EXHIBIT 10.10
STRATEGIC ALLIANCE AGREEMENT
This AGREEMENT, having a date of August 19, 2003, is made by and among, on
the one hand, X.XXXXXXXX-XX XXXXX LTD, a Swiss corporation having its principal
place of business at Xxxxxxxxxxxxxxxxx 000, XX-0000, Xxxxx, Xxxxxxxxxxx and
XXXXXXXX-XX XXXXX INC., a New Jersey corporation, having its principal place of
business at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000 (collectively
"Roche") and, on the other hand, MEMORY PHARMACEUTICALS CORP., a Delaware
corporation, having its principal place of business at 000 Xxxxxxx Xxxxxxx,
Xxxxxxxx, Xxx Xxxxxx 00000 ("Memory").
INTRODUCTION
1. Memory has a development program relating to the neuronal nicotinic
alpha-7 receptor (the "Program"), and owns related intellectual property
rights.
2. Roche has expertise in the research, development, manufacture and
commercialization of pharmaceutical products.
3. Roche desires to secure rights to further develop and commercialize
products developed and to be developed pursuant to the Program.
4. 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 agree as
follows:
ARTICLE 1. DEFINITIONS
As used in this Agreement, the following terms, whether used in the singular or
plural, shall have the following meanings:
1.1 "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 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.
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.
1.2 "Agreement Term" means the term of this Agreement, more fully described in
Section 16.1.
1.3 "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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
1.4 "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.
1.5 "Composition of Matter Claim" means, for a given Product in a given
country of the Territory, a Valid Claim of a Memory Patent Right that
Covers the molecule per se of the compound that is included in such
Product, in whole or as a component thereof, as an active ingredient of
such Product.
1.6 "Cover" (including the variations such as "Covered", "Coverage" or
"Covering") shall mean that the making, using, offering for sale, selling
or importing 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.
1.7 "Effective Date" means the date that all conditions subsequent under
Section 16.1 have occurred.
1.8 "End of Phase I" means the date that all Phase I clinical trials have been
completed.
1.9 "End of Phase IIa" means the date that all Phase IIa clinical trials have
been completed.
1.10 "Europe" means the United Kingdom, Germany, Italy, France and Spain.
1.11 "Field" means prophylaxis and treatment of diseases, in all indications,
for either human or veterinary use.
1.12 "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.
1.13 "IND" means an Investigational New Drug Application filed with the US Food
and Drug Administration ("FDA") for human clinical testing of a drug.
1.14 "Initiation of Phase I" means the date that a human is first dosed with a
Product in a Phase I clinical trial.
1.15 "Initiation of Phase IIa" means the date that a patient is first dosed
with a Product in a Phase IIa clinical trial.
1.16 "Initiation of Phase III" means the date that a patient is first dosed
with a Product in a Phase III clinical trial.
1.17 "Invention" means an invention that is made in the conduct of the
Strategic Alliance.
1.18 "JLT" means the committee organized and operating as provided in Article
7.
1.19 "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.
1.20 "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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
1.21 "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 in such country.
1.22 "License Exercise Period" means, with respect to any Product, except as
otherwise provided in Section 4.6, 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 Product.
1.23 "License Rights Maintenance Fees" means, with respect to any Product, the
payments by Roche to Memory pursuant to Section 4.4 hereof.
1.24 "Major Market Countries" means the US, Canada, Japan and Europe.
1.25 "Memory Compound" means any compound which is a nicotinic alpha-7 agonist
with respect to which (i) Memory has commenced a Phase I human clinical
trial within five (5) years after the Effective Date or (ii) Roche has
designated pursuant to Section 2.2 or Section 4.6 hereof.
1.26 "Memory Know-How" means all Know-How that Memory owns, or otherwise has
the right to grant the licenses herein, during the Agreement Term.
1.27 "Memory Patent Rights" means all Patent Rights that Memory owns, or
otherwise has the right to grant the licenses herein, during the Agreement
Term.
1.28 "NDA" means a New Drug Application filed with the FDA, or its foreign
equivalent, for a drug.
1.29 "NDA Filing" means for a given Product, the date that an NDA is filed for
the Product.
1.30 "Net Sales" " and the related term "Adjusted Gross Sales" mean:
"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 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.
"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).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
"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).
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."
1.31 "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.
1.32 "Other Indication" means any indication other than a Neurological
Indication or a Psychiatric Indication.
1.33 "Party" means Roche and/or Memory.
1.34 "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.
1.35 "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.
1.36 "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.
1.37 "Phase IIa" means one or more Phase II trials (at least one of which
trials was conducted in a Major Market Country) collectively designed to
demonstrate (a) in the case of a Neurological Indication, safety and
tolerability in the target population, and (b) in the case of a
Psychiatric Indication, clinical proof of concept.
1.38 "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.
1.39 "Product" means any and all products that include, in whole or as a
component thereof, a Memory Compound.
1.40 "Psychiatric Indication" means schizophrenia (including management of the
manifestations of symptoms of schizophrenia), depression, bipolar
disorders, anxiety and ADHD.
1.41 "Regulatory Approval" means any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations of any
national or international or local regulatory agency,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
1.42 "Roche Patent Rights" means all Patent Rights that Roche owns, or
otherwise has the right to grant the licenses herein, during the Agreement
Term.
1.43 "ROW Territory" means all countries and territories other than the US.
1.44 "Strategic Alliance" means discovery and development by Memory of
pharmaceuticals acting against nicotinic alpha-7 receptor and development
and commercialization of such pharmaceuticals by Roche and Memory, as
contemplated by this Agreement.
1.45 "Territory" means all countries and territories in the world.
1.46 "Third Party" means a person or entity other than (i) Memory or any of its
Affiliates, or (ii) Roche or any of its Affiliates.
1.47 "US" means the United States of America and its possessions and
territories, including Puerto Rico.
1.48 "Valid Claim" means a claim in any (i) unexpired and issued Memory 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
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.
ARTICLE 2. GRANTS
2.1 Grants. Subject to the terms and conditions of this Agreement, during the
License Exercise Period, Roche shall have the right with respect to each
Product to obtain a sole and exclusive license, including the right to
grant sublicenses pursuant to Section 2.3, under the Memory Patent Rights
and to use the Memory Know-How, to make, use, offer for sale, sell and
import such Product in the Territory for use in the Field (each, a
"License"). The right of Roche to obtain a License 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 a Neurological Indication or a Psychiatric
Indication. If Roche exercises such right as provided herein, Memory shall
be deemed to have granted such License hereunder without any requirement
for further action by or on behalf of either Party.
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 and import 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 not related to the making, using, offering for
sale, selling or importing Products in the Territory for use in the Field.
2.2 Designation of Additional Compounds. In the event that, as of the date
that is [*] years after the Effective Date, there are fewer than [*]
Memory Compounds for either a Neurological Indication or a Psychiatric
Indication with respect to which Memory has commenced the Initiation of
Phase I, then Roche shall have the right to designate as Memory Compounds
additional compounds
[*] CONFIDENTIAL TREATMENT IS REQUESTED
which are nicotinic alpha-7 agonists in preclinical development by Memory,
up to the number of compounds fewer than [*] as to which Memory has then
not commenced the Initiation of Phase I. For example, if Memory has
commenced the Initiation of Phase I with respect to one (1) Product for a
Neurological Indication and one (1) Product for a Psychiatric Indication
at the end of such [*] year period, then Roche shall have the right to
designate as Memory Compounds up to [*] additional compounds which are
nicotinic alpha-7 agonists in preclinical development by Memory. If Roche
desires to exercise such right, Roche shall give written notice thereof to
Memory and Memory shall provide to Roche, for evaluation purposes only,
all test results, data (e.g., in vivo data, safety data and
structure-activity relationship data) and applicable Memory Patent Rights
relating to up to [*] compounds which are nicotinic alpha-7 agonists in
preclinical development by Memory as may be selected by Roche. Within the
sixty (60) day period following receipt by Roche of such items, Roche may
designate such additional compounds, up to the number of compounds it is
permitted to designate pursuant to this Section 2.2.
After Roche has designated one or more such compounds as Memory Compounds,
Memory may elect either to (i) continue development of such Memory
Compound through the End of Phase IIa and be entitled to receive all
License Rights Maintenance Fees with respect thereto, as and when provided
in Section 4.4 hereof, or (ii) have Roche assume all preclinical and
clinical development of such Memory Compound(s) and pay all costs related
thereto, in which case the License Rights Maintenance Fees otherwise
payable by Roche with respect to such Memory Compound(s) shall be reduced
by [*] percent ([*]), the events for payments by Roche specified in
Section 4.4 shall not include the delivery of any data or reports and
Roche shall have a License to such Memory Compound(s) as provided in
Section 2.1 effective as of the date Roche assumes the preclinical and
clinical development of such Memory Compound.
2.3 Restrictions on Third Party Rights. Memory shall not grant any license or
rights to a Third Party with respect to any compound that is a nicotinic
alpha-7 agonist 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 to such
compound.
2.4 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 or import
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.
Notwithstanding the above, 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 Product (i) in a Major Market Country, except upon the
prior written approval of Memory, which approval Memory shall not
unreasonably withhold and (ii) in the US, except upon the prior written
approval of Memory so long as Memory has a co-promotion right for such
Product, which approval may be granted or withheld by Memory in its sole
discretion.
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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
2.5 Memory Co-Promotion Right. Memory shall have the right to co-promote each
Product in the US, on a Product-by-Product basis, in accordance with the
provisions of Exhibit A hereto. Within forty-five (45) days after the end
of Phase II with respect to each 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 each 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 a 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 Product, the Parties shall negotiate in good faith and
enter into a Co-Promotion Agreement consistent with terms set forth in
Exhibit A hereto.
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 and/or 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 and/or Product in accordance with Section
16.5.
ARTICLE 3. DILIGENCE
3.1 Diligence. Memory shall use reasonable diligence in proceeding with the
development of Products through the End of Phase IIa, except for (i)
compounds designated by Roche as Memory Compounds with respect to which
Roche has assumed all preclinical and clinical development pursuant to
Section 2.2hereof and (ii) Products with respect to which Roche has
exercised its rights pursuant to Section 4.6 hereof. Roche shall use
reasonable diligence in proceeding with the development of each Product,
including obtaining required Regulatory Approvals, manufacturing,
marketing and sale of such Product in the Major Market Countries, from and
after the date Roche obtains the License related thereto.
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 a
Neurological Indication or a Psychiatric Indication as the compounds for
which Roche has obtained a License, 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 IS REQUESTED
During the [*] year period after the Effective Date, Memory agrees to
devote at least [*] FTEs to the Strategic Alliance. During the [*] year
period after the Effective Date, Memory shall use reasonable diligence to
characterize and advance development of nicotinic alpha-7 agonist
compounds for Alzheimer's disease and schizophrenia, but such diligence
shall be not less than Memory's diligence to develop nicotinic alpha-7
agonist compounds for other specific disease states.
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 Memory 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.
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.
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.
3.2 [*]
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.
ARTICLE 4. PAYMENT TO MEMORY
4.1 Technology Access Fee. Roche shall pay Memory a technology access fee of
ten million dollars ($10,000,000), which shall be non-refundable and
non-creditable, and due and payable on or before the later of twenty (20)
days after the Effective Date or five (5) days after the closing of the
purchase by Roche of Memory's Series Roche Preferred Stock as provided in
Section 4.2 hereof.
4.2 Purchase of Series Roche Preferred Stock. Contemporaneous with the
execution of this Agreement, Roche shall execute a Securities Purchase
Agreement to purchase from Memory shares of Memory's Series Roche
Preferred Stock in the aggregate amount of ten million dollars
($10,000,000), based on a purchase price of $3.60 per share, upon the
terms and conditions set forth in the Securities Purchase Agreement
attached as Exhibit B hereto.
4.3 Research and Development Support. Roche shall pay to Memory a total of six
million dollars (US $6,000,000) for research and development support,
which amount shall be non-refundable and non-creditable, and which will be
due and payable in eight (8) equal quarterly installments of seven hundred
fifty thousand dollars (US $750,000) per installment, each installment due
and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
payable within thirty (30) days after (i) the first day of each calendar
quarter after the Effective Date and (ii) receipt by Roche of an invoice
for such sums.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
4.4 Payments to Maintain Roche License Rights.
(a) Neurological Indications. Roche shall pay to Memory, in order to
maintain its license rights pursuant to Section 2.1 and the other
provisions of this Agreement with respect to such Product, the
following non-refundable and non-creditable payments upon the first
occurrence of the following events for such Product if such Product
contains a different Memory Compound then any Memory Compound
contained in the Product for which any payment has been made under
Section 4.4(b):
EVENT PAYMENT (MIO US$)
----- -----------------
[*] (or foreign equivalent)] for a Neurological [*]*
Indication and delivery of the data and reports
specified in Schedule 1
[*] (or foreign equivalent) for a Neurological [*]**
Indication and delivery of the data and reports
specified in Schedule 1]
[*] (or foreign equivalent) for a Neurological Indication [*]***
and delivery of the data and reports specified in
Schedule 1
--------
* Based upon this event occurring on or before [*]. If this event occurs
after such date, the payment shall be reduced to [*] dollars ($[*]).
** Based upon this event occurring on or before [*]. If this event occurs
after such date, the payment shall be reduced to [*] dollars ($[*]).
*** If any Product is for a Neurological Indication other than Alzheimer's
disease, then the payment shall be reduced to [*] dollars ($[*]).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(b) Psychiatric Indications. Roche shall pay to Memory, in order to
maintain its license rights pursuant to Section 2.1 and the other
provisions of this Agreement with respect to such Product, the
following non-refundable and non-creditable payments upon the first
occurrence of the following events for such Product if such Product
contains a different Memory Compound than any Memory Compound
contained in a Product for which any payment has been made under
Section 4.4(a):
EVENT PAYMENT (MIO US$)
----- -----------------
[*] (or foreign equivalent) for Psychiatric Indication [*]*
and delivery of the data and reports specified in
Schedule 1
[*] (or foreign equivalent) for a Psychiatric Indication [*]**
and delivery of the data and reports specified in
Schedule 1
[*] (or foreign equivalent) for a Psychiatric Indication [*]***
and delivery of the data and reports specified in
Schedule 1
Each payment in Section 4.4 (a) and 4.4 (b) 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, for the first occurrence of a respective event, regardless
of how many times the event may be subsequently achieved with such
Product.
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.
(c) Reduction of Milestone Payments. Notwithstanding anything to the
contrary contained in this Section 4.4, if within [*] of Memory's
receipt of a payment pursuant to Section (a) or (b) with respect to
the [*] for a Product for a Neurological Indication or a Psychiatric
Indication, Memory otherwise would be entitled to receive a payment
upon the occurrence of the same or any other event set forth in
Section (a) or (b) for another Product for a Neurological Indication
or a Psychiatric Indication, respectively, the amount of such
payment shall be reduced by [*] percent ([*]%).
(d) Limitation on Payment Reductions. Notwithstanding anything to the
contrary contained in this Section 4.4, in no event shall the
payment by Roche to Memory with respect to the occurrence of the [*]
be less than [*] dollars ($[*]) for a Product for a Neurological
Indication or [*] dollars ($[*]) for a Product for a Psychiatric
Indication.
4.5 Development Event Based Payments.
----------
* Based upon this event occurring on or before [*]. If this event occurs
after such date, the payment shall be reduced to [*] dollars ($[*]).
** Based upon this event occurring on or before [*]. If this event occurs
after such date, the payment shall be reduced to [*] dollars ($[*]).
*** If any Product is for a Psychiatric Indication other than schizophrenia,
then the payment shall be reduced to [*] dollars ($[*]).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(a) Neurological Indications. Roche shall pay to Memory with respect to
such Product the following non-refundable and non-creditable
payments upon the first occurrence of the following events for such
Product if such Product contains a different Memory Compound than
any Memory Compound contained in a Product for which any payment has
been made under Section 4.4(b) or 4.4(c):
EVENT PAYMENT (MIO US$)
----- -----------------
[*] (or a foreign equivalent) for a Neurological [*]
Indication
[*] for a Neurological Indication [*]
[*] for a Neurological Indication [*]
(b) Psychiatric Indications. Roche shall pay to Memory with respect to
such Product the following non-refundable and non-creditable
payments upon the first occurrence of the following events for such
Product if such Product contains a different Memory Compound than
any Memory Compound contained in a Product for which any payment has
been made under Section 4.4(a) or 4.4(c):
EVENT PAYMENT (MIO US$)
----- -----------------
[*] (or foreign equivalent) for a Psychiatric Indication [*]
[*] for a Psychiatric Indication [*]
[*] for a Psychiatric Indication [*]
(c) Other Indications. Roche shall pay to Memory the following
non-refundable, non-creditable payments upon the first occurrence of
the following events for a Product if such Product contains a
different Memory Compound than any Memory Compound contained in a
Product for which any payment has been made under Sections 4.4(a) or
4.4(b):
EVENT PAYMENT (MIO US$)
----- -----------------
[*] (or foreign equivalent) for an Other Indication [*]
[*] for an Other Indication [*]
[*] for an Other Indication [*]
Each payment in Section 4.5(a) and 4.5(b) 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, for the first occurrence of a respective event, regardless
of how many times the event may be subsequently achieved with such
Product.
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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
4.6 Early Exercise of Rights. If, at any time after the Initiation of Phase I
with respect to a Product for a Neurological Indication or a Psychiatric
Indication and prior to the earlier of the [*] related thereto and the
date that is five (5) years after the Effective Date, Roche desires to
obtain the license rights as described in Section 2.1 hereof with respect
to a compound for a Neurological Indication or Psychiatric Indication, (i)
Roche shall give written notice thereof to Memory and (ii) Memory shall
provide to Roche, during any calendar year, for evaluation purposes only,
all test results, data (e.g., in vivo data, safety data and
structure-activity relationship data) and applicable Memory Patent Rights
relating to up to [*] compounds which are nicotinic alpha-7 agonists in
preclinical development by Memory as may be selected by Roche. Within the
sixty (60) day period following receipt by Roche of such items with
respect to each compound, Roche may designate such compound to obtain a
License to such compound. Roche shall then pay to Memory a one-time
payment of [*] percent ([*]%) all unpaid License Rights Maintenance Fees
with respect to such Product; and thereupon Roche shall obtain a License
with respect to such Product. Thereafter, Roche shall pay to Memory the
remaining [*] percent ([*]%) of the License Rights Maintenance Fees with
respect to such Product as and when provided in Section 4.4, except the
events for payments by Roche specified in Section 4.4 shall not include
the delivery of any data or reports. From and after the date of such
notice, Roche shall be responsible for and pay all costs and expenses
relating to the continued development of such Product, including obtaining
all Regulatory Approvals with respect thereto.
In the event that, within [*] years after the Effective Date, Memory has
not [*] with respect to any Product, Roche shall thereafter have the right
pursuant to this Section 4.6 to have Memory provide to Roche, during any
calendar year, for evaluation purposes only, all test results, data (e.g.,
in vivo data, safety data and structure-activity relationship data) and
applicable Memory Patent Rights relating to an unlimited number of
compounds which are nicotinic alpha-7 agonists in preclinical development
by Memory as may be selected by Roche. Within the sixty (60) day period
following receipt by Roche of such items with respect to each compound,
Roche may designate such compound to obtain a License to such compound.
Roche shall then pay to Memory the License Rights Maintenance Fees with
respect to such Product as and when provided in Section 4.4, except the
events for payments by Roche specified in Section 4.4 shall not include
the delivery of any data or reports. From and after the date of such
notice, Roche shall be responsible for and pay all costs and expenses
relating to the continued development of such Product, including obtaining
all Regulatory Approvals with respect thereto.
ARTICLE 5. ROYALTIES
5.1 Royalties. Roche shall pay to Memory the following payments for a given
Product having a Regulatory Approval for a Neurological Indication, based
upon the Net Sales of such Product, which such Net Sales shall be subject
to adjustment as provided in this Article 5. Such royalty payments shall
be calculated by multiplying the following percentages by the following
annual Net Sales of such Product (all Net Sales amounts in $ US million):
ANNUAL NET SALES PERCENT (%) OF NET SALES
---------------- ------------------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
By way of illustration, assume in calendar year 2012 that (i) Net Sales of
the Product total $[*] and (ii) no adjustments or deductions to payments
under this Article 5 apply. The royalties due and payable by Roche to
Memory for such Net Sales would be $[*], calculated as follows:
APPLICABLE SALES-BASED AMOUNT PAYABLE (IN
NET SALES (IN MILLIONS) PAYMENT PERCENTAGE MILLIONS)
----------------------- ------------------ ---------
US$[*] [*]% US$[*]
US$[*] [*]% US$[*]
US$[*] [*]% US$[*]
US$[*] [*]% US$[*]
US$[*] US$[*]
5.2 Roche shall pay to Memory the following payments for a given Product
having a Regulatory Approval for a Psychiatric Indication, based upon the
Net Sales of such Product, which such Net Sales shall be subject to
adjustment as provided in this Article 5. Such royalty payments shall be
calculated by multiplying the following percentages by the following
annual worldwide Net Sales of such Product (all Net Sales amounts in $ US
million):
ANNUAL NET SALES PERCENT (%) OF NET SALES
---------------- ------------------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
5.3 Roche shall pay to Memory royalties for given Product having a Regulatory
Approval for an Other Indication, in an amount equal to [*] of the
royalties payable for a 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.
5.4 Adjustment Related to Multiple Indications. Notwithstanding anything to
the contrary contained in Section 5.1 hereof, in the event that a 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 the 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 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 another indication, the royalties payable by Roche shall be based upon
Net Sales of such Product in the Territory as if all of such Net Sales
occurred for the Psychiatric Indication; and (iii) multiple Other
Indications, then the royalties payable by Roche to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Memory shall be equal to [*] of the royalties payable under the royalty
schedule for a Product approved for a Neurological Indication.
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 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.
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 only [*] 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.
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 only [*] 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.
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 [*] or [*] 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 by greater
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).
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 entitled to any
deduction from payments due and payable to Memory under this Agreement.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
5.9 Bonus Payment. 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 first Product having Regulatory Approval for a
Neurological Indication:
EVENT PAYMENT (US$)
----- -------------
Net Sales exceed [*] dollars ($[*]) for a full calendar [*]
year (Jan. 1 - Dec. 31) during the Agreement Term
Net Sales exceed [*] dollars ($[*]) for a full calendar [*]
year (Jan 1 - Dec 31) during the Agreement Term
Roche shall pay to Memory a one-time, non-refundable and non-creditable
amount after the first occurrence of the following event with respect to
the first Product having a Regulatory Approval for a Psychiatric
Indication:
EVENT PAYMENT (US$)
----- -------------
Net Sales exceed [*] dollars ($[*]]) for a full calendar [*]
year (Jan. 1 - Dec. 31) during the Agreement Term
Net Sales exceed [*] dollars ($[*]) for a full calendar [*]
year (Jan. 1 - Dec. 31) during the Agreement Term
Each payment in this Section 5.9 shall be due and payable by Roche within
sixty (60) days after occurrence of the applicable event. Notwithstanding
anything to the contrary, payment shall be made pursuant to this Section
5.9 with respect to a Product for a Neurological Indication or a
Psychiatric Indication only if such Product contains a different Memory
Compound than any Memory Compound contained in a Product for which payment
previously has been made pursuant to this Section 5.9.
5.10 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.
5.11 Mechanisms for Adjustments. In no event shall any adjustments pursuant to
Sections 5.6, 5.7 and 5.8 result in Memory receiving royalties for a given
calendar quarter pursuant to Sections 5.1, 5.2 and 5.3 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
ARTICLE 6. PAYMENT, REPORTING, AUDITING
6.1 Currency and Conversion.
(a) 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.
(b) Whenever calculation of Net Sales requires conversion from any
foreign currency, Roche shall convert the amount of Net Sales 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.
(c) 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.
6.2 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.
With each such payment, Roche shall deliver to Memory the following
information split between the US and the ROW Territory:
(a) Adjusted Gross Sales for each Product;
(b) Net Sales for each Product;
(c) the royalty payments due to Memory for the reporting period;
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.
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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
6.3 Taxes.
(a) Memory shall pay all applicable taxes levied on Memory under this
Agreement.
(b) 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.
6.4 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.
6.5 Accounting.
(a) 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.
(b) 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.
(c) 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, employed by Memory and at Memory's
own expense, to perform such appropriate audit procedures.
(d) 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
calendar year to which each shall pertain. Audit results shall be
shared by Roche and Memory.
(e) 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.
(f) 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.
ARTICLE 7. GOVERNANCE
7.1 The Strategic Alliance. The Parties hereby establish a Strategic Alliance
with respect to the development of Products and the determination of
licensing rights with respect thereto.
7.2 Joint Liaison Team. A Joint Liaison Team ("JLT") shall govern the research
and development activities of the Strategic Alliance, including preparing
development plans, supervising ongoing research and development
activities, recommending actions in response to unforeseen events,
supervising the transition of development and manufacturing 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).
(a) Organization. The JLT shall consist of five (5) members, two (2)
members to be designated by Roche and three (3) members to be
designated by Memory. 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 JLT and designate a
replacement at any time by giving prior written notice of the
withdrawal and identifying the replacement to the other Party. The
chairperson of the JLT shall be from Memory.
(b) Meetings. The JLT shall hold semi-annual meetings on mutually
agreeable dates, with the location of the meetings to alternate
between Memory and Roche, or their Affiliate's, facilities. The
frequency and location of such meetings may be modified by mutual
agreement of the Parties. Notwithstanding the foregoing, one of the
semi-annual meetings per year may be held by videoconference. Each
Party shall pay its own expenses associated with the meeting. Each
Party may, in its discretion, invite non-member employees to attend
meetings of the JLT.
(c) Decision-Making. Decisions of the JLT shall be by consensus, with
each Party having one collective vote. If the JLT is unable to
decide a matter by consensus, the Parties shall refer such matter
for resolution to the Head of Global Research or the Head of Global
Development on behalf of Roche and the Chief Scientific Officer of
Memory ("Alliance
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Executives"). If the Alliance Executives are unable to resolve any
such matter after good faith discussions, then the final decision
shall rest with Memory.
(d) Dissolution. The JLT automatically shall be dissolved upon the end
of the last to expire License Exercise Period, unless the Parties
otherwise agree in writing.
7.3 Research and Development Activities. Subject to the provisions of Section
3.1 and the oversight of the JLT, Memory shall conduct, at its cost except
as provided in Section 4.3 those research and development activities
through the End of Phase IIa with respect to the Products that Memory
deems necessary or appropriate.
During the five (5) year period after the Effective Date, Memory shall
obtain the prior written consent of Roche (which consent shall not be
unreasonably withheld) before Memory shall commence the Initiation of
Phase I with respect to more than [*] nicotinic alpha-7 agonist compounds.
7.4 Progress Reports. Within fifteen (15) days after the end of each calendar
quarter, Memory shall prepare and deliver to Roche a written progress
report for the JLT summarizing in reasonable detail the results to date of
the Strategic Alliance, although Memory shall have no obligation to
disclose any compound structures until the Initiation of Phase I with
respect to such compound, except for Memory's obligation to provide such
information to Roche pursuant to Section 2.2 or Section 4.6 hereof. In
addition, upon request, Roche shall have the right to receive copies of
the raw data from all test results of nicotinic alpha-7 agonist compounds.
After each meeting, the JLT shall prepare a report summarizing the
discussions held and conclusions reached and setting forth plans for the
Strategic Alliance for the next six (6) months.
ARTICLE 8. CLINICAL DEVELOPMENT
8.1 Development. Memory, at its sole cost except as provided in Section 2.5,
shall pursue clinical development of each Product through the date that
Roche obtains a License with respect to such Product and, subject to the
provisions of Section 3.1 hereof and oversight of the JLT, shall have sole
control of all such clinical development activities. Roche, at its sole
cost except as provided in Section 2.5, shall (1) pursue clinical
development of each Product from and after the date that Roche obtains a
License with respect to such Product and, subject to the provisions of
Section 3.1 hereof and oversight of the DRT, be responsible for all such
clinical development activities, and (2) obtain all government and health
authority approvals which are required for Products to be manufactured and
offered for sale in the Territory, including authorizations as may be
required for the production, importation, pricing, reimbursement, and sale
of Products in the Territory.
8.2 Development Review Team.
(a) Development Review Team Membership. For a given Product, no later
than sixty (60) days after the End of Phase IIa for a Product, the
Parties shall establish a Development Review Team (the "DRT")
consisting of up to three (3) representatives from Roche and one (1)
representative of Memory. Each Party may select alternative
representatives to replace its DRT members selected by such Party as
necessary, and may have other representatives attend meetings of the
DRT in addition to the representatives of the Team. All guidance
provided by the DRT shall be based upon the majority opinion of the
DRT.
(b) DRT Meetings and Responsibilities. No less than two times per year
for so long as the DRT contemplates clinical development of a Memory
Compound in the Territory for the
[*] CONFIDENTIAL TREATMENT IS REQUESTED
purpose of obtaining Regulatory Approval in a country of the
Territory. Roche shall organize meetings of the DRT.
At its meetings, the DRT shall conduct a peer review of Roche's
development of Products in the Territory and shall provide Roche
with strategic guidance with respect to Roche's development of
Products in the Territory.
Roche shall report to the DRT on all significant clinical and
regulatory issues relating to Products, and the DRT shall make
recommendations and provide strategic guidance with respect to such
issues.
(c) Costs. Each party shall be responsible for bearing its own costs
related to the DRT.
ARTICLE 9. REGULATORY APPROVALS
Memory, at its sole cost, except as provided in Section 4.3, shall pursue all
Regulatory Approvals in the Territory related to each Product through the date
that Roche obtains a License with respect to such Product. Roche, at its sole
cost, shall pursue all Regulatory Approvals in the Territory related to each
Product from and after the date that Roche obtains a License with respect to
such Product, including the preparation and filing of applications for
Regulatory Approvals, as well as any or all governmental approvals required to
manufacture, or have manufactured, and sell Products. Roche shall be responsible
for pursuing, compiling and submitting all regulatory filing documentation, and
for interacting with regulatory agencies, for all Products in all countries in
the Territory. Roche or its Affiliates shall own and file all regulatory filings
and Regulatory Approvals for all Products in all countries of the Territory.
Roche shall supply Memory with a copy of all material communications related to
Product to or from the regulatory agencies for all Major Market Countries. Upon
request of Memory, Roche shall supply Memory with a copy of all such
communications in all countries.
Roche, at its sole cost, shall report to appropriate authorities in accordance
with local requirements all adverse events related to use of Products worldwide.
Adverse events related to the use of Product worldwide shall be in a single
database, centralized, held and owned by Roche. Roche shall notify Memory of
material adverse events related to Products.
ARTICLE 10. MANUFACTURE AND SUPPLY
10.1 Clinical Supplies of Product. Memory shall supply at its own cost all
clinical supply of each Product and placebo to be used in the Territory
through the date that Roche obtains a License with respect to such
Product, either by itself or through a Third Party. Roche shall supply at
its own cost all clinical supply of each Product and placebo to be used in
the Territory from and after the date that Roche obtains a License with
respect to such Product and during the remainder of the Agreement Term,
either by itself or through a Third Party. Roche's requirements for
supplying Product necessary to fill orders for sales for any particular
calendar quarter shall take precedence over providing clinical supplies of
the Product to Memory for that calendar quarter. The Parties shall
cooperate in all reasonable respects relating to the transition of
manufacturing activities from Memory to Roche. (For example, Roche will
need Memory to continue to provide clinical supplies of the Product during
this transition period.)
10.2 Commercial Supply. Roche shall be solely and exclusively responsible at
its own expense for the manufacture and supply of Product for sale in the
Territory, either by itself or through Third Parties.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
ARTICLE 11. COMMERCIALIZATION
Except as expressly set forth in Section 2.5, Roche, at its own expense, shall
have sole responsibility and decision making authority for the marketing,
promotion, sale and distribution of Product in the Territory. During the
Agreement Term, upon written request of Memory not to exceed once per year,
Roche will fully inform Memory regarding the commercialization of Products in
the Territory by Roche, its Affiliates and sublicensees.
ARTICLE 12. TRADEMARKS
Roche shall own worldwide all trademarks on and in connection with Products, and
shall, at its cost, be responsible for procurement, maintenance and enforcement
of all worldwide trademarks registration on and in connection with Products.
ARTICLE 13. OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
13.1 Ownership of Intellectual Property. Ownership of any Patent Rights
developed in the course of the Strategic Alliance shall be determined in
accordance with United States federal law. Memory shall own all Inventions
having as inventors only employees, consultants or agents of Memory or its
Affiliate. Memory shall require all of its employees, consultants and
agents to assign all inventions related to Products made by them to
Memory.
13.2 Patent Prosecution and Maintenance.
(a) General. Memory shall have the right, but not the obligation, to
prepare, file, prosecute (including interference and opposition
proceedings) and maintain (including interferences, re-examination
and opposition proceedings) (collectively, "Handle") the Memory
Patent Rights.
Should Memory decide that it does not desire to Handle a Memory
Patent Right in a given country, it shall provide written notice to
Roche thereof no less than sixty (60) days prior to the date when
the Memory Patent Right would become abandoned in such country.
After receiving such notice, Roche may, but is not obligated, to
Handle the Memory Patent Right in such country.
(b) Memory Prosecution Obligations Prior to Roche Exercise. Prior to
Roche exercising its right to obtain a License pursuant to Section
2.1 hereof, Memory shall have no obligation to consult Roche with
respect to prosecution or maintenance of any Memory Patent Rights.
However, Memory shall have an obligation to keep Roche informed
generally as to the status of any pending patent applications and
issued patents. Memory will provide Roche with updates as to the
status of Memory's patent prosecution on a regular basis (but no
less than once per quarter).
(c) Memory Prosecution Obligations After Roche Exercise. After Roche has
exercised its right to obtain a License pursuant to Section 2.1
hereof, Roche shall reimburse Memory, on a patent-by-patent basis,
as to any Memory Patent Rights Covering the Product for which Roche
has exercised its right to a License for fifty percent (50%) of any
reasonable and documented external costs for Handling such patent or
patent application incurred after the date Roche obtained such
License.
If Roche obtains a License with respect to any Patent Rights
Covering a Product, then:
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(A) Memory shall use reasonable efforts to consult with Roche as
to the Handling of any Memory Patent Rights in sufficient time
(for example, thirty (30) days for instances where actions are
due within three (3) months of a communication from a Patent
Office) before any action is due to allow Roche to provide
comments thereon, which comments Memory must reasonably
consider if provided to Memory at least thirty (30) days
before such action is due.
(B) Memory shall promptly notify and consult with Roche regarding
any priority patent application ("Invention Priority
Application") Covering such Product before filing said
application.
(C) Memory shall promptly prepare and send to Roche a draft of the
Invention Priority Application for the Roche's comment and
approval, which shall be provided within thirty (30) days
after receipt of such draft Invention Priority Application
("Comment Period").
(D) After reasonably considering Roche's comments, Memory shall
file the Invention Priority Application. If Roche fails to
provide comments on a draft within the Comment Period, Memory
shall be free to file the Application at the end of the
Comment Period or later.
(E) Within nine (9) months after the filing of an Invention
Priority Application, Memory shall provide Roche a written
list of countries ("Country List") in which Memory intends to
file patent applications that claim priority from the given
Invention Priority Application. Roche, as promptly as
practicable, shall notify Memory in writing of those countries
on the Country List and any additional countries ("Additional
Countries") where Roche requests that patent applications be
filed. In turn, Memory promptly shall notify Roche if it
agrees with the filing of applications in such Additional
Countries selected by Roche.
(F) Memory shall file patent applications at least in those
countries where Roche and Memory agree to the filing of patent
applications ("Mutually Agreed to Countries") as well as in
Additional Countries selected by Roche that are not within the
Mutually Agreed to Countries, provided that Roche shall
reimburse Memory for the reasonable external prosecution costs
in the Additional Countries. Memory shall have the option of
filing an international application designating at least the
Mutually Agreed to Countries, to be followed by national
filings in the desired countries.
(G) Memory shall be responsible for the filing and prosecution of
the patent applications and the maintenance of the granted
patents as to the Mutually Agreed to Countries. Memory and
Roche each will pay fifty percent (50%) of the reasonable
external costs relating to the preparation, filing and
prosecution of the patent applications and the maintenance of
the granted patents.
(H) As to those countries where Roche and Memory do not agree to
the filing of patent applications, the Party requesting the
filing in said country shall be responsible for all costs
relating to the filing and prosecution of the patent
applications and the maintenance of the granted patents in
said countries.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(I) Should Roche not respond to Memory within thirty (30) days
after the date Memory provides the Country List, then Memory
shall be free to initiate patent filings, at Memory's sole
expense and discretion, in the countries Memory has selected
or still selects.
(J) Memory's failure to notify Roche to the contrary within thirty
(30) days after the date upon which Roche notifies Memory of
the Additional Countries will be deemed an agreement on the
part of Memory to file patent applications in all such
Additional Countries and to pay fifty percent (50%) of the
reasonable external costs associated with such filings.
(K) If, in a country, at any time, Roche decides not to continue
funding the prosecution of a patent application or maintenance
of a patent under this Section 13.2, Roche shall notify Memory
in writing ("Withdrawal Notice"), and Roche shall be relieved
from paying any further expenses with regard to the patent
filing in the country. After receiving the Withdrawal Notice,
Memory may but is not obligated, at its sole expense and
discretion, to continue to prosecute and maintain the patent
filing in the country.
(L) If, in a country, at any time, Memory decides not to continue
the prosecution of a patent application or maintenance of a
patent under this Section 13.2, and such patent application or
patent is not one as to which Roche has already sent a
Withdrawal Notice, then Memory shall notify Roche in writing
no less than sixty (60) days prior to the date when the patent
application or patent would become abandoned in such country.
At Roche's written request and no cost to Memory, Memory shall
then assign to Roche such patent application or patent in such
country, and Roche may thereafter continue to prosecute and
maintain the patent filing in the country, at Roche's own cost
and in Roche's name, to the extent Roche desires to do so.
(M) For the Mutually Agreed to Countries and Additional Countries,
Memory shall consult with Roche as to the prosecution and
maintenance of all patent applications and patents claiming
Inventions in sufficient time (for example, thirty (30) days
for instances where actions are due within three (3) months of
a communication from a Patent Office) before any action is due
to allow Roche to provide comments thereon, which comments
Memory must reasonably consider.
13.3 Prosecution Costs. Memory shall be solely responsible for payment of the
reasonable costs to Handle the Memory Patent Rights, except as otherwise
provided in Section 13.2 above.
13.4 Cooperation. The Parties agree to cooperate in the preparation,
prosecution and maintenance of all patent applications filed under Article
13, including obtaining and executing necessary powers of attorney and
assignments by the named inventors, providing relevant technical reports
to Memory concerning the invention disclosed in such patent application,
obtaining execution of such other documents which shall be needed in the
filing and prosecution of such patent applications, discussing in good
faith foreign filing strategy, and, as requested, updating each other
regarding the status of such patent applications.
13.5 Infringement. Each Party shall promptly provide written notice to the
other Party during the Agreement Term of any known infringement or
suspected infringement of any Memory Patent Right by a Third Party making,
using, offering for sale, selling, or importing a compound which
[*] CONFIDENTIAL TREATMENT IS REQUESTED
is a nicotinic alpha-7 agonist or a product containing a compound which is
a nicotinic alpha-7 agonist (collectively "NA7 Infringement").
After Roche has exercised its right to obtain a License with respect to a
Product, Roche shall have the first right to bring and control any action
or proceeding with respect to NA7 Infringement relating to a Memory Patent
Right Covering such Product at Roche's own expense and by counsel of its
own choice, and Memory shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice. If Roche
fails to bring any such action or proceeding with respect to NA7
Infringement within (a) [*] days following the notice of alleged
infringement or (b) [*] days before the time limit, if any, set forth in
the appropriate laws and regulations for the filing of such actions,
whichever comes first, Memory shall have the right to bring and control
any such action at its own expense and by counsel of its own choice, and
Roche shall have the right, at its own expense, to be represented in any
such action by counsel of its own choice.
A Party that elects to bring and control an infringement action pursuant
to this Section 13.5 shall provide prompt written notice to the other
Party of any such suit commenced or action taken by such Party.
Upon written request, the Party bringing suit or taking action
("Initiating Party") shall keep the other Party informed of the status of
any such suit or action and shall provide the other Party with copies of
all substantive documents and communications filed in such suit or action.
The Initiating Party shall have the sole and exclusive right to select
counsel for any such suit or action.
The Initiating Party shall, except as provided below, pay all expenses of
the suit or action, including, without limitation, the Initiating Party's
attorneys' fees and court costs. Prior to Roche exercising its right to
obtain a License with respect to the Product that is the subject of the
suit or action, Memory shall pay attorneys' fees and court costs and shall
be entitled to retain any damages, settlement fees or other consideration
received as a result of such suit or action. After Roche has exercised its
right to obtain a License with respect to the Product which is the subject
of such suit or action, the Parties' attorneys' fees and court costs in
connection with any such suit or action shall be deducted from any
damages, settlement fees or other consideration received as a result of
such suit or action and the balance thereof shall belong to the Initiating
Party, except to the extent such damages, settlement fees or other
consideration are attributable to lost profits with respect to Products in
the Territory, in which case the Parties shall share in such recovery as
follows: (i) if Memory has exercised its co-promotion right with respect
to such Product, Memory shall receive [*]% of the lost profits for such
Product and Roche shall receive the remaining [*]%; or (ii) if Memory has
not exercised its co-promotion right with respect to such Product, Memory
shall receive the royalty that it would have pursuant to Article 5 had the
infringing sales been made by the Parties, and Roche would receive the
balance of the recovery.
If the Initiating Party believes it reasonably necessary, upon written
request to the other Party, the other Party shall join as a party to the
suit or action but shall be under no obligation to participate except to
the extent that such participation is required as the result of its being
a named party to the suit or action. At the Initiating Party's written
request, the other Party shall offer reasonable assistance to the
Initiating Party at no charge to the Initiating Party except for
reimbursement of reasonable out-of-pocket expenses incurred by the other
Party in rendering such assistance. The other Party shall have the right
to participate and have its own representation in any such suit or action
at its own expense.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Prior to Roche obtaining a License with respect to the Product which is
the subject of such suit or action, Memory shall have the sole right to
control any settlement and all negotiations relating thereto. After Roche
has exercised its right to obtain a License with respect to the Product
which is the subject of suit or action, the Initiating Party shall have
the right to control settlement; provided, however, that no settlement
shall be entered into without the written consent of the other Party, not
to be unreasonably withheld.
For the avoidance of doubt, Memory shall have the right, but not the
obligation, to bring and control any action or proceeding with respect to
any Memory Patent Right relating to infringement other than NA7
Infringement, at its own expense, without obligation or notice to Roche.
13.6 Xxxxx-Xxxxxx. Notwithstanding anything to the contrary, should a Party
receive a certification for a Product pursuant to the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417),
as amended, or its equivalent in a country other than the US, then such
Party shall immediately provide the other Party with a copy of such
certification. Prior to Roche exercising its right to obtain a License
which respect to a Product, then Memory shall have the sole right to
enforce Memory Patent Rights Covering such Product. After Roche has
exercised its right to obtain a License with respect to a Product, then
Roche shall have the right to enforce Memory Patent Rights Covering such
Product; and Roche shall have [*] days from the date on which it receives
or provides a copy of such certification to provide written notice to
Memory ("H-W Suit Notice") whether Roche will bring suit, at its expense,
within a [*] day period from the date of such certification. Should such
[*] day period expire without Roche bringing suit or providing such H-W
Suit Notice, then Memory shall be free to immediately bring suit in its
name. If Roche brings suit, at Roche's written request, Memory agrees to
be named as a party to such suit.
13.7 Patent Notices. All notices provided under this Article 13 to Roche shall
be given to:
X.Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx, Xxxxxxxxxxx
Attn: Head, Patent Law
with copies of all notices relating to U.S. cases to:
Xxxxxxxx-Xx Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attn: Chief Patent Counsel
All notices provided under this Article 13 to Memory shall be given to:
Memory Pharmaceutical Corp.
000 Xxxxxxx Xxxxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attn: Head of Business Development
With copies of all notices to:
Millen, White, Xxxxxx and Xxxxxxxx, P.C.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Arlington Courthouse, Plaza I
0000 Xxxxxxxxx Xxxx, Xxxxx 0000
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxxx Xxxxxx, Esq.
ARTICLE 14. REPRESENTATIONS AND WARRANTIES
14.1 Representations and Warranties of Both Parties. Each Party warrants and
represents to the other Party that it has the full right and authority to
enter into this Agreement and that it is not aware of any impediment which
would inhibit its ability to perform the terms and conditions imposed on
it by this Agreement.
14.2 Representations and Warranties of Memory.
(a) Corporate Action. Memory represents and warrants to Roche that all
corporate action on the part of Memory, its officers, directors and
stockholders necessary for (i) the authorization, execution and
delivery of this Agreement and (ii) the performance of all
obligations of Memory hereunder has been taken and this Agreement
constitutes the legal and binding obligation of Memory, enforceable
against Memory in accordance with its terms.
(b) No Conflict. Memory represents and warrants to Roche that the
execution of this Agreement and the performance of the transactions
contemplated by this Agreement by Memory will not conflict with or
result in a breach of any of the terms, conditions or provisions of,
or constitute a default under any agreement or other instrument to
which Memory is a party or by which it or any of its property is
bound.
(c) Right to Grant Licenses. Memory represents and warrants to Roche
that it has the right to xxxxx Xxxxx the licenses and sublicenses
that Memory hereby grants to Roche under this Agreement.
(d) Third Party Patent Infringement. Memory represents and warrants that
as of the Effective Date, to its actual knowledge of its senior
executives, after consultation with patent counsel, there is no
issued patent right owned or controlled by any Third Party which
Covers the lead compounds of the Program identified by Memory to
Roche and would prevent Roche from selling such Memory Compound in
any country of the Territory. As of the date hereof, the Memory
Patent Rights in existence as of the Effective Date are owned
exclusively by Memory; and Memory's senior executives, after
consultation with patent counsel, have no actual knowledge of any
information that would, in their opinion, render invalid and/or
unenforceable Composition of Matter Claims for the lead compounds of
the Program in such Memory Patent Rights.
(e) No Material Mistatements. Memory warrants and represents to Roche
that (i) its senior executives have not intentionally failed to
disclose any information actually known to them which in their
reasonable opinion, would be material to Roche entering into this
Agreement, and to the actual knowledge of such senior executives
such information does not contain any untrue statement of material
fact or omit to state a material fact; (ii) it has provided correct
and complete copies of all documents furnished to Roche.
14.3 Representations and Warranties of Roche. Roche represents and warrants to
Memory that all corporate action on the part of Roche, its officers,
directors and stockholders necessary for (i) the
[*] CONFIDENTIAL TREATMENT IS REQUESTED
authorization, execution and delivery of this Agreement and (ii) the
performance of all obligations of Roche hereunder has been taken and this
Agreement constitutes the legal and binding obligation of Roche,
enforceable against Roche in accordance with its terms. The execution of
this Agreement and the performance of the transactions contemplated by
this Agreement by Roche will not conflict with or result in a breach of
any of the terms, conditions or provisions of, or constitute a default
under any agreement or other instrument to which Roche is a party or by
which it or any of its property is bound.
14.4 Disclaimer. THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF
ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN.
MEMORY AND ROCHE DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES,
WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH,
DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT
LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR
MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL
OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS. IN NO EVENT SHALL EITHER
MEMORY OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT,
TORT OR ANY OTHER LEGAL THEORY.
ARTICLE 15. CONFIDENTIAL INFORMATION
15.1 Treatment of Confidential Information. In carrying out rights and
obligations under this Agreement, the Parties will be sharing proprietary
information ("Confidential Information") with each other. Except as
permitted by this Agreement, each Party shall and shall cause its
Affiliates to treat Confidential Information received from the other Party
as it treats its own proprietary information. In particular, it shall not
disclose, divulge or otherwise communicate such Confidential Information
to Third Parties, or use it for any purpose except pursuant to and in
order to carry out its obligations under this Agreement during the
Agreement Term and for a period of [*] years thereafter; provided that,
each Party (i) may disclose the Confidential Information to such of its
directors, officers, employees, Affiliates, consultants, subcontractors,
sublicensees or agents to the extent reasonably necessary to carry out its
obligations under this Agreement, and (ii) hereby agrees to exercise every
reasonable precaution to prevent and restrain the unauthorized disclosure
or use of Confidential Information.
15.2 Release from Restrictions. The provisions of Section 15.1 shall not apply
to any Confidential Information which:
(a) was known or used by the Receiving Party or its Affiliates prior to
its date of disclosure to the Receiving Party or its Affiliates by
the Disclosing Party or its Affiliates, as evidenced by the prior
written records of the Receiving Party or its Affiliates; or
(b) either before or after the date of the disclosure to the Receiving
Party or its Affiliates, is lawfully disclosed to the Receiving
Party or its Affiliates by a Third Party rightfully in possession of
the Confidential Information; or
(c) either before or after the date of the disclosure to the Receiving
Party or its Affiliates, becomes published or generally known to the
public through no fault or omission on the
[*] CONFIDENTIAL TREATMENT IS REQUESTED
part of the Receiving Party or its Affiliates, but such
inapplicability applies only after such information is published or
becomes generally known; or
(d) is independently developed by the Receiving Party or its Affiliates
without reference to or reliance upon any Confidential Information
of the Disclosing Party or its Affiliates; or
(e) is reasonably determined to be required to be disclosed by the
Receiving Party or its Affiliates to comply with applicable
securities or other laws, to defend or prosecute litigation or to
comply with governmental regulations, provided that, the Receiving
Party or its Affiliates uses all reasonable efforts to provide prior
written notice of such disclosure to the Disclosing Party or its
Affiliates and to take reasonable and lawful actions to avoid or
limit such disclosure; or
(f) is disclosed to a Party's financial sources or potential acquirors
of its stock or assets (directly or indirectly) so long as, with
respect to a potential purchase the potential acquirer or financial
source executes a confidentiality agreement which is at least as
restrictive as the provisions of this Article 15.
15.3 Exceptions. The restrictions set forth in this Article 15 shall not
prevent either Party from (i) preparing, filing, prosecuting or
maintaining a patent application or its resulting patents related to a
Product in accordance with the terms of this Agreement or (ii) disclosing
Confidential Information to governmental agencies to the extent required
or desirable to secure government approval for the development or
marketing of a Product.
15.4 Publications. During the Agreement Term, the following provisions shall
apply with respect to the disclosure in scientific journals, publications
or scientific presentations by any Party relating to any scientific work
performed as part of the Strategic Alliance:
(a) A Party (the "Publishing Party") shall provide the other Party with
a copy of any proposed publication relating to the work performed
and/or the results achieved in the conduct of the Strategic Alliance
at least forty-five (45) days prior to submission for publication so
as to provide such other Party an opportunity to recommend any
changes it reasonably believes are necessary to preserve the
Confidential Information belonging in whole or in part to such other
Party, and the incorporation of such recommended changes shall not
be unreasonably refused;
(b) If such other Party in writing notifies ("Notice") the Publishing
Party, within forty-five (45) days of receipt of the copy of the
proposed publication, that such publication in its reasonable
judgment (i) contains an Invention for which the other Party
reasonably desires patent protection or (ii) disclosure to
competitors could be expected to have a material adverse effect on
the commercial value of any Confidential Information, the Publishing
Party shall prevent such publication or delay such publication for a
mutually agreeable period of time. In the case of Inventions, a
delay shall be for a period reasonably sufficient to permit the
timely preparation and filing of a patent application(s) or
application(s) on the Invention, and in no event less than ninety
(90) days from the date of Notice.
ARTICLE 16. TERM AND TERMINATION
16.1 Conditions Subsequent. If the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act
of 0000 (xxx "XXX Xxx") applies to the transactions contemplated by this
Agreement, the effectiveness of this
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Agreement and the transactions contemplated hereunder shall be subject to
and shall be contingent upon the satisfaction under the following
condition subsequent to the execution of this Agreement. The condition
subsequent shall be the earlier to occur of (i) approval of the
transaction by the Federal Trade Commission or the appropriate US
anti-trust authorities or (ii) the expiration or termination of all
applicable waiting periods, requests for information (and any extensions
thereof) under the HSR Act.
Subject to the terms and conditions of this Agreement, each Party shall
use all reasonable efforts to take, or cause to be taken, all reasonable
actions and to do, or cause to be done, all things necessary and
appropriate to satisfy the condition subsequent and to consummate the
transactions contemplated by this Agreement in accordance with the terms
hereof.
Each Party shall cooperate with the other Party in the preparation,
execution and filing of all documents that are required or permitted to be
filed on or before the Effective Date for the purpose of consummating this
transaction, including, filings pursuant to the Xxxx-Xxxxx-Xxxxxx
Antitrust Improvements Act of 1976. Each Party shall bear its own costs
with respect to preparing, executing and filing such documents.
16.2 Agreement Term. The Agreement Term shall commence on the Effective Date
and end, unless earlier terminated upon the mutual agreement of the
Parties or in accordance with the provisions of this Article 16, on the
date of expiration of all royalty and other payment obligations (the
"Expiration Date") under this Agreement. Upon the occurrence of the
Expiration Date, if any, the Licenses granted to Roche by Memory under
this Agreement to make, have made, use, offer for sale, sell and import
Products shall be fully paid-up.
16.3 Termination for Breach. (a) Each Party ("Non-Breaching Party") shall be
entitled to terminate this Agreement by written notice to the other Party
("Breaching Party") in the event that the Breaching Party is in default of
any of its material obligations hereunder and fails to remedy such default
within sixty (60) days (thirty (30) days for payment defaults) after
provision of written notice thereof by the Non-Breaching Party. Any such
notice shall specifically state that the Non-Breaching Party intends to or
reserves the right to terminate this Agreement in the event that the
Breaching Party shall fail to timely remedy the default.
The effective date of termination under this Section for breach of a
material obligation shall be the date sixty (60) days after provision of
written notice thereof by the Non-Breaching Party.
In the event Roche does not pay any full payment by reason of a good faith
dispute as to whether such payment is due pursuant to the terms of this
Agreement, Memory shall not have the right to terminate this Agreement as
a result of such nonpayment until resolution of the dispute.
16.4 Roche's Right to Terminate.
(a) Roche shall have the unilateral right to elect not to maintain its
license rights with respect to any Product pursuant to Section 2.1
hereof, on a Product-by-Product basis, upon the occurrence of each
event described in Section 4.4 hereof with respect to such Product.
Roche may exercise such right by giving written notice thereof to
Memory within thirty (30) days after the occurrence of such event.
In the event Roche exercises such right, Roche shall not have any
obligation to make the payment to Memory related to such event and
shall not have the right to obtain a License with respect to such
Product, and this Agreement shall terminate with respect to such
Product and Roche shall have no
[*] CONFIDENTIAL TREATMENT IS REQUESTED
further obligation to make any payments pursuant to Sections 4.4 and
4.5 and Article 5 hereof relating to such Product.
(b) Roche shall have the unilateral right to terminate this Agreement on
a region-by-region basis (the regions being North America (US and
Canada), Europe and Asia)) or Product-by-Product, either on a
worldwide basis or as to North America (US and Canada) only or
ex-North America only, at any time by providing six (6) months prior
written notice to Memory; provided, however, that if the Parties do
not agree as to a proposed sublicense for which Memory has withheld
consent, Roche shall have a unilateral right to terminate this
Agreement for the territory to which such proposed sublicense
relates. Notwithstanding the preceding sentence, if there has been a
launch of a Product in a Major Market Country, then such prior
notice must be for twelve (12) months. The effective date of
termination under this Section shall be the date six (6) months (or
twelve (12) months as the case may be) after Roche provides such
written notice to Memory.
16.5 Consequences of Termination.
Upon (a) any termination of this Agreement in its entirety pursuant to
Section 16.2, (b) termination of this Agreement by Roche of this Agreement
in its entirety or in a region or country or in respect of a Product
pursuant to Section 16.4 hereof, or (c) termination of this Agreement by
Memory in its entirety or in a region pursuant to Article 3, any and all
rights and licenses of any kind or nature granted by Memory to Roche under
this Agreement (or, as applicable, with respect to termination of this
Agreement as to a country, region or Product, respectively) shall
terminate on the effective date of termination. In the event of any such
termination, the following shall apply.
(a) Roche shall, upon Memory's written request, assign and transfer to
Memory, or its Affiliates as requested by Memory, at no expense to
Memory, or its Affiliates, and free of any liens, pledges or
security interests other than those incurred in the
commercialization of the Product, all of Roche's right, title and
interest in and to (i) all trademarks and trademark applications
used or intended for use specifically for the relevant Product(s),
(ii) all regulatory filings (such as INDs and drug master files),
Regulatory Approvals, and clinical trial agreements (to the extent
assignable and not cancelled) for the relevant Product(s), and (iii)
all data, including clinical data, materials and information of any
kind or nature whatsoever, in Roche's possession or in the
possession of its Affiliates or its or their respective agents
related to the relevant Product(s) and (iv) all rights relating to
the infringement of Memory Patent Rights and Joint Patent Rights,
related to and necessary for the commercialization of the relevant
Product(s). Without limiting the generality of the preceding
sentence, Memory shall, upon such transfer, have the right to
disclose such filings, approvals and data to (i) governmental
agencies of the country or region to the extent required or
desirable to secure government approval for the development,
manufacturing or sale of Product in the country or region, (ii)
Third Parties acting on behalf of Memory, its Affiliates or
sublicensees, to the extent reasonably necessary or desirable for
the development, manufacture, or sale of Product in the country or
region, and (iii) Third Parties to the extent reasonably necessary
or desirable to market Product in the country or region. All such
filings, approvals and data transferred to Memory pursuant to this
Section 16.4 shall be deemed to be Memory Confidential Information.
(b) In addition, for a given Product and country or region so
terminated, or for the Territory in the case of termination of this
Agreement in its entirety, Roche hereby grants to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Memory the right to obtain a sole and exclusive, royalty bearing
license, under Roche Patent Rights and Roche Know-How Covering the
Product and Roche trademarks used or intended for use in connection
with the sale of Product, to make, have made, use, offer for sale,
sell and import such Product(s) in such country, region or the
Territory, as applicable. Memory shall exercise such right by giving
written notice thereof to Roche within sixty (60) days after the
date of termination. In consideration of such license, Memory shall
pay Roche reasonable milestones and royalties consistent with
industry practices as may be mutually agreed upon by the Parties
(such royalties not to exceed [*] percent ([*]%) of Net Sales); and
if the Parties are unable to agree upon such financial terms, such
matter shall be resolved by arbitration in accordance with Article
17.
(c) Roche shall supply, or cause to be supplied, to Memory, upon
Memory's written request, Memory or its licensee's clinical and/or
commercial requirements of Product(s), pursuant to a supply
agreement to be negotiated in good faith by the parties, provided
that (i) such requirements shall be supplied to Memory or its
licensee at Roche's direct manufacturing costs and allocation of
manufacturing overhead, and (ii) Roche's supply obligation shall not
continue for more than [*] years after such termination, and (iii)
Roche shall maintain the same Product(s) quality and specifications
as immediately prior to notice of termination, and (iv) as to other
terms, such agreement shall be reasonably consistent with Roche's
other arm's length supply agreements, and (v) Memory shall use
reasonable best efforts to effect a transfer as soon as practicable
of Product(s) manufacturing activities from Roche to another
supplier. In addition, Roche shall also transfer to Memory and its
designated supplier a manufacturing transfer package that will
enable Memory or such designated supplier to manufacture the
Product(s) in a timely manner.
Roche shall take prompt actions, including the execution of such
instruments, agreements and documents, as are necessary or desirable to
effect the foregoing. It is agreed such transfers and actions shall be
completed in a manner that will permit Memory to continue without
interruption the business of developing, manufacturing, marketing and
selling the Product(s).
16.6 Royalty and Payment Obligations. Termination of this Agreement by either
Party for any reason will not release Roche from any obligation to pay
royalties or make any payments to Memory which were accrued prior to the
effective date of termination (including for sales made and Events
achieved under Article 4, prior to the date of termination). However,
termination of this Agreement by either Party for any reason will release
Roche from any obligation to pay royalties or make any payments to Memory
which would have otherwise become accrued after the effective date of
termination.
16.7 Termination for failure to satisfy the condition subsequent. Either Party
may terminate this Agreement in its entirety, upon ten (10) days prior
written notice to the other Party if the condition subsequent under
Section 16.1 has not been fulfilled by February 8, 2004, in which case,
upon termination there shall be no liabilities for obligations on the part
of either party except that Article 15 shall survive such termination and
except for any breach of Section 16.1.
16.8 Survival of Obligations. Section 2.3, Article 6, Section 13.5, Section
13.6, Section 13.7, Article 14, Article 15, Section 16.5, Section 16.6,
Section 16.8, Article 17 and Article 18, and any definitions used in such
Section or Article, shall survive the termination of this Agreement in its
entirety. Except for obligations which clearly are not intended to
continue in respect of a partial termination (including the diligence
obligation, and except as provided in Section 16.6, royalty obligations),
with respect to the region, country or Product terminated, all obligations
in this Agreement shall survive a partial termination.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
ARTICLE 17. ARBITRATION
Any dispute, controversy or claim ("Dispute") arising out of or in relation to
this Agreement, or the breach, termination or invalidity thereof, that cannot be
settled amicably by the Parties after a good faith discussion to resolve the
Dispute by the appropriate officers of the Parties, shall be submitted by either
Party to arbitration conducted in accordance with the rules then in effect of
the American Arbitration Association ("AAA"). Arbitration shall take place in
Newark, New Jersey and shall be conducted by three (3) arbitrators, one of whom
shall be designated by each Party, and the third selected by the other two (2)
arbitrators, all within the time limits established by the then existing rules
of the AAA. If the two (2) designated arbitrators are unable to agree upon a
third arbitrator by two (2) months after submission of the matter to
arbitration, the AAA shall select such third arbitrator within three (3) months
of such original submission. The written decision of the arbitrators shall be
final and binding on the parties and may be enforced in any court having
jurisdiction over the Parties or their current assets. The award rendered by the
arbitrators shall include the cost of arbitration, reasonable attorneys' fees
and reasonable costs for expert and other witnesses, and in the event of a
termination, in whole or in part, a transition procedure, including the
performance of transition services by Roche, so as to maintain the value of the
assets being transferred to Memory and, to the extent contemplated by Section
16.4, permit Memory to conduct the business being transferred to it. The parties
shall be entitled to discovery as provided in the Federal Rules of Civil
Procedure then in effect in the District of New Jersey. If the issues in dispute
involve scientific or technical matters, at least one of the arbitrators chosen
hereunder shall have educational training and/or experience sufficient to
demonstrate a reasonable level of knowledge in the Field and pharmaceutical drug
development. Notwithstanding the preceding provisions of this Article 17, with
respect to any breach or threatened breach of this Agreement of Section 15.1,
16.4 or any other provision where a Party would not be appropriately compensated
by the payment of money, a party has a right to seek injunctive relief from any
court of competent jurisdiction to enjoin such breach or threatened breach
and/or to seek specific performance.
In the event of a Dispute, a Party shall have no right to toll or delay any
obligation in this Agreement unrelated to the Dispute as a result of the
Dispute. By way of example, if Roche owes Memory $5,000,000 and claims a
$2,000,000 payment is not due by reason of breach of Memory, then Roche shall
pay the $5,000,000, and the parties will resolve such $2,000,000 Dispute
pursuant to Article 17.
ARTICLE 18. MISCELLANEOUS
18.1 Indemnification.
(a) Roche agrees to defend Memory and the other Memory Indemnified
Parties at Roche's cost and expense, and will indemnify and hold
Memory and its directors, officers, employees and agents (the
"Memory Indemnified Parties") harmless from and against any claims,
losses, costs, damages, fees or expenses arising out of or otherwise
relating to (i) activities of Roche and its Affiliates in the
conduct of the Strategic Alliance, (ii) the development,
manufacture, use, offer for sale, sale or other disposition of any
Product by Roche, its Affiliates or sublicensees, and each of their
distributors, representatives or anyone in privity therewith, or
(iii) the gross negligence or willful misconduct of Roche, its
Affiliates or sublicensees. In the event of any such claim against
the Memory Indemnified Parties by a Third Party, Memory shall
promptly notify Roche in writing of the claim (provided that any
failure or delay to notify shall not excuse any obligations of Roche
except to the extent Roche is actually prejudiced thereby) and Roche
shall solely manage and control, at its sole expense, the defense of
the claim and its settlement provided further that Roche shall not
settle any such claim, if such settlement may have an adverse effect
on Memory, without the prior written consent of Memory, which
[*] CONFIDENTIAL TREATMENT IS REQUESTED
consent shall not be unreasonably withheld. The Memory Indemnified
Parties shall cooperate with Roche and may, at their option and
expense, be represented in any such action or proceeding. Roche
shall not be liable for any litigation costs or expenses incurred by
the Memory Indemnified Parties without Roche's written
authorization.
(b) Memory agrees to defend Roche and the other Roche Indemnified
Parties at Memory's cost and expense, and will indemnify and hold
Roche and its directors, officers, employees and agents (the "Roche
Indemnified Parties") harmless from and against any claims, losses,
costs, damages, fees and expenses arising out of any claim, arising
out of or otherwise relating to (i) activities of Memory in the
conduct of the Strategic Alliance, (ii) the development,
manufacture, use, offer for sale, sale or other disposition of any
Product by Memory, its Affiliates, licensees other than Roche,
sublicensees and each of their distributors, representatives or
anyone in privity therewith (but only to the extent same is a
consequence of Section 2.5, Article 3 and/or Article 16), and (iii)
the gross negligence or willful misconduct of Memory, its
Affiliates, licensees, distributors, representatives or anyone in
privity therewith. In the event of any such claim against the Roche
Indemnified Parties by an Independent Third Party, Roche shall
promptly notify Memory in writing of the claim (provided that any
failure or delay to notify shall not excuse any obligation of Memory
except to the extent Memory is actually prejudiced thereby) and
Memory shall solely manage and control, at its sole expense, the
defense of the claim and its settlement provided further that Memory
shall not settle any such claim if such settlement may have an
adverse effect on Roche without the prior written consent of Roche,
which consent shall not be unreasonably withheld. The Roche
Indemnified Parties shall cooperate with Memory and may, at their
option and expense, be represented in any such action or proceeding.
Memory shall not be liable for any litigation costs or expenses
incurred by the Roche Indemnified Parties without Memory's written
authorization.
18.2 Publicity. Neither Party shall originate any publicity, news release or
other public announcement, written or oral, relating to this Agreement,
including its terms, without the prior approval of the other Party except
solely to the extent a Party reasonably believes same is otherwise
required by law. Such approval shall not be unreasonably withheld. Each
Party shall to the extent consistent with applicable laws and regulations
limit the disclosure of the financial terms set forth in this Agreement
(such as by requesting confidential treatment of such terms in documents
required to be filed with the US Securities and Exchange Commission).
18.3 Force Majeure. Neither Party to this Agreement shall be responsible to the
other Party for nonperformance or delay in performance of the terms or
conditions of this Agreement due to acts of God, acts of governments, war,
riots, strikes, accidents in transportation, or other causes beyond the
reasonable control of such Party, but such force majeure shall toll any
and all obligations and time periods for so long as such force majeure
continues.
18.4 Bankruptcy. All licenses (and to the extent applicable rights) granted
under or pursuant to this Agreement by Memory to Roche are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US
Code (the "Bankruptcy Code"), licenses of rights to "intellectual
property" as defined under Section 101(60) of the Bankruptcy Code. Unless
Roche elects to terminate this Agreement under Article 16, the Parties
agree that Roche, as a licensee or sublicensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code, subject to the continued performance
of its obligations under this Agreement.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
18.5 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the laws of New Jersey, without giving effect to
principles of conflicts of law.
18.6 Waiver. The waiver by a Party of a breach or a default of any provision of
this Agreement by the other Party shall not be construed as a waiver of
any succeeding breach of the same or any other provision, nor shall any
delay or omission on the part of a Party to exercise or avail itself of
any right, power or privilege that it has or may have hereunder operate as
a waiver of any right, power or privilege by such Party.
18.6 Notices. Any notice or other communication in connection with this
Agreement must be in writing and may be given by any of the following
methods: (i) personal delivery against a signed receipt; (ii) registered
or certified mail, postage prepaid, return receipt requested; or (iii) by
overnight delivery service which obtains a signed receipt. Notice shall be
effective when delivered to the addressee at the address listed below or
such other address as the addressee shall have specified in a written
notice actually received by the addresser.
If to Memory:
Memory Pharmaceuticals Corp.
000 Xxxxxxx Xxxxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attn: Head of Business Development
and
Xxxxx Xxxxxx Xxxxx Tischman Xxxxxxx & Xxxxx, P.A.
Xxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attn: Xxx X. Xxxxxxxxx, Esq.
If to Roche:
X. Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000
Xxxxx, Xxxxxxxxxxx
Attn: Legal Department
and
Xxxxxxxx Xx-Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attn.: Corporate Secretary
18.8 No Agency. Nothing herein shall be deemed to constitute either Party as
the agent or representative of the other Party. Each Party shall be an
independent contractor, not an employee or partner of the other Party.
Each Party shall be responsible for the conduct of activities at its own
facilities and for any liabilities resulting therefrom. Neither Party
shall be responsible for the acts or omissions of the other Party, and
neither Party will have authority to speak for, represent or obligate the
other Party in any way without prior written authority from the other
Party.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
18.9 Entire Agreement. This Agreement and the Schedules hereto (which Schedules
are deemed to be a part of this Agreement for all purposes) contain the
full understanding of the Parties with respect to the subject matter
hereof and supersede all prior understandings and writings relating
thereto. No waiver, alteration or modification of any of the provisions
hereof shall be binding unless made in writing and signed by the Parties.
18.10 Headings. The headings contained in this Agreement are for convenience of
reference only and shall not be considered in construing this Agreement.
18.11 Severability. In the event that any provision of this Agreement is held by
a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any law of any relevant jurisdiction, the
validity of the remaining provisions shall not be affected, and the
Parties shall negotiate a substitute provision that, to the extent
possible, accomplishes the original business purpose. During the period of
such negotiation, and thereafter if no substituted provision is agreed
upon, any such provision which is enforceable in part but not in whole
shall be enforced to the maximum extent permitted by law.
18.12 Assignment. Neither this Agreement nor any of the rights or obligations
hereunder may be assigned by either Party without the prior written
consent of the other Party, except to an Affiliate of the assigning Party
or to any other party who acquires all or substantially all of the
pharmaceutical business of the assigning Party by merger, sale of assets
or otherwise, so long as such Affiliate or other party agrees in writing
to be bound by the terms of this Agreement. Notwithstanding the preceding,
if Memory assigns its rights and/or obligations under this Agreement to a
party who acquires all or substantially all of the pharmaceutical business
of Memory by merger, sale of assets or otherwise, then Memory's rights
under Section 2.4 shall become null and void.
18.13 Successors and Assigns. Except as otherwise provided herein, this
Agreement shall be binding upon and inure to the benefit of the Parties
hereto and their successors and permitted assigns under Section 18.12.
18.14 Non-Solicitation. Each party agrees that, during the period from the
Effective Date to the date that is two (2) years after the Effective Date,
it shall not directly or indirectly solicit the services (by way of
employment or otherwise), or employ or otherwise engage the services, of
any of the other Party's personnel involved in the Strategic Alliance
(including, without limitation, any member of the JLT, any subteam or the
DRT). Roche agrees that, during such two (2) year period and for a period
of one (1) year thereafter, it shall not directly or indirectly solicit
the services (by way of employment or otherwise), or employ or otherwise
engage the services, of any member of senior management of Memory
(including, without limitation, any Director, Associate Director or
Assistant Director or any higher-ranking personnel of Memory).
18.15 Interpretation. The words "include," "includes" and "including" shall be
deemed to be followed by the phrase "without limitation." All references
herein to Articles, Sections, and Schedules shall be deemed references to
Articles and Sections of, and Schedules to, this Agreement unless the
context shall otherwise require. Except as otherwise expressly provided
herein, all terms of an accounting or financial nature shall be construed
in accordance with international accounting standards ("IAS"), as in
effect from time to time. Unless the context otherwise requires, countries
shall include territories.
18.6 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of such
together shall constitute one and the same instrument.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed in their names by their properly and duly authorized officers or
representatives as of the dates below written.
MEMORY PHARMACEUTICALS CORP. XXXXXXXX-XX XXXXX INC.
By: /s/ Xxxx Xxxxxxxx By: Xxxxxx X. Xxxxx
-------------------------- -----------------------------------------
Title: Chief Executive Officer Title: VP, Global Head of Business Development
----------------------- --------------------------------------
X. XXXXXXXX-XX XXXXX LTD
By: /s/ Xxxx Xxxxxx
-----------------------------------------
Title: EVP, Business Development Licensing
& Alliances
--------------------------------------
By: [Illegible]
-----------------------------------------
Title: VP, Global Head Licensing
--------------------------------------
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1
DATA AND REPORTS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
EXHIBIT A
HEADS OF AGREEMENT FOR CO-PROMOTION OF PRODUCT
1 MEMORY ELECTION TO CO-PROMOTE. Memory shall have the right to elect to
co-promote each Product in the US, on a Product-by-Product basis, during
the Co-Promotion Term beginning on the date of the first commercial sale
of such Product in the Co-Promotion Territory. Within forty-five (45) days
after the end of Phase II with respect to each 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 each
Product by giving written notice thereof to Roche within forty-five (45)
days after receipt of the items described in the immediately preceding
sentence.
2. CO-PROMOTION TERRITORY. United States of America and its possessions and
territories, including Puerto Rico.
3. TERM AND TERMINATION. The Co-Promotion Term for each Product shall be for
a period of ten (10) years from the first commercialization of such
Product in the first approved co-promotion indication in the Co-Promotion
Territory. Memory shall have the right to terminate the Co-Promotion
Agreement with respect to any Product if the Net Sales thereof in the US
are less than an amount for which a co-promotion arrangement for such
Product would be financially practicable and profitable.
4. ASSIGNABILITY. Memory may not assign its co-promotion rights without
Roche's express written consent.
5. ADDITIONAL INDICATIONS. The co-promotion by the Parties with respect to
any Product that has received a Regulatory Approval for a Neurological
Indication or a Psychiatric Indication and has been the subject of a
Launch in the US shall extend to any additional Neurological Indication or
Psychiatric Indication which Roche determines to obtain the applicable
Regulatory Approvals to market and sell the Product in the US for such
additional Neurological Indication or Psychiatric Indication. In such
case, Memory shall be responsible for [*] percent ([*]%) of the cost of
obtaining such Regulatory Approvals, including the cost of conducting
clinical trials, which shall be paid by Memory to Roche promptly after
Roche obtains all Regulatory Approvals for such Product in the US to
enable Roche and Memory to market and sell such Product in the US for such
additional Neurological Indication or Psychiatric Indication.
If Roche has received all Regulatory Approvals in the US to market and
sell a Product for a Neurological Indication or a Psychiatric Indication
and an Other Indication and is the subject of co-promotion by Memory, the
Parties shall negotiate in good faith and agree upon an equitable
adjustment to the compensation and cost-sharing provisions set forth in
the Co-Promotion Agreement, to account for the fact that Memory shall not
have any right or obligation to co-promote such Product for the Other
Indication.
6. FINANCIALS. If Memory exercises its right to co-promote a Product in the
Co-Promotion Territory, Memory will be responsible for (i) carrying out
[*] percent ([*]%) of the Product detailing and (ii) [*] percent ([*]%) of
the marketing costs of such Product in the US; and Memory shall be
entitled to receive from Roche [*] percent ([*]%) of the gross profits
from the sale of such Product in the US. For avoidance of doubt, the
marketing costs referred to in Section 5(ii) hereto do not include any
direct cost of Roche field force; by way of example, but not limitation,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
marketing costs include direct to consumer advertising, professional
journal advertising and professional symposia. In addition, if Memory
exercises its right to co-promote a Product, 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 ([*]%). Furthermore, in
order to exercise its right to co-promote a Product, Memory must make 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 final, approved Phase III development plan (including budget).
7. GOVERNANCE. Within ninety (90) days after Memory's notice to Roche that it
wishes to co-promote a Product, the Parties shall form a Joint Promotional
Team ("JPT"), which will oversee the co-promotional activities of the
Parties with respect to such Product. Consistent with prudent business
practices, the JPT will discuss co-promotional activities relating to such
Product and establish mechanisms for achieving an effective co-promotion
collaboration. The JPT shall be comprised of three Roche representatives
and one Memory representative, and a Roche representative will be Chair of
the JPT. Each Party shall have one collective vote, and decisions shall be
made by consensus. For avoidance of doubt, the final decision in all
co-promotion matters will reside with Roche.
8. MEMORY'S OBLIGATIONS. Memory must provide at least [*] percent ([*]%) of
the total promotional effort in a given calendar year as established by
number and type of details in accordance with the Co-Promotion Plan.
Memory may not subcontract its field sales force to fulfill its
co-promotion obligations.
9. ROCHE'S OBLIGATIONS AND AUTHORITY. Roche shall be ultimately responsible
for establishing and modifying the terms and conditions with respect to
the sale of the Product, including, without limitation, pricing for the
Product. Roche shall provide Memory, without charge, with copies of
relevant training materials regarding the detailing and promotion of the
Product. Memory shall then supply such copies of such training materials
to its sales force. Roche may elect, at its discretion, to make available
sales and training personnel to assist Memory in training Memory's sales
force to detail and promote the Product. For avoidance of doubt, each
Party has final responsibility for the adequate training of its own sales
force.
10. NON-SOLICITATION. Neither Party shall recruit sales personnel from the
other Party.
11. REPORTING PROVISIONS. The Parties will negotiate in good faith and agree
to appropriate reporting provisions to be included in the Co-Promotion
Agreement. Memory shall have an obligation to report adverse events to
Roche in a timely fashion.
12. INDEMNIFICATION. Each Party shall indemnify the other Party for all claims
related to the marketing or promotion of the Product to the extent that
such Party is negligent or fails to promote the Product in accordance with
applicable federal and state laws.
13. FULL AGREEMENT. Consistent with the terms of this Heads of Agreement, the
Co-Promotion Agreement shall contain ordinary and customary terms for an
agreement in which a pharmaceutical product of like nature is jointly
co-promoted and detailed in the US, such as insurance, additional
warranties and the like.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
EXHIBIT B
SECURITIES PURCHASE AGREEMENT
[*] CONFIDENTIAL TREATMENT IS REQUESTED
