Exhibit 10.9
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED
BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT. THE NON-PUBLIC INFORMATION
HAS BEEN FILED WITH THE COMMISSION.
COLLABORATION AND LICENSE AGREEMENT
This AGREEMENT, having a date of July 29, 2002, 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
("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 discovered compounds active as PDE4 inhibitors, including a
compound known as MEM1414, and owns related intellectual property
rights.
2. Roche has expertise in the research, development, manufacture and
commercialization of pharmaceutical products.
3. The parties wish to collaborate to develop MEM1414 for
commercialization; develop potential back-up compounds and other PDE4
inhibitors focused on central nervous system indications; and explore
potential applications for other therapeutic areas such as respiratory
disease.
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 preceeding 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.
In addition, Roche is presently seeking permission to acquire an
interest in [*]. Nothing in this Agreement is to be construed as
binding [*] to any of the terms and conditions contained in this
Agreement. However, should [*] become a Roche Affiliate it shall be
bound by the terms and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
conditions of this Agreement. If [*] should become a Roche Affiliate
but 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 Roche shall not grant a
sublicense to [*] under this Agreement without prior written consent of
Memory.
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 PDE4 inhibitor (or an acid, salt or ester thereof) as such
Product.
1.4 "Clinical Candidate" shall be a PDE4 inhibitor that the JLT approves
after consideration of the guidelines as provided in the Research
Workplan.
1.5 "Collaboration Compound" means any PDE4 inhibitor that (i) either or
both Parties or its Affiliates conceives in the conduct of the Research
Collaboration, or (ii) the JLT otherwise agrees shall constitute a
Collaboration Compound pursuant to the Research Workplan.
1.6 "Collaboration Patent Right" means a Patent Right Covering an
Invention.
1.7 "Collaboration Technology" means all Know-How generated in the conduct
of the Research Collaboration, other than Collaboration Compounds.
Collaboration Technology includes all Inventions, other than
Collaboration Compounds.
1.8 "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.
1.9 "Composition of Matter Claim" means, for a given Product in a given
country of the Territory, a Valid Claim of a Memory Patent Right or a
Collaboration Patent Right that Covers the molecule per se of the PDE4
inhibitor that is included in such Product, in whole or as a component
thereof, as an active ingredient of such Product.
1.10 "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.
1.11 "Effective Date" means the date that all conditions subsequent under
Section 16.1(a) have occurred.
1.12 "Europe" means the United Kingdom, Germany, Italy, France and Spain.
1.13 "Field" shall mean prophylaxis and treatment of diseases, in all
indications, for either human or veterinary use.
1.14 "IND" means an Investigational New Drug Application filed with the
United States Food and Drug Administration ("FDA") for human clinical
testing of a drug.
1.15 "Initiation of Phase II" means the date that a patient is first dosed
by or on behalf of Roche, its Affiliate or sublicensee with a Product
in a Phase II clinical trial.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
1.16 "Initiation of Phase III" means the date that a patient is first dosed
by or on behalf of Roche, its Affiliate or sublicensee with a Product
in a Phase III clinical trial.
1.17 "Invention" means an invention that is made in the conduct of the
Research Collaboration.
1.18 "JLT" means that committee organized and operating as provided in
Article 7.
1.19 "Joint Invention" means an Invention having at least one co-inventor
who is an employee, consultant or agent of each of the Parties or its
Affiliate.
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.
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 "Major Market Countries" means the US, Canada, Japan, Europe, China and
Korea.
1.23 "Memory Compound" means any PDE4 inhibitor for which Memory either
prior to the Effective Date or during the Agreement Term has rights,
whether by reason of its own conception of such inhibitor, or under
agreement with a Third Party.
1.24 "Memory Invention" means an Invention having as inventors only
employees, consultants or agents of Memory or its Affiliate.
1.25 "Memory Know-How" means all Know-How that Memory owns, or otherwise has
the right to grant the licenses herein, during the Agreement Term.
1.26 "Memory Patent Rights" means all Patent Rights that Memory owns, or
otherwise has the right to grant the licenses herein, during the
Agreement Term. Schedule A lists all Memory Patent Rights that Cover
the Memory Compounds as of the date hereof ("Base Patents").
1.27 "NCE" means a PDE4 inhibitor that itself, or its ester, salt or other
noncovalent derivative, has not been the subject of a Regulatory
Approval.
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 Roche, its
Affiliate or sublicensee files an NDA 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 (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, 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.,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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).
"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 Alzheimers'
disease, prophylaxis or treatment of mild cognitive impairment ("MCI")
or treatment of vascular dementia.
1.32 "Non-Memory Compound" means a PDE4 inhibitor, other than a Memory
Compound or a Collaboration Compound, with respect to which the initial
IND for the inhibitor is for a Neurological Indication or Psychiatric
Indication, and which initial IND has been filed within five (5) years
after the Effective Date by Roche or its Affiliate.
1.33 "Other Indication" means any indication other than a Neurological
Indication or a Psychiatric Indication.
1.34 "Party" means Roche and/or Memory.
1.35 "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.
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 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
1.38 "Product" means any and all products that include, in whole or as a
component thereof, a Memory Compound or a Collaboration Compound.
1.39 "Psychiatric Indication" means depression, anxiety or mixed
anxiety/depression.
1.40 "Regulatory Approval" means any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations of
any national or international or local regulatory agency, department,
bureau or other governmental entity, necessary for the manufacture and
sale of a Product in the Field in a regulatory jurisdiction in the
Territory by Roche, its Affiliate or sublicensee.
1.41 "Research Collaboration" means the collaborative non-clinical research
program between the Parties, more fully described in the Research
Workplan.
1.42 "Research Workplan" means the plan of preclinical and non-clinical
development activities attached as Schedule B, as it may be amended
from time to time.
1.43 "Research Term" shall have the meaning provided in Section 7.1(b)(iii).
1.44 "Roche Invention" means an Invention having as inventors only
employees, consultants or agents of Roche or its Affiliate.
1.45 "ROW Territory" means all countries and territories other than the US.
1.46 "Territory" means all countries and territories in the world.
1.47 "Third Party" means a person or entity other than (i) Memory or any of
its Affiliates, or (ii) Roche or any of its Affiliates.
1.48 "US" means the United States of America and its possessions and
territories, including Puerto Rico.
1.49 "Valid Claim" means a claim in any (i) unexpired and issued Memory
Patent Right or Collaboration Patent Right that has not been
disclaimed, revoked or held invalid by a final unappealable decision of
a court of competent jurisdiction or government agency or (ii) pending
patent application that is a Memory Patent Right or a Collaboration
Patent Right which application has been on file with the applicable
patent office for no more than ten (10) years and for which there has
been reasonably consistent activity to advance to issuance of a patent.
ARTICLE 2. LICENSE GRANTS
2.1 License Grants. Subject to the terms and conditions of this Agreement,
Memory grants to Roche the sole and exclusive license, including the
right to grant sublicenses pursuant to Section 2.2, under the Memory
Patents and to use the Memory Know-How, to make, use, offer for sale,
sell and import Products in the Territory for use in the Field.
The exclusivity of the above license is subject to the retained right
of Memory and its respective Affiliates to conduct preclinical and
non-clinical development activities related to Product, solely to the
extent expressly contemplated by this Agreement. In addition, 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
purpose not related to the making, using, offering for sale, selling or
importing Products in the Territory for use in the Field.
2.2 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 in a
Major Market Country, except upon the prior written approval of Memory,
which approval Memory shall not unreasonably withhold.
Any sublicense may, at the written election of Memory, continue in full
force and effect after the termination of any of the underlying
licenses granted herein to Roche (the foregoing shall apply to a
termination in whole or in part of such underlying licenses). Upon the
licenses granted herein to Roche becoming fully paid up pursuant to
Section 16.1(b), any and all sublicenses granted by Roche similarly
shall become fully paid up as to Memory.
2.3 Memory Co-Promotion Right. If Roche wishes to offer a right to
co-promote a Product to a Third Party for the United States of America,
then Roche shall first present an offer to Memory for such rights.
Memory shall have a right to enter into good faith negotiations with
Roche for up to ninety (90) days from the date Memory receives the
offer, provided Memory can provide a capable established sales force or
equivalent alternative. If, at the end of the ninety (90) day period,
the Parties have been unable to reach an agreement granting Memory
co-promotion rights in the United States of America, then Roche shall
be free to offer the rights to a Third Party, provided that Roche shall
not make an offer more favorable to any such Third Party than the offer
last made to Memory by Roche without first giving Memory at least
thirty (30) days to accept such more favorable offer if Memory can
provide an established sales force or alternative having at least
equivalent capability to the Third Party.
2.4 Products Containing Non-Memory Compounds. Roche represents, and Memory
acknowledges, that prior to the date hereof Roche has, or during the
Agreement Term Roche may have rights in or to Non-Memory Compounds,
whether by reason of its own conception, or acquired under agreement
with a Third Party. Memory shall have the right from time to time to
request an inventory of Non-Memory Compounds, and Roche shall promptly
provide Memory with such inventory. With respect to each Non-Memory
Compound, Memory shall be entitled to receive the financial
consideration from Roche as provided in Schedule C.
Memory covenants not to xxx Xxxxx relating to any Non-Memory Compound,
so long as Memory shall be entitled to receive the financial
consideration with respect thereto under Schedule C, unless Roche is in
breach of its obligations relating to Non-Memory Compounds under this
Agreement.
2.5 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, Collaboration Compound, and/or Product, not yet
Launched in such country, then Roche shall use its reasonable best
efforts
[*] CONFIDENTIAL TREATMENT IS REQUESTED
to obtain authority to fulfill such requirement by returning rights to
Memory to the Memory Compound, Collaboration Compound and/or Product
without consideration to Memory or Roche (except as provided in Section
16.4(c)) under the conditions of Section 16.4.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
ARTICLE 3. DILIGENCE
3.1 Diligence. Roche shall use reasonable diligence in proceeding with the
development, including obtaining required Regulatory Approvals,
manufacturing, marketing and sale of Products in the Major Market
Countries.
Reasonable diligence as used in this Agreement shall mean the same
standard of effort as used by Roche, or in any case not less than
common in the industry taken as a whole, in the research, 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 as the Product, taking into account scientific,
business and marketing and return on investment considerations. It is
understood that such Product 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) does not
always seek to market its own products in every such country or seek to
obtain regulatory approval in every such country or for every potential
indication. As a result, the exercise by Roche of reasonable diligence
is to be determined by judging its efforts taken as a whole in the
following regions on a region-by-region basis (the regions being North
America (US and Canada), Europe and Asia (Japan, China and Korea)).
If Memory believes in good faith that Roche has failed to utilize
reasonable diligence as required in the above paragraph, then Memory
may give Roche written notice of such alleged failure, identifying the
Product and region at issue and giving specific detailed reasons of
such allegation. Within sixty (60) days following Roche's receipt of
any such notice from Memory ("Response Period"), Roche shall have the
right to provide Memory with a written response specifying, in
reasonable detail, how it has used reasonable diligence as required in
the above paragraph.
If Roche 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 Roche has failed within the
Response Period to remedy any breach of its obligations under this
Section 3.1, then Memory shall have the right to terminate this
Agreement, in whole or in part, as described below in this Section 3.1,
upon written notice to Roche effective as of the end of the Response
Period. Memory shall have the right to terminate this Agreement as to
any region described above if Roche fails to comply with its
obligations under this Section 3.1 with respect to the Products (taken
as a whole) in such region. Memory shall have the right to terminate
this Agreement in the Territory with respect to any Product if Roche
fails to comply with its obligations under this Section 3.1 for such
Product in at least two of the three regions described above. Memory
shall have the right to terminate this Agreement in its entirety if
Roche fails to comply with its obligations under this Section 3.1 for
the Products (taken as a whole) in at least two of the three regions
described above.
In the event of a dispute between the Parties with respect to whether
Roche 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 shall be as set
forth in Section 16.4 and Article 17.
3.2 Effect of Merger on Diligence. If (i) substantially all of the
pharmaceutical business of Roche becomes merged or acquired or (ii)
Roche acquires substantially all of the pharmaceutical business of an
entity having an average annual pharmaceutical pre-clinical research
expenditure in excess of [*] per year, then at any time during the
period from a public announcement by
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Roche of its intention to effect such merger or acquisition
("Transaction") through [*] after the closing of such Transaction,
Memory shall have the right to request in writing to the Head of Global
Pharmaceuticals of Roche a status of and future plans for the progress
of development and commercialization of Products ("Status Request").
This right may be exercised by Memory not more than [*].
If, following a Status Request, Memory believes in good faith that
Roche has failed to progress development and commercialization of
Products solely because of the Transaction, then Memory may give Roche
written notice of such alleged failure, identifying the Product and
region at issue and giving specific detailed reasons of such
allegation. Within [*] following Roche's receipt of any such notice
from Memory ("Status Response Period"), Roche shall have the right to
provide Memory with a written response specifying, in reasonable
detail, how the Transaction per se has not had any negative impact on
such development and commercialization progress.
If Roche has failed to provide within the Status Response Period a
written response, in reasonable detail, indicating the manner in which
development and commercialization of Products has not failed to
progress solely because of the Transaction or in which it has remedied
any such failure, or Roche has failed within the Status Response Period
to remedy any such failure to progress, then Memory shall have the
right to terminate this Agreement, in whole or in part, as described
below in this Section 3.2, upon written notice to Roche effective as of
the end of the Status Response Period. Memory shall have the right to
terminate this Agreement as to any region described in Section 3.1 if
development and commercialization of the Products has failed to
progress solely because of the Transaction with respect to the Products
(taken as a whole) in such region. Memory shall have the right to
terminate this Agreement in the Territory with respect to any Product
if development and commercialization of such Product has failed to
progress solely because of the Transaction in at least two of the three
regions described in Section 3.1. Memory shall have the right to
terminate this Agreement in its entirety if development and
commercialization of the Products (taken as a whole) has failed to
progress solely because of the Transaction in at least two of the three
regions described in Section 3.1.
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. PAYMENTS TO MEMORY
4.1 Payment for Platform Technology. Roche shall pay Memory a total of
thirteen million dollars ($13,000,000), which shall be non-refundable
and non-creditable, and due and payable as follows:
Event Payment (mio US$)
----- -----------------
The Effective Date 8
JLT decides on MEM 1414 2
as a Clinical Candidate for
Alzheimers' disease
[*] [*]
[*] [*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Each payment in this Section 4.1 shall be due and payable by Roche
within thirty (30) days after occurrence of the applicable Event
(except that the payment of $8,000,000 payable on the Effective Date
shall be paid within fifteen (15) calendar days of the occurrence of
the Effective Date) Notwithstanding anything to the contrary, Roche
will make each of such payments only once, for the first occurrence of
a respective Event, regardless of how many times the Event may be
achieved.
4.2 CRO Reimbursement. Roche shall promptly reimburse Memory the actual
amount of payments by Memory to contract research organizations
("CROs") for MEM1414, not to exceed one million five hundred thousand
dollars (US $1,500,000). Such reimbursement shall only apply to amounts
previously paid in respect of the 10 kilogram GMP MEM1414 batch
produced by MediChem Research Inc., or hereafter paid to any CRO for
MEM1414. Such reimbursement shall not become due and payable from Roche
to Memory in any amount until after the JLT analyzes the relevant study
reports from the CROs.
4.3 Development Event Based Payments.
(a) Neurological Indications. Roche shall pay to Memory the
following non-refundable and non-creditable payments upon the
first occurrence of the following Events for a Product.
(i) First Product
# Event Payment (mio US$)
----- -----------------
1. [*] [*]
2. [*] [*]
3. [*] [*]
4. [*] [*]
5. [*] [*]
6. [*] [*]
7. [*]** [*]
8. [*] [*]
** For the US, the Product should not have a black box warning in its
label at time of Launch and should not receive one during its first 6
months on the market. During that period there should not be any "Dear
Doctor" letters issued by the US FDA regarding this Product. In the US,
the Product is the first or second non-achetylcholinesterase inhibitor
(AChEI) having regulatory approval for the treatment of mild to
moderate dementia of the Alzheimer's type or MCI, and a third non-AchEI
having regulatory approval for the treatment of mild to moderate
dementia of the Alzheimer's type or MCI does not launch in the US
during the 6 month period following the Launch of the Product in the
US.
(ii) Second Product
Roche shall pay to Memory the following non-refundable and
non-creditable payments upon the first occurrence of the following
Events for a Product having an NCE that is different from an NCE for
which any payment occurred under Section 4.3(a)(i).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Event Payment (mio US$)
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[*] for a Neurological Indication [*]
[*] for a Neurological Indication [*]
[*] for a Neurological Indication [*]
[*] for a Neurological Indication [*]
[*] for a Neurological Indication [*]
(b) Psychiatric Indications. Roche shall pay to Memory the
following non-refundable and non-creditable payments upon the
first occurrence of the following Events for a Product having
an NCE that is different from an NCE for which any payment
occurred under Sections 4.3(a).
Event Payment (mio US$)
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[*] for depression [*]
[*] for depression [*]
[*] for depression [*]
[*] for depression [*]
[*] for depression [*]
[*] for depression [*]
[*] for depression [*]
[*]** [*]
[*] for anxiety [*]
** In the US, the Product does not have a black box warning in its label
at time of Launch and does not receive one during its first 6 months on
the market in the US. During that period there is not any "Dear Doctor"
letters issued by the US FDA regarding this Product. The Product is the
first PDE4 inhibitor having regulatory approval in the US for the
treatment of depression, and a second PDE4 inhibitor having regulatory
approval for the treatment of depression does not launch in the US
during the 6 month period following the Launch of the Product in the
US.
(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 having an NCE
that is different from those NCE's for which any payment
occurred under Sections 4.3(a) and/or 4.3(b).
Event Payment (mio US$)
----- -----------------
[*] for an Other Indication [*]
[*] for an Other Indication [*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
[*] for an Other Indication [*]
[*] for an Other Indication [*]
[*] for an Other Indication [*]
(d) Each payment in Section 4.3(a)(i), 4.3(a)(ii), 4.3(b) and
4.3(c) shall be due and payable by Roche within thirty (30)
days after occurrence of the applicable Event. Roche will make
each of such payments only once, for the first occurrence of a
respective Event, regardless of how many times the Event may
be subsequently achieved with a Product. An Event shall be
deemed to have occurred regardless of whether a Product or a
Non-Memory Compound first achieved the Event.
(e) 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.
ARTICLE 5. ROYALTIES
5.1 Royalties.
(a) Roche shall pay to Memory the following payments for a given
Product having a Regulatory Approval in the US for a
Neurological Indication, based upon the Net Sales of such
Product in the US, 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
in the US (all Net Sales amounts in $ US million):
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ANNUAL US NET SALES PERCENT (%) OF NET SALES
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[*] [*]
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[*] [*]
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[*] [*]
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[*] [*]
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By way of illustration, assume in calendar year 2012 that (i) Net Sales
of the Product in the US total $950,000,000 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:
--------------------------------------------------------------------------------
US NET SALES APPLICABLE SALES-BASED AMOUNT PAYABLE
(IN MILLIONS) PAYMENT PERCENTAGE (IN MILLIONS)
--------------------------------------------------------------------------------
[*] [*] [*]
--------------------------------------------------------------------------------
[*] [*] [*]
--------------------------------------------------------------------------------
[*] [*] [*]
--------------------------------------------------------------------------------
[*] [*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
Notwithstanding the foregoing, if for a given Product there is no
Regulatory Approval in the US for a Neurological Indication, then,
Roche shall pay to Memory the following payments for such Product,
based upon the Net Sales of such Product in the US, which such Net
Sales shall be subject to adjustment as provided in this Article 5.
Such royalty
[*] CONFIDENTIAL TREATMENT IS REQUESTED
payments shall be calculated by multiplying the following percentages
by the following annual Net Sales of such Product in the US (all Net
Sales amounts in $ US million):
--------------------------------------------------------------------------------
ANNUAL US NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
(b) Roche shall pay to Memory the following payments for a given Product
having a Regulatory Approval in Europe for a Neurological Indication,
based upon the Net Sales of such Product in all countries of the
Territory other than the US ("ROW Territory"), 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
in the ROW Territory (all Net Sales amounts in $ US million):
--------------------------------------------------------------------------------
ANNUAL ROW TERRITORY NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
Notwithstanding the foregoing, if for a given Product there is no
Regulatory Approval in Europe for a Neurological Indication, then,
Roche shall pay to Memory the following payments for such Product,
based upon the Net Sales of such Product in the ROW Territory, 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 in the ROW Territory (all Net Sales amounts in $ US
million):
--------------------------------------------------------------------------------
ANNUAL ROW TERRITORY NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
[*] [*]
--------------------------------------------------------------------------------
Any reduction in royalty rates provided for in this Section 5.1 by
reason of not having a Regulatory Approval for a Neurological
Indication shall cease after the relevant Regulatory Approval for a
Neurological Indication is obtained and for so long as it is
maintained.
5.2 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
5.3 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.
5.4 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.
5.5 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 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 license under a patent which Covers the molecule per se
of the PDE4 inhibitor 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 5.5 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.
5.6 Bonus Royalty. 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 Product having Regulatory Approval in the US for a
Neurological Indication:
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Event Payment (US$)
----- -------------
Net Sales in the US [*]
exceeds [*] dollars ($[*])
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 a Product:
Event Payment (US$)
----- -------------
Net Sales in the US [*]
exceeds [*] dollars ($[*])
for a full calendar
year (Jan 1 - Dec. 31)
during the Agreement Term.
Each payment in this Section 5.6 shall be due and payable by Roche
within thirty (30) days after occurrence of the applicable Event.
Notwithstanding anything to the contrary, Roche will make each of such
payments only once, for the first occurrence of a respective Event with
a Product, regardless of how many times the Event may be achieved.
5.7 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
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 of which is the
reasonable fair market value in the aggregate, of all pharmaceutically
active agents contained in the Combination Product.
5.8 Mechanisms for Adjustments. In no event shall any adjustments pursuant
to Sections 5.3, 5.4 and/or 5.5 result in Memory receiving royalties
for a given calendar quarter pursuant to Section 5.1 in amount less
than [*]% of the amounts set forth therein as if no adjustment (s) had
been made. If Roche obtains a license to a PDE4 inhibitor from a Third
Party and includes such PDE4 inhibitor in a Product, as a result of
which the Product becomes a Combination Product, Roche shall not be
entitled to an adjustment pursuant to Section 5.5 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(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 among U.S., Europe and rest of world:
(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 (excluding China
and Korea), 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 in the weekly Federal Reserve H.15 bulletin plus
[*]% (or a successor or similar publication) from time to time, for the
applicable period calculated on the number of days such a payment is
overdue.
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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
(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. THE RESEARCH COLLABORATION
7.1 The Research Collaboration
(a) The Parties agree to conduct a Research Collaboration in
accordance with the Research Workplan. The goal of the
Research Collaboration shall be to (1) deliver to Roche an IND
package for the lead Memory Compound MEM1414 and (2) identify
back-up and follow-up Memory Compounds and Collaboration
Compounds for MEM1414, and identify a lead compound for
depression, as well as back-up compounds.
(b) (i) The original term of the Research Collaboration
shall be for a period of two (2) years from the
Effective Date of this Agreement ("Original Term"),
unless this Agreement is terminated sooner in
accordance with Article 16. Except as provided in
Article 16, neither Party may terminate the Research
Collaboration.
(ii) The Original Term of the Research Collaboration
may be extended by mutual written agreement prior to
the expiration of the Original Term. During such
extension, the Research Collaboration will explore
potential applications of Products for other
therapeutic areas such as respiratory disease, in
addition to those goals of the Original Term.
(iii) The total time period during which the Research
collaboration is ongoing, including any extensions of
the Original Term, is the "Research Term."
7.2 Joint Liaison Team. A Joint Liaison Team ("JLT") shall govern the
Research Collaboration by overseeing two subteams: (1) a subteam for
developing an IND package for the lead compound MEM1414 and (2) a
subteam for developing back-up and follow-up compounds for Neurological
Indications; developing lead compounds for Psychiatric Indications as
well as back-up compounds for Psychiatric Indications; and commencing
to explore potential applications of Memory Compounds and Collaboration
Compounds for other therapeutic areas such as respiratory disease.
(a) Organization. The JLT shall consist of six (6) members, three
(3) 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. The
Committee shall function only during the Research Term unless
otherwise agreed by the Parties. 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 Roche.
(b) Meetings. The JLT shall hold quarterly meetings on mutually
agreeable dates during the Research Term, 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, two of the quarterly meetings
per year may be held by videoconference. Each Party shall pay
its
[*] CONFIDENTIAL TREATMENT IS REQUESTED
own expenses associated with the meeting. Each Party may, in
its discretion, invite non-member employees ("invitee") to
attend meetings of the JLT.
The JLT shall meet in January, 2003 to analyze relevant study
reports from the CROs, as contemplated by Section 4.2.
The JLT shall meet in January, 2003 to decide if MEM1414 is a
Clinical Candidate.
(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 on behalf of Roche and the Chief Scientific Officer
of Memory ("Research Collaboration Executives"). If the
Research Collaboration Executives are unable to resolve any
such matter after good faith discussions, then the final
decision shall rest with Roche, provided that no such decision
on any matter may have the effect of increasing the economic
burdens, including FTE burdens of Memory (except for any
increases which in the aggregate are immaterial).
7.3 Research Support. For the Original Term, Roche shall pay to Memory a
total of seven million dollars (US $7,000,000), which amount shall be
non-refundable and non-creditable, and which will be due and payable in
eight (8) equal installments of eight hundred and seventy five thousand
dollars (US $875,000) per installment, each installment due and payable
within thirty (30) days after (1) the first day of each calendar
quarter during the Original Term and (2) receipt by Roche of an invoice
for such sums. If the Effective Date of this Agreement is July 31,
2002, the first payment and the last payment under this Section shall
be due and payable respectively within thirty (30) days after (1)
October 1, 2002/July 1, 2004 and (2) receipt by Roche of an invoice for
such sum.
7.4 Research Collaboration Activities. Subject to the oversight of the JLT,
during the Research Term each Party shall diligently conduct, at its
cost except as provided in Section 7.3, those research activities that
are assigned in the Research Workplan. At no cost to Roche, except as
provided for in Sections 4.2 and 7.3, Memory shall use all reasonable
best efforts to maintain in full force and effect all agreements and
relationships with Third Parties in effect as of the Effective Date so
that there is no interruption in the development of an IND package for
MEM1414 during any transition from Memory to the JLT.
7.5 Progress Reports. At least fifteen (15) days prior to each quarterly
meeting of the JLT, each subteam shall prepare written progress reports
for the JLT summarizing progress to date in achieving the primary goals
for the Research Collaboration, including an inventory of Collaboration
Compounds, Collaboration Technology and Memory Compounds. Following
each such meeting, the JLT shall prepare a report summarizing the
discussions held and conclusions reached and setting forth plans for
the Research Collaboration for the next three (3) months.
7.6 Acknowledgement of Obligations. Each Party will cause each of its and
its Affiliates FTEs, as specified in the Research Workplan, prior to
and as a condition of becoming a member of the Research Collaboration,
to review and acknowledge in writing that they understand and agree to
abide by the terms and conditions of this Agreement related to the
Research Collaboration (Article 7), Intellectual Property (Article 13),
Confidential Information (Article 15, specifically as related to
non-disclosure and non-use restrictions).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
7.7 Screening. During the Agreement Term Roche shall have the right to use
Memory Compounds and Collaboration Compounds in Roche screening assays.
ARTICLE 8. CLINICAL DEVELOPMENT
8.1 Development. Roche, at its sole cost, shall (1) pursue clinical
development of Products 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 given Product, no
later than thirty (30) days after development of an IND filing
package for the Product, the Parties shall establish a
Development Review Team consisting of up to three (3)
representatives from Roche and one (1) representative of
Memory. Each Party may select alternative representatives to
replace its Development Review Team members selected by such
Party as necessary, and may have other representatives attend
meetings of the Development Review Team in addition to the
representatives of the Team. All guidance provided by the
Development Review Team shall be based upon the majority
opinion of the Development Review Team.
(b) Development Review Team Meetings and Responsibilities. No less
than two times per year for so long as the Development Review
Team contemplates clinical development of a Memory Compound or
Collaboration Compound in the Territory for the purpose of
obtaining Regulatory Approval in a country of the Territory,
Roche shall organize meetings of the Development Review Team.
At its meetings, the Development Review Team 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 Development Review Team on all
significant clinical and regulatory issues relating to
Products, and the Development Review Team 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 Development Review Team.
ARTICLE 9. REGULATORY AFFAIRS
Roche, at its sole cost, shall pursue all regulatory affairs in the Territory
related to Product, including the preparation and filing of applications for
Regulatory Approval, 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 (other
than China and Korea). Upon request of Memory, Roche shall supply Memory with a
copy of all such communications in all countries.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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. Roche understands and acknowledges that
as of the Effective Date, pursuant to an agreement with Memory,
Medichem Research Inc. is providing Phase I clinical supply of MEM1414.
Beyond the clinical supply provided by Memory through Medichem, Roche
shall supply at its own cost all clinical supply of Product and placebo
to be used in the Territory during the Agreement Term, either by
itself, or through a Third Party. Memory shall use all reasonable best
efforts to maintain in full force and effect all agreements and
relationships with Third Parties in effect as of the Effective Date so
Roche has uninterrupted access to non-clinical and Phase I clinical
supply prior to and during any manufacturing transition from Memory to
Roche during the Agreement Term, at no cost to Roche. In addition,
Memory shall use its reasonable best efforts to cause transfer of a
manufacturing transfer package to Roche to enable to Roche commence
manufacture of MEM1414 in a timely manner.
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.
ARTICLE 11. COMMERCIALIZATION
11.1 Responsibilities of Roche. Except as expressly set forth in Section 2.3
and Section 3.1, 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.
As between the Parties, Memory shall own all Memory Inventions, Roche
shall own all Roche Inventions, and Memory and Roche shall jointly own
all Joint Inventions. Except to the extent any Collaboration Technology
is exclusively licensed by one Party to the other Party hereunder, each
Party shall have the right to practice Collaboration Technology,
including Inventions, and to grant licenses to Affiliates and Third
Parties to such Collaboration Technology, without the other party's
consent and without any duty to account to the other Party with respect
thereto. Each Party shall require all of its employees to assign all
inventions related to Products made by them to such Party.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
13.2 Patent Prosecution and Maintenance.
(a) Base Patents. 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 Base Patents.
Memory shall use reasonable efforts to consult with Roche as
to the Handling of the Base Patents in sufficient time (for
example 30 days for instances where actions are due within 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.
Should Memory decide that it does not desire to Handle a Base
Patent in a given country, it shall provide written notice to
Roche thereof no less than sixty (60) days prior to the date
when the Base Patent would become abandoned in such country.
After receiving such notice, Roche may, but is not obligated,
to Handle the Base Patent in such country.
(i) Except as provided in Section 13.2 (a)(ii) and (iii)
below, Memory shall be responsible for payment of the
reasonable costs to Handle the Base Patents.
(ii) Roche will assume and pay for the reasonable costs to
Handle any given Base Patents as described in
Schedule A as Memory 1, 2 and 3 in Europe from and
after national phase entry in Europe. For a given
Base Patent as described in Schedule A as Memory 1, 2
and 3 no less than three (3) months before PCT
national phase entry, Roche shall provide to Memory
in writing a list of countries, other than the US and
Europe, for which Roche requests that a national
phase entry be filed ("Other Countries"). Unless the
Parties otherwise agree after discussion in good
faith, such list shall include Japan and additional
countries, consistent with Roche's practices for
Roche's other potential products. Roche shall be
responsible for the payment of the reasonable costs
to Handle the Base Patents as described in Schedule A
as Memory 1, 2 and 3 in the Other Countries.
(iii) For a given Base Patent in a given country for which
Roche shall be responsible under Section 13.2(a)(ii)
for the payment of the reasonable costs to Handle
such Base Patent, Roche may elect, at its option, to
discontinue the payment of such costs, upon giving at
least ninety (90) day's prior written notice to
Memory. At Memory's request, Roche shall advise to
the specific reasons for such decision. Memory may,
in its sole discretion, continue to Handle such Base
Patent in such country, at its own expense. If,
however, a Valid Claim of such Base Patent Covers a
Product in such country in which Roche Launches the
Product, Roche shall reimburse Memory for all
reasonable costs to Handle such Base Patent with
respect to such country.
(b) Inventions.
(i) Priority Applications. Each Party promptly will
notify the other Party in writing ("Patent Notice")
of any Inventions on which it intends to file a
patent application.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Within sixty (60) days after receipt of the Patent
Notice, the Parties shall agree upon which Party
shall prepare and file a priority application
("Invention Priority Application") Covering such
Invention. As a general rule, Memory shall prepare
and file an Invention Priority Application Covering
Memory Inventions and Roche shall prepare and file an
Invention Priority Application Covering Roche
Inventions. For a Joint Invention, if both Parties
wish to have an Invention Priority Application filed,
then the Parties shall agree upon a mutually
acceptable external patent counsel for such activity.
For purposes of this Article, the Party preparing and
filing an Invention Priority Application is a "Filing
Party" and the other Party is a "Non-Filing Party".
For a Joint Invention, the Parties shall agree which
shall be the Filing Party and which shall be the
Non-Filing Party on a case-by-case basis.
(A) Subject to Subsection 13.2(b)(iii), and any
other provision in this Article 13, the
Non-Filing Party will reimburse the Filing
Party for fifty percent (50%) of the
reasonable and documented external costs for
preparing, filing and prosecuting the
Invention Priority Application and
maintaining any resulting Patent Rights
within forty-five (45) days of invoice by
the Filing Party;
(B) The Filing Party promptly will prepare and
send to the Non-Filing Party a draft of the
Invention Priority Application for the
Non-Filing Party's comment and approval; and
(C) The Non-Filing Party shall confirm receipt
of the draft Invention Priority Application
and provide its comments on the draft to the
Filing Party within thirty (30) days after
receipt thereof ("Comment Period").
After reasonably considering the Non-Filing Party's
comments, the Filing Party shall file the Invention
Priority Application. If the Non-Filing Party fails
to provide comments on a draft within the Comment
Period, the Filing Party shall be free to file the
Application at the end of the Comment Period or
later.
If Non-Filing Party does not timely notify the Filing
Party in writing of interest in a Invention Priority
Application, the Filing Party shall be free to file
the application at its sole expense and discretion.
(ii) Corresponding Application in Foreign Countries.
Within nine (9) months after the filing of an
Invention Priority Application, the Filing Party
shall provide the Non-Filing Party a written list of
countries ("Country List") in which the Filing Party
intends to file patent applications that claim
priority from the given Invention Priority
Application. The Non-Filing Party, as promptly as
practicable, shall notify the Filing Party in writing
of those countries on the Country List and any
additional countries ("Additional Countries") where
the Non-Filing Party requests that patent
applications be filed. In turn, the Filing Party
promptly shall notify the Non-Filing Party if it
agrees with the filing of applications in such
Additional Countries selected by the Non-Filing
Party.
The Filing Party shall file patent applications at
least in those countries where the Non-Filing Party
and the Filing Party agree to the filing of patent
[*] CONFIDENTIAL TREATMENT IS REQUESTED
applications ("Mutually Agreed to Countries") as well
as in Additional Countries selected by the Non-Filing
Party that are not within the Mutually Agreed to
Countries. The Filing Party 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.
The Filing Party 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. Subject to the provisions of
Section 13.2(b)(iii) as to the Mutually Agreed to
Countries, the Filing Party and the Non-Filing Party
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.
As to those countries where the Non-Filing Party and
the Filing Party 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.
Should the Non-Filing Party not respond to the Filing
Party within thirty (30) days after the date the
Filing Party provides the Country List, then the
Filing Party shall be free to initiate patent
filings, at the Filing Party's sole expense and
discretion, in the countries the Filing Party has
selected or still selects.
The Filing Party's failure to notify the Non-Filing
Party to the contrary within thirty (30) days after
the date upon which the Non-Filing Party notifies the
Filing Party of the Additional Countries will be
deemed an agreement on the part of the Filing Party
to file patent applications in all such Additional
Countries and to pay fifty percent (50%) of the
reasonable external costs associated with such
filings.
(iii) Withdrawal of Funding/Lack of Further Interest. If,
in a country, at any time, the Non-Filing Party
decides not to continue funding the prosecution of a
patent application or maintenance of a patent under
this Section 13.2, the Non-Filing Party shall notify
the Filing Party in writing ("Withdrawal Notice"),
and the Non-Filing Party shall be relieved from
paying any further expenses with regard to the patent
filing in the country. After receiving the Withdrawal
Notice, the Filing Party may but is not obligated, at
its sole expense and discretion, to continue to
prosecute and maintain the patent filing in the
country.
If, in a country, at any time, the Filing Party
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 the Non-Filing Party has
already sent a Withdrawal Notice, then the Filing
Party shall notify the Non-Filing Party 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 the Non-Filing Party's written
request and no cost to the Filing Party, the Filing
Party shall then assign to the non-Filing Party such
patent application or patent in such country, and the
Non-Filing Party may thereafter continue to prosecute
and maintain the patent filing in the country, at the
Non-Filing Party's own cost
[*] CONFIDENTIAL TREATMENT IS REQUESTED
and in the Non-Filing Party's name, to the extent the
Non-Filing Party desires to do so
To the extent the provisions of this Section
13.2(b)(iii) conflict with any other provision of
this Section 13.2, this Section 13.2(b)(iii) shall
control.
(iv) Copies of Communications with Patent Offices. For the
Mutually Agreed to Countries and Additional
Countries, the Filing Party shall consult with the
Non-Filing Party as to the prosecution and
maintenance of all patent applications and patents
claiming Inventions in sufficient time (for example
30 days for instances where actions are due within 3
months of a communication from a Patent Office)
before any action is due to allow the Non-Filing
Party to provide comments thereon, which comments the
Filing Party must reasonably consider.
13.3 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 the filing Party 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.
13.4 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 or Collaboration
Patent Right by a Third Party making, using, offering for sale,
selling, or importing a PDE4 inhibitor or a product containing a PDE4
inhibitor (collectively "PDE4 Infringement").
Roche shall have the first right to bring and control any action or
proceeding with respect to such PDE4 Infringement at its 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 PDE4 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 13.4 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. After deducting the Parties'
attorneys fees and court costs in connection with any such suit or
action,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
any damages, settlement fees or other consideration received as a
result of such suit or action 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, which shall form part of the Net Sales for
determining amounts due to Memory in any calendar year.
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.
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 and action or proceeding with respect
to any Memory Patent Right relating to infringement other than PDE4
Infringement, at its own expense, without obligation or notice to
Roche.
13.5 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
United States of America, then such Party shall immediately provide the
other Party with a copy of such certification. 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.
13.6 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:
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
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.
(a) 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.
(b) Each Party represents and warrants that all of its FTEs, as
specified in the Research Workplan, and its Affiliates FTEs,
as specified in the Research Workplan, have entered into an
agreement with it or its Affiliate assigning to it or its
Affiliate all their rights to Inventions.
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 compound
identified by Memory to Roche (MEM1414) and would prevent
Roche from selling such Memory Compound in any country of the
Territory. As of the date hereof, the Base Patents are owned
exclusively by Memory and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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 MEM1414 in such Base Patents.
(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 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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 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 of 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 not be required to disclose and/or minimize
the degree of such disclosure.
(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 Research Collaboration:
(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
Collaboration 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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 (a) Conditions Subsequent. The effectiveness of this Agreement
and the transaction contemplated hereunder shall be subject to
and shall be contingent upon the satisfaction under the
following condition subsequent to the execution of this
Agreement by February 28, 2003. 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 Xxxx-Xxxxx-Xxxxxx Antitrust
Improvements Act of 1976.
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.
(b) 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.
16.2 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
16.3 Roche's Right to Terminate. Beginning on the second anniversary of the
Effective Date, 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 Japan) 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, after the second anniversary, 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. The first date that Roche shall have a right
to provide written notice to Memory of intention to terminate this
Agreement, in whole or in part, shall be the date that is eighteen (18)
months after the Effective Date.
Notwithstanding the above, Roche shall have the unilateral right to
terminate this Agreement in its entirety prior to the second
anniversary of the Effective Date only in the event that for each of
the three different Memory PDE4 inhibitor chemical series, Memory 1, 2
and 3 as seen in Schedule A, a lead compound from each series, selected
by the JLT, fails to progress due to failure of each compound to pass
GLP safety and toxicity studies, defined as those GLP safety and
toxicity studies generally required by the FDA for entry into man.
16.4 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 16.3, or (c) termination of this Agreement
by Memory in its entirety or in a region pursuant to Article 3, and
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, provided Roche shall
maintain a non-exclusive license to practice Collaboration Technology
to make, use and sell products other than PDE4 inhibitors. 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 Collaboration Patent
Rights, related to the relevant Product(s). Without limiting
the generality of the preceding sentence, Memory shall, upon
such transfer, have the right to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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 Memory
a sole and exclusive, non-royalty bearing fully paid-up
license, under Roche intellectual property (including
Collaboration Technology and Patent Rights Covering
Collaboration Technology and Collaboration Compounds, and
including any 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.
(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).
16.5 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.
16.6 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 16.1a has not been fulfilled by February 28, 2003, in
which
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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(a).
16.7 Survival of Obligations. Section 2.2 (the last sentence only), Section
2.4 and Schedule C, Article 6 (except for Section 6.2), Section 7.6,
Section 13.1, Article 15, Section 16.4, Section 16.5, Section 16.7,
Article 17, Article 18, and any definitions used in such Section of
Article, shall survive the termination of this Agreement in its
entirety. Except for obligation which clearly are not intended to
continue in respect of a partial termination (including the diligence
obligation, and except as provided in Section 16.5, royalty
obligations), with respect to the region, country or Product
terminated, all obligations in this Agreement shall survive a partial
termination.
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. 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 preceeding 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
to (i) activities of Roche and its Affiliates in the conduct
of the Collaboration, (ii) the development, manufacture, use,
offer for sale, sale or other disposition of any Product or
Non-Memory Compound 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 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 Collaboration, (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 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
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.
18.7 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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.
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 2.3 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 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
18.15 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: /s/ 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, PL
--------------------------------------
By: Xxxxxxx Xxxx
-----------------------------------------
Title: Authorized Signatory
--------------------------------------
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Exhibit 10.9
SCHEDULE A
MEMORY PATENT RIGHTS
I. MEMORY 1
A. U.S.
(a) First US provisional filed January 22, 2001
(60/262,651).
(b) Second US provisional filed February 8, 2001
(60/267,196).
(c) Third US provisional filed July 19, 2001 (60/306,140)
(d) A regular US patent application (10/051,309) was
filed on January 22, 2002, claiming priority to the
above-mentioned three US provisional applications.
B. PCT
An International PCT application (PCT/US02/01508) was also
filed on January 22, 2002, claiming priority to the
above-mentioned three US provisional applications.
C. Additional
(a) An application filed July 19, 2002
(b) A second application filed July 19, 2002
II. MEMORY 2
A. U.S.
(a) First US provisional filed February 8, 2001
(60/267,195)
(b) Second US provisional filed January 7, 2002
(60/344,824).
(c) A regular US patent application (10/067,996) was
filed on February 8, 2002, claiming priority to the
above-mentioned two US provisional applications.
(d) Possible Second US family to be filed; awaiting
analysis from MPC.
B. PCT
An International PCT application (no serial no issued yet) was
also filed on February 8, 2002, claiming priority to the
above-mentioned two US provisional applications.
III. MEMORY 3
A. U.S.
A first US provisional application (Memory 3 V1) was filed
October 16, 2001 (60/329,314).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
IV. MEMORY 4 (CYCLIC AMP PHOSPHODIESTERASE ISOFORM 4D7 AND METHODS OF USE)
A. U.S.
(a) First US provisional filed November 15, 2001
(60/331,422)
(b) Second US provisional filed January 23, 2002
(60/349,985).
V. MEMORY 5 (CYCLIC AMP PHOSPHODIESTERASE ISOFORMS AND METHODS OF USE)
A. U.S.
(a) U.S. provisional application filed June 25, 1999
(60/141,196
(b) A regular U.S. Patent Application was filed June 23,
2000 (09/602,735), claiming priority to the
above-mentioned provisional application.
B. PCT
An International Patent Application was filed June 23, 2000,
and was published January 4, 2001 (WO 01/00851). This
application claims priority the above-mentioned provisional
application.
C. EP
A European Patent Application was filed December 21, 2001
claiming priority to the above-mentioned provisional
application and International application (application EP
00944829.1; publication EP 1190070).
D. JP
A Japanese Patent Application was filed December 25, 2001
claiming priority to the above-mentioned provisional
application and International application (JP 2001-506843).
E. AU
An Australian Patent Application was filed December 20, 2001
claiming priority to the above-mentioned provisional
application and International application (AU 58864/00).
F. CA
A Canadian Patent Application was filed December 20, 2001
claiming priority to the above-mentioned provisional
application and International application (serial no. not yet
issued).
G. MX
A Mexican Patent Application was filed December 25, 2001
claiming priority to the above-mentioned provisional
application and International application (serial no. not yet
issued).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE B
RESEARCH WORKPLAN
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE C
USE OF NON-MEMORY COMPOUNDS
1 Development Event Based Payments. If Roche (alone or with its
Affiliates) develops a Non-Memory Compound for a Neurological
Indication or a Psychiatric Indication, then Roche shall pay Memory for
such Non-Memory Compound achieving the Events of Sections 4.3(a) and
4.3(b) as if such Non-Memory Compound were a Product except (i) Roche
shall pay [*] percent ([*]%) of such payments related to IND, Phase II
and Phase III Events, and (ii) [*] percent ([*]%) of all other payments
provided under Section 4.3(a) and 4.3(b).
If Roche (alone or with its Affiliates) develops a Non-Memory Compound
for an Other Indication, then Roche shall pay Memory for such
Non-Memory Compound achieving the Events of Sections 4.3(c) as if such
Non-Memory Compound were a Product except (i) Roche shall pay [*]
percent ([*]%) of such payments related to IND, Phase II and Phase III
Events, and (ii) [*] percent ([*]%) of all other payments provided
under Section 4.3(c).
Each payment in this Schedule C shall be due and payable by Roche
within thirty (30) days after occurrence of the applicable Event. Roche
will make each of such payments only once, for the first occurrence of
a respective Event, regardless of how many times the Event may be
subsequently achieved with a Non-Memory Compound. An Event shall be
deemed to have occurred regardless of whether a Product or a Non-Memory
Compound first achieved the Event.
2. ROYALTIES.
(a) Roche shall pay to Memory the following payments for a given
product containing a Non-Memory Compound having a Regulatory
Approval in the US for a Neurological Indication, based upon
the net sales (defined as in Section 1.30 but applied to the
given product) of such product in the US. Such royalty
payments shall be calculated by multiplying the following
percentages by the following annual net sales of such product
in the US (all Net Sales amounts in $ US million):
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ANNUAL US NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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Notwithstanding the foregoing, if for such product there is
Regulatory Approval in the United States of America for a
Psychiatric Indication, but no Regulatory Approval in the US
for a Neurological Indication, then Roche shall pay to Memory
the following payments for such product, based upon the net
sales of such product in the US. Such royalty payments shall
be calculated by multiplying the following percentages by the
following incremental annual net sales of such product in the
US (all Net Sales amounts in $ US million):
--------------------------------------------------------------------------------
ANNUAL US NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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[*] [*]
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[*] CONFIDENTIAL TREATMENT IS REQUESTED
Notwithstanding the foregoing, if for such product there is no
Regulatory Approval in the US for a Neurological Indication or
a Psychiatric Indication, then Roche shall pay to Memory the
following payments for such product, based upon the net sales
of such product in the US. Such royalty payments shall be
calculated by multiplying the following percentages by the
following incremental annual net sales of such product in the
US (all Net Sales amounts in $ US million):
--------------------------------------------------------------------------------
ANNUAL US NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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(b) Roche shall pay to Memory the following payments for a given
product containing a Non-Memory Compound having Regulatory
Approval in Europe for a Neurological Indication, based upon
the net sales (defined as in Section 1.30 but applied to the
given product) of such product in all countries in the ROW
Territory. Such royalty payments shall be calculated by
multiplying the following percentages by the following
incremental annual worldwide net sales of such product in the
ROW Territory (all net sales amounts in $ US million):
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ANNUAL ROW TERRITORY NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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Notwithstanding the foregoing, if for such product there is
Regulatory Approval in the Europe for a Psychiatric Indication
but no Regulatory Approval in Europe for a Neurological
Indication, then, Roche shall pay to Memory the following
payments for such product, based upon the net sales of such
product in the ROW Territory. Such royalty payments shall be
calculated by multiplying the following percentages by the
following annual worldwide net sales of such product in the
ROW Territory (all net sales amounts in $ US million):
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ANNUAL ROW TERRITORY NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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[*] [*]
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[*] [*]
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Notwithstanding the foregoing, if for such product there is no
Regulatory Approval in the Europe for a Neurological
Indication or a Psychiatric Indication, then Roche shall pay
to Memory the following payments for such product, based upon
the net sales of such product in the ROW Territory. Such
royalty payments shall be calculated by multiplying the
following percentages by the following incremental annual net
sales of such product in the ROW Territory (all Net Sales
amounts in $ US million):
[*] CONFIDENTIAL TREATMENT IS REQUESTED
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ANNUAL ROW TERRITORY NET SALES PERCENT (%) OF NET SALES
--------------------------------------------------------------------------------
[*] [*]
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[*] [*]
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Roche shall calculate and pay royalty payments to Memory under
this Schedule C commencing on the launch of the product 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 (i) ten (10) years from the launch of such
product in such country, or (ii) expiration of the last to
expire Memory Patent Right Covering the product in country,
after which time Roche's license from Memory for such product
shall be fully-paid up for such country.
All of the provisions of Article VI, including the timing of
payments and rights under Section 6.5, shall apply to the
payments required pursuant to this Schedule C.
There shall be no further adjustments to such royalty
payments.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
