AMENDED AND RESTATED LICENSE AGREEMENT between NPS Allelix Corp. and Memory Pharmaceuticals Corp. [*] CONFIDENTIAL TREATMENT IS REQUESTED
Exhibit 10.1
AMENDED AND RESTATED
between
NPS Allelix Corp.
and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
Table of Contents
Page | ||||||||
ARTICLE 1
|
Definitions | 3 | ||||||
ARTICLE 2
|
License Grants | 7 | ||||||
ARTICLE 3
|
Diligence | 8 | ||||||
ARTICLE 4
|
Payments to NPS | 9 | ||||||
ARTICLE 5
|
Royalties | 10 | ||||||
ARTICLE 6
|
Payment, Reporting, Auditing | 12 | ||||||
ARTICLE 7
|
Pre-Clinical Development | 14 | ||||||
ARTICLE 8
|
Clinical Development | 14 | ||||||
ARTICLE 9
|
Regulatory Affairs | 15 | ||||||
ARTICLE 10
|
Manufacture and Supply | 15 | ||||||
ARTICLE 11
|
Commercialization | 16 | ||||||
ARTICLE 12
|
Trademarks | 16 | ||||||
ARTICLE 13
|
Ownership of Intellectual Property and Patent Rights | 16 | ||||||
ARTICLE 14
|
Representations and Warranties | 20 | ||||||
ARTICLE 15
|
Confidential Information | 21 | ||||||
ARTICLE 16
|
Term and Termination | 23 | ||||||
ARTICLE 17
|
Arbitration | 26 | ||||||
ARTICLE 18
|
Miscellaneous | 27 | ||||||
Schedule A
|
33 | |||||||
Schedule B
|
35 | |||||||
Schedule C
|
36 | |||||||
Schedule D
|
38 |
[*] CONFIDENTIAL TREATMENT IS REQUESTED
i
AMENDED AND RESTATED LICENSE AGREEMENT
This AMENDED AND RESTATED LICENSE AGREEMENT (the “Agreement”), entered into as of April 20,
2007 (the “Execution Date”), and having an effective date of October 15, 2003 (the “Effective
Date”), is between, NPS ALLELIX CORP., an Ontario corporation having it principal place of business
at 0000 Xxxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx X0X 0X0 Xxxxxx (“NPS”) and MEMORY PHARMACEUTICALS
CORP., a Delaware corporation, having its principal place of business at 000 Xxxxxxx Xxxxxxx,
Xxxxxxxx, Xxx Xxxxxx 00000 (“Memory”).
Introduction
1. | Each of NPS and Memory has discovered compounds active as 5-HT6 receptor antagonists and owns related intellectual property rights. |
2. | Memory has expertise in the research and development of pharmaceutical products, and desires to develop and commercialize products containing compounds active as 5-HT6 receptor antagonists. |
3. | NPS and Memory have previously entered into a License Agreement dated October 15, 2003 relating to 5-HT6 receptor antagonists (the “Original License Agreement”) and NPS and Memory now desire to amend and restate the Original License Agreement in its entirety. |
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, NPS and Memory agree to amend and restate the Original License Agreement 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. 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.
1.2 “Agreement Term” means the term of this Agreement, more fully described in Section 16.1.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
2
1.3 “Bioequivalent Product” means, with respect to a given Product or Memory Product sold in a
given country of the Territory by Memory, its Affiliate or sublicensee, a product sold by a Third
Party in such country containing [*], as the case may be, as such Product or Memory Product, as the
case may be.
1.4 “Combination Product” means any product containing both (a) an NPS Compound and/or a
Memory Compound which causes it to be considered a Product and/or Memory Product, and (b) one or
more other pharmaceutically active agents that are not Products or Memory Products.
1.5 “Cover” (including the variations such as “Covered”, “Coverage” or “Covering”) shall mean
that the making, using, offering for sale, selling, importing, or exporting of a given product
would infringe a claim of a Patent Right in the absence of a license under such Patent Right. The
determination of whether a product is Covered by a particular Patent Right shall be made on a
country-by-country basis.
1.6 “Effective Date” means October 15, 2003.
1.7 “Field” shall mean prophylaxis and treatment of diseases, in all indications, for either
human or veterinary use.
1.8 “IND” means an Investigational New Drug Application filed with the United States Food and
Drug Administration (“FDA”) for human clinical testing of a drug.
1.9 “Initiation of Phase I” means the date that a human is first dosed by or on behalf of
Memory, its Affiliate or sublicensee with a Product or Memory Product, as the case may be, in a
Phase I clinical trial or foreign equivalent.
1.10 “Initiation of Phase II” means the date that a patient is first dosed by or on behalf of
Memory, its Affiliate or sublicensee with a Product or Memory Product, as the case may be, in a
Phase II clinical trial or foreign equivalent.
1.11 “Initiation of Phase III” means the date that a patient is first dosed by or on behalf of
Memory, its Affiliate or sublicensee with a Product or Memory Product, as the case may be, in a
Phase III clinical trial or foreign equivalent.
1.12 “Launch” means, with respect to a Product or Memory Product, as the case may be, in a
country of the Territory, the date of the first commercial sale by Memory, its Affiliate or its
sublicensee of the given Product or Memory Product in the given country after Regulatory Approval
in such country.
1.13 “Major Market Countries” means [*].
1.14 “Memory Compound” means any 5-HT6 receptor antagonist for which Memory as of the
Effective Date or during the term of this Agreement has rights, by reason of its own conception of
such antagonist, and are Covered by Memory Patent Rights, but are not covered by the NPS Patent
Rights. A list of the Memory Compounds is set forth in Schedule A hereto, as shall be updated from
time-to-time.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
3
1.15 “Memory Patent Rights” means all Patent Rights that Memory owns relating to 5-HT6
receptor antagonists as listed in Schedule B as updated from time-to-time, including (a) any
patents issuing from any such patent applications listed in Schedule B and (b) any divisional
applications, continuation applications, continuation-in-part applications, substitutions,
extensions, supplementary protection certificates, reissues, reexaminations, renewals or the like
related to the patents and patent applications listed in Schedule B.
1.16 “Memory Product” means any pharmaceutical product that includes, in whole or as a
component, any Memory Compound as an active ingredient thereof.
1.17 “NPS Compound” means any 5-HT6 receptor antagonist for which NPS as of the Effective Date
has rights, whether by reason of its own conception of such antagonist, or under agreement with a
Third Party, and are Covered by NPS Patent Rights. NPS Compounds shall include any 5-HT6 receptor
antagonist for which Memory during the term of this Agreement has rights by reason of its own
conception of such antagonist and which also is Covered by the NPS Patent Rights. A list of the
NPS Compounds is set forth in Schedule C hereto, as shall be updated from time-to-time.
1.18 “NPS 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 or Memory Product in
the Territory. NPS Know-How does not include the 5-HT6 receptor nor the non-exclusive license NPS
obtained from NIH regarding the 5-HT6 receptor.
1.19 “NPS Patent Rights” means all Patent Rights that NPS owns, or otherwise has the right to
grant the licenses herein relating to 5-HT6 receptor antagonists as listed in Schedule D as updated
from time-to-time, including (a) any patents issuing from any such patent applications listed in
Schedule D and (b) any divisional applications, continuation applications, continuation-in-part
applications, substitutions, extensions, supplementary protection certificates, reissues,
reexaminations, renewals or the like related to the patents and patent applications listed in
Schedule D. NPS Patent Rights do not include NPS’ non-exclusive license from NIH to the 5-HT6
receptor patents.
1.20 “NDA” means a New Drug Application filed with the FDA, or its foreign equivalent, for a
drug.
1.21 “NDA Approval” means for a given Product or Memory Product, the date that the FDA, or its
foreign equivalents, approves the NDA for the marketing of the Product or Memory Product.
1.22 “Net Sales” shall mean the amount of gross sales of the Product or Memory Product, as the
case may be, invoiced by Memory, its Affiliates and its sub-licensees to independent third parties
(which are, e.g., distributors, pharmacies, etc.) less deductions of returns (including allowances
actually given for spoiled, damaged, out-dated, rejected, returned Product or Memory Product sold,
withdrawals and recalls), rebates to the extent consistently applied by Memory 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
4
accounted for within Memory on a product-by-product basis)), government mandated rebates and
similar types of rebates (e.g., P.P.R.S, Medicaid, each as consistently applied by Memory to its
products), volume (quantity) discounts, each as consistently applied by Memory 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 Net Sales.
Notwithstanding the foregoing, amounts received by Memory, its Affiliates and sublicensees for
the sale of Product or Memory Product among Memory, its Affiliates or sublicensees for resale shall
not be included in the computation of Net Sales.
1.23 “Party” and “Parties” means NPS or Memory, or both, as applicable.
1.24 “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.
1.25 “Phase I” means the first phase of human clinical trials of a drug required by the US
FDA, or similar regulatory body, to gain evidence of safety and determine optimal dosage for
Product(s) or Memory Product(s), as the case may be. For the US FDA, it is described in 21 CFR
Part 312, as it may be amended.
1.26 “Phase II” means the second phase of human clinical trials of a drug required by the US
FDA, or similar regulatory body, to gain evidence of efficacy in the target population, determine
optimal dosage, and obtain expanded evidence of safety for Product(s) or Memory Product(s), as the
case may be. For the US FDA, it is described in 21 CFR Part 312, as it may be amended.
1.27 “Phase III” or “Pivotal Phase” means the third phase of human clinical trials of a drug
required by the US FDA, or similar regulatory body, to gain evidence of efficacy in the target
population, and obtain expanded evidence of safety for Product(s) or Memory Product(s), as the case
may be. For the US FDA, it is described in 21 CFR Part 312, as it may be amended.
1.28 “Pre-Clinical Candidate” shall be an NPS Compound that Memory designates within 18
(eighteen) months of receipt of NPS Compounds and NPS Compound intermediates from NPS, which NPS
has in stock.
1.29 “Product” means any and all products for humans or animals that include, in whole or as a
component thereof, a NPS Compound.
1.30 “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 or Memory Product, as the case may be, in the Field in a regulatory
jurisdiction in the Territory by Memory, its Affiliate or sublicensee.
1.31 “Territory” means all countries and territories in the world.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
5
1.32 “Third Party” means a person or entity other than (i) NPS or any of its Affiliates, or
(ii) Memory or any of its Affiliates.
1.33 “US” means the United States of America and its possessions and territories, including
Puerto Rico.
1.34 “Valid Claim” means a claim in any (i) unexpired and issued patent under NPS Patent
Rights or Memory Patent Rights, as the case may be, 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 under NPS Patent Rights or Memory Patent Rights, as the case may
be.
ARTICLE 2
LICENSE GRANTS
2.1 License Grants. Subject to the terms and conditions of this Agreement, NPS grants to
Memory the sole and exclusive license, even with respect to NPS other than as provided in Sections
16.5(c) or (d), including the right to grant sublicenses pursuant to Section 2.2, under the NPS
Patent Rights and to use the NPS Know-How, to make, have made, use, have used, offer for sale,
sell, import, export, register and/or market Products and/or Memory Products in the Territory for
use in the Field.
Nothing in this Agreement grants to Memory any right or license to use NPS Know-How for any
purpose other than to make, have made, use, have used, offer for sale, sell, import, export,
register and/or market Products and/or Memory Products in the Territory for use in the Field.
2.2 Sublicense Rights.
(a) The rights and licenses granted to Memory 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, have made, use, have used, offer for sale, sell,
import, export, register, and/or market Products and/or Memory Products in the Territory for use in
the Field. If Memory grants such a sublicense, Memory 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 Memory for all purposes. Memory 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 NPS for all payments due under this Agreement by
reason of such sublicense.
(b) Intentionally Omitted.
(c) Intentionally Omitted.
(d) Any sublicense may, at the written election of NPS, continue in full force and effect
after the termination of any of the underlying licenses granted herein to Memory. Upon the
licenses granted herein to Memory becoming fully paid up pursuant to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
6
Section 16.1, any and all sublicenses granted by Memory similarly shall become fully paid up as to NPS.
ARTICLE 3
DILIGENCE
3.1 Diligence. Memory shall use reasonable diligence in proceeding with the development,
including: pursuing a clinical candidate; conducting safety and efficacy trials; obtaining required
Regulatory Approvals; manufacturing; marketing; and sale of Products and/or Memory Products, at
Memory’s option, in the Major Market Countries.
Reasonable diligence as used in this paragraph shall mean the same standard of effort as used
by Memory, 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
or Memory Product, as the case may be, taking into account scientific, business and marketing and
return on investment considerations. It is understood that such Product or Memory Product
potential may change from time to time based upon changing scientific, business, marketing and
return on investment considerations. The Parties also acknowledge that, even within the Major
Market Countries, Memory (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 Memory 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 [*]).
[* ]
In the event of a dispute between the Parties with respect to whether Memory 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
Sections 16.3(e), 16.5 and Article 17.
ARTICLE 4
PAYMENTS TO NPS
4.1 Milestones. Memory shall pay NPS $[*] ([*] dollars) upon [*].
Notwithstanding the above, for each NPS Compound and Memory Compound, Memory shall pay NPS the
following milestones for Products and Memory Products being developed by Memory, which shall be
non-refundable and non-creditable, and due and payable as follows:
Event | Payment (US$) | |||||||
A. | (i) | [*] | $[*] |
[*] CONFIDENTIAL TREATMENT IS REQUESTED
7
Event | Payment (US$) | |||||||
(ii) | [*] | $[*] | ||||||
(iii) | [*] | $[*] | ||||||
(iv) | [*] | $[*] | ||||||
B. | (i) | [*] | $[*] | |||||
(ii) | [*] | $[*] | ||||||
(iii) | [*] | $[*] |
Each payment in this Section 4.1 shall be due and payable by Memory within [*] days after
occurrence of the applicable event, with the exception of [*] events, in which the payments shall
be due and payable by Memory within [*] days after occurrence of the [*] event. Notwithstanding
anything to the contrary, Memory will make each of such payments only once, for each NPS Compound
and/or Memory Compound for a given indication upon the first occurrence of a respective event,
regardless of how many times the event may be achieved. For the avoidance of doubt, if a product
constitutes both a Product and a Memory Product, each such payment shall be due only once with
respect to such product.
In the event a milestone payment for a given event for a given NPS Compound or Memory Compound
and indication becomes due, and Memory has not made payment for such NPS Compound or Memory
Compound in such indication for a milestone listed prior to the milestone payment due, then Memory
shall pay the milestone that is due and all prior listed milestones that were not previously paid.
The costs Memory incurred for the validation of the patents in European countries for European
patent application no. [*] or no. [*] pursuant to Section 13.2(b)(v) (which costs totaled, in the
aggregate, $[*]) will be directly subtracted from owed milestone payments, starting with the [*]
and including subsequent milestones due until validation costs incurred by Memory equals withheld
milestones. For the avoidance of doubt, as a result of such subtraction, (a) Memory has not and
shall not be required to make payment of the [*], and (b) the milestone payment due with respect to
the [*] shall be reduced from $[*] to $[*]. As set forth in Section
13.2(b)(iii), Memory shall not incur or be required to pay any additional costs in connection with
the validation of the patents in European countries for European patent application no. [*] or no.
[*] and, accordingly, no further subtraction beyond the subtraction described in the immediately
preceding sentence shall be applied.
4.2 Upfront Payment. Upon execution and delivery of the Agreement, Memory shall pay to NPS a
one-time nonrefundable payment in the amount of fifty thousand dollars ($50,000.00).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
8
ARTICLE 5
ROYALTIES
5.1 Royalties.
(a) Memory shall pay to NPS a royalty payment of [*]% ([*] percent) for a given Product or
Memory Product sold by Memory or its sublicensee having a Regulatory Approval, based upon the Net
Sales of such Product or Memory Product, as the case may be, which such Net Sales shall be subject
to adjustment as provided in this Article 5. For the avoidance of doubt, if a product constitutes
both a Product and a Memory Product, each such payment shall be due only once with respect to such
product.
(b) Intentionally Omitted.
5.2 Term of Royalty Payments. Memory shall calculate and make royalty payments to NPS 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, in the case of a Product or a
Memory Product, for a period of ten (10) years after Launch of such Product or Memory Product in
such country, and upon the expiration of this ten (10) year period, the licenses granted hereunder
by NPS shall be fully paid-up and irrevocable.
5.3 Adjustments Related to Third Party Competition. For a given Product or Memory Product in
a given calendar quarter, if in a country of the Territory (a) a Third Party is selling
Bioequivalent Product, and (b) Memory has an obligation to make payments under this Agreement with
respect to Net Sales of the given Product or Memory Product in such country, and (c) a Valid Claim
Covers the given Product or Memory 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 (A) Bioequivalent Products and (B) Products or Memory Products, as the case may be, as
measured at the end of such calendar quarter, and (e) Memory has, if it is reasonable under the
circumstances, brought in the country and continued to diligently prosecute a patent infringement
suit against the Third Party selling the Bioequivalent Product or another in privity, then Memory
shall have the right to calculate royalties with respect to such calendar quarter by including only
[*] percent ([*]%) of the amount Memory would have otherwise included for such country to calculate
sales-based payments if no Bioequivalent Product existed in such country.
5.4 Adjustments Related to Third Party Payments. Memory shall be responsible for payment of
the entire consideration owed to any Third Party pursuant to the terms of any existing or future
patent licensing agreement entered into by Memory relating to the Product or Memory Product, as the
case may be. Memory shall have the right to deduct a maximum of [*] percent ([*]%) of the
consideration actually paid by Memory or its Affiliate to a Third Party with respect to a license
under a patent which Covers an NPS Compound or Memory Compound, from payments otherwise due and
payable by Memory to NPS under this Agreement.
5.5 Combination Products. In the event Memory, or its sublicensees, 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
9
agree to an appropriate adjustment to Net Sales to reflect the relative significance and value of
the Product or Memory Product, as the case may be, and the other pharmaceutically active agent(s)
contained in the Combination Product. If, after good faith negotiations (not to exceed [*]), the
Parties cannot agree to an appropriate adjustment, Net Sales shall equal [*]. However, in no event
shall NPS receive less than [*] percent ([*]%) of the royalties it would receive for sale of the
Product or Memory Product, as the case may be, if it were not in a Combination Product.
5.6 Certain Sublicensee Payments. In the event that Memory grants a sublicense to
commercialize a Product or Memory Product under the NPS Patent Rights to a Third Party, Memory
shall pay to NPS, within [*] days after receipt thereof by NPS from such sublicensee, an amount
equal to [*]. Notwithstanding anything contained herein to the contrary, the aggregate amounts
paid by Memory to NPS pursuant to this Section 5.6 [*] shall in no event exceed $[*].
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, Memory
shall convert the amount of its monthly Net Sales in foreign currencies for the countries
concerned, using for internal foreign currency translation the monthly average rate of exchange
published in the Wall Street Journal (or some other source agreed upon by the Parties for any
particular country).
(c) For sublicensees in a country, when calculating the Net Sales, the sublicensee shall
report to Memory 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 US Dollars
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 or Memory Product in any country of the
Territory, Memory shall calculate royalty payments set forth in Article 5 [*] as of [*]. Memory
shall pay such payments [*] within [*] days after the end of each reporting period in which Net
Sales occur during the Agreement Term.
[*] days after the end of each reporting period, Memory shall deliver to NPS the following
information split among [*] and rest of world:
(a) Net Sales for each Product and Memory Product; and
(b) the royalty payments due to NPS for the reporting period.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
10
If NPS reasonably requests additional information relating to gross sales of the Products and
Memory Products in the Major Market Countries, deductions therefrom to calculate Net Sales and/or
adjustments thereto, Memory agrees to provide such information to NPS within a reasonable time,
provided, that NPS shall have the rights to exercise such requests not more than [*].
In the event Memory does not pay NPS any amounts due under this Agreement, including pursuant
to Articles 4 and 5, within the applicable time period set forth herein, without limiting NPS’s
rights under Article 16, such payment shall bear interest, to the extent permitted by applicable
law, at the rate of interest [*] from time to time, for the applicable period calculated on the
number of days such a payment is overdue.
6.3 Taxes.
(a) NPS shall pay all applicable taxes levied on NPS under this Agreement.
(b) If provision is made in law or regulation of any country for withholding of taxes of any
type, levies on NPS or other charges against NPS with respect to any amounts payable under this
Agreement to NPS, Memory shall promptly pay such tax, levy or charge for and on behalf of NPS to
the proper governmental authority, and shall promptly furnish NPS with receipt of such payment.
Memory shall have the right to deduct any such tax, levy or charge actually paid from payment due
NPS or be promptly reimbursed by NPS if no further payments are due NPS. Each Party agrees to
assist the other Party in claiming exemption from such deductions or withholdings under double
taxation or similar agreement or treaty from time to time in force and in minimizing the amount
required to be so withheld or deducted.
6.4 Blocked Countries. If by reason of law Memory is unable to convert to U.S. Dollars a
portion of the amount due by Memory under this Agreement, then Memory shall notify NPS in writing
and, upon written request from NPS, Memory shall pay to NPS such portion, in the currency of any
other country designated by NPS and legally available to Memory.
6.5 Accounting.
(a) Memory 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. NPS shall have the right to engage an independent, certified public accountant to
perform, on behalf of NPS, an audit of such books and records of Memory and its Affiliates and
sublicensees as is necessary to confirm any amounts payable to NPS under this Agreement for the
period or periods requested by NPS 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 NPS (minimum of thirty (30) days) in such a manner as to
not unnecessarily interfere with Memory’s normal business activities, and shall include
results of no more than three (3) preceding calendar years prior to audit notification.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
11
(c) Such audit shall not occur more frequently than [*] nor more frequently
than [*] with respect to records covering any specific period of time.
(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 Memory
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 [*] years from the end of the calendar year to which each shall pertain.
Audit results shall be shared by Memory and NPS.
(e) If any audit hereunder reveals an underpayment, Memory shall promptly make up such
underpayment. In the event that any audit performed reveals an underpayment for a [*] payment in
excess of [*] percent ([*] %) of the amount actually paid, such underpayment shall bear interest,
to the extent permitted by applicable law, at the rate of interest [*] from time to time plus [*]
percent ([*] %), for the applicable period calculated on the number of days such a payment is
overdue. If any audit hereunder reveals an overpayment, NPS shall promptly reimburse such
overpayment. [*].
(f) The failure of NPS 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 NPS.
ARTICLE 7
PRE-CLINICAL DEVELOPMENT
7.1 Memory, at its sole cost, shall pursue further pre-clinical development of any
Pre-clinical Candidate and other preclinical candidates selected by it.
7.2 [*].
ARTICLE 8
CLINICAL DEVELOPMENT
Memory, at its sole cost and option, shall (1) pursue clinical development of Product(s) and/or
Memory Product(s), and (2) obtain all Regulatory Approvals which are required for such Product(s)
and/or Memory Product(s) to be manufactured, developed, marketed and sold in the Territory. During
the Agreement Term, Memory shall provide NPS with an [*] summary report on or before [*] describing
the development of the NPS Compounds and/or Memory Compounds by Memory, its Affiliates, and
sublicensees.
In particular, Memory shall in such [*] reports, provide NPS with a written report describing the
then current status and plan, if applicable, for the development of an NPS Compound/Product and/or
Memory Compound/Memory Product. Said report may be in summary form but shall be
comprehensive and shall include at least (a) the name and location of each Affiliate or
sub-licensee which is then conducting, or during the preceding period has conducted any licensed
activity or which is involved in any research or development utilizing NPS Compound/Product
[*] CONFIDENTIAL TREATMENT IS REQUESTED
12
and/or
Memory Compound/Memory Product, (b) a reasonable summary of the status of each such research or
development activity and of the plan for the same for the following calendar year without the
requirement to report any experimental results and details thereof, and (c) any information
concerning the timing of initiation of all clinical and important pre-clinical studies.
ARTICLE 9
REGULATORY AFFAIRS
Memory, at its sole cost, shall pursue all regulatory affairs in the Territory related to Product
and/or Memory Product, at Memory’s option, including the preparation and filing of applications for
Regulatory Approval, as well as any or all governmental approvals required to manufacture, or have
manufactured, market and sell such Products and/or Memory Products. Memory shall be responsible for
pursuing, compiling and submitting all regulatory filing documentation, and for interacting with
regulatory agencies, for all such Products and/or Memory Products in all countries in the
Territory. Memory, its sublicensees, or its Affiliates shall own and file all regulatory filings
and obtain all Regulatory Approvals for all Products and/or Memory Products in all countries of the
Territory.
Memory, at its sole cost, shall report to appropriate authorities in accordance with local
requirements all adverse events related to use of Products and/or Memory Products worldwide.
Adverse events related to the use of Product and/or Memory Product worldwide shall be in a single
database for each Product and/or Memory Product, centralized, held and owned by Memory.
ARTICLE 10
MANUFACTURE AND SUPPLY
10.1 Clinical Supplies of Product and/or Memory Product. Memory shall supply at its own cost
all clinical supply of NPS Compounds, Memory Compounds, Product(s) and/or Memory Product(s) and
placebo to be used in the Territory during the Agreement Term, either by itself, or through a Third
Party.
10.2 Commercial Supply. Memory shall be solely and exclusively responsible at its own
expense for the manufacture and supply of Product and/or Memory Product for sale in the Territory,
either by itself or through Third Parties.
ARTICLE 11
COMMERCIALIZATION
11.1 Responsibilities of Memory. Except as expressly set forth in Sections 16.5(c) and
16.5(d) Memory, at its own expense, shall have sole responsibility and decision making authority
for the marketing, promotion, sale and distribution, if any, of Product and/or Memory Product in
the Territory. During the Agreement Term, Memory shall provide NPS [*] with [*] summary
report describing the commercialization of Products and/or Memory Products in the Territory by
Memory, its Affiliates and sublicensees including the name and location of each Affiliate or
sub-
[*] CONFIDENTIAL TREATMENT IS REQUESTED
13
licensee which is involved in the commercialization of Product and/or Memory Product and a
reasonable summary of the pricing, sales and marketing activity in the Territory for the previous
calendar year and the following calendar year.
ARTICLE 12
TRADEMARKS
Memory shall own worldwide all trademarks on and in connection with Products and Memory Products,
and shall, at its cost, be responsible for procurement, maintenance and enforcement of all
worldwide trademarks registration on and in connection with Products and Memory Products.
ARTICLE 13
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
13.1 Ownership of Intellectual Property.
Memory shall require all of its employees to assign all inventions related to Products and/or
Memory Products made by them to Memory, and Memory shall own such inventions. Within sixty (60)
days after the Execution Date, NPS shall file in the respective patent offices for recordation the
appropriate name changes for all U.S. patents, foreign patents, U.S. patent applications and
allowed foreign patent applications under the NPS Patent Rights to NPS.
13.2 NPS Patent Rights Prosecution and Maintenance.
(a) NPS Patent Rights. Promptly after the [*], but in any event within [*], NPS shall deliver
to Memory all records, correspondence, and other information not in Memory’s possession that is
required to prepare, file, prosecute (including interference and opposition proceedings) and
maintain (including interferences, re-examination, and opposition proceedings) (collectively
“Handle”) the NPS Patent Rights. During the foregoing [*] day period, the Parties jointly shall
develop and implement a transfer plan, including identifying all such records, correspondence and
information, transferring the patent files from NPS’ patent counsel to Memory’s patent counsel (as
selected by Memory in its sole discretion) and segregating and storing under NPS’ control, with
access rights by Memory, all applicable laboratory notebooks and other records, correspondence and
information relevant to the ability of Memory to Handle the NPS Patent Rights. Memory shall have
the right, but not the obligation, to Handle the NPS Patent Rights. Memory shall use reasonable
efforts to consult with NPS as to how Memory will Handle the NPS Patent Rights in sufficient time
before any action is due to allow NPS to provide comments thereon, which comments Memory must
reasonably consider if provided to Memory at least [*] days before such action is due.
Should Memory decide that it does not desire to Handle a patent or patent application under
NPS Patent Rights in a given country, it shall provide written notice to
NPS thereof no less than [*] days prior to the date when the patent or patent application
under NPS Patent Rights would become abandoned in such country. After receiving such notice, NPS
[*] CONFIDENTIAL TREATMENT IS REQUESTED
14
may, but is not obligated, to Handle the patent or patent application under NPS Patent Rights in
such country.
(b) Patent Costs.
(i) As of the Effective Date, [*]. For the avoidance of doubt, Memory and NPS acknowledge and
agree that Memory has previously reimbursed NPS for costs incurred by NPS for Handling the patents
and patent applications under the NPS Patent Rights from the period of eighteen (18) months after
the Effective Date. Within forty-five (45) days after the end of the [*] day period referred to in
the first sentence of Section 13.2(a), NPS shall cause to be prepared and submitted to Memory a
final xxxx that sets forth all reasonable patent costs and expenses payable by Memory pursuant to
this Section 13.2(b). Except as set forth in such final xxxx (or as otherwise may be mutually
agreed upon by the Parties in writing), Memory shall have no further obligation or liability to NPS
with respect to such patent costs and expenses.
(ii) For a given patent or patent application under NPS Patent Rights in a given country for
which [*]. At [*] request, [*] shall advise to the specific reasons for such decision. [*] may,
in its sole discretion, continue to Handle such patent or patent application under NPS Patent
Rights in such country, [*]. If, however, a Valid Claim of such patent under NPS Patent Rights
Covers a Product in such country in which Memory Launches the Product, [*] to Handle such patent or
patent application under NPS Patent Rights with respect to such country.
(iii) The Parties acknowledge that pursuant to the terms of the Original Agreement (a) Memory
was required to pay the costs of validation of the patents in European countries for European
patent application no. [*] and no. [*] up to the first $[*] ([*] dollars) for both applications
combined, (b) for costs exceeding the first $[*] ([*] dollars) to a maximum of the first $[*] ([*]
dollars) for both applications combined, Memory and NPS agreed to [*], (c) Memory agreed to pay the
costs exceeding the first $[*] ([*] dollars) for both applications combined, and (d) Memory, at its
sole discretion, selected the countries for validation, which included at the minimum for both
European patent applications, [*]. For the avoidance of doubt, Memory and NPS each acknowledge and
agree that Memory has previously paid all costs required to be paid by it pursuant to Section
13.2(b)(v) of the Original Agreement (which costs totaled, in the aggregate, $[*]) and that Memory
shall not incur or be required to make any further payment in connection with such matters, except
for annuity costs.
(iv) Intentionally Omitted.
(v) Intentionally Omitted.
13.3 Cooperation. The Parties agree to cooperate in the preparation, prosecution and
maintenance of all patent applications filed under Section 13.2, 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.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
15
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 patent or patent
application under NPS Patent Rights by a Third Party (hereinafter “Infringement”). Each Party
shall promptly provide written notice to the other Party during the Agreement Term of any known
infringement or suspected infringements of any patent or patent application under NPS Patent Rights
by a Third Party making, using, offering for sale, selling, or importing a 5-HT6 receptor
antagonist or a product containing a 5-HT6 receptor antagonist (hereinafter “5-HT6 Infringement”).
Memory shall have the first right to bring and control any action or proceeding with respect
to such 5-HT6 Infringement [*] and by counsel of its own choice, and NPS shall have the right, [*],
to be represented in any such action by counsel of its own choice. If Memory fails to bring any
such action or proceeding with respect to 5-HT6 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, NPS shall
have the right, but not the obligation, to bring and control any such action [*] and by counsel of
its own choice, and Memory shall have the right, [*], 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, [*]
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 minimal extent that such participation is required as the result of
its being a named party to the suit or action and provided the Initiating Party provides [*]. 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 [*]. 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.
13.5 Patent Infringement Suit by Third Party. In the event Memory is named or joined as a
party in a suit or action for patent infringement because of its exercise of a license granted
under the Agreement, Memory shall defend the suit [*].
[*] CONFIDENTIAL TREATMENT IS REQUESTED
16
13.6 Xxxxx-Xxxxxx. Notwithstanding anything to the contrary, should a Party receive a
certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act
of 1984 (Public Law 98-417), as amended, or its equivalent in a country other than the United
States of America, then such Party shall immediately provide the other Party with a copy of such
certification. Memory shall have twenty-five (25) days from the date on which it receives or
provides a copy of such certification to provide written notice to NPS (“H-W Suit Notice”) whether
Memory will bring suit, [*], within a forty-five (45) day period from the date of such
certification. Should such twenty-five (25) day period expire without Memory bringing suit or
providing such H-W Suit Notice, then NPS shall be free to immediately bring suit in its name. If
Memory brings suit, at Memory’s written request, NPS agrees to be named as a party to such suit.
At the initiating Party’s written request, [*]. The other Party shall have the right to
participate and have its own representation in any such suit or action [*].
13.7 Memory Patent Rights. For the avoidance of doubt, during and after the termination of
this Agreement, Memory shall own the Memory Compounds, Memory Products, Memory Patent Rights and
all inventions related to the Memory Compounds, Memory Products and/or Covered by the Memory Patent
Rights and, except as specifically provided in this Agreement, does not grant any license, interest
or other right with respect thereof to NPS. Memory shall have the right, but not the obligation,
at its expense, to Handle the Memory Patent Rights and/or to bring and control an action or
proceeding with respect to any Memory Patent Rights, at its own expense, without obligation or
notice to NPS.
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.
14.2 Representations and Warranties of NPS.
(a) Corporate Action. NPS represents and warrants to Memory that all corporate action on the
part of NPS, its officers, directors and stockholders necessary for (i) the authorization,
execution and delivery of this Agreement and (ii) the performance of all obligations of NPS
hereunder has been taken and this Agreement constitutes the legal and binding obligation of NPS,
enforceable against NPS in accordance with its terms.
(b) No Conflict. NPS represents and warrants to Memory that the execution of this Agreement
and the performance of the transactions contemplated by this Agreement by NPS 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 NPS is
a party or by which it or any of its property is bound.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
17
(c) Right to Grant Licenses. NPS represents and warrants to Memory that it has the right to
grant Memory the licenses and sublicenses that NPS hereby grants to Memory under this Agreement.
NPS represents and warrants to Memory that to the best of its knowledge all Patent Rights owned or
controlled by NPS that are directed to 5-HT6 selective receptor antagonists are included in
Schedule D.
(d) No Material Misstatements. NPS warrants and represents to Memory that to the best of its
knowledge (i) it has not intentionally failed to disclose any information which would be material
to Memory entering into this Agreement; and (ii) it has provided correct and complete copies of all
documents furnished to Memory.
(e) NPS Development of 5-HT6 Receptor Antagonists. NPS warrants and represents that it does
not have an active program to develop 5-HT6 receptor antagonists nor does it, as of the Effective
Date and as of the Execution Date, have any plans to pursue such a program.
14.3 Representations and Warranties of Memory. Memory represents and warrants to NPS 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. 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.
14.4 Disclaimer. THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. NPS AND MEMORY 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 OR MEMORY 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 OR MEMORY PRODUCTS. IN NO EVENT
SHALL EITHER NPS OR MEMORY 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
18
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 (hereinafter “Other Parties”) to the extent reasonably necessary to carry out its
obligations under this Agreement, provided such Other Parties are bound to confidentiality terms
equivalent to those herein and (ii) hereby agrees to exercise every reasonable precaution to
prevent and restrain the unauthorized disclosure or use of Confidential Information.
15.2 Release from Restrictions. The provisions of Section 15.1 shall not apply to any
Confidential Information which:
(a) was known or used by the party receiving the Confidential Information (“Receiving Party”)
or its Affiliates prior to its date of disclosure to the Receiving Party or its Affiliates by the
party disclosing the Confidential Information (“Disclosing Party”) or its Affiliates, as evidenced
by the prior written records of the Receiving Party or its Affiliates, provided such Receiving
Party did not know of such Confidential Information through confidential provisions with NPS or
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 or other laws, to defend or prosecute litigation or
to comply with governmental regulations, provided that, the Receiving Party or its Affiliates uses
all reasonable efforts to provide prior written notice of such disclosure to the Disclosing Party
or its Affiliates and to take reasonable and lawful actions to 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 (with the exception of the term of the
obligations set forth in this Article 15, which shall be at least [*] years).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
19
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 or Memory 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 Regulatory Approvals for a Product or Memory Product.
15.4 Publications. During the Agreement Term, the following provisions set forth in
subsections (a) and (b) below shall apply with respect to the disclosure in scientific journals,
publications or scientific presentations by any Party relating to any scientific work relating to
NPS Compounds, and in the case of Memory Compounds the provisions of subsection (c) set forth below
shall apply:
(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
development of a NPS Compound at least [*] 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 [*] days
of receipt of the copy of the proposed publication, that such publication in its reasonable
judgment (i) contains an Invention for which the other Party reasonably desires patent protection
or (ii) disclosure to competitors could reasonably 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
[*] days from the date of Notice.
(c) Memory solely shall initiate all proposed publications relating to the work performed
and/or the results achieved in the conduct of the development of a Memory Compound, will provide
NPS with a copy of such proposed publication at least [*] days prior to the submission of the
publication, and shall reasonably consider comments by NPS before disclosure.
ARTICLE 16
TERM AND TERMINATION
16.1 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, the license
granted under this Agreement to make, have made, use, have used,
offer for sale, sell, import, export, register and/or market Products and/or Memory Products
shall be fully paid-up.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
20
16.2 Termination for Breach. 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 (other than a
default by Memory of its obligations pursuant to Article 3 hereof, which shall be governed solely
by Section 16.3(e) below) and fails to remedy such default within [*] days ([*]) 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 [*] days after provision of written notice thereof by the Non-Breaching Party.
In the event Memory 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, NPS shall not have the right
to terminate this Agreement as a result of such nonpayment until resolution of the dispute pursuant
to Article 17.
16.3 NPS’s Right to Terminate.
(a) Intentionally Omitted.
(b) Intentionally Omitted.
(c) Intentionally Omitted.
(d) Intentionally Omitted.
(e) In the event that both Memory is in default of Article 3 hereof and Memory fails to remedy
such default and failure within [*] after provision of written notice thereof by NPS, then NPS
shall have the unilateral right to terminate the Agreement [*]. The effective date of termination
shall be [*] days after [*].
16.4 Memory’s Right to Terminate. In the event that Memory determines it has a scientific
and/or technical problem relating to the development and/or Regulatory Approval of NPS Compound,
Memory Compound, Product and/or Memory Product, or an economic and/or business problem relating to
the development, Regulatory Approval, and/or marketing of any NPS Compound, Memory Compound,
Product and/or Memory Product, Memory shall have the unilateral right to terminate this Agreement
upon written notice to NPS. The effective date of termination will be [*] days after provision of
written notice by Memory.
16.5 Consequences of Termination. Upon any termination of this Agreement in its entirety
pursuant to Sections 16.1—16.4, or termination of this Agreement by NPS in its entirety, the
rights and licenses of any kind or nature granted by NPS to Memory under this Agreement
shall terminate on the effective date of termination. In the event of any such termination,
the following shall apply:
[*] CONFIDENTIAL TREATMENT IS REQUESTED
21
(a) Memory shall, upon NPS’s written request, assign and transfer to NPS, or its Affiliates as
requested by NPS, at no expense to NPS, or its Affiliates, and free of any liens, pledges or
security interests other than those incurred in the commercialization of the Product, all of
Memory’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 Memory’s possession or in the
possession of its Affiliates or sub-licensees, or its or their respective agents, related to the
relevant Product(s), (iv) all rights relating to the infringement of NPS Patent Rights, related to
the relevant Product(s) and (v) all patents/patent applications filed, owned or controlled by
Memory, its Affiliates or sublicensees Covering the Product(s). Without limiting the generality of
the preceding sentence, NPS shall, upon such transfer, have the right to disclose such filings,
approvals and data to (i) governmental agencies of the country or region to the extent required or
desirable to secure government approval for the development, manufacturing, marketing or sale of
Product in the country or region, (ii) Third Parties acting on behalf of NPS, its Affiliates or
sublicensees, to the extent reasonably necessary or desirable for the development, manufacture,
marketing or sale of Product in the country or region, and (iii) Third Parties to the extent
reasonably necessary or desirable to develop, manufacture, market, or sell Product in the country
or region. All such filings, approvals, patents/patent applications, proceedings, rights and data
transferred to NPS pursuant to this Section 16.5 shall be deemed to be NPS Confidential
Information.
(b) Upon NPS’s written request, Memory shall supply, or cause to be supplied, to NPS, its
Affiliates or its licensee’s the clinical and/or commercial supplies 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 NPS, its Affiliates or its licensee at Memory’s direct manufacturing costs and
allocation of manufacturing overhead, and (ii) Memory’s supply obligation shall not continue for
more than [*] after such termination, and (iii) Memory 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 Memory’s other arm’s length supply agreements, and
(v) NPS shall use reasonable best efforts to effect a transfer as soon as practicable of Product(s)
manufacturing activities from Memory to another supplier. In addition, Memory shall also transfer
to NPS and its designated supplier a manufacturing transfer package that will enable NPS or such
designated supplier to manufacture the Product(s) in a timely manner.
(c) Subject to Section 16.5(d), in the event any NPS Compound or Product is commercialized by
NPS or its licensee, which NPS Compound or Product has completed [*], then NPS shall pay a Royalty
on Net Sales of Products of [*] for the longer of [*] years from first Launch or end of patent
protection in a country. Thereafter, the license is fully paid up and irrevocable.
(d) In the event any NPS Compound or Product is commercialized by NPS or its licensee, which
NPS Compound or Product has completed [*], in lieu of the amount set forth in Section 16.5(c), then
NPS shall pay a Royalty on Net Sales of Products of [*] for the
[*] CONFIDENTIAL TREATMENT IS REQUESTED
22
longer of [*] years from first Launch or end of patent protection in a country. Thereafter,
the license is fully paid up and irrevocable.
(e) If, upon termination of this Agreement by NPS pursuant to Section 16.3, NPS notifies
Memory in writing that NPS desires to obtain a license with respect to the Memory Compounds, NPS
shall have the right to negotiate with Memory for not more than [*] days the right to obtain such
license, provided that Memory’s only obligation shall be to negotiate in good faith (but, by
example, not to reach agreement).
(f) Memory shall take prompt actions, including the execution of such instruments, agreements
and documents, as are necessary or desirable to effect its obligations described in Sections
16.(4)(a) and (b). It is agreed such transfers and actions shall be completed in a manner that
will permit NPS to continue without interruption the business of developing, manufacturing,
marketing and selling the Product(s).
16.6 Royalty and Payment Obligations. Termination of this Agreement by either Party for any
reason will not release a Party from any obligation to pay royalties or make any payments, 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, except as specifically
provided in the immediately following sentence, termination of this Agreement by either Party for
any reason will release a Party from any obligation to pay royalties or make any payments, which
would have otherwise become accrued after the effective date of termination. Solely upon
termination by NPS of this Agreement pursuant to Section 16.2 or Section 16.3 or by Memory of this
Agreement pursuant to Section 16.4, Memory’s obligation to make royalty payments with respect to
Memory Products (but not, for the avoidance of doubt, with respect to Products) which would have
otherwise terminated from and after the effective date of termination pursuant to Section 16.2,
Section 16.3 or Section 16.4, as the case may be, shall continue as provided in the Agreement.
16.7 Survival of Obligations. Section 2.2(d), Article 6 (except for Section 6.2), Section
13.1, Section 13.7, Article 15, Section 16.5, Section 16.6, 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.
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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
23
decision of the arbitrators shall be made within one (1) year of the selection of the third
arbitrator and 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 a transition procedure, including the
performance of transition services by Memory, so as to maintain the value of the assets being
transferred to NPS and, to the extent contemplated by Section 16.5, permit NPS 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 preceding provisions of this Article 17,
with respect to any breach or threatened breach of this Agreement of Section 15.1, 16.2 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 Memory owes
NPS $2,000,000 and claims a $1,000,000 payment is not due by reason of breach of NPS, then Memory
shall pay the $2,000,000, and the parties will resolve such $1,000,000 Dispute pursuant to Article
17.
ARTICLE 18
MISCELLANEOUS
18.1 Indemnification.
(a) Memory agrees to defend NPS and the other NPS Indemnified Parties at Memory’s cost and
expense, and will indemnify and hold NPS and its directors, officers, employees and agents (the
“NPS Indemnified Parties”) harmless from and against any claims, losses, costs, damages, fees or
expenses arising out of or otherwise relating to (i) activities of Memory and its Affiliates or
sublicensees in the conduct of the License, (ii) the development, manufacture, use, offer for sale,
sale or other disposition of any Product by Memory, its Affiliates or sublicensees, and each of
their distributors, representatives or anyone in privity therewith, or (iii) the gross negligence
or willful misconduct of Memory, its Affiliates, sublicensees, distributors, representatives or
anyone in privity therewith. In the event of any such claim against the NPS Indemnified Parties by
a Third Party, NPS shall promptly notify Memory in writing of the claim (provided that any failure
or delay to notify shall not excuse any obligations 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 NPS, without the prior written consent of
NPS, which consent shall not be unreasonably withheld. The NPS 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
24
liable for any litigation costs or expenses incurred by the NPS Indemnified Parties without
Memory’s written authorization.
(b) NPS agrees to defend Memory and the other Memory Indemnified Parties at NPS’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
and expenses arising out of any claim, arising out of or otherwise relating to (i) activities of
NPS in the conduct of the License, (ii) the development, manufacture, use, offer for sale, sale or
other disposition of any Product by NPS, its Affiliates, licensees other than Memory, sublicensees
and each of their distributors, representatives or anyone in privity therewith, and (iii) the gross
negligence or willful misconduct of NPS, its Affiliates, licensees, distributors, representatives
or anyone in privity therewith. In the event of any such claim against the Memory Indemnified
Parties by an Independent Third Party, Memory shall promptly notify NPS in writing of the claim
(provided that any failure or delay to notify shall not excuse any obligation of NPS except to the
extent NPS is actually prejudiced thereby) and NPS shall solely manage and control, at its sole
expense, the defense of the claim and its settlement provided further that NPS 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 NPS and may, at their option and expense, be represented in any such
action or proceeding. NPS shall not be liable for any litigation costs or expenses incurred by the
Memory Indemnified Parties without NPS’s written authorization.
18.2 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). Neither Party shall originate any publicity, news release, or other public
announcement (with the exception of disclosures in scientific journals, publications, or scientific
presentations that will be controlled by Section 15.4), written or oral, relating to this Agreement
(including without limitation, the terms of this Agreement) without the prior approval of the other
Party (such approval not to be unreasonably withheld) except solely to the extent a Party
reasonably believes same is otherwise required by law. In the event prior approval is not provided
within [*] days of notice of the publicity, the Party originating the publicity may proceed with
the publicity.
18.3 Force Majeure. Neither Party to this Agreement shall be responsible to the other Party
for nonperformance or delay in performance of the terms or conditions of this Agreement due to acts
of God, acts of governments, war, riots, strikes, accidents in transportation, or other causes
beyond the reasonable control of such Party, but such force majeure shall toll any and all
obligations and time periods for so long as such force majeure continues.
18.4 Bankruptcy. All licenses (and to the extent applicable rights) granted under or pursuant
to this Agreement by NPS to Memory 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 Memory elects to
terminate this Agreement under Article 16, the Parties agree that Memory, as a licensee or
sublicensee of such rights under this Agreement, shall retain and may fully exercise
[*] CONFIDENTIAL TREATMENT IS REQUESTED
25
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
000 Xxxxxxx Xxxxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attn: Head of Business Development
and
Xxxxx Xxxxxx Xxxxxxx & Xxxxx P.C.
Xxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attn: Xxx X. Xxxxxxxxx, Esq.
Xxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attn: Xxx X. Xxxxxxxxx, Esq.
If to NPS:
NPS Pharmaceuticals, Inc.
Xxxxxx Corporate Center 1
4th Floor, Building 8
000 Xxxxxxxxx Xxxxxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attn: Head of Business Development
Xxxxxx Corporate Center 1
4th Floor, Building 8
000 Xxxxxxxxx Xxxxxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attn: Head of Business Development
and
NPS Pharmaceuticals, Inc.
Xxxxxx Corporate Center 1
4th Floor, Building 8
000 Xxxxxxxxx Xxxxxxx
Xxxxxx Corporate Center 1
4th Floor, Building 8
000 Xxxxxxxxx Xxxxxxx
[*] CONFIDENTIAL TREATMENT IS REQUESTED
26
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attn: General Counsel
Attn: General Counsel
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.
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
27
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
28
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.
NPS ALLELIX CORP. | MEMORY PHARMACEUTICALS CORP. | |||||||||
By:
|
/s/ N. Xxxxxxx Xxxxx | By: | /s/ Xxxxx X. Xxxxx | |||||||
Title: President & CEO | Title: President & CEO |
[*] CONFIDENTIAL TREATMENT IS REQUESTED
29
Schedule A
MEMORY COMPOUNDS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
30
Schedule B
MEMORY PATENT RIGHTS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
31
Schedule C
NPS COMPOUNDS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
32
Schedule D
NPS PATENT RIGHTS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
33