AMENDED AND RESTATED
STRATEGIC ALLIANCE AGREEMENT
(Nicotinic Alpha-7
Program)
and Hoffmann-La Roche
Inc.
Memory Pharmaceuticals
Corp.
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Page
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DEFINITIONS
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1
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GRANTS
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8
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DILIGENCE
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10
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PAYMENTS TO
MEMORY
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13
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ROYALTIES
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13
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PAYMENT,
REPORTING, AUDITING
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18
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GOVERNANCE;
STRATEGIC ALLIANCE
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20
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INTENTIONALLY
OMITTED
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24
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CLINICAL
DEVELOPMENT AND REGULATORY MATTERS
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24
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MANUFACTURE AND
SUPPLY
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26
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COMMERCIALIZATION
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26
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TRADEMARKS
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26
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OWNERSHIP OF
INTELLECTUAL PROPERTY AND PATENT RIGHTS
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26
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REPRESENTATIONS
AND WARRANTIES
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33
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CONFIDENTIAL
INFORMATION
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35
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TERM AND
TERMINATION
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38
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ARBITRATION
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43
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MISCELLANEOUS
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43
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COMPOUND 3454
DATA AND REPORTS
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INTENTIONALLY
OMITTED
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[*] GUIDELINES FOR COMPOUNDS
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END OF PHASE I
CRITERIA
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WORKPLAN
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PAYMENTS WITH
RESPECT TO 3454 PRODUCTS
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PAYMENTS WITH
RESPECT TO MEMORY PRODUCTS
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PAYMENTS WITH
RESPECT TO COLLABORATION PRODUCTS
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ROYALTIES WITH
RESPECT TO 3454 PRODUCTS
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ROYALTIES WITH
RESPECT TO MEMORY PRODUCTS
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[*] CONFIDENTIAL TREATMENT
REQUESTED
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ROYALTIES WITH
RESPECT TO COLLABORATION PRODUCTS
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INTENTIONALLY
OMITTED
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MEMORY PATENT
RIGHTS
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MEMORY PATENT
RIGHTS PRIMARILY APPLICABLE TO MEMORY SCREENING
TECHNOLOGY
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HEADS OF
AGREEMENT FOR CO-PROMOTION OF 3454 PRODUCT
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INCLUDED ROCHE
COMPOUNDS
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[*] CONFIDENTIAL TREATMENT
REQUESTED
AMENDED AND RESTATED STRATEGIC
ALLIANCE AGREEMENT
This
AGREEMENT, having a date of February 27, 2006, is made by and
among, on the one hand, F. HOFFMANN-LA ROCHE LTD, a Swiss
corporation having its principal place of business at
Grenzacherstrasse 124, CH-4070, Basel, Switzerland and HOFFMANN-LA
ROCHE INC., a New Jersey corporation, having its principal place of
business at 340 Kingsland Street, Nutley, New Jersey 07110
(collectively “ Roche ”) and, on the other hand,
MEMORY PHARMACEUTICALS CORP., a Delaware corporation, having its
principal place of business at 100 Philips Parkway, Montvale, New
Jersey 07645 (“ Memory ”). This “
Agreement ” means this Amended and Restated Strategic
Alliance Agreement, as hereafter amended or otherwise
modified.
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1.
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Memory has a research and
development program relating to the neuronal nicotinic alpha-7
receptor (“ Memory’s Program ”), and owns
related intellectual property rights.
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2.
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Roche has a research and
development program relating to the neuronal nicotinic alpha-7
receptor, and owns related intellectual property rights (“
Roche’s Program ” and together with
Memory’s Program, the “ Program
”).
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3.
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Roche has expertise in the
research, development, manufacture and commercialization of
pharmaceutical products.
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4.
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Memory and Roche previously entered
into a Strategic Alliance Agreement dated August 19, 2003 with
respect to Memory’s Program (the “ Original
Strategic Alliance Agreement ”) and Memory and Roche
desire to amend and restate the Original Strategic Alliance
Agreement in its entirety.
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5.
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In consideration of the mutual
covenants and promises contained in this Agreement and other good
and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, Memory and Roche hereby amend and restate
the Original Strategic Alliance Agreement in its entirety and agree
as follows:
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As
used in this Agreement, the following terms, whether used in the
singular or plural, shall have the following meanings:
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1.1
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“ Affiliate ”
means (a) a business entity which owns, directly or
indirectly, at least fifty percent (50%) of the voting shares or
other means of control of a Party; or (b) a business entity in
which at least fifty percent (50%) of the voting shares or other
means of control are owned by a Party, either directly or
indirectly; or (c) a business entity, the majority ownership
of which is directly or indirectly common to the majority ownership
of a Party. Anything to the contrary in this paragraph
notwithstanding, [*] a Delaware corporation, shall not be
deemed an Affiliate of Roche unless Roche provides written notice
to Memory of its desire to include [*] as an Affiliate of
Roche. Notwithstanding
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[*] CONFIDENTIAL TREATMENT
REQUESTED
1
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the preceding provisions, once an
entity ceases to be an Affiliate, then such entity shall, without
any further action, cease to have any rights, including license and
sublicense rights, under this Agreement that it has by reason of
being an Affiliate.
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If [*] does not agree to be
bound by the terms and conditions of this Agreement, then
[*] shall have none of the rights and obligations of an
Affiliate of Roche under this Agreement, and [*] shall be
treated as a Third Party under this Agreement and, accordingly,
Roche may not grant a sublicense to [*] except as provided
in Section 2.4 hereof.
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1.2
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“ Agreement Term
” means the term of this Agreement, more fully described in
Section 16.2.
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1.3
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“ Bioequivalent
Product ” means, with respect to a given Product sold in
a given country of the Territory by Roche, its Affiliate or
sublicensee, a product sold by a Third Party in such country
containing the same or similar compound (or an acid, salt or ester
thereof) as such Product.
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1.4
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“ Change of Control
” means (i) the sale, lease, exchange, transfer or other
disposition (including, without limitation, by merger,
consolidation or otherwise) of assets constituting all or
substantially all of the assets of the company and its
subsidiaries, taken as a whole, to a person (or entity) or group of
persons (or entities) acting together, (ii) any merger,
consolidation or other business combination or refinancing or
recapitalization of the company as a result of which the voting
securities of the continuing or surviving entity issued in respect
of the company’s voting securities outstanding immediately
prior to the transaction represent less than [*] % of the
total issued and outstanding voting securities of the continuing or
surviving entity immediately following such transaction,
(iii) any transaction or series of transactions in or as a
result of which any “person” (as that term is defined
in Sections 3(a)(9) or 13(d) of the Securities Exchange Act of
1934, as amended (the “1934 Act”)) becomes the
“beneficial owner” (as that term is defined in
Rule 13d-3 under the 1934 Act), directly or indirectly, of
securities of the company representing [*] % or more of the
total voting power represented by the company’s then
outstanding voting securities, and (iv) whether by virtue of
an actual or threatened proxy contest (including a consent
solicitation) or any merger, reorganization, consolidation or
similar transaction persons who are directors of the company
immediately prior to such proxy contest or the execution of the
agreement pursuant to which such transaction is consummated (other
than a director whose initial assumption of office was in
connection with a prior actual or threatened proxy contest) cease
to constitute [*] of the Board of Directors of the company
or any successor entity immediately following such proxy contest or
the consummation of such transaction.
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1.5
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“ Collaboration
Compound ” means (a) a compound (or a prodrug or
metabolite thereof) other than a Memory Compound or Compound 3454,
which is: (i) a nicotinic alpha-7 agonist [*] that is
conceived, acquired or Controlled by either Party prior to the date
hereof and (ii) has previously been demonstrated by either Party to
have Threshold Activity prior to the Effective Date or during the
Extended Period [*] or (b) a compound (or a prodrug or
metabolite thereof), other than a Memory Compound or
Compound
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[*] CONFIDENTIAL TREATMENT
REQUESTED
2
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3454, which is: (i) a
nicotinic alpha-7 agonist [*] is conceived, acquired or
Controlled by either party after the date hereof and prior to the
end of the Extended Period and (ii) demonstrated by either Party to
have Threshold Activity prior to the end of the Extended
Period.
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1.6
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“ Collaboration Patent
Rights ” means all Patent Rights other than Memory Patent
Rights that Memory and/or Roche owns or Controls during the
Agreement Term that Cover any Collaboration Compound and/or
relating to any other invention conceived, acquired or Controlled
by either Party during the Extended Period.
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1.7
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“ Collaboration
Product ” means any pharmaceutical product that includes,
in whole or as a component, a Collaboration Compound as an active
ingredient thereof.
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1.8
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“ Combination Product
” means any product containing both a pharmaceutically active
agent which causes it to be considered a Product and one or more
other pharmaceutically active agents which are not
Products.
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1.9
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“ Composition of Matter
Claim ” means, for a given Product in a given country of
the Territory, a Valid Claim of a Memory Patent Right and/or a
Collaboration Patent Right that Covers the molecule per se of any
compound that is included in such Product, in whole or as a
component thereof, as an active ingredient of such
Product.
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1.10
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“ Compound ”
means any Memory Compound, Collaboration Compound or, from and
after the date that Roche obtains a License to Compound 3454
pursuant to Section 2.1 hereof, Compound 3454.
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1.11
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“ Compound 3454
” means the compound developed by Memory, designated as
“compound 3454” [*].
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1.12
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“ Control ”
(including the variations such as “Controls” or
“Controlled”) means with respect to a Party and as to
any material, data, information or intellectual property right,
that such Party owns, co-owns or has a license to such material,
data, information or intellectual property right and has the
ability to grant access a license, or a sublicense to such
material, data, information or intellectual property right to the
other Party and its Affiliates and Sublicensees for use or
application as provided herein, without violating an agreement
with, or infringing any rights of, a Third Party.
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1.13
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“ Cover ”
(including the variations such as “Covered”,
“Coverage” or “Covering”) shall mean that
the making, using, offering for sale, selling, importing or
exporting of a given product would infringe a claim of a Patent
Right in the absence of a License under such Patent Right. The
determination of whether a product is Covered by a particular
Patent Right shall be made on a country-by-country
basis.
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1.14
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“ Effective Date
” means the date that all conditions subsequent under
Section 16.1 have occurred provided that if Section 16.1
is inapplicable, Effective Date means the date on which this
Agreement was last executed by Memory or Roche.
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1.15
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“ End of Phase I
” means the date that all Phase I clinical trials have been
completed.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
3
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1.16
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“ End of Phase IIa
” means the date that all Phase IIa clinical trials have been
completed.
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1.17
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“ Europe ” means
the United Kingdom, Germany, Italy, France and Spain.
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1.18
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“ Event ” means
any of the events listed in Section 5.9 hereof and Exhibits B
through G hereto with respect to which payments are required to be
made by Roche to Memory as provided therein.
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1.19
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“ Extended Period
” means the period commencing on the Effective Date and
ending on the later of (a) the date that is six
(6) months after the end of the Strategic Alliance Term and
(b) March 31, 2008.
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1.20
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“ Field ” means
prophylaxis and treatment of diseases, in all indications, for
either human or veterinary use.
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1.21
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“ FTE ” means a
full-time equivalent scientific person year, consisting of a total
of 1840 hours per year of scientific work on an annualized basis,
in the conduct of the Program.
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1.22
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“ Included Roche
Compounds ” means the compounds listed on Exhibit L
[*] .
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1.23
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“ IND ” means an
Investigational New Drug Application filed with the US Food and
Drug Administration (“ FDA” ) for human clinical
testing of a drug.
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1.24
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“ Indication ”
means a Neurological Indication, a Psychiatric Indication or an
Other Indication.
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1.25
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“ Initiation of Phase
I ” means the date that a human is first dosed with a
Product in a Phase I clinical trial.
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1.26
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“ Initiation of Phase
IIa ” means the date that a patient is first dosed with a
Product in a Phase IIa clinical trial.
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1.27
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“ Initiation of Phase
III ” means the date that a patient is first dosed with a
Product in a Phase III clinical trial.
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1.28
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“ Invention ”
means an invention that is made in the conduct of the Strategic
Alliance.
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1.29
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“ Joint Patent Rights
” means all Patent Rights that Memory and Roche jointly own,
or otherwise jointly have the right to grant the licenses herein,
during the Agreement Term.
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1.30
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“ JSC ” means
the committee organized and operating as provided in
Article 7.
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1.31
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“ Know-How ”
means data, knowledge and information, including materials,
samples, chemical manufacturing data, toxicological data,
pharmacological data, preclinical data, assays, platforms,
formulations, specifications, quality control testing data, that
are necessary or useful for the discovery, manufacture, development
or commercialization of Product in the Territory.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
4
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1.32
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“ Launch ”
means, with respect to a Product in a country of the Territory, the
date of the first commercial sale by Roche, its Affiliate or its
sublicensee of the given Product in the given country after
Regulatory Approval, if any, in such country.
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1.33
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“ License Exercise
Period ” means, with respect to Compound 3454, the sixty
(60) day period immediately following the later of the End of
Phase IIa or the date of delivery by Memory to Roche of the data
and reports specified in Schedule 1 related to such Compound
3454.
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1.34
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“ License Rights
Maintenance Fees ” means, with respect to any Product,
the payments by Roche to Memory pursuant to Section 4.4
hereof.
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1.35
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“ Major Market
Countries ” means the US, Canada, Japan and
Europe.
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1.36
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“ Memory Compound
” means any compound which is a nicotinic alpha-7 agonist
[*] (a) (i) the composition of matter of which is Covered in
the United States by any of the Memory Patent Rights as of the
Effective Date or (ii) that is listed in a letter of even date
from Memory to Roche and (b) demonstrated by either Party to
have Threshold Activity prior to the Effective Date or during the
Extended Period provided that Compound 3454 is not a Memory
Compound.
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1.37
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“ Memory Know-How
” means all Know-How that Memory owns or Controls during the
Extended Period and thereafter, to the extent necessary for the
discovery, manufacture, development, making use, sale or
commercialization of Product in the Territory, during the Agreement
Term.
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1.38
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“ Memory Patent Rights
” means all Patent Rights that Memory owns, or otherwise has
the right to grant the licenses herein, (a) as of the
Effective Date, and listed in Exhibit I hereto, (b) that
Covers a Memory Compound during the Agreement Term or (c) if
Roche exercises the License to Compound 3454, that Covers Compound
3454 during the Agreement Term.
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1.39
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“ Memory Product
” means any pharmaceutical product that includes, in whole or
as a component, any Memory Compound as an active ingredient
thereof.
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1.40
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“ NDA ” means a
New Drug Application filed with the FDA, or its foreign equivalent,
for a drug.
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1.41
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“ NDA Filing ”
means for a given Product, the date that an NDA is filed for the
Product.
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1.42
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“ Net Sales ”
and the related term “Adjusted Gross Sales”
mean:
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“Adjusted Gross Sales”
means the amount of gross sales of the Product invoiced by Roche,
its Affiliates and its sub-licensees to independent third parties
less deductions of returns and return reserves (such reserves
consistent with Generally Accepted Accounting Principles)
(including allowances actually given for spoiled, damaged,
out-dated, rejected, returned Product sold, withdrawals and
recalls), rebates to the extent consistently applied by Roche to
its products (price reductions, rebates to social and
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[*] CONFIDENTIAL TREATMENT
REQUESTED
5
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welfare systems, charge backs and
charge back reserves (such reserves consistent with Generally
Accepted Accounting Principles), cash sales incentives (but only to
the extent it is a sales related deduction which is accounted for
within Roche on a product-by-product basis)), government mandated
rebates and similar types of rebates (e.g., P.P.R.S, Medicaid, each
as consistently applied by Roche to its products), volume
(quantity) discounts, each as consistently applied by Roche to
its products, taxes (value added or sales taxes, government
mandated exceptional taxes and other taxes directly linked to the
gross sales amount), it being understood that income and capital
gains taxes are not the type of taxes contemplated as a deduction
in this definition of Adjusted Gross Sales.
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“Net Sales” means, for
the US, the amount calculated by subtracting from the amount of
Adjusted Gross Sales a lump sum deduction of [*] percent (
[*] %) of Adjusted Gross Sales in lieu of those sales
related deductions which are not accounted for within Roche on a
product by product basis (e.g. outward freights, postage charges,
transportation insurance, packaging materials for dispatch of
goods, custom duties, bad debt, discounts granted later than at the
time of invoicing, and cash discounts).
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“Net Sales” means, for
the ROW Territory, the amount calculated by subtracting from the
amount of Adjusted Gross Sales a lump sum deduction of [*]
percent ( [*] %) of Adjusted Gross Sales in lieu of those
sales related deductions which are not accounted for within Roche
on a product by product basis (e.g. outward freights, postage
charges, transportation insurance, packaging materials for dispatch
of goods, custom duties, bad debt, discounts granted later than at
the time of invoicing, and cash discounts).
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Notwithstanding the foregoing,
amounts received by Roche, its Affiliates and sublicensees for the
sale of Product among Roche, its Affiliates or sublicensees for
resale shall not be included in the computation of Adjusted Gross
Sales and Net Sales.
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1.43
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“ Neurological
Indication ” means prophylaxis or treatment of
Alzheimer’s disease (including management of psychotic
symptoms of Alzheimer’s disease), prophylaxis or treatment of
mild cognitive impairment (“ MCI ”) or treatment
of vascular dementia.
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1.44
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“ Other Indication
” means any indication other than a Neurological Indication
or a Psychiatric Indication.
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1.45
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“ Party ” means
Roche and/or Memory.
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1.46
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“ Patent Right ”
means all rights under any patent or patent application in any
country of the Territory, including any substitution, extension or
supplementary protection certificate, reissue, reexamination,
renewal, division, continuation or continuations-in-part thereof,
relating to the discovery, manufacture, development or
commercialization of nicotinic alpha-7 agonist [*] compounds
in the Territory.
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1.47
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“ Phase I ”
means the first phase of human clinical trials of a drug required
by the US FDA to gain evidence of safety in volunteers, as
described in 21 CFR Part 312, as it may be amended.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
6
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1.48
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“ Phase II ”
means the second phase of human clinical trials of a drug required
by the US FDA to gain evidence of efficacy in the target
population, determine optimal dosage, and obtain expanded evidence
of safety for Product(s), as described in 21 CFR Part 312, as
it may be amended.
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1.49
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“ Phase IIa ”
means one or more Phase IIa trials (at least one of which is
conducted in a Major Market Country) collectively designed to
demonstrate preliminary proof of clinical efficacy using medically
recognized surrogate markers or end points.
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1.50
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“ Phase IIb ”
means one or more Phase IIb trials (at least one of which trials
was conducted in a Major Market Country) collectively designed to
demonstrate efficacy of a pharmaceutical product in a target
population and/or to establish the optimal dosing regimen for such
product.
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1.51
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“ Phase III ”
means the third phase of human clinical trials of a drug required
by the US FDA to gain evidence of efficacy in the target
population, and obtain expanded evidence of safety for Product(s),
as described in 21 CFR Part 312, as it may be
amended.
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1.52
|
|
“ Product ”
means any and all products that include, in whole or as a component
thereof, a Memory Compound, Collaboration Compound or, after Roche
obtains a License to Compound 3454 pursuant to Section 2.1
hereof, Compound 3454, as an active ingredient thereof.
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1.53
|
|
“ Psychiatric
Indication ” means schizophrenia (including management of
the manifestations of symptoms of schizophrenia), depression,
bipolar disorders, anxiety and ADHD.
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1.54
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[*] means, with respect to any Compound,
[*].
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1.55
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[*] means, with respect to any Compound
, [*].
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1.56
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“ Regulatory Approval
” means any approvals (including pricing and reimbursement
approvals), licenses, registrations or authorizations of any
national or international or local regulatory agency, department,
bureau or other governmental entity, necessary for the manufacture
and sale of a Product in the Field in a regulatory jurisdiction in
the Territory.
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1.57
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“ Roche Patent Rights
” means all Patent Rights that Roche owns, or otherwise has
the right to grant the licenses herein, during the Agreement
Term.
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1.58
|
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“ ROW Territory
” means all countries and territories other than the
US.
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1.59
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|
“ Strategic Alliance
” means discovery and development by Memory and/or Roche and
its Affiliates of pharmaceuticals acting against nicotinic alpha-7
receptor and development and commercialization of such
pharmaceuticals by Roche and/or Memory, as provided for in this
Agreement.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
7
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1.60
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“ Strategic Alliance
Term ” means the period commencing on the Effective Date
and ending on December 31, 2007, as such period may be
extended by mutual agreement of the Parties in writing.
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1.61
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“ Territory ”
means all countries and territories in the world.
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1.62
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“ Third Party ”
means a person or entity other than (i) Memory or any of its
Affiliates, or (ii) Roche or any of its Affiliates.
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1.63
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“ Threshold Activity
” means [*] .
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1.64
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|
“ 3454 Product ”
means any pharmaceutical product that includes, in whole or as a
component, the Compound 3454 as an active ingredient
thereof.
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1.65
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“ US ” means the
United States of America and its possessions and territories,
including Puerto Rico.
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1.66
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“ Valid Claim ”
means a claim in any (i) unexpired and issued Memory Patent
Right or Collaboration Patent Right that has not been disclaimed,
revoked or held invalid by a final unappealable decision of a court
of competent jurisdiction or government agency or (ii) pending
patent application that is a Memory Patent Right or Collaboration
Patent Right, which application has been on file with the
applicable patent office for no more than ten (10) years and
for which there has been reasonably consistent activity to advance
to issuance of a patent.
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2.1
|
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Grants . Subject to the terms and
conditions of this Agreement, Memory hereby grants to Roche a sole
and exclusive license, including the right to grant sublicenses
pursuant to Section 2.4, under the Memory Patent Rights and
Memory’s interest in the Collaboration Patent Rights and to
use the Memory Know-How, to make, use, offer for sale, sell, import
and export all Products other than Compound 3454 in the Territory
for use in the Field. Subject to the terms and conditions of this
Agreement, during the License Exercise Period, Roche shall have the
right with respect to Compound 3454 to obtain a sole and exclusive
license, including the right to grant sublicenses pursuant to
Section 2.3, under the Memory Patent Rights and Memory’s
interest in the Collaboration Patent Rights and to use the Memory
Know-How, to make, use, offer for sale, sell, import and export
such Compound 3454 and 3454 Products in the Territory for use in
the Field (a “ License ”). In addition, subject
to the terms and conditions of this Agreement, Memory hereby grants
to Roche a non-exclusive license, including the right to grant
sublicenses pursuant to Section 2.4, under any additional
patent rights that Memory Controls to the extent necessary to make,
use, offer for sale, sell, import and export (i) all Products
other than Compound 3454 in the Territory for use in the Field and
(ii) if Roche exercises the right to obtain the license for
Compound 3454, Compound 3454. The right of Roche to obtain a
License to Compound 3454 as provided in this Section 2.1 shall
be exercisable by Roche giving written notice to Memory and making
or having made payment to Memory of all License Rights Maintenance
Fees for such Product under Section 4.4 with respect to a
License for a Product for an Indication. If Roche exercises such
right as provided
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[*] CONFIDENTIAL TREATMENT
REQUESTED
8
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herein, Memory shall be deemed to
have granted such License hereunder without any requirement for
further action by or on behalf of either Party.
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Nothing in this Agreement grants to
Roche any right or license to use Memory Know-How for any purpose
other than to make, use, offer for sale, sell, import and export
Products in the Territory for use in the Field. Further, nothing in
this Agreement shall limit the right of Memory to use Memory
Know-How for any purpose other than the making, using, offering for
sale, selling, importing or exporting Products in the Territory for
use in the Field.
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2.2
|
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Intentionally Omitted
.
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2.3
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Restrictions on Third Party
Rights .
Memory shall not grant any license or rights to a Third Party with
respect to Compound 3454 or itself commercialize Compound 3454
unless and until Roche has declined or failed to exercise its right
to obtain a License to such compound pursuant to Sections 2.1
and 16.4(a) hereof. In the event that Roche so declines or fails to
exercise its right to obtain a License to such compound, Memory
shall be free to license or grant any rights to a Third Party with
respect Compound 3454 and/or itself commercialize Compound
3454.
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2.4
|
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Sublicense Rights
. The rights and
licenses granted to Roche under Section 2.1 shall include the
right to grant sublicenses to its Affiliates and Third Parties
under such rights and licenses, in whole or in part, solely to the
extent necessary to make, use, offer for sale, sell, import or
export Products in the Territory for use in the Field. If Roche
grants such a sublicense, Roche shall ensure that all of the
applicable terms and conditions of this Agreement shall apply to
the Affiliate or Third Party sublicensee to the same extent as they
apply to Roche for all purposes. Roche assumes full responsibility
for the performance of all obligations and observance of all terms
so imposed on such Affiliate or Third Party sublicensee and will
itself account to Memory for all payments due under this Agreement
by reason of such sublicense.
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Roche shall not sublicense its
rights to offer a Memory Product for sale or sell a Memory Product
in a Major Market Country [*] without the prior written
consent of Memory which shall not be unreasonably withheld. With
respect to any 3454 Product, Roche shall not have the right to
sublicense the rights granted to Roche under Section 2.1 to
any Third Party with respect to any 3454 Product, except upon the
prior written approval of Memory, which approval Memory shall not
unreasonably withhold.
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Any sublicense may, at the written
election of Memory, continue in full force and effect after the
termination of any of the underlying licenses granted herein to
Roche (the foregoing shall apply to a termination in whole or in
part of such underlying licenses). Upon the licenses granted herein
to Roche becoming fully paid up pursuant to Section 16.1(b), any
and all sublicenses granted by Roche similarly shall become fully
paid up as to Memory.
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2.5
|
|
Memory Co-Promotion
Right .
Memory shall have the right to co-promote in the US each Product
containing Compound 3454, in accordance with the provisions of
Exhibit K
|
[*] CONFIDENTIAL TREATMENT
REQUESTED
9
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hereto. Within forty-five
(45) days after the end of Phase II with respect to any such
Product, Roche shall provide Memory with (i) the results and
analysis of Phase II studies, and (ii) Roche’s then
final, approved Phase III development plan (including budget).
Memory shall exercise its co-promotion right with respect to any
such Product by (a) giving written notice thereof to Roche
within forty-five (45) days after receipt of the items
described in the immediately preceding sentence, and
(b) making a one-time payment to Roche in the amount of
[*] percent ( [*] %) of Roche’s budgeted Phase
III global development costs for such Product as set forth in
Roche’s then final, approved Phase III development plan
(including budget). If Memory exercises its right to co-promote any
such Product in the US, the royalties otherwise payable by Roche to
Memory hereunder with respect to the Net Sales of such Product in
the US shall be reduced by [*] percent ( [*] %). Upon
Memory’s exercise of its co-promotion right with respect to
any such Product, the Parties shall negotiate in good faith and
enter into a Co-Promotion Agreement consistent with terms set forth
in Exhibit K hereto.
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2.6
|
|
Requirement to Divest
. If Roche is required
by a relevant government authority in a given country of the
Territory to divest rights to a Memory Compound, Compound 3454,
3454 Product, and/or a Memory Product with respect to which Roche
has not commenced the Initiation of Phase III, then Roche shall use
its reasonable best efforts to obtain authority to fulfill such
requirement by returning rights to Memory to the Memory Compound,
Compound 3454, 3454 Product and/or Memory Product, as the case may
be, in accordance with Section 16.5.
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3.1
|
|
Diligence . Memory shall use reasonable
diligence in proceeding with the development of Compound 3454
through the End of Phase IIa. Roche shall use reasonable diligence
in proceeding in the Major Market Countries with the development
[*] of at least one Compound [*] .
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Reasonable diligence as used in
this Agreement shall mean the same standard of effort as used by
the Parties, or in any case not less than common in the industry
taken as a whole for similarly situated companies for the
activities to be undertaken pursuant to this Agreement, including,
in the case of Roche, the development, clinical testing,
manufacturing, marketing and sale of a product which (i) must
receive regulatory approval in Major Market Countries and
(ii) has similar potential for an Indication as the compounds
for which Roche has obtained a license hereunder, taking into
account scientific, business and marketing and return on investment
considerations. It is understood that such compound potential may
change from time to time based upon changing scientific, business
and marketing and return on investment considerations. The Parties
also acknowledge that, even within the Major Market Countries,
Roche and its Affiliates do not always seek to market their own
products in every such country or seek to obtain regulatory
approval in every such country or for every potential indication or
every compound that has potential for an indication. As a result,
the exercise by Roche of reasonable diligence is to be determined
by judging its efforts taken as a whole.
|
[*] CONFIDENTIAL TREATMENT
REQUESTED
10
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If either Party believes in good
faith that the other Party has failed to utilize reasonable
diligence as required by this Section 3.1, then such Party may
give the other Party written notice of such alleged failure,
identifying the nicotinic alpha-7 agonist [*] compound or
Product (if known) and giving specific detailed reasons of such
allegation. Within sixty (60) days following the other
Party’s receipt of any such notice (“ Response
Period ”), the other Party shall have the right to
provide such Party with a written response specifying, in
reasonable detail, how it has used reasonable diligence as required
hereby.
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If the other Party has failed to
provide within the Response Period a written response, in
reasonable detail, indicating the manner in which it is in
compliance with its obligations under this Section 3.1 or in
which it has remedied any breach thereof, or the other Party has
failed within the Response Period to remedy any breach of its
obligations under this Section 3.1, then the non-defaulting
Party shall have the right to terminate this Agreement, in whole or
in part, as described in this Section 3.1, upon written notice
to such Party effective as of the end of the Response
Period.
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In the event of a dispute between
the Parties with respect to whether either Party has complied with
its obligation under this Section 3.1, then such dispute shall
be resolved in accordance with Article 17. The consequences of
any termination under this Section 3.1 are set forth in
Section 16.5 and Article 17.
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3.2
|
|
Effect of Merger on
Diligence .
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(a)
|
|
Acquisition of Roche
. If
(i) substantially all of the pharmaceutical business of Roche
becomes merged or acquired or (ii) Roche acquires
substantially all of the pharmaceutical business of an entity
having an average annual pharmaceutical preclinical research
expenditure in excess of [*] dollars (US $ [*] ) per
year, then at any time during the period from a public announcement
by Roche of its intention to effect such merger or acquisition
(each such transaction described in clauses (i) and
(ii) being hereinafter called a “ Transaction
”) through [*] after the closing of such Transaction,
Memory shall have the right to request in writing to the Head of
Global Pharmaceuticals of Roche a status of and future plans for
the progress of development and commercialization of Products
(“ Status Request ”). This right may be
exercised by Memory not more than [*].
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If, following a Status Request,
Memory believes in good faith that Roche has failed to progress
development and commercialization of Products solely because of the
Transaction, then Memory may give Roche written notice of such
alleged failure, identifying the Product and region at issue and
giving specific detailed reasons of such allegation. Within
[*] days following Roche’s receipt of any such notice
from Memory (“ Status Response Period ”), Roche
shall have the right to provide Memory with a written response
specifying, in reasonable detail, how the Transaction per se has
not had any negative impact on such development and
commercialization progress.
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If Roche has failed to provide
within the Status Response Period a written response, in reasonable
detail, indicating the manner in which development and
|
[*] CONFIDENTIAL TREATMENT
REQUESTED
11
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commercialization of Products has
not failed to progress solely because of the Transaction or in
which it has remedied any such failure, or Roche has failed within
the Status Response Period to remedy any such failure to progress,
then Memory shall have the right to terminate this Agreement, in
whole or in part, as described below in this Section 3.2, upon
written notice to Roche effective as of the end of the Status
Response Period. Memory shall have the right to terminate this
Agreement as to any region described in Section 16.4(b) if
development and commercialization of the Products has failed to
progress solely because of the Transaction with respect to the
Products (taken as a whole) in such region. Memory shall have the
right to terminate this Agreement in the Territory with respect to
any Product if development and commercialization of such Product
has failed to progress solely because of the Transaction in at
least two of the three regions described in Section 16.4(b).
Memory shall have the right to terminate this Agreement in its
entirety if development and commercialization of the Products
(taken as a whole) has failed to progress solely because of the
Transaction in at least two of the three regions described in
Section 16.4(b). The Parties confirm and agree that nothing in
this Section 3.2 limits the obligations of Roche or the rights
of Memory under Section 3.1.
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(b)
|
|
Change of Control of
Memory .
Upon a Change of Control of Memory, Roche shall have the right to
terminate Memory’s participation in the Strategic Alliance,
as provided in Section 7.5(g) hereof provided that any such
termination shall not in any manner terminate, reduce or otherwise
modify any of Memory’s rights to royalty and event payments
hereunder. In addition, upon a Change of Control of Memory, Roche
shall have the right to terminate Memory’s participation in
Phase I studies and all other work or activities pursuant to
Articles 7 and 9 of this Agreement; provided that (i) any such
termination shall not in any manner terminate, reduce or otherwise
modify any of Memory’s rights to royalty and milestone
payments hereunder and (ii) Roche shall complete any Phase I
studies then in process.
|
Article 4. Payments to
Memory
|
4.1
|
|
Intentionally Omitted
.
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4.2
|
|
Intentionally Omitted
.
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4.3
|
|
Intentionally Omitted
.
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4.4
|
|
Payments With Respect to Certain
Events .
Roche shall pay to Memory, in order to maintain its License rights
pursuant to Section 2.1 and the other provisions of this
Agreement with respect to Compound 3454 and to reimburse Memory for
previously incurred research expenditures, and with respect to
certain development based Events, the non-refundable and
non-creditable payments set forth in Exhibit B hereto upon the
first occurrence of the Events relating to Compound 3454 described
therein. With respect to each Memory Product and each Collaboration
Product, Roche shall pay to Memory, the
|
[*] CONFIDENTIAL TREATMENT
REQUESTED
12
|
|
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non-refundable and non-creditable
payments set forth in Exhibit C and Exhibit D hereto,
respectively, upon the first occurrence of the Events listed
therein for such Product.
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Each payment required pursuant to
this Section 4.4 shall be due and payable by Roche within
sixty (60) days after occurrence of the applicable Event.
Roche will make each of such payments only once for each Product,
regardless of the number of Indications for which such Product may
be developed or the subject of any Regulatory Approvals.
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For the avoidance of doubt, the
Parties confirm and agree that no amount payable under this
Article 4 shall reduce any royalties payable under
Article 5.
|
|
5.1
|
|
Royalties . Roche shall pay to Memory the
percentage of Net Sales of any 3454 Products, Memory Products and
Collaboration Products as set forth in Exhibit E,
Exhibit F and Exhibit G hereto, respectively. Such
royalty payments shall be calculated by multiplying the percentages
set forth in such Exhibit by the annual Net Sales of such Product
(all Net Sales amounts in $ US million) set forth in such Exhibit
and shall be subject to adjustment as provided in this
Article 5.
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5.2
|
|
Intentionally Omitted
.
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5.3
|
|
Adjustment Related to Other
Indications of 3454 Products . Roche shall pay to Memory
royalties for a given 3454 Product having a Regulatory Approval for
an Other Indication, in an amount equal to [*] of the
royalties otherwise payable for such 3454 Product having a
Regulatory Approval for a Neurological Indication based upon the
Net Sales of such Product, which royalty rate shall be subject to
adjustment as provided in this Article 5.
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5.4
|
|
Adjustment Related to Multiple
Indications of 3454 Products . Notwithstanding anything to the
contrary contained in Sections 5.1 or 5.2 hereof, in the event
that a given 3454 Product has a Regulatory Approval for more than
one indication, Roche shall pay royalties to Memory based upon the
royalty schedule providing the highest applicable royalty rates for
which a Regulatory Approval has been obtained in a Major Market
Country. Specifically, if any such 3454 Product is approved for
(i) a Neurological Indication in a Major Market Country and
for another indication other than a Psychiatric Indication, the
royalties payable by Roche to Memory shall be based upon Net Sales
of such 3454 Product in the Territory as if all of such Net Sales
occurred for such Neurological Indication; (ii) a Psychiatric
Indication in a Major Market Country and for an Other Indication,
the royalties otherwise payable by Roche shall be based upon Net
Sales of such 3454 Product in the Territory as if all of such Net
Sales occurred for the Psychiatric Indication; and
(iii) multiple Other Indications only, then the royalties
payable by Roche to Memory shall be equal to [*] of the
royalties otherwise payable under the royalty schedule for a 3454
Product approved for a Neurological Indication.
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5.5
|
|
Term of Royalty Payments
. Roche shall calculate
and make royalty payments to Memory under this Article 5
commencing on Launch in any country. The Net Sales of a given
country shall be included for purposes of calculating royalties
under this Section until the later of (a) expiration of the
last to expire of Composition of Matter Claim in
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[*] CONFIDENTIAL TREATMENT
REQUESTED
13
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such country and (b) ten
(10) years from the Launch of such Product in such country.
With respect to the ten (10) year period, the EU will be
considered as one country.
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5.6
|
|
Adjustments Related to Valid
Claims . For
a given Product, if in, or with respect to, a country of the
Territory no Valid Claim Covers such Product, then Roche may
calculate royalties for such Product using [*] percent (
[*] %) of the amount Roche would have used for such country
to calculate royalties for such Product if a Valid Claim Covered
such Product in such country unless prior to ten years from the
Launch of such Product in, or with respect to, such country (EU
considered as one country) a Valid Claim Covering such Product
exists in, or with respect to, such country in which case Roche
shall resume calculating royalties using [*] percent (
[*] %) of such amount.
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5.7
|
|
Adjustments Related to Third Party
Competition .
For a given Product in a given calendar quarter, if in a country of
the Territory (a) a Third Party is selling Bioequivalent
Product, and (b) Roche has an obligation to make payments
under this Agreement with respect to Net Sales of the given Product
in such country, and (c) a Valid Claim Covers the given
Product in such country and (d) in such country, sales of
units of Bioequivalent Products in aggregate total at least
[*] percent ( [*] %) of the aggregate sales of units
of Bioequivalent Products and Products as measured at the end of
such calendar quarter, and (e) Roche has, if it is reasonable
under the circumstances, brought in the country and continued to
diligently prosecute a patent infringement suit under any relevant
Composition of Matter Claims against the Third Party or another in
privity, then Roche shall have the right to calculate royalties
with respect to such calendar quarter by including [*]
percent ( [*] %) of the amount Roche would have otherwise
included for such country to calculate sales-based payments if no
Bioequivalent Product existed in such country.
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5.8
|
|
Adjustments Related to Third Party
Payments .
Roche or its Affiliate shall pay and be responsible for the entire
consideration owed to any Third Party pursuant to the terms of any
existing or future patent licensing agreement relating to a
Product. Roche shall have the right to deduct a maximum of
[*] percent ( [*] %) of the consideration actually
paid by Roche or its Affiliate to a Third Party (other than
[*] ) with respect to any license under a patent which
Covers the molecule per se of the compound which is the nicotinic
alpha-7 agonist [*] that is included in a given Product,
from payments otherwise due and payable by Roche to Memory under
this Agreement. In no event as a result of this Section 5.8
shall Roche reduce the royalties owed to Memory under this
Article 5 such that the royalties payable pursuant to this
Article 5 for such Product are less than [*] percent (
[*] %)of Net Sales in the Territory for a given calendar
quarter (and Roche shall be entitled to accumulate amounts not
permitted to be deducted in a prior period and deduct such amounts
in a future period).
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|
Notwithstanding the above,
(i) any payment owed under an agreement between Memory and The
Trustees of Columbia University dated July 22, 1998, as it may
be amended, shall be the sole responsibility of Memory, and
(ii) any payment owed under any agreement between Roche or its
Affiliate and any Third Party entered into prior to the Effective
Date shall be the sole responsibility of Roche, for which Roche
shall not be
|
[*] CONFIDENTIAL TREATMENT
REQUESTED
14
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entitled to any deduction from
payments due and payable to Memory under this Agreement.
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5.9
|
|
Bonus Payment
.
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(a)
|
|
With Respect to 3454
Products .
Roche shall pay to Memory a one-time, non-refundable and
non-creditable amount after the first occurrence of the following
Event with respect to the 3454 Product if it receives Regulatory
Approval for a Neurological Indication:
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Event
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Payment (US$)
|
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|
Net Sales
exceed [*] for a full calendar year (Jan. 1 - Dec. 31
(during the Agreement Term
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[*]
|
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|
Net Sales
exceed [*] for a full calendar year (Jan 1 - Dec 31) during
the Agreement Term
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[*]
|
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Roche shall pay to Memory a
one-time, non-refundable and non-creditable amount after the first
occurrence of the following event with respect to the 3454 Product
if it receives Regulatory Approval for a Psychiatric
Indication:
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Event
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Payment (US$)
|
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|
Net Sales
exceed [*] for a full calendar year (Jan. 1 - Dec. 31)
during the Agreement Term
|
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|
[*]
|
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|
|
Net Sales
exceed [*] for a full calendar year (Jan. 1 - Dec. 31)
during the Agreement Term
|
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[*]
|
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Each payment in this
Section 5.9(a) shall be due and payable by Roche within sixty
(60) days after occurrence of the applicable Event. If a 3454
Product receives Regulatory Approval for both a Neurological
Indication and a Psychiatric Indication, then bonus payments will
be due and payable only once for the first Indication for which a
bonus Event in this Section 5.9(a) is achieved.
[*].
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(b)
|
|
With Respect to Memory
Products .
Roche shall pay to Memory a one-time, non-refundable and
non-creditable amount after the first occurrence of the following
Event with respect to each Memory Product having Regulatory
Approval for any Indication:
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Event
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Payment (US$)
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Net Sales
exceed [*] for a full calendar year (Jan. 1 - Dec. 31
(during the Agreement Term
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[*]
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Each payment in this
Section 5.9(b) shall be due and payable by Roche within sixty
(60) days after occurrence of the applicable Event.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
15
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(c)
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With Respect to Collaboration
Products .
Roche shall pay to Memory a one-time, non-refundable and
non-creditable amount after the first occurrence of the following
Event with respect to each Collaboration Product having Regulatory
Approval for any Indication:
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Event
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Payment (US$)
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Net Sales
exceed [*] for a full calendar year (Jan. 1 - Dec. 31
(during the Agreement Term
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[*]
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Each payment in this
Section 5.9(c) shall be due and payable by Roche within sixty
(60) days after occurrence of the applicable Event.
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5.10
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Combination Products
. In the event Roche or
its Affiliates intend to sell a Combination Product, the Parties
shall meet approximately one (1) year prior to the anticipated
commercial launch of such Combination Product to negotiate in good
faith and agree to an appropriate adjustment to Net Sales to
reflect the relative significance and value (including
consideration of relative market share, sales potential and price
potential) of the Product and the other pharmaceutically active
agent(s) contained in the Combination Product. If, after good faith
negotiations (not to exceed ninety (90) days), the Parties
cannot agree to an appropriate adjustment, Net Sales shall equal
Net Sales of the Combination Product multiplied by a fraction, the
numerator of which is the reasonable fair market value of the
Product and the denominator (including consideration of relative
market share, sales potential and price potential) of which is the
reasonable fair market value (including consideration of relative
market share, sales potential and price potential) in the aggregate
of all pharmaceutically active agents contained in the Combination
Product.
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5.11
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Mechanisms for
Adjustments . Notwithstanding anything to the
contrary in this Agreement, in no event shall any adjustments,
individually or in the aggregate, pursuant to Sections 5.6,
5.7 and 5.8 result in Memory receiving royalties for a given
calendar quarter pursuant to Section 5.1 in an amount less
than [*] percent ( [*] %) of the amounts set forth
therein as if no adjustment(s) had been made. If Roche obtains a
license to a compound which is a nicotinic alpha-7 agonist
[*] from a Third Party and includes such compound in a
Product, as a result of which the Product becomes a Combination
Product, Roche shall not be entitled to an adjustment pursuant to
Section 5.8 as a result of such license.
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Article 6. Payment,
Reporting, Auditing
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6.1
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Currency and Conversion
.
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(a)
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All payments under this Agreement
shall be in U.S. Dollars by wire transfer of immediately available
funds in accordance with instruction or instructions from the Party
being paid.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
16
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(b)
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Whenever calculation of Net Sales
or any other payment pursuant to this Agreement requires conversion
from any foreign currency, Roche shall convert the amount of Net
Sales or any other payment pursuant to this Agreement in foreign
currencies as computed in Roche’s central Swiss Francs Sales
Statistics for the countries concerned, using for internal foreign
currency translation Roche’s then current standard practices
actually used on a consistent basis in preparing its audited
financial statements.
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(c)
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For sublicensees in a country, when
calculating the Net Sales, the sublicensee shall report to Roche
the amount of such sales within thirty (30) days from the end
of the reporting period, after having converted each applicable
monthly sales in foreign currency into Swiss Francs using the
average rate of exchange published in the Wall Street Journal (or
some other source agreed upon by the Parties for any particular
country) for each respective month of the reporting
period.
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6.2
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Payments . After the Launch of the Product in
any country of the Territory, Roche shall calculate royalty
payments set forth in Article 5 quarterly as of March 31,
June 30, September 30 and December 31 (each being
the last day of a reporting period). Roche shall pay such payments
quarterly within sixty (60) days after the end of each
reporting period in which Net Sales occur during the Agreement
Term.
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With each such payment, Roche shall
deliver to Memory the following information split between the US
and the ROW Territory:
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(a)
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Adjusted Gross Sales for each
Product;
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(b)
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Net Sales for each
Product;
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(c)
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the royalty payments due to Memory
for the reporting period;
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If Memory reasonably requests
additional information relating to gross sales of the Products in
the Major Market Countries, deductions therefrom to calculate
Adjusted Gross Sales or Net Sales and/or adjustments thereto, Roche
agrees to provide such information to Memory within a reasonable
time, provided, that Memory shall have the rights to exercise such
requests not more than once during any period of twelve
(12) consecutive months.
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In the event Roche does not pay
Memory any amounts due under this Agreement, including pursuant to
Articles 4 and 5, within the applicable time period set forth
herein, without limiting Memory’s rights under
Article 16, such payment shall bear interest, to the extent
permitted by applicable law, at the rate of interest (prime rate)
as published from time to time in the weekly Federal Reserve H.15
bulletin (or a successor or similar publication) plus [*] %
for the applicable period calculated on the number of days such a
payment is overdue.
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6.3
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Taxes .
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[*] CONFIDENTIAL TREATMENT
REQUESTED
17
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(a)
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Memory shall pay all applicable
taxes levied on Memory under this Agreement.
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(b)
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If provision is made in law or
regulation of any country for withholding of taxes of any type,
levies on Memory or other charges against Memory with respect to
any amounts payable under this Agreement to Memory, Roche shall
promptly pay such tax, levy or charge for and on behalf of Memory
to the proper governmental authority, and shall promptly furnish
Memory with receipt of such payment. Roche shall have the right to
deduct any such tax, levy or charge actually paid from payment due
Memory or be promptly reimbursed by Memory if no further payments
are due Memory. Each Party agrees to assist the other Party in
claiming exemption from such deductions or withholdings under
double taxation or similar agreement or treaty from time to time in
force and in minimizing the amount required to be so withheld or
deducted.
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6.4
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Blocked Countries
. If by reason of law
Roche is unable to convert to U.S. Dollars a portion of the amount
due by Roche under this Agreement, then Roche shall notify Memory
in writing and, upon written request from Memory, Roche shall pay
to Memory such portion, in the currency of any other country
designated by Memory and legally available to Roche.
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6.5
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Accounting .
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(a)
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Roche shall maintain and cause its
Affiliates and sublicensees to maintain books of account containing
all particulars that may be necessary for the purpose of
calculating all payments under this Agreement. Such books of
account shall be kept at their principal place of business. Memory
shall have the right to engage Roche’s independent, certified
public accountant to perform, on behalf of Memory, an audit of such
books and records of Roche and its Affiliates and sublicensees as
is necessary to confirm any amounts payable to Memory under this
Agreement for the period or periods requested by Memory and the
correctness of any report or payments made under this
Agreement.
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(b)
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Such audits shall be conducted
during normal business hours upon reasonable prior written notice
from Memory (minimum of thirty (30) days) in such a manner as
to not unnecessarily interfere with Roche’s normal business
activities, and shall include results of no more than three
(3) preceding calendar years prior to audit
notification.
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(c)
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Such audit shall not occur more
frequently than once per calendar year nor more frequently than
once with respect to records covering any specific period of time.
Notwithstanding the preceding, if Memory reasonably believes, after
reviewing information received from Roche’s independent
public accountant, that an additional audit is appropriate to
address an apparent discrepancy between Roche’s returns and
other information as is necessary for reporting hereunder, Memory
shall have the right, by an audit specialty firm reasonably
acceptable to Roche and employed by Memory and at Memory’s
own expense, to perform such appropriate audit
procedures.
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[*] CONFIDENTIAL TREATMENT
REQUESTED
18
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(d)
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The use of all information, data,
documents and abstracts referred above shall be for the sole
purpose of verifying statements or compliance with this Agreement,
shall be treated as Roche Confidential Information subject to
Article 15 of this Agreement and, except in the event of a
dispute between the Parties regarding amounts payable hereunder or
the results of any audit, need not be retained more than three (3)
years from the end of the calendar year to which each shall
pertain. Audit results shall be shared by Roche and
Memory.
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(e)
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If any audit hereunder reveals an
underpayment, Roche shall promptly make up such underpayment. If
any audit hereunder reveals an overpayment, Memory shall promptly
reimburse such overpayment. Memory shall bear the full cost of any
audit under this Section 6.5, unless such audit discloses an
underpayment by Roche of more than [*] percent ( [*]
%) of the amount owed hereunder if Net Sales exceeds [*]
dollars ($ [*] ) in the Territory for the calendar year, or
[*] percent ( [*] %) of the amount owed hereunder if
Net Sales are equal to or less than [*] dollars ($
[*]) in the Territory for the calendar year, in which case
Roche shall bear the full cost of such audit as performed by
Roche’s independent, certified public accountant and any
audit specialty firm employed by Memory, together with interest on
any such underpayment from the date otherwise due through the date
of payment at the rate set forth in Section 6.2.
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(f)
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The failure of Memory to request
verification of any payment calculation during which corresponding
records are required to be retained under this Section 6.5
shall be considered acceptance of such reporting by
Memory.
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Article 7. Governance;
Strategic Alliance
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7.1
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The Strategic Alliance
. The Parties hereby
continue their Strategic Alliance with respect to the development
of Products and the determination of licensing rights with respect
thereto.
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7.2
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Joint Steering Committee
. Subject to
Section 7.2(e), a Joint Steering Committee (“ JSC
”) shall govern the research and development of Products,
including prioritization of compounds for research and development,
approving research plans and development plans (and updates and
modifications thereof), supervising ongoing research and
development activities, recommending actions in response to
unforeseen events, supervising the transition of development,
manufacturing and regulatory activities from Memory to Roche and
development of preclinical and clinical strategies (including
clinical candidate selection, the commencement of the Initiation of
Phase I and the Initiation of Phase IIa). Neither Party shall
conduct activities with respect to Compounds outside the scope of
the Workplan pursuant to Exhibit A unless approved by the JSC.
On a quarterly basis during the Strategic Alliance Term and
promptly after the end of the Extended Period, the JSC shall
specify what Compounds have met the Threshold Activity.
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(a)
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Organization
. The JSC shall consist
of six (6) members, three (3) members to be designated by
Roche and three (3) members to be designated by Memory.
Each
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[*] CONFIDENTIAL TREATMENT
REQUESTED
19
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Party may add additional members to
the JSC. At least one (1) of each Party’s three
(3) members of the JSC shall not be members of such
Party’s Working Team, as defined pursuant to
Section 7.2(b). A JSC member may not be a member of more than
one Working Team. As appropriate, other employee representatives of
the Parties may attend JSC meetings, subject to the reasonable
approval of the other Party. Each Party shall notify the other
Party of the member(s) designated by such Party, in writing, within
thirty (30) days after the Effective Date. Any Party may
withdraw the designation of any of its members of the JSC and
designate a replacement at any time by giving prior written notice
of the withdrawal and identifying the replacement to the other
Party. [*]. The JSC is authorized to establish separate
subcommittees from time to time, provided that the decision-making
process established in Section 7.2(d) shall continue to
apply.
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(b)
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Working Teams
. Each Party shall
appoint members to working teams (“ Working Teams
”), such as a research team and a development team. The
Working Teams will be responsible for delivering a plan for
research and/or development activities to the JSC for their review,
modification and approval pursuant and subject to
Section 7.2(d). Further, any issues that are not resolved by
the Working Teams shall be submitted to the JSC for resolution
pursuant and subject to Section 7.2(d). The Working Teams
shall be cooperative bodies that will work together and have
meetings as appropriate.
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(c)
|
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Meetings . The JSC shall hold quarterly
meetings during the Extended Period and there
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