Counterparts.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
[Remainder
of page intentionally left blank - signature pages to
follow]
19
IN
WITNESS WHEREOF,
the
Parties have executed this Agreement as of its Effective Date.
|
WYETH,
acting through its
WYETH
PHARMACEUTICALS DIVISION
|
NEUROGEN
CORPORATION
|
|||||
|
By:
|
/s/
Xxxxxx X. Xxxxx
|
By:
|
/s/
Xxxxxxx Xxxxxx
|
|||
|
Name:
|
Xxxxxx
X. Xxxxx
|
Name:
|
Xxxxxxx
Xxxxxx
|
|||
|
Title:
|
Vice
President
|
Title:
|
President
and CEO
|
|||
|
November
16, 2006
|
November
21, 2006
|
|||||
|
Date
|
Date
|
|||||
20
.
