EXHIBIT 10.38
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (this "AGREEMENT"), having a date
of October 14, 2005 (the "EFFECTIVE DATE"), is made by and between, on the one
hand, AMGEN INC., a Delaware corporation, having its principal place of business
at Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 ("AMGEN"), 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 PDE10 inhibitors and owns
related intellectual property rights.
2. Amgen has expertise in the research, development, manufacture and
commercialization of human therapeutics.
3. The parties wish to collaborate to research inhibitors and other
modulators of PDE10.
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 Amgen 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 person or business entity which owns, directly or
indirectly, more than fifty percent (50%) of the voting shares or other
means of control of a Person; or (b) a business entity in which more than
fifty percent (50%) of the voting shares or other means of control are
owned by a Person, 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 Person. Notwithstanding the preceding
provisions, with respect to an Affiliate of a Party to this Agreement,
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 12.1.
1.3 "AMGEN INVENTION" means an Invention having as inventors employees,
consultants or agents of Amgen or its Affiliates, but not employees,
consultants or agents of Memory or its Affiliates, as determined under US
patent law.
1.4 "AMGEN KNOW-HOW" means all Know-How that Amgen owns, or otherwise is
Controlled by Amgen, during the Agreement Term. Notwithstanding the
foregoing, Amgen Know-
[*] CONFIDENTIAL TREATMENT IS REQUESTED
1
How shall not be deemed to include Memory Know-How solely based upon the
fact that Amgen may Control such Memory Know-How under this Agreement.
1.5 "AMGEN PROPERTY" means (1) an exclusive, royalty bearing license, under
intellectual property (including Collaboration Technology, Joint
Inventions, Patent Rights Covering Collaboration Technology, and Joint
Patent Rights) controlled by Amgen that is exclusively related to the Lead
Compounds to make, have made, use, offer for sale, sell and import the
Lead Compounds (subject to Amgen's retained non-exclusive research license
to Memory Inventions that relate to Memory compounds consisting of PDE10
inhibitors or modulators, including Memory Compounds, and non-exclusive
license to any other Memory Invention as provided under Section 2.1 and
further subject to Sections 12.5(a) and 12.5(b)); (2) [*] (in the case of
each of (1) and (2), in the event that the Lead Compounds is not in
clinical trials at the time of termination of the Agreement, then (1) and
(2) shall [*]); and (3) the assignment and transfer to Memory, or its
Affiliates as requested by Memory, free of any liens, pledges or security
interests (collectively, "LIENS"), of all of Amgen's right, title and
interest in and to (i) [*](to the extent assignable and not cancelled by
the party(ies) thereto other than Amgen) to the extent relating solely to
the Lead Compounds, (ii) [*] in Amgen's possession or in the possession of
its Affiliates or its or their respective agents to the extent solely
relating to the Lead Compounds (PROVIDED, HOWEVER, that Amgen may redact
any information that does not relate to the Lead Compounds), (iii) all
rights relating to the infringement of Memory Patent Rights and Joint
Patent Rights by Third Parties, solely relating to the Lead Compounds,
(iv) all rights relating to patent prosecutions described in Section 9.2
relating solely to the Lead Compounds (and Amgen shall thereafter use
diligent efforts to file divisionals to separate any patent claims solely
relating to the Lead Compounds from those relating to other compounds) and
(v) any trademarks or trademark applications that are solely used or
solely intended for use for the Lead Compounds, and not for any products
of Amgen or any of its Affiliates, and so long as any such trademarks or
trademark applications do not use the name Amgen or any derivative
thereof.
1.6 "CALENDAR QUARTER" means each respective period of 3 consecutive months
ending on March 31, June 30, September 30 and December 31 of each Calendar
Year.
1.7 "CALENDAR YEAR" means each successive period of 12 months commencing on
January 1 and ending on December 31.
1.8 "CHANGE OF CONTROL OF MEMORY" means the occurrence of any of the following
events:
(a) Any person (as such term is defined under Section 13(d)(3) of the
Securities Exchange Act of 1934, as amended (the "EXCHANGE ACT")),
corporation or other entity hereafter becomes the beneficial owner
(as such term is defined in Rule 13d-3 under the Exchange Act) of
securities of Memory [*] representing [*] percent ([*]%) or more of
the combined voting power of the outstanding securities of Memory
which ordinarily (and apart from rights accruing under special
circumstances) have the right to vote in the election of directors
(calculated as provided in paragraph (d) of such Rule 13d-3 in the
case of rights to acquire the Memory's securities) (the
"SECURITIES");
[*] CONFIDENTIAL TREATMENT IS REQUESTED
2
(b) As a result of a tender offer, merger, sale of assets or other major
transaction, the persons who are directors of Memory immediately
prior to such transaction cease to constitute a majority of the
Board of Directors of Memory (or any successor corporations)
immediately after such transaction;
(C) [*] Memory is merged or consolidated with any other person, firm,
corporation or other entity and, as a result, the shareholders of
Memory, as determined immediately before such transaction, own less
than [*] percent ([*]%) of the outstanding Securities of the
surviving or resulting entity immediately after such transaction;
(d) Memory transfers all or substantially all of its assets to another
person, firm, corporation or other entity;
(e) An Industry Buyer acquires twenty percent (20%) or more of the
outstanding Securities of Memory; or
(f)
(1) Memory becomes bankrupt or insolvent, or files a petition in
bankruptcy or makes a general assignment for the benefit of
creditors or otherwise acknowledges in writing insolvency, or
is adjudged bankrupt, and Memory (i) fails to assume this
Agreement in any such bankruptcy proceeding within thirty (30)
days after filing or (ii) assumes and assigns this Agreement
to a Third Party;
(2) Memory grants to a party other than Amgen a security interest
in any intellectual property licensed to Amgen hereunder
(unless Memory has first granted to Amgen a security interest
in such intellectual property to secure Memory's obligations
under this Agreement and the security interest granted by
Memory to such party is subordinated or junior in priority to
the security interest granted by Memory to Amgen, PROVIDED,
HOWEVER, [*];
(3) Memory goes into or is placed in a process of complete
liquidation;
(4) a trustee or receiver is appointed for any substantial portion
of Memory's business who is not discharged within [*] days
after appointment;
(5) any case or proceeding shall have been commenced or other
action taken against Memory in bankruptcy or seeking
liquidation, reorganization, dissolution, a winding-up
arrangement, composition or readjustment of its debts or any
other relief under any bankruptcy, insolvency, reorganization
or similar act or law of any jurisdiction now or hereafter in
effect and is not dismissed or converted into a voluntary
proceeding governed by clause (f)(1) above within [*] days
after filing; or
[*] CONFIDENTIAL TREATMENT IS REQUESTED
3
(6) there shall have been issued a warrant of attachment,
execution, distraint or similar process against any
substantial part of the property of Memory and such event
shall have continued for a period of [*] days undismissed, not
bonded in a manner reasonably satisfactory to Amgen or
undischarged.
1.9 "CHANGE OF CONTROL RIGHTS" means [*].
1.10 "COLLABORATION COMPOUND" means a PDE10 inhibitor or modulator (a) for
which Amgen during the Agreement Term has rights, whether by reason of its
own conception of such inhibitor or modulator or under agreement with a
Third Party, (b) was identified or confirmed as a PDE10 inhibitor or
modulator through the use of the Memory Screening Technology, and (c)
subject to Section 7.3(a), with respect to which the initial IND for the
inhibitor or modulator has been filed within [*] years after the Effective
Date by Amgen or its Affiliate.
1.11 "COLLABORATION TECHNOLOGY" means all Know-How generated in the conduct of
the Research Collaboration by Amgen and Memory jointly or solely by
Memory, as well as all Know-How, inventions, and/or intellectual property
rights created, developed or generated by Memory or its Affiliates with
respect to any PDE10 inhibitors or modulators in violation of Section 2.5.
1.12 "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
Joint Patent Right that Covers the composition of matter of the PDE10
inhibitor or modulator per se that is included in such Product, in whole
or as a component thereof, as an active ingredient of such Product.
1.13 "COMPOUND" means either a Primary Compound or a Secondary Compound.
1.14 "CONTROL" means, with respect to any Know-How, Material or intellectual
property right (including Patent Rights), possession by a party of the
ability (whether by ownership, license or otherwise) to grant access, a
license or a sublicense to such Know-How, Material or intellectual
property right as provided for in this Agreement without violating the
terms of any agreement with any Third Party in existence as of the
Effective Date. With respect to any Know-How, Material or intellectual
property right (including Patent Rights) to which either party obtains
rights after the Effective Date, then Control shall include possession by
such party of the ability (whether by ownership, license or otherwise) to
grant access, a license or a sublicense to such Know-How, Material or
intellectual property right as provided for in this Agreement without
violating the terms of any agreement with any Third Party pursuant to
which such Know-How, Material or intellectual property rights were
obtained or developed (PROVIDED, HOWEVER, that with respect to Know-How
that is obtained or developed outside of the Research Collaboration, then
Control means possession by such party of the ability (whether by
ownership, license or otherwise) to grant access, a license or a
sublicense to such Know-How as provided for in this Agreement without
violating the terms of any agreement with any Third Party pursuant to
which such Know-How was obtained or developed or in existence as of the
date such party obtains such rights).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
4
1.15 "COVER" (including the variations such as "Covered", "Coverage" or
"Covering") means that the making, using, offering for sale, selling or
importing of the product or invention being referenced would infringe a
Valid Claim of a Patent Right in the absence of a license under such
Patent Right. Except to the extent set forth in Section 5.2, the
determination of whether a product or invention is Covered by a particular
Patent Right shall be made on a country-by-country basis.
1.16 "DEDICATED PERSONNEL" means [*] percent ([*]%) of the Memory personnel who
performed the Amgen funded FTE activities under the Research Collaboration
during the [*] immediately preceding the occurrence of the applicable
Change of Control of Memory (rounded down to the nearest whole number).
1.17 "EUROPE" means the [*].
1.18 "FDA" means the United States Food and Drug Administration, or its foreign
equivalent.
1.19 "FIELD" means all uses, including prophylaxis, palliative, diagnostic, and
therapeutic.
1.20 "FTE" means the equivalent of the work of one employee full time for one
year (consisting of at least a total of [*] weeks or [*] hours per year
(excluding vacations and holidays) of work on or directly related to the
Research Collaboration), carried out by a Memory employee or a permitted
subcontractor. No more than [*] hours per week of overtime shall be
counted toward the number of hours that are used to calculate the FTE
contribution. No one person shall be permitted to account for more than
one FTE.
1.21 "FTE RATE" means [*] Dollars ($[*]) per FTE per year.
1.22 "GENERAL INVENTION" means a Memory Invention that is not specifically
related to a Compound, a Product or the inhibition or modulation of PDE10.
1.23 "IND" means an Investigational New Drug Application filed with the FDA for
human clinical testing of a drug.
1.24 "INDUSTRY BUYER" means an entity that, together with its Affiliates, has
an average annual pharmaceutical and/or biotechnology pre-clinical
research expenditure of more than [*]. Notwithstanding the foregoing, a
bona fide venture capital or private equity firm that is not owned or
controlled by, and does not own or control a significant biotechnology or
pharmaceutical company shall not be deemed to be an Industry Buyer. For
the purposes of illustration, the Parties consider the following to not be
Industry Buyers because they are bona fide venture capital or private
equity firms that are not owned or controlled by, and do not own or
control a significant biotechnology or pharmaceutical company: [*]
1.25 "INITIATION XX XXXXX 0X XXXXXXXX XXXXX" means the date that a patient is
first dosed by or on behalf of Amgen, its Affiliate or sublicensee with a
Product in a clinical trial on sufficient numbers of patients that is
designed to establish the safety and efficacy of a drug for its intended
use, and to define warnings, precautions and adverse reactions that are
associated with the drug in the dosage range to be prescribed and that
satisfies the requirements of 21 CFR 312.21(b) (or its successor
regulation), or its foreign equivalent.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
5
1.26 "INITIATION OF PHASE 2B CLINICAL TRIAL" means the date that a patient is
first dosed by or on behalf of Amgen, its Affiliate or sublicensee with a
Product in a second clinical trial (of such Product) on sufficient numbers
of patients that is designed to establish the safety and efficacy of a
drug for its intended use, and to define warnings, precautions and adverse
reactions that are associated with the drug in the dosage range to be
prescribed and that satisfies the requirements of 21 CFR 312.21(b) (or its
successor regulation), or its foreign equivalent. Notwithstanding the
foregoing, if the first such clinical trial for such Product was
prematurely terminated or suspended and the parameters of such second
clinical trial are similar to those of the first such clinical trial of
such Product, then the date that a patient is first dosed in such second
clinical trial shall be deemed to be another Initiation of Phase 2a
Clinical Trial and not an Initiation of Phase 2b Clinical Trial.
1.27 "INITIATION OF PHASE 3 CLINICAL TRIAL" means the date that a patient is
first dosed by or on behalf of Amgen, its Affiliate or sublicensee with a
Product in a clinical trial of sufficient numbers of patients that, if the
defined end-points are met, is intended to be a pivotal trial for
obtaining Regulatory Approval or otherwise intended to supplement existing
data on the drug and thereby establish that a drug is sufficiently safe
and efficacious for its intended use for the purposes of obtaining
Regulatory Approval, and to provide an adequate basis for defining in
physician labeling the warnings, precautions and adverse reactions that
are associated with the drug in the dosage range to be prescribed, and
which is intended to support Regulatory Approval of such drug in the
United States, European Union or any country in the European Union and
that satisfies the requirements of 21 CFR 312.21(c), or its successor
regulation, or an equivalent foreign clinical trial.
1.28 "INVENTION" means an invention, including any Compound, that is made in
the conduct of the Research Collaboration.
1.29 "JOINT COMPOUND" means any PDE10 inhibitor or modulator which is Covered
by a Composition of Matter Claim under a Joint Patent Right.
1.30 "JOINT INVENTION" means an Invention having at least one co-inventor who
is an employee, consultant or agent of Amgen and/or its Affiliates, and at
least one co-inventor who is an employee, consultant or agent of Memory
and/or its Affiliates, as inventorship is determined under U.S. patent
law.
1.31 "JOINT PATENT RIGHTS" means patent claims (and the Patent Rights in which
those claims are contained), which if issued would, or as issued do, Cover
a Joint Invention and, under US patent law, require the naming of at least
one co-inventor who is an employee, consultant or agent of Amgen and/or
its Affiliates, and at least one co-inventor who is an employee,
consultant or agent of Memory and/or its Affiliates.
1.32 "JRC" means that committee organized and operating as provided in Article
7.
1.33 "KNOW-HOW" means data, know-how, trade secrets, methods, 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 research,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
6
discovery, manufacture, development or commercialization of any Product in
the Territory.
1.34 "LAUNCH" means, with respect to a Product in a country of the Territory,
the date of the first commercial sale by or on behalf of Amgen, its
Affiliate or its sublicensee of the given Product in the given country
after Regulatory Approval (if required) in such country.
1.35 "LEAD COMPOUND(S)" shall mean the Compound which, prior to the events
triggering the provisions of Section 12.5(a), has [*] (unless another
Memory Compound or Joint Compound that has reached IND enabling toxicology
studies is selected in writing by Memory as a lead compound), together
with a [*] Compound which other than the aforementioned Compound has [*]
(unless another Memory Compound or Joint Compound that has reached IND
enabling toxicology studies is selected in writing by Memory as a back-up
compound).
1.36 "MAJOR MARKET COUNTRIES" means the [*].
1.37 "MATERIALS" means certain biological materials or chemical compounds
including assays, Compounds, screens, knock-out mice and other animal
models, cell lines, cells, nucleic acids, receptors and reagents
Controlled by the supplying Party. "Materials" shall be deemed to include
the materials listed on Schedules 1.42, 1.60, and 1.65 each as attached
hereto, which Memory will provide to Amgen pursuant to Section 7.1(c) of
this Agreement.
1.38 "MEMORY COMPOUND" means any PDE10 inhibitor or modulator for which Memory
during the Agreement Term has rights, whether by reason of its own
conception of such inhibitor or modulator or under agreement with a Third
Party, which is Covered by a Valid Claim of a Memory Patent Right.
1.39 "MEMORY INVENTION" means an Invention having as inventors employees,
consultants or agents of Memory or its Affiliates, but not employees,
consultants or agents of Amgen or its Affiliates, as determined under US
patent law.
1.40 "MEMORY KNOW-HOW" means all Know-How that Memory owns, or otherwise is
Controlled by Memory, during the Agreement Term.
1.41 "MEMORY PATENT RIGHTS" means all Patent Rights that Memory owns, or
otherwise are Controlled by Memory, during the Agreement Term, excluding
any Joint Patent Rights. Schedule 1.41 lists all Memory Patent Rights that
claim compounds that inhibit or modulate PDE10 as of the date hereof
("BASE PATENTS").
1.42 "MEMORY SCREENING TECHNOLOGY" means all of the screens and counterscreens
for the PDE10 program [*] Controlled by Memory during the Agreement Term.
To each parties knowledge, as of the Effective Date, Schedule 1.42 sets
forth all Memory Screening Technology then in existence.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
7
1.43 "MEMORY TECHNOLOGY" means the Memory Compounds, the Memory Screening
Technology and in addition to the foregoing the reagents, protocols and
documentation necessary and/or useful for Amgen to perform Memory's PDE10
assay(s), Controlled by Memory during the Agreement Term, including in
vitro and in vivo behavioral and other assays, as well as all Know-How,
Materials and documentation Controlled by Memory relating to PDE10.
1.44 "NDA" means a New Drug Application, or its foreign equivalent, filed with
the FDA for a drug.
1.45 "NET SALES" means, with respect to a certain time period, the gross
invoiced sales prices charged for all Products sold by or for Amgen, its
Affiliates and sublicensees in arms length transactions to Third Parties
(but not including sales relating to transactions between Amgen, its
Affiliates, and/or their respective sublicensees) during such time period,
less the total of the following estimated and/or incurred charges or
expenses to the extent attributable to the sale of the Product: [*].
All of the sales, and deductions taken above, shall be determined in
accordance with GAAP. [*]. For the purposes of this Agreement, "GAAP"
means generally accepted accounting principles.
Any disposal of Products for, or use of Products in, clinical or
pre-clinical trials, given as free samples in accordance with applicable
law, or distributed at no charge to patients unable to purchase Product
shall not be included in Net Sales.
Where a Product is sold together with other pharmaceutical products
(excluding devices used for using or administering the Product excluded
from Net Sales above) for a single price (whether sold together in the
same package, or merely price bundled) then for the purposes of
calculating the Net Sales for the Products under this Agreement, the
Product shall be deemed to be sold for an amount equal to the following:
(X divided by Y) multiplied by Z
where X is the average sales price during the applicable reporting period
generally achieved for the Product in the country in which such sale or
other disposal occurred when such Product is sold alone and not with other
pharmaceutical products; Y is the sum of the average sales price during
the applicable reporting period generally achieved in that country when
sold alone by each product (including the Product) included in the bundle
of pharmaceutical products that is sold for the single price; and Z equals
the single price at which the bundle of pharmaceutical products
represented in Y was actually sold. In the event one or more of the
products in the bundled product are not sold separately, the parties shall
confer in good faith to determine a fair market price that shall be
equitable for the value of the Product within the bundled product.
1.46 "PARTY" means Amgen or Memory. "PARTIES" means Amgen and Memory.
1.47 "PATENT RIGHT" means all rights under (a) any patent or patent application
in any country of the Territory, (b) all patent applications filed in any
jurisdiction corresponding to or
[*] CONFIDENTIAL TREATMENT IS REQUESTED
8
claiming priority from the patents and/or patent applications referred to
in the foregoing clause (a); (c) all divisionals, continuations and
continuations-in-part of the patent applications referred to in the
foregoing clauses (a) and (b); (d) all patents issuing from the patent
applications referred to in the foregoing clauses (a), (b) and (c); and
(e) all reissues, re-examination certificates, registrations,
confirmations, extensions, substitutions, renewals and supplementary
protection certificates of the patent and/or patent applications referred
to in the foregoing clauses (a), (b), (c) and (d).
1.48 "PDE10" means any biological molecule that is a member of the family of
[*] generally known as PDE10, [*], PDE10A (amino acid sequences of which
are attached hereto as Schedule 1.48), and any and all of the following
biological molecules related to PDE10: [*]
1.49 "PERSON" means any individual, corporation (including any non-profit
corporation), general partnership, limited partnership, limited liability
partnership, joint venture, estate, trust, company (including any limited
liability company or joint stock company), firm or other enterprise,
association, organization, entity or governmental entity.
1.50 "PRIMARY COMPOUND" means a Memory Compound, a Joint Compound or a
Collaboration Compound.
1.51 "PRIMARY PRODUCT" means a product that includes, in whole or as a
component thereof, a Primary Compound.
1.52 "PRODUCT" means any Primary Product or Secondary Product.
1.53 [*]
1.54 "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
Amgen, its Affiliate or sublicensee.
1.55 "REINSTATABLE RIGHTS" means [*].
1.56 "RESEARCH COLLABORATION" means the collaborative non-clinical research
program between the Parties relating to PDE10 inhibitors and modulators,
as more fully described in the Research Workplan.
1.57 "RESEARCH WORKPLAN" means the plan of non-clinical research activities
attached as Schedule 1.57, as it may be amended in writing from time to
time.
1.58 "RESEARCH TERM" shall have the meaning provided in Section 7.1(b)(iii).
1.59 "ROYALTY TERM" means with respect to (i) a given Primary Product in a
given country the period of time commencing on Launch in such country and
continuing until the later of (a) expiration of the last to expire of a
Memory Patent Right or Composition of Matter
[*] CONFIDENTIAL TREATMENT IS REQUESTED
9
Claim Covering such Product in such country or (b) ten (10) years from the
Launch of such Product in such country, and (ii) a given Secondary Product
in a given country the period of time commencing on Launch in such country
and continuing until ten (10) years from the Launch of such Product in
such country. Notwithstanding the foregoing, with respect to any given
Product that becomes a Primary Product in a given country subsequent to
Launch in such country, the Royalty Term shall expire in such country upon
the later of (x) expiration of the last to expire of a Memory Patent Right
or Composition of Matter Claim Covering such Product in such country or
(y) ten (10) years from the Launch of such Product in such country. The
Launch within any country in the European Union shall be deemed the date
of Launch for all countries in the European Union.
1.60 "SECONDARY COMPOUND" means (i) a PDE10 inhibitor or modulator, other than
a Primary Compound, (a) for which Amgen during the Agreement Term has
rights, whether by reason of its own conception of such inhibitor or
modulator, or under agreement with a Third Party, (b) was identified or
confirmed as a PDE10 inhibitor or modulator through the use of the Memory
Screening Technology, and (c) subject to Section 7.3(a), with respect to
which the initial IND for the inhibitor or modulator has not been filed
within [*] after the Effective Date by Amgen or its Affiliate, or (ii) [*]
or as identified by Memory on Schedule 1.60 attached hereto.
1.61 "SECONDARY PRODUCT" means a product that includes, in whole or as a
component thereof, a Secondary Compound; PROVIDED, HOWEVER, that if a
Product includes in whole or as a component thereof, a Primary Compound
then such Product shall be deemed a Primary Product. No Product shall be
deemed both a Primary Product and a Secondary Product concurrently.
1.62 "TERRITORY" means all countries and territories in the world.
1.63 "THIRD PARTY" means a person or entity other than (i) Memory or any of its
Affiliates, or (ii) Amgen or any of its Affiliates.
1.64 "THIRD PARTY ACQUIRER" means a Third Party that obtains ownership or
control of (whether directly or indirectly) or otherwise acquires all or
substantially all of the business or assets of Memory in connection with a
Change of Control of Memory, whether in one transaction or a series of
transactions.
1.65 "TRIGGERING EVENT" means a [*] determination by [*] resulting from the
performance of the research set forth in Schedule 1.65-A attached hereto
that [*] and that such [*] the central nervous system effects described
in Schedule 1.65-B.
1.66 "US" means the United States of America and its possessions and
territories, including Puerto Rico.
1.67 "VALID CLAIM" means a claim [*].
ARTICLE 2. LICENSE GRANTS
[*] CONFIDENTIAL TREATMENT IS REQUESTED
10
2.1 License Grants. Subject to the terms and conditions of this Agreement,
Memory grants to Amgen the sole and exclusive license, including the right
to grant sublicenses pursuant to Section 2.2, under the Memory Patent
Rights, the Memory Know-How, the Memory Inventions and Memory Technology
to perform Amgen's responsibilities under the Research Collaboration and
to research, develop, make, have made, use, offer for sale, sell, have
sold, import, export or otherwise exploit, or transfer possession of or
title in, Compounds and Products in the Territory for use in the Field.
Subject to the terms and conditions of this Agreement, Memory grants to
Amgen the sole and exclusive license, including the right to grant
sublicenses pursuant to Section 2.2, under its joint interest in Joint
Patent Rights (other than with respect to General Inventions) to perform
Amgen's responsibilities under the Research Collaboration and to research,
develop, make, have made, use, offer for sale, sell, have sold, import,
export or otherwise exploit, or transfer possession of or title in,
Compounds and Products in the Territory for use in the Field.
Subject to the terms and conditions of this Agreement, Memory grants to
Amgen the sole and exclusive license, including the right to grant
sublicenses pursuant to Section 2.2, under its joint interest in
Collaboration Technology to research, develop, make, have made, use, offer
for sale, sell, have sold, import, export or otherwise exploit, or
transfer possession of or title in, products solely to the extent related
to PDE10; PROVIDED, HOWEVER, that Memory and Amgen shall each have the
non-exclusive right (including the right to grant sublicenses) under the
Collaboration Technology to research, develop, make, have made, use, offer
for sale, sell, have sold, import, export or otherwise exploit, or
transfer possession of or title in, products except solely to the extent
related to PDE10.
During the Agreement Term, subject to the terms and conditions of this
Agreement, Memory grants to Amgen a worldwide, fully paid-up,
royalty-free, non-exclusive license, including the unrestricted right to
grant sublicenses, under the Memory Inventions, and all intellectual
property rights to the extent relating thereto, for any and all purposes.
Upon expiration or termination of this Agreement, subject to the terms and
conditions of this Agreement (including Section 12.1), Memory grants to
Amgen and its Affiliates a worldwide, fully paid-up, royalty-free,
non-exclusive license, with no right to grant sublicenses or assign such
license, under the Memory Inventions to the extent relating to Memory
compounds consisting of PDE10 inhibitors or modulators, including Memory
Compounds and all intellectual property rights to the extent relating
thereto solely for internal research purposes (the "RESEARCH LICENSE"),
and Memory grants to Amgen and its Affiliates a worldwide, fully paid-up,
royalty-free, non-exclusive license, including the unrestricted right to
grant sublicenses, under any other Memory Invention (including General
Inventions), and all intellectual property rights to the extent relating
thereto, for any and all purposes.
Amgen's right to use Memory's pre-existing technology and all intellectual
property rights relating thereto pursuant to the licenses granted under
this Section 2.1 shall be limited solely to Amgen's and its Affiliates'
and sublicensees' use in connection with activities under this Agreement
related to PDE10. Pursuant to the licenses granted under this Section 2.1,
Amgen shall have exclusive rights to all technology and all intellectual
[*] CONFIDENTIAL TREATMENT IS REQUESTED
11
property rights to the extent relating thereto developed solely or jointly
by Memory during the Research Collaboration for use solely in connection
with activities under this Agreement related to PDE10, including Memory
Inventions and Collaboration Technology, and non-exclusive rights relating
thereto for activities unrelated to PDE10. Further, nothing in this
Agreement shall limit the right of Memory to use Memory Know-How
(including the Memory Screening Technology, but excluding Memory
Inventions pursuant to which Amgen has been granted an exclusive license
under the first paragraph of this Section 2.1) for any purpose except
solely to the extent related to researching, developing, making, having
made, using, offering for sale, selling, having sold, importing, exporting
or otherwise exploiting, or transferring possession of or title in,
Compounds and Products in the Territory for use in the Field.
2.2 Sublicense Rights. Except with respect to the Research License, the rights
and licenses granted to Amgen under Section 2.1 shall include the
unrestricted right to grant sublicenses to its Affiliates and Third
Parties under such rights and licenses, in whole or in part. Amgen assumes
full responsibility for the performance of all obligations and observance
of all terms of this Agreement 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 sublicensee's activities.
Upon the licenses granted herein to Amgen becoming fully paid up pursuant
to Section 12.1, any and all sublicenses granted by Amgen similarly shall
become fully paid up as to Memory.
2.3 Products Containing Amgen Compounds. Memory acknowledges that prior to the
Effective Date Amgen has or, during the Agreement Term Amgen may have,
rights in or to Amgen Compounds. For the purposes of this Agreement,
"AMGEN COMPOUND" means a PDE10 inhibitor or modulator, other than a
Primary Compound or Secondary Compound, (a) for which Amgen during the
Agreement Term has rights, whether by reason of its own conception of such
inhibitor or modulator, or under agreement with a Third Party, and (b) was
not identified or confirmed as a PDE10 inhibitor or modulator through the
use of the Memory Screening Technology.
All rights in and to any Amgen Compound shall remain solely owned by
Amgen, and Memory shall have no rights, and Amgen shall have no
obligations, financial or otherwise, to Memory, under this Agreement with
respect to any Amgen Compound.
2.4 No Implied License. No rights or licenses with respect to any intellectual
property owned or Controlled by either party are granted or shall be
deemed granted hereunder or in connection herewith, other than those
rights or licenses expressly granted in this Agreement.
2.5 Exclusivity. Notwithstanding anything to the contrary in this Agreement,
during the Agreement Term, Memory and its Affiliates will not, internally
(other than in performance of the Research Workplan) or in conjunction
with a Third Party, conduct, effect, participate in or cause, or advise,
assist or encourage any Third Party (including, without limitation,
through the transfer of information, materials or technology) to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
12
conduct, effect, participate in or cause, in any way, directly or
indirectly, any activities related to PDE10 inhibitors or modulators;
PROVIDED, HOWEVER, that nothing contained herein shall prohibit any
activity with respect to inhibitors or modulators of phosphodiesterases
other than those that inhibit or modulate PDE10. For the purposes of this
Section 2.5, Affiliates shall [*].
2.6 Registration. The Parties shall execute the short-form of license attached
hereto as Schedule 2.6 concurrently with this Agreement. From time to time
after the Effective Date, upon request by Amgen, Memory agrees to execute
such similar short-forms of license to evidence the license of rights
granted to Amgen by this Agreement. Amgen shall have the right to record
such short-forms of license in the United States Patent and Trademark
Office, the corresponding offices outside the United States, and/or with
other appropriate governmental agencies. Amgen shall provide Memory with
prompt written notice of any such recordation, including a copy of all
papers recorded. Upon termination of the Agreement in its entirety for any
reason, Amgen at its sole cost and expense shall promptly execute and
deliver to Memory, or cause to be filed with the United States Patent and
Trademark Office, the corresponding offices outside the United States,
and/or with other appropriate governmental agencies, appropriate
terminations of such short-forms of license.
ARTICLE 3. DILIGENCE
3.1 Amgen's Diligence. Amgen shall use reasonable diligence in proceeding with
the research, 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 Amgen, 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 of similar
profile, market potential and at a similar stage in its product life as
that of the applicable Product, taking into account safety, efficacy,
competition, the patent and other proprietary position of the Product, the
likelihood of Regulatory Approval given the regulatory structure involved,
the profitability of the Product including the royalties payable to
licensors of patent rights, alternative products and product candidates
and other relevant factors, including scientific, business and marketing
and return on investment considerations. The Parties also acknowledge
that, even within the Major Market Countries, Amgen (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 or seek to obtain regulatory approvals in different
countries concurrently. As a result, reasonable diligence shall be
determined by judging Amgen's efforts taken as a whole in the following
regions on a region-by-region basis (the regions being [*]) (taking into
account factors including pricing strategy, applicable law and regulation
and the availability and strength of protection for intellectual property
and proprietary rights), and it is anticipated that the level of effort
will change over time, reflecting changes in the status of the Product and
the market and/or region involved and based upon changing scientific,
business, marketing, return on investment and other considerations.
Additionally, the Parties acknowledge that prior to Initiation of Phase 3
[*] CONFIDENTIAL TREATMENT IS REQUESTED
13
Clinical Trial conducted to support Regulatory Approval of a Product in
the [*], Amgen shall have no diligence obligations under this Section 3.1
with respect to [*].
3.2 Memory's Diligence. Memory shall use reasonable diligence, and shall
commit the personnel, facilities and resources, to perform its obligations
under the Research Workplan. Memory will conduct its activities under the
Research Collaboration in good scientific manner, using qualified
personnel, and in material compliance with applicable laws and
regulations. Memory will prepare and maintain complete and accurate
written records relating to its activities under the Research
Collaboration consistent with industry standards including, for purposes
of patent and regulatory matters, prompt, but in no event less than daily,
signing and corroboration of laboratory notebooks and conception
documents. Amgen shall have the right to use such source data to support
submissions to regulatory agencies and the filing, prosecution,
maintenance, defense and enforcement of Joint Patent Rights and for such
other purposes as reasonably necessary in pursuit of performing Amgen's
responsibilities under the Research Collaboration and researching,
developing, making, having made, using, offering for sale, selling, having
sold, importing, exporting or otherwise exploiting, or transferring
possession of or title in, Compounds and Products in the Territory for use
in the Field. Memory shall maintain such records for the later of (a) the
Agreement Term or (b) five (5) years following the expiration or
termination of the Research Collaboration. Upon Amgen's written request
and within fifteen (15) business days after such request, Memory shall
make available for inspection by the Amgen Audit Representative (as that
term is defined in Section 7.3 hereof) the records of Memory (including
source data such as laboratory notebook records) regarding the activities
conducted and results achieved under the Research Collaboration, including
all records related to Collaboration Technology and Inventions, at any
reasonable time during Memory's regular working hours, and copies of all
or any part of such data and records (whether in tangible or electronic
form) shall be furnished to the Amgen Audit Representative upon request,
provided that the Amgen Audit Representative shall execute a
confidentiality agreement of the type described in Section 7.3 prior to
the Amgen Audit Representative exercising any such rights. The rights and
obligations contained in the preceding sentence shall survive for the
later of (a) the Agreement Term or (b) five (5) years after the expiration
or termination of the Research Collaboration.
3.3 Use of Memory Screening Technology. After the occurrence of the Triggering
Event, Amgen shall [*] the Memory Screening Technology with respect to its
use in the Research Collaboration, [*].
ARTICLE 4. PAYMENTS TO MEMORY
4.1 Up-Front Payment. Subject to Section 12.2, Amgen shall pay Memory an
up-front payment of five million dollars ($5,000,000), which shall be
non-refundable and non-creditable. Payment for such up-front fee shall be
made within thirty (30) days following the Effective Date.
4.2 Triggering Event. Upon the occurrence of the Triggering Event, Amgen
shall pay Memory a payment of [*] dollars ($[*]), which shall be
non-refundable and non-
[*] CONFIDENTIAL TREATMENT IS REQUESTED
14
creditable. Upon the occurrence of the Triggering Event, Amgen shall
notify Memory of such occurrence, and Memory will invoice Amgen for such
payment. Such payment shall be due and payable by Amgen within [*] days
after receipt of the applicable invoice from Memory. Amgen shall use
reasonable diligence to cause the Triggering Event to occur as soon as
reasonably practicable. If, within [*] days from the date hereof, the
Triggering Event has not occurred, Memory shall have the right, at
Memory's expense, to, and/or the right to cause a Third Party to, [*]. The
Triggering Event shall only be deemed to have occurred if [*] results in
the occurrence of the Triggering Event. The Parties confirm that the
absence of the Triggering Event shall not eliminate, reduce or otherwise
modify any obligation to make any milestone payments or royalty payments
hereunder (other than the payment provided for in this Section 4.2).
4.3 Milestone Payments. (a) Amgen shall pay to Memory each of the following
applicable one-time milestone payments following achievement of the
corresponding milestone event by Amgen, its Affiliates or sublicensees,
and all such payments shall be nonrefundable and non-creditable, except to
the extent expressly set forth in this Section 4.3 or Section 6.5.
MILESTONE PAYMENT MILESTONE PAYMENT
MILESTONE EVENT (PRIMARY PRODUCT) (SECONDARY PRODUCT)
------------------------- ----------------- -------------------
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
[*] US$[*] US$[*]
TOTAL US$[*] US$[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
15
(b) Notwithstanding Section 4.3(a) but subject to Section 4.3(g) and Section
5.9, in the event that either:
(i) a Primary Product has a black box warning, in the US or the European
Union, in its label at time of Launch in the US or the European
Union, respectively, or receives one during its first [*] after
Launch in the US or the European Union, respectively;
(ii) a "Dear Doctor" letter is issued in the US or the European Union,
respectively, in relation to such Primary Product during such
period;
(iii) a Primary Product is not the first or second PDE10 inhibitor or
modulator (excluding any Secondary Product) having regulatory
approval for the treatment of [*] in the US or the European Union,
respectively; or
(iv) a third PDE10 inhibitor or modulator (excluding any Product) having
regulatory approval for the treatment of [*] launches in the US or
the European Union, respectively, during the [*] period following
the Launch of the Primary Product in the US or the European Union,
respectively,
then with respect to any such event in the US the milestone payment
payable for such Primary Product upon approval of an NDA for such Primary
Product in the US shall be reduced to $[*] (PROVIDED, HOWEVER, that, if
such event occurs with respect to the US within [*] after Launch in the US
then Amgen shall be entitled to deduct $[*] from subsequent payments of
royalties to Memory), and with respect to any such event in the European
Union the milestone payment payable for such Primary Product upon approval
of an NDA for such Primary Product in the European Union shall be reduced
to $[*] (PROVIDED, HOWEVER, that, if such event occurs with respect to the
European Union within [*] after Launch in the European Union then Amgen
shall be entitled to deduct $[*] from subsequent payments of royalties to
Memory).
(c) Notwithstanding Section 4.3(a) but subject to Section 4.3(g) and Section
5.9, in the event that either:
(i) a Secondary Product has a black box warning, in the US or the
European Union, in its label at time of Launch in the US or the
European Union, respectively, or receives one during its first [*]
after Launch in the US or the European Union, respectively;
(ii) a "Dear Doctor" letter is issued in the US or the European Union,
respectively, in relation to such Secondary Product during such
period;
(iii) a Secondary Product is not the first or second PDE10 inhibitor or
modulator having regulatory approval for the treatment of [*] in the
US or the European Union, respectively; or
[*] CONFIDENTIAL TREATMENT IS REQUESTED
16
(iv) a third PDE10 inhibitor or modulator (excluding any Product) having
regulatory approval for the treatment of [*] launches in the US or
the European Union, respectively, during the [*] period following
the Launch of the Secondary Product in the US or the European Union,
respectively,
then with respect to any such event in the US the milestone payment
payable for such Secondary Product upon approval of an NDA for such
Secondary Product in the US shall be reduced to $[*] (PROVIDED, HOWEVER,
that, if such event occurs with respect to the US within [*] after Launch
in the US then Amgen shall be entitled to deduct $[*] from subsequent
payments of royalties to Memory), and with respect to any such event in
the European Union the milestone payment payable for such Secondary
Product upon approval of an NDA for such Secondary Product in the European
Union shall be reduced to $[*] (PROVIDED, HOWEVER, that, if such event
occurs with respect to the European Union within [*] after Launch in the
European Union then Amgen shall be entitled to deduct $[*] from subsequent
payments of royalties to Memory).
(d)
(i) Upon the occurrence of a milestone event, Amgen shall promptly
notify Memory of such occurrence, and Memory will invoice Amgen for
the related payment. Such payment shall be due and payable by Amgen
within [*] days after receipt of the applicable invoice from Memory.
(ii) Notwithstanding Section 4.3(d)(i), except as provided in the next
sentence, a Product that includes, in whole or as a component
thereof, a Collaboration Compound shall be presumed to be a
Secondary Product until such time as it is determined to be a
Primary Product. An inhibitor or modulator of PDE10 comprising a
composition of matter claimed in a patent application within a
Memory Patent Right or a Joint Patent Right shall, prior to Launch,
be presumed to be a Primary Product.
(iii) If at the time of Launch no Valid Claim under a Memory Patent Right
or a Composition of Matter Claim Covers such Product, then, subject
to Section 5.9, Amgen shall be entitled to deduct from subsequent
payments of royalties to Memory the difference between the milestone
payments actually paid for such Product and the milestone payments
that would have otherwise been paid for such Product, if any, by
Amgen but for the presumption provided for in Section 4.3(d)(ii).
(iv) If a Valid Claim under a Memory Patent Right or a Composition of
Matter Claim subsequently Covers such Product, then Amgen shall
promptly reimburse Memory for the amounts deducted pursuant to
Section 4.3(d)(iii).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
17
(v) Amgen shall only be obligated to make each milestone payment
once, for the first occurrence of a respective event,
regardless of how many times the event may be subsequently
achieved with one or more Products.
(vi) If Amgen's obligation to pay Memory for an occurrence of an
event for a Secondary Product arises, and subsequently,
Amgen's obligation to pay Memory for an occurrence of a
corresponding event for a Primary Product should arise, then
Amgen shall be required to pay Memory, promptly after such
occurrence of the corresponding event for a Primary Product,
an amount equal to the difference between the amount payable
for such event for a Primary Product and the amount previously
paid for such event as a Secondary Product. Accordingly,
should Amgen's obligation to pay Memory for an occurrence of
an event for a Primary Product arise, then Amgen's obligation
to pay Memory for a corresponding event for a Secondary
Product shall expire.
(e) In the event that a milestone event relating to clinical development
is achieved and payment with respect to the previous milestone
event(s) has not been made by Amgen, then Amgen shall promptly pay
Memory all such unpaid payments with respect to such previous
milestone event(s).
(f) In no event shall Amgen be obligated to pay to Memory milestone
payments in excess of $[*] in the aggregate for the achievement of
all milestone events, regardless of how many times milestone events
are achieved and regardless of whether they are achieved by Primary
Products, Secondary Products or both.
(g) Notwithstanding the foregoing provisions of this Section 4.3, if
during any Calendar Year after the Launch of a Product with respect
to which the milestone payments have been reduced pursuant to
Section 4.3(b) or (c) hereof the annual worldwide Net Sales of such
Product exceed US$[*], Amgen shall promptly pay to Memory the amount
of such reduction in the milestone payments, but in any event within
[*] days following the end of such Calendar Year.
ARTICLE 5. ROYALTIES
5.1 Royalties Payable by Amgen.
(a) Primary Products. With respect to each Calendar Year (or portion
thereof) during the Royalty Term of a Primary Product, Amgen shall
pay to Memory royalties on total annual Net Sales of such Primary
Product in such Calendar Year (or portion thereof) by Amgen, its
Affiliates and its sublicensees, which royalties shall be at the
following rates:
(i) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is less than or equal to US$[*];
(ii) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is greater than US$[*] and less
than or equal to US$[*]; and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
18
(iii) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is greater than US$[*].
(b) Secondary Products. With respect to each Calendar Year (or portion
thereof) during the Royalty Term of a Secondary Product, Amgen shall
pay to Memory royalties on total annual Net Sales of such Secondary
Product in such Calendar Year (or portion thereof) by Amgen, its
Affiliates and its sublicensees, which royalties shall be at the
following rates:
(i) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is less than or equal to US$[*];
(ii) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is greater than US$[*] and less
than or equal to US$[*]; and
(iii) [*] percent ([*]%) of that portion of such total annual Net
Sales of such Product that is greater than US$[*].
(c) Subsequent Events. Notwithstanding the foregoing, a Product may
change from time to time from a Primary Product to a Secondary
Product and vice versa. Royalties for Primary Products shall be
payable at the applicable rates set forth in Section 5.1(a) until
the beginning of the first Calendar Quarter following the Calendar
Quarter in which such Product has been determined to be a Secondary
Product at which time royalties for such Product shall be payable at
the applicable rates set forth in Section 5.1(b), and royalties for
Secondary Products shall be payable at the applicable rates set
forth in Section 5.1(b) until the beginning of the first Calendar
Quarter following the Calendar Quarter in which such Product has
been determined to be a Primary Product at which time royalties for
such Product shall be payable at the applicable rates set forth in
Section 5.1(a).
5.2 Royalty Term; Royalty Rate; Net Sales. Royalties for sales of any Product
shall be paid for a period equal to the Royalty Term for such Product. If
a Memory Patent Right or a Joint Patent Right has been found to be
unpatentable, invalid or unenforceable by a court or other authority of
competent jurisdiction in the country in which a Patent Right has issued,
as a result of which Amgen is no longer required to pay royalties for a
Product in such country, and subsequently such ruling is reversed upon
appeal and such Patent Right is thereafter not subject to such
determination of unpatentability, invalidity or unenforceability, then
[*]. The royalty rates set forth above shall be determined on a
Product-by-Product basis. [*] Nothing contained in this Section 5.2 shall
affect the obligations of Amgen under Section 3.1. Additionally, when
determining annual Net Sales of any given Product, the total annual Net
Sales of such Product shall be the total annual Net Sales of such Product
in all countries in which the Royalty Term is in effect for such Product
(and shall only include sales made while such Royalty Term is in effect).
5.3 Third Party Licenses. If Amgen reasonably determines, in its reasonable
discretion, that in order to avoid the potential infringement of the
patent or know-how rights of a Third
[*] CONFIDENTIAL TREATMENT IS REQUESTED
19
Party or Third Parties one or more licenses to access such intellectual
property rights of a Third Party or Third Parties are required for Amgen,
its Affiliates and/or its sublicensees to research, develop, make, have
made, use, import, offer to sell and/or sell, export or otherwise exploit,
or transfer physical possession of or title in a Product ("THIRD PARTY
LICENSE(s)"), then [*] of any compensation (including, without limitation,
up-front payments, milestones and royalties) actually paid by Amgen, its
Affiliates and/or sublicensees with respect to such Product under any such
Third Party License(s) entered into by Amgen, its Affiliates or
sublicensees shall be creditable against the royalty payments to be paid
to Memory by Amgen hereunder with respect to the sale of such Product;
PROVIDED, HOWEVER, that the royalty rates due to Memory under Section
5.1(a) in any given Calendar Year will not be reduced to less than [*];
FURTHER PROVIDED, HOWEVER, that the royalty rates due to Memory under
Section 5.1(b) in any given Calendar Year will not be reduced to less than
[*].
5.4 Cumulative Royalties. The obligation under Section 5.1 to pay royalties on
the Net Sales of a Product shall be imposed only once with respect to the
same unit of said Product.
5.5 No Other Compensation. Other than as explicitly set forth (and as
applicable) in this Article 5, and in Article 4 and Section 7.3, Amgen
shall not be obligated to pay any additional fees, milestone payments,
royalties or any other compensation to Memory under this Agreement.
5.6 Cross License. In the event that Amgen, in its sole business judgment,
shall determine it is reasonably necessary to grant a sublicense, or a
covenant not to xxx, under Memory Patent Rights claiming a Product or
method of using a Product, to any Third Party in a country in order for
Amgen to obtain the right to make, have made, use, sell, lease, offer to
sell or lease, or import, export or otherwise exploit, transfer physical
possession of or otherwise transfer title in such Product in the Field in
any case where any one or more such activities by Amgen, its Affiliates or
sublicensees otherwise may infringe the intellectual property rights of
such Third Party, and wherein no compensation or consideration other than
the cross-licenses is exchanged between Amgen and such Third Party as a
result thereof, Amgen shall have the right to grant such sublicense or
covenant not to xxx to such Third Party solely in connection with the
manufacture, use, sale or other commercialization of an inhibitor or
modulator of PDE10. For purposes of this Section 5.6, the determination of
Net Sales of Products for purposes of calculating the royalties payable by
Amgen to Memory under Section 5.1 shall not include sales of such
inhibitor or modulator of PDE10 by or on behalf of such Third Party (or
its Affiliates or sublicensees) receiving such sublicense or covenant not
to xxx.
5.7 Adjustments Related to Third Party Competition.
(a) For a given Primary Product in a given Calendar Quarter, if, in
addition to such Primary Product, there are [*] PDE10 inhibitors or
modulators (excluding any Product) having regulatory approval for
the treatment of [*] in the US, then Amgen shall have the right to
reduce for the entire Territory the applicable royalty rate provided
for under Section 5.1(a) to [*] percent ([*]%) of the applicable Net
Sales in clause (i), [*] percent ([*]%) of the applicable Net
[*] CONFIDENTIAL TREATMENT IS REQUESTED
20
Sales in clause (ii), and [*] percent ([*]%) of the applicable Net
Sales in clause (iii).
(b) Additionally, so long as there are [*] PDE10 inhibitors or
modulators (excluding any Product) having regulatory approval for
the treatment of [*] in the US, the minimum royalty rates provided
for under Section 5.3 due to Memory for royalties payable under
Section 5.1(a) in any given Calendar Year may be further reduced by
Amgen to not less than [*] percent ([*]%) of the applicable annual
Net Sales in clause (i), [*] percent ([*]%) of the applicable annual
Net Sales in clause (ii), and [*] percent ([*]%) of the applicable
annual Net Sales in clause (iii).
(c) For a given Secondary Product in a given Calendar Quarter, if, in
addition to such Secondary Product, there are [*] PDE10 inhibitors
or modulators (excluding any Product) having regulatory approval for
the treatment of [*] in the US, then Amgen shall have the right to
reduce for the entire Territory the applicable royalty rate provided
for under Section 5.1(b) to [*] percent ([*]%) of the applicable Net
Sales in clause (i), [*] percent ([*]%) of the applicable Net Sales
in clause (ii), and [*] percent ([*]%) of the applicable Net Sales
in clause (iii).
(d) Additionally, so long as there are [*] PDE10 inhibitors or
modulators (excluding any Product) having regulatory approval for
the treatment of [*] in the US, the minimum royalty rates provided
for under Section 5.3 due to Memory for royalties payable under
Section 5.1(b) in any given Calendar Year may be further reduced by
Amgen to not less than [*] percent ([*]%) of the applicable annual
Net Sales in clause (i), [*] percent ([*]%) of the applicable annual
Net Sales in clause (ii), and [*] percent ([*]%) of the applicable
annual Net Sales in clause (iii).
(e) Notwithstanding the foregoing provisions of this Section 5.7, if
during any Calendar Year after the Launch of a Product, the annual
worldwide Net Sales of such Product exceed US$[*], the reductions
provided for in this Section 5.7 as to such Product shall terminate
for the Calendar Year in which such Net Sales amount is achieved and
all future Calendar Years.
5.8 Adjustments Related to Black Box Label and "Dear Doctor" letters.
(a) For a given Primary Product in a given Calendar Quarter in which
there is a black box warning in the US as referred to in clause (1)
below or a "Dear Doctor" letter in the US as referred to in clause
(2) below (and for every Calendar Quarter thereafter until and
unless such black box warning or "Dear Doctor" letter is removed or
withdrawn), if, (1) in the US the Primary Product has a black box
warning in its label or (2) there should be any "Dear Doctor"
letters issued in the US regarding such Primary Product, Amgen shall
have the right to reduce for the entire Territory the applicable
royalty rate provided for under Section 5.1(a) to [*] percent ([*]%)
of the applicable Net Sales in clause (i), [*] percent ([*]%) of the
applicable Net Sales in clause (ii), and [*] percent ([*]%) of the
applicable Net Sales in clause (iii).
[*] CONFIDENTIAL TREATMENT IS REQUESTED
21
(b) Additionally, during the continuance of a black box warning in the
US or a "Dear Doctor" letter in the US, the minimum royalty rates
provided for under Section 5.3 due to Memory for royalties payable
under Section 5.1(a) in any given Calendar Year may be further
reduced by Amgen to not less than [*] percent ([*]%) of the
applicable annual Net Sales in clause (i), [*] percent ([*]%) of the
applicable annual Net Sales in clause (ii), and [*] percent ([*]%)
of the applicable annual Net Sales in clause (iii).
(c) For a given Secondary Product in a given Calendar Quarter in which
there is a black box warning in the US as referred to in clause (1)
below or a "Dear Doctor" letter in the US as referred to in clause
(2) below (and for every Calendar Quarter thereafter until and
unless such black box warning or "Dear Doctor" letter is removed or
withdrawn), if, (1) in the US the Secondary Product has a black box
warning in its label or (2) there should be any "Dear Doctor"
letters issued in the US regarding such Secondary Product, Amgen
shall have the right to reduce for the entire Territory the
applicable royalty rate provided for under Section 5.1(b) to [*]
percent ([*]%) of the applicable Net Sales in clause (i), [*]
percent ([*]%) of the applicable Net Sales in clause (ii), and [*]
percent ([*]%) of the applicable Net Sales in clause (iii).
(d) Additionally, during the continuance of a black box warning in the
US or a "Dear Doctor" letter in the US, the minimum royalty rates
provided for under Section 5.3 due to Memory for royalties payable
under Section 5.1(b) in any given Calendar Year may be further
reduced by Amgen to not less than [*] percent ([*]%) of the
applicable annual Net Sales in clause (i), [*] percent ([*]%) of the
applicable annual Net Sales in clause (ii), and [*] percent ([*]%)
of the applicable annual Net Sales in clause (iii).
(e) Notwithstanding the foregoing provisions of this Section 5.8, if
during any Calendar Year after the Launch of a Product, the annual
worldwide Net Sales of such Product exceed US$[*], the reductions
provided for in this Section 5.8 as to such Product shall terminate
for the Calendar Year in which such Net Sales amount is achieved and
all future Calendar Years.
5.9 Maximum Aggregate Deductions. Notwithstanding the preceding provisions of
this Article 5, and/or any credit or deduction to which Amgen is entitled
pursuant to Section 4.3 hereof, under no circumstances shall the royalty
rates provided for in this Agreement, after taking into account all
possible reductions pursuant to this Article 5 and/or Section 4.3, be less
than (a) for Primary Products, [*]% of the applicable annual Net Sales in
clause (i) of Section 5.1(a), [*]% of the applicable annual Net Sales in
clause (ii) of Section 5.1(a), and [*]% of the applicable annual Net Sales
in clause (iii) of Section 5.1(a), and (b) for Secondary Products, [*]% of
the applicable annual Net Sales in clause (i) of Section 5.1(b), [*]% of
the applicable annual Net Sales in clause (ii) of Section 5.1(b), and [*]%
of the applicable annual Net Sales in clause (iii) of Section 5.1(b). Any
remaining credit Amgen is entitled to receive pursuant to Section 4.3
hereof shall carry forward to the following Calendar Year until such time
as the remaining credit has been received in full. This Section 5.9 shall
not limit Amgen's right to off-set against any
[*] CONFIDENTIAL TREATMENT IS REQUESTED
22
payments due from Amgen hereunder any credit for overpayment under Section
6.5 hereof.
ARTICLE 6. PAYMENT, REPORTING, AUDITING
6.1 Payment; Reports. Beginning with the Calendar Quarter after the Launch of
the first Product until the expiration of Amgen's obligation to pay
royalties hereunder, royalty payments and reports of the sale of Products
for each Calendar Quarter will be calculated and delivered to Memory under
this Agreement within [*] days of the end of each such Calendar Quarter.
Each payment of royalties will be accompanied by a report of Net Sales of
Products stating: (a) Net Sales of Products, on a Product-by-Product and
country-by-country basis, during the applicable Calendar Quarter within
the Field in the Territory; and (b) a calculation of the royalty payment
due hereunder for such Calendar Quarter (a "ROYALTY REPORT").
6.2 Invoices. All invoices submitted by Memory to Amgen shall be addressed to:
Amgen
Accounts Payable
[*]
Invoices not submitted to the foregoing address will be subject to delay
or return. In addition, each invoice should reference an applicable
purchase order number to be provided by Amgen.
6.3 Exchange Rate; Manner and Place of Payment.
(a) All payments hereunder will be payable in U.S. dollars. With respect
to Net Sales invoiced or expenses incurred in U.S. dollars, the Net
Sales or expense due to the receiving Party hereunder shall be
expressed in U.S. dollars. With respect to Net Sales invoiced or
expenses incurred in a currency other than U.S. dollars, the Net
Sales invoiced or expenses incurred shall be converted into the US
dollar equivalent using a rate of exchange which corresponds to the
rate used by Amgen, for the respective reporting period, related to
recording such Net Sales in its books and records that are
maintained in accordance with GAAP. All payments shall be made in
U.S. dollars. If at any time legal restrictions in any country in
the Territory prevent the prompt remittance of any payments with
respect to sales in that country, the paying Party shall have the
right and option to make such payments by depositing the amount
thereof in local currency to the receiving Party's account in a bank
or depository in such country. Amgen will deliver to Memory proper
evidence of such deposit. As soon as practicable thereafter, Amgen
shall transfer such deposited payment to Memory or, upon the request
of Memory, to an account of Memory at a commercial bank within the
applicable country.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
23
(b) All payments owed under this Agreement will be made by wire transfer
in immediately available funds to a bank account designated in
writing by Memory, unless otherwise specified by Memory.
6.4 Taxes. Memory shall provide Amgen with a completed Form W-9 and an
electronic funds transfer form (which form has been provided by Amgen to
Memory on or prior to the date hereof) within ten (10) days of the
Effective Date.
6.5 Audits.
(a) Amgen will keep, and will cause its Affiliates and sublicensees to
keep, complete and accurate records pertaining to the sale of
Products in sufficient detail to permit Memory to confirm the
accuracy of all payments due hereunder, and such records will be
open to inspection for [*] years following the end of the period to
which they pertain. Not more than once in any [*] consecutive
Calendar Quarters, Memory will have the right to cause an
independent, certified public accountant reasonably acceptable to
Amgen to audit such records to confirm Net Sales and royalty and
other payments for a period covering not more than the preceding [*]
Calendar Years; PROVIDED, HOWEVER, that, the records for any
particular Calendar Year shall not be subject to more than one audit
hereunder.
(b) Such audits may be exercised during normal business hours upon
reasonable prior written notice to Amgen (but in no event less than
[*] days prior written notice). Memory shall submit an audit plan,
including audit scope, to Amgen for Amgen's approval, which shall
not be unreasonably withheld, prior to audit implementation. The
parties shall cooperate in all reasonable respects relating to the
amicable resolution of any objections Amgen may have to any audit
plan.
(c) The independent certified public accountant shall keep confidential
any information obtained during such inspection and shall report to
Memory only the amounts of Net Sales and royalties due and payable,
but may include, in the event such accountant shall be unable to
verify the correctness of any such payment, information relating to
why such payment is unverifiable. Amgen shall receive a copy of each
such report concurrently with receipt by Memory. In the event that
such payment is unverifiable, Amgen and Memory shall use good faith
efforts to arrive at an equitable solution. Memory shall bear the
full cost of such audit unless such audit discloses an underpayment
of more than [*] percent ([*]%) from the aggregate amount of
royalties or other payments due for the period audited. In such
case, Amgen shall bear the full cost of such certified public
accountant, to the extent such costs are reasonable and customary,
to perform such audit and will promptly remit to Memory the amount
of any underpayment. Conversely, if the audit reveals any
overpayment by Amgen, the amount of such overpayment shall be
creditable against any other amounts otherwise due from Amgen to
Memory hereunder (or, if further payments otherwise due hereunder
from Amgen to Memory are insufficient to fully use up such credit,
Memory shall promptly reimburse Amgen for any remaining amount).
Upon the expiration of [*] years following the end of any Calendar
Year, except with respect to any specific claims
[*] CONFIDENTIAL TREATMENT IS REQUESTED
24
for additional royalty payments that result from an audit that was
initiated prior to the expiration of such [*] year period pursuant
to Section 6.5(a) but not yet completed [*], and except for royalty
payments acknowledged by Amgen to be payable and not paid, the
calculation of royalties payable with respect to such year shall be
binding and conclusive upon Memory, and Amgen and its Affiliates and
sublicensees shall be released from any liability or accountability
with respect to royalties for such year, and Amgen shall no longer
be required to retain such records for such year. The independent
certified public accountant shall be required to execute a
confidential disclosure agreement reasonably satisfactory to Amgen
prior to performing any audit procedures or receiving any
information from Amgen.
6.6 Confidentiality. Memory shall treat all financial information subject to
review under this Article 6, or under any related sublicense agreement, as
Amgen's Confidential Information, and shall cause its accounting firm to
be bound to obligations of confidentiality with respect to such
information at least as restrictive as Memory's obligations of
confidentiality in this Agreement.
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 [*] lead series of Memory Compounds (as described in
Schedule 7.1) and [*].
(b) (i) The original term of the Research Collaboration shall be for a
period of two (2) years from the beginning of the Research
Collaboration as set forth in the Research Workplan ("ORIGINAL
TERM"), unless this Agreement is terminated sooner in accordance
with Article 12 or the Research Term is extended pursuant to Section
12.4. Except as provided in Article 12, neither Party may terminate
the Research Collaboration.
(ii) The Original Term of the Research Collaboration may be extended
by mutual written agreement of the Parties prior to the expiration
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."
(c) As soon as is reasonably possible, but in no event later than thirty
(30) days after the Effective Date, Memory shall deliver to Amgen
the Materials listed on Schedule 1.42 attached to this Agreement, as
well as any other Memory Technology (including protocols for
applicable in vivo behavioral assays) (the "TECHNOLOGY TRANSFER");
PROVIDED, HOWEVER, that animals and/or other physical materials for
performing such in vivo behavioral assays are not required to be
[*] CONFIDENTIAL TREATMENT IS REQUESTED
25
delivered within such thirty (30) day period after the Effective
Date and such delivery is not a condition to Amgen's obligations
under Section 4.1. Promptly after completing the Technology Transfer
Memory shall provide Amgen with written notice of the completion
thereof. Thereafter, to the extent reasonably requested by Amgen in
connection with its research, development, and/or commercialization
of any Compounds or Products, Memory shall, where it Controls the
relevant Compounds and/or Material, provide reasonable quantities of
physical samples of such Compounds and/or other Materials that are
in Memory's possession that are necessary or useful to the Research
Collaboration (including animals and/or other physical materials for
performing in vivo behavioral assays). In addition, prior to Launch
of the first Product, Memory shall promptly notify Amgen of any
Memory Technology obtained and Controlled by Memory that is
reasonably necessary for the research, development, and/or
commercialization of any Product. Further, Memory shall deliver to
Amgen such Memory Technology described in the preceding sentence as
Amgen may reasonably request from time to time and such Memory
Technology shall be used solely as permitted under Section 2.1 of
the Agreement.
7.2 Joint Research Committee. A JRC shall govern the Research Collaboration.
(a) Organization. The JRC shall consist of six (6) members, three (3)
members to be designated by Amgen 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 JRC
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 JRC shall be from Amgen.
(b) Meetings. The JRC shall hold [*] meetings on mutually agreeable
dates during the Research Term, with the location of the meetings to
[*]. The frequency and location of such meetings may be modified by
mutual agreement of the Parties. Notwithstanding the foregoing, the
[*] meetings may be held by teleconference or videoconference. Each
Party shall pay its own expenses associated with the meetings. Each
Party may, in its discretion, invite non-member employees
("invitee") to attend meetings of the JRC.
(c) Decision-Making. Decisions of the JRC shall be by consensus, with
each Party having one collective vote. If the JRC is unable to
decide a matter by consensus, then the final decision shall [*],
PROVIDED, HOWEVER, that no such decision on any matter may be
inconsistent with the provisions of this Agreement or have the
effect of increasing the economic burdens, including unfunded FTE
burdens, of Memory (except for any increases which in the aggregate
are immaterial).
(d) Sharing of Information. On a regular basis during the Research Term,
the Parties will exchange a summary report describing new
discoveries and data generated
[*] CONFIDENTIAL TREATMENT IS REQUESTED
26
under the Research Collaboration. Additionally, during the Research
Term, the Parties will exchange the raw data obtained from the
primary in vitro potency screen within the Memory Screening
Technology that relate to inhibitors or modulators of PDE10,
reasonably promptly after such data are obtained.
7.3 Research Support.
(a) Subject to Sections 7.3(d), 7.3(e) and 7.3(f), for the first year of
the Research Term, Amgen shall, in support of Memory's efforts under
the Research Collaboration, make research funding payments to Memory
for [*] FTEs at the FTE Rate [*]. Within [*] days before the end of
the first year of the Research Collaboration the Parties shall meet
to review (i) the progress of the Research Collaboration, (ii) the
goals for the following year, (iii) [*]. Within [*] days before the
end of the first year of the Research Collaboration, Amgen shall
inform Memory of the number of Memory FTEs that Amgen will agree to
reimburse for the following year. If Amgen notifies Memory that the
number of FTEs that Amgen will fund for the second year of the
Research Term will be less than [*] FTEs, then the time period
referenced in Section 1.10(c) and 1.60(c) shall be deemed to be [*]
years instead of [*] years.
(b) In the event that Amgen terminates this Agreement pursuant to
Section 12.3 (other than for safety reasons as provided for in
Section 12.3) during the first year of the Research Term, Amgen
shall pay to Memory an amount equal to [*] multiplied by the FTE
Rate, less any amounts previously paid by Amgen to Memory related to
research funding in such first year (with any payments for work
performed by permitted subcontractors pursuant to Section 7.3(f)
counted as if Amgen paid the FTE Rate for such hours), plus an
amount equal to [*] under the Research Collaboration (with any
payments for work performed by permitted subcontractors pursuant to
Section 7.3(f) counted as if Amgen paid the FTE Rate for such hours)
(PROVIDED, HOWEVER, that if [*]. In the event that Amgen terminates
this Agreement pursuant to Section 12.3 (other than for safety
reasons as provided for in Section 12.3) during the second year of
the Research Term, Amgen shall pay to Memory an amount equal to the
lesser of (a) [*] of the research funding required to be paid by
Amgen for FTEs for the second year of the Research Term under the
Research Collaboration (with any payments for work performed by
permitted subcontractors pursuant to Section 7.3(f) counted as if
Amgen paid the FTE Rate for such hours), or (b) the [*]. In
addition, consistent with the provisions of Section 12.6, Amgen will
also pay any amounts related to research funding for FTEs allocated
for such second year that has accrued but not yet been paid.
(c) Memory shall invoice Amgen not earlier than [*] days before the
beginning of each Calendar Quarter during the Original Term for the
number of FTEs expected to be dedicated to performance of the
Research Collaboration during such Calendar Quarter consistent with
the Research Workplan. Payment of each invoice shall be due within
[*] days following Amgen's receipt of an invoice indicating the
appropriate amount. Unless agreed to by Amgen in writing such
invoice shall not exceed [*] of the annual amount of FTE funding for
such year,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
27
but in no event shall the annual amount increase beyond the number
of FTEs allocated for such year.
(d) Amgen shall only be required to reimburse Memory for the lesser of
(i) the number of FTEs set forth in Section 7.3(a) and (ii) the
number of FTEs Memory actually dedicates to the performance of the
Research Collaboration. Memory shall deliver written reports
(certified to his or her actual knowledge by an officer of Memory)
to Amgen on a quarterly basis within [*] days after the end of such
Calendar Quarter setting forth the number of FTEs actually dedicated
by Memory to the performance of the Research Collaboration and a
summary of all such FTE-funded Research Collaboration activities
during such Calendar Quarter. In the event that Amgen has overpaid
Memory for FTEs in any Calendar Quarter, then Amgen shall be
entitled to deduct any amounts to be paid to Memory under this
Section 7.3 for FTEs in any subsequent Calendar Quarter (unless such
overpayment is made in the last Calendar Quarter of the Research
Term, in which event, Memory shall refund such overpayment to
Amgen).
(e) Memory shall maintain complete and accurate records in sufficient
detail to permit an audit of the number of hours worked and work
performed in the Research Collaboration by Memory. During the
Research Term and for a period of [*] years thereafter, Amgen shall
have the right to cause an independent certified public accountant,
[*] that has not directly or indirectly performed any work with
respect to PDE10, including any work with respect to the Research
Collaboration (collectively, "AMGEN AUDIT REPRESENTATIVE") that is
reasonably acceptable to Memory, at Amgen's sole cost, in order to
verify the accuracy and completeness of the foregoing FTE reports.
Such audit may be exercised during normal business hours upon
reasonable prior written notice to Memory (but in no event less than
[*] days prior written notice). Such Amgen Audit Representative
performing the audit shall be required to execute a confidential
disclosure agreement reasonably satisfactory to Memory prior to
performing any audit procedures or receiving any information from
Memory. Memory shall receive a copy of each such report concurrently
with receipt by Amgen. Amgen shall bear the full cost of such audit
unless such audit discloses an overpayment of more than [*] of the
aggregate amount of payments due for the period audited. In such
case, Memory shall bear the full cost of such audit, to the extent
such costs are reasonable and customary, to perform such audit and
will promptly remit to Amgen the amount of any overpayment.
Conversely, if the audit reveals any underpayment by Amgen, the
amount of such underpayment shall be promptly paid by Amgen to
Memory (but in no event shall Amgen be required to pay Memory in
excess of the amounts set forth in Section 7.3(a)). Upon the
expiration of [*] years following the end of any Calendar Year,
except with respect to any specific claims for overpayment of
research funding that result from an audit that was initiated prior
to the expiration of such [*] year period but not yet completed [*],
the calculation of research funding payable with respect to such
year shall be binding and conclusive upon Amgen and Memory shall be
released from any liability or accountability with respect to any
potential claims that research funding was overpaid for such year,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
28
and Memory shall no longer be required to retain such records for
such year. The Amgen Audit Representative shall agree with Memory
to, and shall, keep confidential any information obtained during
such inspection and shall report to Amgen only the amount due and
payable with respect to FTEs, but may include, in the event such
Amgen Audit Representative shall be unable to verify the correctness
of any such payment, information relating to why such payment is
unverifiable. Memory shall receive a copy of each such report
concurrently with receipt by Amgen. Amgen shall cause the Amgen
Audit Representative to treat all information subject to review
under this Section 7.3 as Memory's Confidential Information, and
shall cause its accounting firm or external scientific advisor(s) to
be bound to obligations of confidentiality with respect to such
information at least as restrictive as Amgen's obligations of
confidentiality in this Agreement.
(f) Memory shall not be permitted to subcontract work to be performed by
Memory under the Research Collaboration without Amgen's prior
written approval such approval not to be unreasonably withheld
provided existing work subcontracted as of the date hereof and
listed on Schedule 7.3(f) shall not require such consent. Any work
performed under the Research Collaboration by permitted
subcontractors shall be reimbursed by Amgen at the actual
out-of-pocket cost to Memory paid to such subcontractors for such
work or, if less, at the FTE Rate. Any hours of work performed by
permitted subcontractors under the Research Collaboration shall
count towards the total FTE hours for which Amgen is required to
compensate Memory pursuant to Section 7.3(a).
7.4 Progress Reports. Following each [*] meeting of the JRC, the chairperson
of the JRC shall prepare a report summarizing the discussions held and
conclusions reached and setting forth plans for the Research Collaboration
for the next [*].
7.5 Acknowledgment of Obligations. Except to the extent already bound by
similar general obligations at least as restrictive as those provided for
under this Agreement, each Party will cause each of its and its Affiliates
FTEs, as specified in the Research Workplan, prior to and as a condition
of participating in 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 and Patent Rights (Article 9), and
Confidential Information (Article 11, specifically as related to
non-disclosure and non-use restrictions).
7.6 Screening. During the Agreement Term, Amgen shall have the right to [*].
7.7 Research Results. On a regular basis, but no less frequently than [*],
Memory will keep Amgen fully informed as to all data, discoveries and
technical developments made in its performance of activities relating to
the Research Collaboration. In addition, no later than [*] days after the
end of the Research Term, and at such other times as Amgen may reasonably
request, Memory will provide Amgen with a written summary of all data,
discoveries and technical developments made in its performance of
activities relating to the Research Collaboration and any other
information in its possession reasonably related to the Research
Collaboration. Upon request by Amgen, Memory will provide Amgen
[*] CONFIDENTIAL TREATMENT IS REQUESTED
29
with copies of all data, discoveries and technical developments, including
all Collaboration Technology, Know-How and Inventions arising out of
Memory's performance of the Research Collaboration, and/or the opportunity
at reasonable times and upon reasonable advance notice to examine
originals thereof at Memory's facilities at any time during the Agreement
Term.
ARTICLE 8. DEVELOPMENT, REGULATORY MATTERS, MANUFACTURING AND COMMERCIALIZATION
Subject to Section 3.1 hereof, Amgen shall have sole and full control,
authority, discretion and right to conduct (by itself, through its Affiliates or
via a Third Party), at its own expense, and make all decisions regarding all
development, regulatory matters (including interaction with all governmental
authorities and preparation of any regulatory filings), manufacturing, and
commercialization (including determination of price, sales and distribution,
packaging, labeling, language to be included on the package insert, promotion,
reimbursement matters, detailing and selection of trademarks and phase 4
clinical trials) for each Product. Reasonably promptly after [*], Amgen shall
provide Memory with a written summary of material development and regulatory
events related to its PDE10 program subject to this Agreement.
ARTICLE 9. INTELLECTUAL PROPERTY AND PATENT RIGHTS
9.1 Ownership of Technology. As between the Parties, Memory shall own all
Memory Inventions and Memory Know-How, Amgen shall own all Amgen
Inventions and Amgen Know-How, and Memory and Amgen shall jointly own all
Joint Inventions, Joint Patent Rights and Collaboration Technology. Memory
shall have the right to use the Collaboration Technology (i) during the
Agreement Term, solely for the purpose of performing its obligations under
this Agreement and as provided for under Section 2.1 and (ii) after the
Agreement Term, as Memory may in its sole discretion elect from time to
time (subject to any provisions of Article 11). Each Party shall require
all of its employees, consultants and other agents to assign all
inventions related to Compounds and/or Products made by them to such
Party. Memory promptly will notify Amgen in writing of any Inventions of
which it becomes aware during the Research Term in sufficient detail to
permit the filing of patent applications relating thereto.
9.2 Patent Prosecution.
(a) Amgen shall have the exclusive right to prepare, file, prosecute,
defend and maintain (including using outside counsel selected by
Amgen and reasonably satisfactory to Memory) all Memory Patent
Rights to the extent related to PDE10 or to the extent related to
PDE10 inhibitors or modulators, including methods of use, methods of
manufacture and compositions of matter relating to such inhibitors
or modulators, Base Patents and Joint Patent Rights (including their
issuance, reissuance, reexamination and the defense of any
interference, revocation or opposition proceedings), in Amgen's
reasonable judgment and at Amgen's sole expense. Promptly after the
Effective Date, but in any event within [*] days after the Effective
Date, Memory shall deliver to Amgen all records, correspondence and
other information in its possession required to enable the
preparation, filing, prosecution, defense and maintenance of such
Memory Patent
[*] CONFIDENTIAL TREATMENT IS REQUESTED
30
Rights (including the Base Patents); provided, however, that all
such Memory Patent Rights (including the Base Patents) will remain
in the name of Memory. Memory shall use its reasonable best efforts
to obtain any records, correspondence and other information not in
its possession that are required to enable the preparation, filing,
prosecution, defense and maintenance of such Memory Patent Rights
(including the Base Patents), and to promptly deliver such to Amgen.
Amgen shall, to the extent reasonably requested by Memory, use
diligent efforts to file divisionals, or take other reasonable
action, to separate any patent claims of a Memory Patent Right that
do not relate to PDE10 or to PDE10 inhibitors or modulators. Amgen
shall promptly furnish Memory with copies of all correspondence
relating to such Memory Patent Rights (including the Base Patents)
to and from patent offices throughout the Territory and provide
Memory a reasonable time to offer its comments before Amgen makes a
material submission to a patent office, provided, however, that in
the event that delay would jeopardize any potential Patent Right,
Amgen shall have the right to proceed without awaiting Memory's
comments. Memory shall offer its comments promptly or indicate
promptly in writing that it waives the right to do so with respect
to each such material submission. In making its decision whether to
prosecute a patent, Amgen shall act in the best interests of the
potential Products and actual Products. Memory will cooperate and
provide such assistance as Amgen may reasonably request regarding
the transition, preparation, filing, prosecution and defense of such
Memory Patent Rights (including the Base Patents) and the Joint
Patent Rights (including executing such documents and taking such
other actions as may be reasonably requested by Amgen), provided
that no actions, including any execution of documents, shall be
inconsistent with this Agreement or increase any economic burdens of
Memory (except for any increases which in the aggregate are
immaterial). Notwithstanding the foregoing, Amgen shall prosecute
patent applications for [*] chemical families described in Schedule
9.2-A attached hereto (the "REQUIRED PATENT PROSECUTIONS") in [*]
the countries listed on Schedule 9.2-B attached hereto, [*].
(b) If Amgen elects to not prosecute any one or more patent applications
or discontinue prosecution of any one or more patent applications
within the Memory Patent Rights or Joint Patent Rights, Amgen shall
provide Memory with [*] days prior written notice of such election
to abandon any such patent application (the "ABANDONMENT NOTICE").
Memory may elect, at Memory's expense, to prosecute such patent
application or continue prosecution of such patent application, as
applicable, by providing Amgen with written notice within [*] days
of receipt of the Abandonment Notice. Memory's right to continue the
prosecution of any patent application under this Section 9.2(b)
shall be limited in scope to specific claims that are unrelated to
the subject matter of any claim actually being prosecuted by Amgen.
Notwithstanding the foregoing, in the event that Amgen reasonably
determines that the prosecution of any such patent application is
not in the best interests of the potential Products and actual
Products, then Memory shall cease to prosecute any such patent
application. Memory shall promptly furnish Amgen with copies of all
correspondence relating to such patent application to
[*] CONFIDENTIAL TREATMENT IS REQUESTED
31
and from patent offices throughout the Territory and provide Amgen a
reasonable time to offer its comments before Memory makes a material
submission to a patent office, provided, however, that in the event
that delay would jeopardize any potential Patent Right, Memory shall
have the right to proceed without awaiting Amgen's comments.
Amgen shall offer its comments promptly or indicate promptly in
writing that it waives the right to do so with respect to each such
material submission. In making its decision whether to prosecute a
patent, Memory shall act in the best interests of the potential
Products and actual Products. [*].
9.3 Patent Term Extensions.
(a) Amgen shall use reasonable efforts, at its sole cost and expense, to
obtain a patent term extension, adjustment or restoration, or
supplementary protection certificate (collectively, "PATENT TERM
EXTENSIONS") with respect to Memory Patent Rights and/or Joint
Patent Rights (including those available under the Xxxxx-Xxxxxx Act)
that it reasonably believes is capable of being obtained under
applicable law. Amgen shall provide Memory with written notice of
receipt of any such Patent Term Extension. Amgen shall make all
filings for such Patent Term Extensions with respect solely to
Memory Patent Rights in Memory's name.
(b) Memory shall execute such authorizations and other documents and
take such other actions as may be reasonably requested by Amgen to
obtain such Patent Term Extensions, including designating Amgen as
its agent for such purpose as provided in 35 U.S.C. Section 156. The
Parties shall cooperate with each other in obtaining Patent Term
Extensions wherever applicable to such Memory Patent Rights and
Joint Patent Rights.
9.4 Patent Certifications. Each Party shall immediately give notice to the
other Party of any notice it receives of certification filed under the
Xxxxx-Xxxxxx Act in respect of any Product and claiming that any of the
Memory Patent Rights and/or Joint Patent Rights is invalid, unenforceable
or that any infringement will not arise from the manufacture, use or sale
of the product by a Third Party. Amgen shall [*] bring infringement
proceedings in its reasonable judgment against the entity making such a
certification with respect to any such Memory Patent Rights and/or Joint
Patent Rights. Any suit may be in the name of either or both Parties, as
may be required by law. For this purpose, Memory shall execute such legal
papers necessary for the prosecution of such suit as may be reasonably
requested by Amgen.
9.5 Enforcement of Patent Rights.
(a) With respect to all of the matters referred to in this Section 9.5
where Amgen controls a decision, Amgen shall make its decisions
solely in a manner that Amgen in good faith believes is in the best
interest of any potential and any actual Products (but Amgen shall
have the right to give effect to any appropriate cost benefit
analysis) and shall, with respect to any material issues, provide
Memory
[*] CONFIDENTIAL TREATMENT IS REQUESTED
32
with the right to comment on preliminary decisions made by Amgen and
give serious consideration to Memory's comments and concerns.
(b) In the event that either Amgen or Memory becomes aware of any
product that is made, used, or sold in the Territory which it
believes to (i) infringe a Valid Claim, or (ii) constitute a
misappropriation of Know-How relating to the making or use of a
Compound or Product, such Party (the "NOTIFYING Party") will
promptly advise the other Party of all the relevant facts and
circumstances known by the Notifying Party in connection with the
infringement or misappropriation.
(c) Amgen shall [*], to enforce [*] any Memory Patent Rights to the
extent related to PDE10 or to the extent related to PDE10 inhibitors
or modulators, including methods of use, methods of manufacture and
compositions of matter relating to such inhibitors or modulators,
Base Patents and/or Joint Patent Rights against such infringement in
the Territory, and to control the defense of any declaratory
judgment action for non-infringement relating thereto. [*].
(d) [*] control the litigation [*]. For any action to terminate any
Third Party infringement, in the event that Amgen is unable to
initiate or prosecute any action solely in its own name or if it is
otherwise advisable to join Memory as a party to such action to
obtain an effective remedy, then Memory will join such action
voluntarily at Amgen's expense and will execute all documents
necessary for Amgen to initiate, prosecute and/or maintain such
action.
(e) Any recovery obtained as a result of an infringement action, whether
by judgment, award, decree or settlement will first be applied to
[*], and the remaining balance will be distributed to [*], provided,
however that [*].
(f) Amgen shall defend and control in its reasonable judgment any action
initiated by a Third Party (or any counterclaim or defense asserted
in any other action) alleging invalidity or unenforceability of any
Memory Patent Right to the extent related to PDE10 or to the extent
related to PDE10 inhibitors or modulators, including methods of use,
methods of manufacture and compositions of matter relating to such
inhibitors or modulators, Base Patents or Joint Patent Right [*],
which shall include the right to settle any such action.
9.6 Patent Infringement Claims.
(a) Each Party shall notify the other Party promptly in writing of any
claim of, or action for, infringement of any patents or
misappropriation of trade secret rights of any Third Party which is
threatened, made or brought against either Party by reason of the
research, development, manufacture, use or sale of any Product.
(b) In any suit, action or proceeding referred to in this Section 9.6,
each Party shall, at its own expense, fully cooperate with the other
Party and use its reasonable efforts to supply all assistance
reasonably requested by the Party carrying on the
[*] CONFIDENTIAL TREATMENT IS REQUESTED
33
proceeding, including providing the other Party with such witnesses,
documents and records and other evidence as may be reasonably
requested.
ARTICLE 10. REPRESENTATIONS, WARRANTIES AND COVENANTS
10.1 Representations and Warranties of Both Parties. Each Party warrants and
represents to the other Party that it has the full right and authority to
enter into this Agreement and that it is not aware of any impediment which
would inhibit its ability to perform the terms and conditions imposed on
it by this Agreement.
10.2 Representations, Warranties and Covenants of Memory. Memory represents and
warrants to and, in the case of Section 10.2(g) covenants with, Amgen the
following:
(a) Corporate Action. 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. 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 has the right to grant Amgen the
licenses and sublicenses that Memory hereby grants to Amgen under
this Agreement.
(d) Intellectual Property. As of the Effective Date, to the actual
knowledge of its senior executives, after consultation with in-house
patent counsel (who shall have undertaken due inquiry), there is no
issued patent right owned or controlled by any Third Party which
would be infringed by the making, using, selling or importing of the
series of compounds identified by Memory to Amgen on Schedule 1.65
or would prevent Amgen from selling such Memory Compound in any
country of the Territory. Schedule 1.41 is a full and complete list
of Base Patents as of the Effective Date. As of the Effective Date,
the Base Patents are owned exclusively by Memory, and Memory's
senior executives, after consultation with in-house patent counsel
(who shall have undertaken due inquiry), have no actual knowledge of
any information that would, in their opinion, render invalid and/or
unenforceable Composition of Matter Claims for the series of
compounds identified by Memory in such Base Patents.
(e) Invention Assignments. 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 and
Know-How.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
34
(f) Solvency. Memory is Solvent and able to pay its debts as they
become due, and Memory's Solvency will not be affected negatively as
a result of entering into this Agreement. For the purposes of this
Agreement, "SZOLVENT" (and "SOLVENCY") means that both (A) [*] and
(B) Memory is "solvent" within the meaning given that term and
similar terms under applicable laws relating to fraudulent transfers
and conveyances.
(g) Security Interest. All of Memory's rights, title and interest in the
Memory Compounds, the Memory Patent Rights, the Memory Know-How and
the Memory Technology are free and clear of all liens and
encumbrances of any kind. Additionally, during the Agreement Term,
Memory will not pledge, or grant a security interest, to any Third
Party with respect to Memory Compounds, Memory Patent Rights, Memory
Know-How, Memory Inventions and/or Memory Technology or Memory's
interest in Collaboration Technology, Joint Compounds, Joint
Inventions, or Joint Patent Rights, unless Memory has first granted
to Amgen a security interest in such intellectual property to secure
Memory's obligations under this Agreement and the security interest
granted by Memory to such Third Party is subordinated or junior in
priority to the security interest granted by Memory to Amgen,
PROVIDED, HOWEVER, [*].
(h) Adequate Compensation. Memory acknowledges that the consideration
provided for under this Agreement, including the up-front payment,
milestone payments and royalties provided for under Articles 4 and
5, represents fair consideration and reasonably equivalent value in
exchange for the licenses and rights granted under this Agreement to
Amgen.
10.3 Representations and Warranties of Amgen. Amgen represents and warrants to
Memory that all corporate action on the part of Amgen, its officers,
directors and stockholders necessary for (i) the authorization, execution
and delivery of this Agreement and (ii) the performance of all obligations
of Amgen hereunder has been taken and this Agreement constitutes the legal
and binding obligation of Amgen, enforceable against Amgen in accordance
with its terms. The execution of this Agreement and the performance of the
transactions contemplated by this Agreement by Amgen 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 Amgen is a party or by which it or any of its property is bound.
10.4 Disclaimer. THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF
ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH IN THIS
AGREEMENT. MEMORY AND AMGEN 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
35
PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS. IN NO EVENT SHALL EITHER
MEMORY OR AMGEN BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT,
TORT OR ANY OTHER LEGAL THEORY. The foregoing limitation on liability
shall not limit the indemnification obligations of either party under
Section 13.1. Accordingly, neither Party is entitled to recover from the
other Party any special, indirect, incidental or consequential damages
that it suffers except to the extent it must pay a Third Party for such
Third Party's special, indirect, incidental or consequential damages and
such payment constitutes an indemnifiable Loss pursuant to Article 13
hereof.
10.5 Memory's Expertise. Memory acknowledges and agrees that Amgen is entering
into this Agreement to obtain the benefit of Memory's unique expertise and
services and Amgen negotiated this Agreement with the expectation of
transacting with Memory.
ARTICLE 11. CONFIDENTIAL INFORMATION
11.1 Treatment of Confidential Information. In carrying out rights and
obligations under this Agreement, the Parties will be disclosing
proprietary and/or confidential information hereunder ("CONFIDENTIAL
INFORMATION") with each other. During the term of this Agreement, and for
a period of [*] years following the expiration or earlier termination
hereof, each party (the "RECEIVING PARTY") shall maintain in confidence
all Confidential Information of the other party (the "DISCLOSING PARTY"),
and shall not use, disclose or grant the use of the Confidential
Information of the other Party except on a need-to-know basis to its, or
its Affiliates', directors, officers, employees, consultants,
subcontractors, sublicensees or agents who are bound by confidentiality
obligations at least as restrictive as set forth herein, to the extent
such disclosure is reasonably necessary in connection with its performance
of this Agreement or as otherwise authorized by this Agreement. Each party
shall be responsible for any breach of the confidentiality and non-use
obligations of this Section 11.1 by its, or its Affiliates', directors,
officers, employees, consultants, subcontractors, sublicensees or agents.
During the Agreement Term, with respect to Memory's obligations under this
Article 11, all Confidential Information of Memory related to Compounds
and Products, including all Collaboration Technology, Know-How and
Inventions to the extent such Collaboration Technology, Know-How and/or
Inventions relate to Compounds, Products or Base Patents, but excluding
Memory Screening Technology, shall be subject to the provisions of this
Article 11 as if it were Amgen Confidential Information (PROVIDED,
HOWEVER, that Amgen shall not be permitted to disclose such Confidential
Information of Memory except as provided for under this Agreement)
(subject to any retained rights of Memory under Section 2.1), and Section
11.2(a)-(b) shall not release Memory from restrictions with respect to
such Confidential Information (subject to early termination of this
Agreement under Article 12). Notwithstanding the foregoing and except as
otherwise provided for under Section 11.3, unless Amgen has agreed to
reinstate the Change of Control Rights pursuant to Section 12.4(b) or the
Reinstatable Rights have been reinstated pursuant to Section 12.4(e), upon
a Change of Control of Memory, Memory shall not disclose any such Memory
Confidential Information (i.e., the Confidential
[*] CONFIDENTIAL TREATMENT IS REQUESTED
36
Information of Memory subject to the provisions of this Section 11 as if
it were Amgen Confidential Information pursuant to the immediately
preceding sentence) or Amgen Confidential Information to any entity that
owns or controls Memory or any of such entity's Affiliates, directors,
officers, employees, consultants, subcontractors, sublicensees or agents
(PROVIDED, HOWEVER, that Memory may disclose [*].
11.2 Release from Restrictions. The provisions of Section 11.1 shall not apply
to any Confidential Information which the Receiving Party shall
demonstrate:
(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, without obligation of confidentiality or
such obligations have expired, 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 commences 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 court or governmental orders or governmental
regulations, PROVIDED, HOWEVER, 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 cooperates with the Disclosing Party with respect to any and all
reasonable and lawful actions requested by the Disclosing Party to
minimize the degree of such disclosure and/or to obtain confidential
treatment or protective order; PROVIDED FURTHER, HOWEVER, that if
the Confidential Information disclosed under this clause (e) is
disclosed subject to confidential treatment or other confidentiality
protection, the obligations of Section 11.1 shall continue to apply
to such Confidential Information.
11.3 Exceptions. The restrictions set forth in this Article 11 shall not
prevent (i) Amgen (and Memory to the extent permitted by Article 9) from
in accordance with the terms of this Agreement, preparing, filing,
prosecuting or maintaining a patent application or its resulting patents
related to a Product, (ii) Amgen or, after the Agreement Term with
[*] CONFIDENTIAL TREATMENT IS REQUESTED
37
respect to Confidential Information Memory is permitted to use pursuant to
Article 12, Memory from disclosing Confidential Information to
governmental agencies to the extent required or desirable to secure
government approval for the development, manufacture or marketing of a
Product, or (iii) Memory from disclosing Confidential Information of
Memory that consists of Memory Know-How that is in existence as of the
Effective Date, Memory Know-How this is developed outside of the Research
Collaboration, Memory Patent Rights, Memory's interest in Joint Patent
Rights, and General Inventions (even if such Confidential Information of
Memory is deemed to be Confidential Information of Amgen pursuant to the
penultimate sentence of Section 11.1), in addition to Confidential
Information related to [*] and amounts payable in the future pursuant to
Articles 4 and 5 of the Agreement to a Third Party that Memory reasonably
believes in good faith to be a [*], so long as, with respect to any such
entity, such [*] executes a confidentiality agreement which is at least as
restrictive as the provisions of this Article 11, PROVIDED, HOWEVER, that
Memory shall provide [*] days prior written notice to Amgen of its intent
to disclose such Confidential Information of Memory that is deemed to be
Confidential Information of Amgen pursuant to the penultimate sentence of
Section 11.1 (such notice need only be delivered once per [*]); PROVIDED
FURTHER, HOWEVER, that such notice shall not be required if such
Confidential Information is limited to the financial provisions contained
in Article 4 and Article 5 of this Agreement. Notwithstanding the
foregoing, Memory may request the consent of Amgen, such consent not to be
unreasonably withheld, to disclose additional terms of this Agreement to
such a Third Party described in the preceding sentence.
11.4 Publications. During the Agreement Term, Amgen shall have the sole right
to publish, either directly or indirectly, scientific results and other
related information of work conducted with respect to the Research
Collaboration and/or Products. Before any such paper is submitted for
publication, Amgen will deliver a complete copy to Memory at least [*]
days prior to submitting the paper to a publisher [*]. Memory will have
the right to review any such paper and give its comments to Amgen within
[*] business days of the delivery of such paper to Memory. With respect to
oral presentation materials and abstracts, Memory will make reasonable
efforts to expedite review of such materials and abstracts, and will
return such items as soon as practicable to Amgen with appropriate
comments, if any, but in no event later than [*] business days from the
date of delivery to Memory. Amgen will consider in good faith any comments
provided by Memory, but Amgen will have no obligation to accept any such
comments. Amgen will comply with any Memory's request to delete references
to Memory's Confidential Information in any such paper. Any such
publication will include recognition of the contributions of Memory
according to standard practice for assigning scientific credit, either
through authorship or acknowledgment, as may be appropriate. Memory will
not publish scientific results or other information resulting from the
Research Collaboration, without the prior written consent of Amgen.
Additionally, during the Agreement Term Memory will not publish scientific
results or other information with respect to any Products, without the
prior written consent of Amgen.
11.5 Use of Names. No right, express or implied, is granted to either Party by
this Agreement to use any trademark of the other Party, including the
names "Amgen" and "Memory," for
[*] CONFIDENTIAL TREATMENT IS REQUESTED
38
any promotional, commercial, advertising or marketing purposes, without
the prior written consent of the owning Party.
ARTICLE 12. TERM AND TERMINATION
12.1 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 12, 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 Amgen by Memory under
this Agreement to thereafter develop, make, have made, use, offer for
sale, sell, have sold, import, export or otherwise exploit, or transfer
possession of or title in, Compounds and Products shall be fully paid-up,
except to the limited extent that a Patent Right was previously found to
be unpatentable, invalid or unenforceable by a court or other authority of
competent jurisdiction and subsequently such ruling is reversed upon
appeal and such Patent Right is thereafter not subject to such
determination of unpatentability, invalidity or unenforceability all as
contemplated under Section 5.2.
12.2 Termination for Breach. In the event that a Party to this Agreement
materially breaches this Agreement ("BREACHING PARTY"), then the
non-breaching Party ("NON-BREACHING PARTY") shall be entitled to provide
written notice thereof to the breaching Party. In the event that the
breaching Party fails to remedy such material breach within [*] days after
receipt of written notice (PROVIDED, HOWEVER, that with respect to a
failure to pay any undisputed amounts under this Agreement, [*] days),
then the non-breaching Party may terminate this Agreement by written
notice of termination to the breaching Party. Any such notice of breach
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 breach. The effective date
of termination under this Section 12.2 for a material breach shall be the
day after provision of written notice of termination by the non-breaching
Party in accordance with this Section 12.2.
Subject to the next sentence, in the event Amgen does not pay any payment
in full by reason of a good faith dispute as to whether such payment is
due pursuant to the terms of this Agreement, Amgen shall pay all amounts
not in dispute, and, so long as Amgen pays all such undisputed amounts,
Memory shall not have the right to terminate this Agreement by reason of
the non-payment of such disputed amount (the "DISPUTED Amount") pursuant
to the terms of this Section 12.2 unless Amgen has continued to fail to
pay any such disputed amount within [*] days after resolution of the
dispute by mutual agreement of the Parties or a court of competent
jurisdiction.
Notwithstanding anything contained in the foregoing to the contrary, in
the event that Memory fails to complete the Technology Transfer or fails
to provide to Amgen a notice of completion as provided for under Section
7.1(c), Amgen shall have the right to provide written notice to Memory of
such failure within [*] business days after the [*] day following the
Effective Date and the right to withhold the up-front
[*] CONFIDENTIAL TREATMENT IS REQUESTED
39
fee provided for under Section 4.1. If Amgen fails to provide such written
notice within [*] business days after the [*] day following the Effective
Date, then Amgen shall pay to Memory the up-front fee provided for under
Section 4.1. Thereafter, Memory shall have [*] days from the receipt of
such notice in which to complete the Technology Transfer. Amgen shall have
[*] business days from receipt of a subsequent notice of completion of the
Technology Transfer to either pay the up-front fee provided for under
Section 4.1 or dispute that Memory has completed the Technology Transfer.
In the event that Memory has not completed the Technology Transfer in the
additional [*] day period or Amgen disputes that Memory has completed the
Technology Transfer and the parties have not resolved such dispute within
[*] business days, Amgen shall either (a) terminate the Agreement by
providing written notice to Memory, or (b) pay the up-front fee provided
for under Section 4.1, and thereafter Memory shall be required to use its
reasonable diligence to complete the Technology Transfer as soon as
reasonably practicable. In the event that Amgen has not taken either of
the steps in the foregoing sentence, this Agreement shall be deemed
terminated effective as of the [*] business day following the end of the
additional [*] day period. Termination of this Agreement pursuant to the
provisions of this last paragraph of Section 12.2 shall, in the absence of
willful misconduct or bad faith of Memory, be without liability to either
party, notwithstanding the provisions of Sections 12.7 or 12.8.
12.3 Amgen's Right to Terminate. Amgen may terminate the Agreement in whole but
not in part (except as provided for under Sections 12.4 and 12.8) at any
time upon sixty (60) days written notice to Memory.
12.4 Consequences of Change of Control of Memory.
(a) Upon each occurrence of a Change of Control of Memory, Memory shall
notify Amgen thereof, specifying the name(s) of the acquiring Third
Party(ies) (if applicable) if known. If the identity of the
acquiring Third Party(ies) is not known, Memory will promptly notify
Amgen upon learning the identity of such party(ies) (if applicable).
(b) Upon a Change of Control of Memory, except to the extent provided
for in Section 12.4(e), the Change of Control Rights shall xxxxx,
suspend, no longer be currently enforceable and may never be
enforceable again unless and to the extent that Amgen provides
Memory with written notice to the contrary abrogating such
abatement.
(c) Amgen shall have the right to terminate this Agreement at any time
after a Change of Control of Memory, and such right shall expire
upon [*] days after the occurrence of such Change of Control of
Memory. In the case of a Change of Control of Memory described in
Section 1.8(f), Amgen's right to terminate the Agreement shall not
expire until [*] days after receiving notice from Memory (or its
successor) of the lifting of any stay which would otherwise prevent
Amgen from providing notice pursuant to this provision. In each case
termination under Section 12.4 shall be effective upon written
notice to Memory (or its successor).
(d) The Parties acknowledge and agree that Amgen shall have no liability
(either during or after any such abatement, suspension and
unenforceability) with respect
[*] CONFIDENTIAL TREATMENT IS REQUESTED
40
to any Change of Control Rights for the period during which such
rights are abated, suspended or no longer enforceable (by way of
example, if during the period in which Change of Control Rights are
abated, suspended and no longer enforceable Amgen fails to fulfill
its diligence obligations under Article 3, then Amgen shall have no
liability (at any time) with respect to that failure to perform,
even if such diligence obligations are subsequently reinstated and
again enforceable).
(e) Notwithstanding Section 12.4(b), if the Third Party Acquirer or an
Affiliate thereof is a pharmaceutical or biotechnology company and
together with its Affiliates has annual research and development
expenditures of [*] prior to the applicable Change of Control of
Memory (PROVIDED, HOWEVER, that upon request by Amgen, Memory shall
provide reasonable documentation to evidence that, or provide a
written certification reasonably satisfactory to Amgen from the
Third Party Acquirer to the effect that, [*], and such Third Party
Acquirer agrees in writing to be bound by the exclusivity provisions
of Section 2.5 in a manner reasonably satisfactory to Amgen, then
(i) Amgen's obligations under Section 3.1 shall be automatically
reinstated (but shall terminate upon the Initiation of Phase 3
Clinical Trial), (ii) Amgen's obligations with respect to payment of
FTE costs under Section 7.3 shall be reinstated (but only in the
event that [*] and (iii) the Reinstatable Rights shall be
reinstated. In the event that at any time during the [*] day period
following the occurrence of a Change of Control of Memory, Memory
ceases to have the requisite number of Dedicated Personnel or such
requisite number of Dedicated Personnel are not working on the
Research Collaboration as requested by Amgen, Memory shall notify
Amgen in writing, and Amgen shall have the right to terminate in
writing the Research Collaboration and its obligations with respect
to payment of FTE costs under Section 7.3 with respect to FTE costs
from and after the date Amgen so terminates the Research
Collaboration by providing written notice of termination to Memory
within [*] days of receipt of the written notice from Memory.
Notwithstanding the foregoing provisions of this Section 12.4(e),
from and after the occurrence of a Change of Control of Memory, at
Amgen's election and upon written Notice to Memory, Amgen shall have
the right to require Memory to cease all activities related to
PDE10, PROVIDED, HOWEVER, that Amgen agrees to pay Memory all
amounts due under the Research Collaboration for FTEs that would
otherwise be dedicated to the Research Collaboration pursuant to the
terms of Section 7.3. The Parties hereby confirm that the provisions
of this Section 12.4 with respect to the suspension of payment of
FTE costs under Section 7.3 are not intended to affect Memory's
right to recover for FTE costs incurred prior to suspension of such
payment of FTE costs.
(f) Upon any such suspension or termination by Amgen of the Research
Collaboration and its obligations with respect to payment of FTE
costs under Section 7.3, Amgen shall, at Amgen's sole expense
(calculated at the FTE Rate), have the right to cause Memory to
transition to Amgen any and all of Memory's activities under the
Research Collaboration.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
41
(g) Upon any suspension by Amgen of the Research Collaboration and its
obligations with respect to payment of FTE costs under Section 7.3,
then Memory shall promptly cease all activities with respect to
PDE10, except as otherwise required under this Section 12.4, and
Memory's obligations under Section 3.2, the last two sentences of
Section 7.1(c), Section 7.2(d), and Section 7.7 shall be suspended,
but only for such time as Amgen has elected to suspend its
obligation with respect to payment of FTE costs. Notwithstanding the
foregoing, Memory shall, regardless of Amgen's election to suspend
payment of FTE costs, comply with the provisions of Section 7.1(c)
(excluding the last two sentences of such Section 7.1(c)) and
Section 12.4(f) (including providing Amgen with copies of all data,
discoveries and technical developments, including all Collaboration
Technology, Know-How and Inventions arising out of Memory's
performance of the Research Collaboration to the extent not
previously provided to Amgen, including animals and/or other
physical materials for performing in vivo behavioral assays).
(h) Promptly after reinstatement of the Research Collaboration and
Amgen's obligations with respect to payment of FTE costs under
Section 7.3, the JRC shall meet to discuss and determine appropriate
revisions to the Research Workplan to take into account any period
that the Research Collaboration was suspended pursuant to the
provisions of this Section 12.4, including other activities
unrelated or outside the scope of the original Research Workplan,
but only to the extent such activities are related to PDE10. If the
Research Collaboration is suspended pursuant to this Section 12.4
and subsequently reinstated, the Research Term shall be extended by
the same of number of days that the Research Term was suspended
pursuant to this Section 12.4.
12.5 Consequences of Termination.
(a) Upon (i) any termination of this Agreement by Memory pursuant to
Section 12.2, or (ii) termination of this Agreement by Amgen
pursuant to Section 12.3 (unless Amgen in its reasonable commercial
judgment concludes that there are [*], all rights and licenses of
any kind or nature granted by Memory to Amgen under this Agreement
shall terminate on the effective date of termination (PROVIDED,
HOWEVER, that the non-exclusive Research License granted to Amgen
with respect to Memory Inventions that relate specifically to Memory
compounds consisting of PDE10 inhibitors or modulators, including
Memory Compounds, and the non-exclusive license granted to Amgen
with respect to any other Memory Invention (including General
Inventions) shall survive any termination or expiration of the
Agreement (other than with respect to the termination of this
Agreement by Memory pursuant to Section 12.2 by reason of Amgen's
default in making payments required under this Agreement in which
case the foregoing licenses terminate)). Additionally, in the event
of any such termination, Memory shall have the right to cause Amgen
to enter into good faith discussions for a period of ninety (90)
days regarding the acquisition by Memory of the items set forth in
Section 12.5(c) below. Memory may exercise the foregoing right by
providing written notice to Amgen within ninety (90) days of
termination of the Agreement.
[*] CONFIDENTIAL TREATMENT IS REQUESTED
42
(b) Upon (i) any termination of this Agreement by Amgen in its entirety
pursuant to Section 12.2, (ii) any termination of this Agreement by
Amgen pursuant to Section 12.3 where Amgen in its reasonable
commercial judgment concludes that there are [*], or (iii) any
termination of this Agreement in its entirety pursuant to Section
12.4, rights and licenses of any kind or nature granted by Memory to
Amgen under this Agreement shall terminate on the effective date of
termination (PROVIDED, HOWEVER, that the non-exclusive Research
License granted to Amgen with respect to Memory Inventions that
relate specifically to Memory compounds consisting of PDE10
inhibitors or modulators, including Memory Compounds, and the
non-exclusive license granted to Amgen with respect to any other
Memory Invention (including General Inventions) as set forth in
Section 2.1 shall survive).
(c) Upon receipt of notice provided for under Section 12.5(a) above,
provided that Amgen has not filed an NDA with respect to any
Product, the Parties shall enter negotiations for the acquisition by
Memory of the Amgen Property. The royalties payable by Memory to
Amgen in connection with the exclusive and non-exclusive licenses
within Amgen Property would be negotiated by the Parties consistent
with following: if, as of the date of termination of the Agreement,
(1) Amgen has not yet achieved Initiation of Phase 2a Clinical Trial
with respect to a Lead Compound, then the royalties would be between
[*] and [*]; and (2) Amgen has achieved Initiation of Phase 2a
Clinical Trial with respect to a Lead Compound, but not yet filed an
NDA with respect to such Lead Compound, then the royalties would be
between [*] and [*].
12.6 Royalty and Payment Obligations. Termination of this Agreement in whole or
in part by either Party for any reason will not release Amgen 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).
12.7 Survival of Obligations. Section 2.2 (the last sentence only), Section
2.4, Section 6.4, Section 6.5, Section 7.5, Section 9.1, Article 11,
Section 12.1 (the last sentence only), Section 12.5, Section 12.6, Section
12.7, Article 13, and any definitions used in such Section or Article,
shall survive the termination of this Agreement in its entirety.
Additionally, the license granted to Amgen under Section 2.1 with respect
to Memory Inventions shall become the non-exclusive Research License under
the Memory Inventions that relate specifically to Memory compounds
consisting of PDE10 inhibitors or modulators, including Memory Compounds,
and the non-exclusive license under any other Memory Invention (including
General Inventions) as set forth under Section 2.1 shall otherwise survive
in all respects the termination of this Agreement (other than with respect
to the termination of this Agreement by Memory pursuant to Section 12.2 by
reason of Amgen's default in making payments required under this Agreement
in which case the foregoing licenses terminate). The parties acknowledge
and agree that, except to the extent a definitive agreement is entered
into between the Parties as contemplated by Section 12.5(c) granting a
license to Memory with respect to certain intellectual property of Amgen,
upon the termination of this Agreement, the rights of each of Memory and
[*] CONFIDENTIAL TREATMENT IS REQUESTED
43
Amgen with respect to Joint Compounds, Joint Inventions and Joint Patent
Rights shall be governed by applicable law.
The Parties joint interest in Collaboration Technology shall survive the
termination or expiration of this Agreement, and accordingly each party
shall have the right to fully exploit its joint interest in Collaboration
Technology. Termination (in whole or in part), relinquishment or
expiration of the Agreement for any reason shall be without prejudice to
any rights that shall have accrued to the benefit of either Party prior to
such termination, relinquishment or expiration, including any other
remedies available to such Party in law or equity. Such termination,
relinquishment or expiration shall not relieve either Party from
obligations that are expressly indicated to survive termination or
expiration of the Agreement.
12.8 Additional Remedies of Amgen. In addition to the remedies available under
Section 12.2 above and cumulative thereto, as well as any other remedies
available under law or equity, and subject to the right to notice and cure
as provided for under Section 12.2, in the event of a material breach of
this Agreement by Memory of Article 2, Article 9, Sections 10.2(b), (c),
(d), (e), or (f), or Article 11, then Amgen and Memory shall discuss in
good faith, for a period of [*] days, the nature and the potential and/or
actual adverse effects of the alleged material breach on Amgen or any
Product and the sufficiency of Memory's efforts to cure such material
breach. In the event [*] of a Change of Control of Memory as described in
Section 1.8(f) and a subsequent rejection of this Agreement by Memory (or
its successor), then Amgen shall have the right to (i) [*] and (iv) cause
Memory to either return or destroy, at Amgen's option, all of Amgen's
Confidential Information. Amgen's effecting the partial termination
provided for in the preceding sentence shall not create a presumption that
Amgen has correctly made such determination, and, after any such
determination is made by Amgen, Memory shall have the right to dispute in
good faith Amgen's right under the circumstances to effect such partial
termination.
ARTICLE 13. MISCELLANEOUS
13.1 Indemnification.
(a) Amgen agrees to defend Memory and its directors, officers, employees
and agents (the "MEMORY INDEMNIFIED PARTIES") at Amgen's cost and
expense, and will indemnify and hold Memory and the other Memory
Indemnified Parties harmless from and against any claims, losses,
costs, damages, fees or expenses (collectively, "LOSSES") resulting
from any Third Party claim (including product liability claims)
arising out of or otherwise relating to (i) Amgen's performance of
its obligations under this Agreement, (ii) the development,
manufacture, use, offer for sale, sale or other disposition of any
Product by or on behalf of Amgen, its Affiliates or sublicensees
(including any Losses resulting from Memory being joined as a party
to an action at Amgen's request pursuant to Section 9.4(d)) or (iii)
breach of this Agreement, or the representations and warranties made
hereunder by Amgen, by Amgen; except, in each case, to the extent
such Losses result from the gross negligence or willful misconduct
of Memory Indemnified
[*] CONFIDENTIAL TREATMENT IS REQUESTED
44
Parties or from the breach of any representation or warranty
hereunder or of this Agreement by Memory. In the event of any such
claim against the Memory Indemnified Parties by a Third Party,
Memory shall promptly notify Amgen in writing of the claim
(PROVIDED, HOWEVER, that any failure or delay to notify shall not
excuse any obligations of Amgen except to the extent Amgen is
actually prejudiced thereby) and Amgen shall solely manage and
control, at its sole expense, the defense of the claim and its
settlement; PROVIDED, HOWEVER, that Amgen 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 Amgen and may, at their option and expense, be
represented in any such action or proceeding. Amgen shall not be
liable for any litigation costs or expenses incurred by the Memory
Indemnified Parties without Amgen's written authorization.
(b) Memory agrees to defend Amgen and its directors, officers, employees
and agents (the "AMGEN INDEMNIFIED PARTIES") at Memory's cost and
expense, and will indemnify and hold Amgen and the other Amgen
Indemnified Parties harmless from and against any Losses resulting
from any Third Party claim (including product liability claims)
arising out of or otherwise relating to (i) Memory's performance of
its obligations under this Agreement, or (ii) breach of this
Agreement, or the representations and warranties made hereunder by
Memory, by Memory; except, in each case, to the extent such Losses
result from the gross negligence or willful misconduct of Amgen
Indemnified Parties or from the breach of any representation or
warranty hereunder or of this Agreement by Amgen.
In the event of any such claim against the Amgen Indemnified Parties
by a Third Party, Amgen shall promptly notify Memory in writing of
the claim (PROVIDED, HOWEVER, 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, HOWEVER, that Memory shall not settle
any such claim if such settlement may have an adverse effect on
Amgen without the prior written consent of Amgen, which consent
shall not be unreasonably withheld. The Amgen 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 Amgen
Indemnified Parties without Memory's written authorization.
13.2 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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
45
US Securities and Exchange Commission). Memory shall provide a proposed
draft to Amgen of any intended press releases or other public disclosure,
which Memory is required to make under applicable law, regulation or stock
exchange rule to the extent relating to Memory's rights and/or obligations
under this Agreement at least [*] business days in advance of its proposed
release. Amgen shall consider Memory's request to make such press release
or statement and within [*] business days of receiving such press release
or statement, indicate to Memory whether Amgen requires any changes to be
made prior to the release thereof, which changes Memory shall be required
to make prior to making such press release or other public disclosure.
Memory's failure to make a change required by Amgen shall be deemed not to
be a breach of this Agreement solely in the event that making such change
is reasonably likely to, based upon Memory's reasonable determination made
after consultation with outside legal counsel, result in Memory violating
any law or regulation or stock exchange rules. Memory shall not be
required to provide Amgen with a draft press release within [*] business
days in advance of its proposed release if the event that gave rise to the
press release is required under applicable law or regulation or stock
exchange rules to be disclosed within a time period of less than [*]
business days of occurrence of the event, based upon Memory's reasonable
determination made after consultation with outside legal counsel,
PROVIDED, HOWEVER, that in such an event Memory shall provide Amgen with a
draft press release as soon as reasonably possible but in no event less
than [*] business days in advance of its proposed release. The Parties
agree to the form of press release as attached as Schedule 13.2 which
Memory may file with the Securities and Exchange Commission in connection
with a filing on Form 8-K.
Notwithstanding anything contained in this Agreement to the contrary, the
Parties agree that nothing set forth in this Agreement is intended to
preclude Memory from making disclosures that are otherwise required under
applicable law or regulation or stock exchange rules.
13.3 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.
13.4 Bankruptcy. All licenses (and to the extent applicable rights) granted
under or pursuant to this Agreement by Memory to Amgen 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
Amgen elects to terminate this Agreement under Article 12, the Parties
agree that Amgen, 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, including, Amgen's right to retain
all licenses to Memory technology and intellectual property granted
herein, subject to payments when due to Memory of all milestone payments
and royalties on Product(s). The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against Memory under
the U.S. Bankruptcy Code, Amgen shall be entitled to a complete duplicate
of (or complete access to, as appropriate)
[*] CONFIDENTIAL TREATMENT IS REQUESTED
46
any such intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession, shall be promptly
delivered to it (i) upon any such commencement of a bankruptcy proceeding
upon its written request therefor, unless Memory elects to continue to
perform all of its obligations under this Agreement, or (ii) if not
delivered under (i) above, following the rejection of this Agreement by or
on behalf of Memory upon written request therefor by Amgen.
13.5 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the laws of New York without giving effect to principles
of conflicts of law. Any litigation initiated under this Agreement shall
be conducted in the state or federal courts located in New York. Each of
the Parties hereto hereby irrevocably and unconditionally consents to
submit to the exclusive jurisdiction of the courts of the State of New
York and of the United States of America located in the State of New York
for any matter arising out of or relating to this Agreement and the
transactions contemplated hereby. Each of the Parties hereto hereby
irrevocably and unconditionally waives any objection to the laying of
venue of any matter arising out of this Agreement or the transactions
contemplated hereby in the courts of the State of New York or of the
United States of America located in the State of New York and hereby
further irrevocably and unconditionally waives and agrees not to plead or
claim in any such court that any such litigation brought in any such court
has been brought in an inconvenient forum.
13.6 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.
13.7 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 delivered pursuant to one of the foregoing methods of providing
notice.
If to Memory:
Memory Pharmaceuticals Corp.
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
[*] CONFIDENTIAL TREATMENT IS REQUESTED
47
Attn: Xxx X. Xxxxxxxxx, Esq.
If to Amgen:
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Vice President, Licensing
and
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Corporate Secretary
13.8 No Agency. The relationship between Memory and Amgen created by this
Agreement is solely that of independent contractors. This Agreement does
not create any agency, distributorship, employee-employer, partnership,
joint venture or similar business relationship between the Parties.
Neither Party is a legal representative of the other Party, and neither
Party can assume or create any obligation, representation, warranty or
guarantee, express or implied, on behalf of the other Party for any
purpose whatsoever. Each Party shall use its own discretion and shall have
complete and authoritative control over its employees and the details of
performing its obligations under this Agreement.
13.9 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.
13.10 Headings. The headings contained in this Agreement are for convenience of
reference only and shall not be considered in construing this Agreement.
13.11 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.
13.12 Assignment. Neither Party may assign or transfer this Agreement or any
rights or obligations hereunder without the prior written consent of the
other, except that, subject to Section 12.4, a Party may make such an
assignment or assumption without the other Party's consent to an entity
that acquires all or substantially all of the business of such Party,
whether in a merger, consolidation, corporate or bankruptcy
reorganization,
[*] CONFIDENTIAL TREATMENT IS REQUESTED
48
acquisition, sale or otherwise. Notwithstanding the foregoing, Amgen shall
have the right to assign this Agreement to any of its Affiliates
(PROVIDED, HOWEVER, that once an entity ceases to be an Affiliate of
Amgen, such entity shall reassign this Agreement to Amgen; FURTHER
PROVIDED, HOWEVER, that notwithstanding any such assignment by Amgen to an
Affiliate Amgen shall remain liable with respect to its obligations under
this Agreement).
This Agreement shall be binding on the successors and assigns of the
assigning Party, and the name of a Party appearing herein shall be deemed
to include the name(s) of such Party's successors and permitted assigns to
the extent necessary to carry out the intent of this Agreement. Any
assignment or attempted assignment by either Party in violation of the
terms of this Section 13.12 shall be null and void and of no legal effect.
The assigning Party shall forward to the other Party a copy of those
portions of each fully executed assignment agreement which relate to the
assumption of the rights and responsibilities of the assigning Party,
within [*] days of the execution of such assignment agreement.
13.13 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. Unless the context otherwise requires,
countries shall include territories.
13.14 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.
13.15 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments and to do all such other acts as may be necessary
or appropriate in order to carry out the purposes and intent of this
Agreement.
13.16 No Benefit of Third Parties. The representations, warranties, covenants
and agreements set forth in this Agreement are for the sole benefit of the
Parties hereto and their successors and permitted assigns, and they shall
not be construed as conferring any rights on any Third Parties.
(Remainder of page intentionally left blank)
[*] CONFIDENTIAL TREATMENT IS REQUESTED
49
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. AMGEN INC.
By:/s/ Xxxxx X. Xxxxx By: /s/ Xxxxx X. Xxxxxxxxxx
--------------------------- -----------------------
Name: Xxxxx X. Xxxxx Name: Xxxxx X. Xxxxxxxxxx, M.D., Ph.D.
Title: President and CEO Title: Executive Vice President,
Research & Development
[*] CONFIDENTIAL TREATMENT IS REQUESTED
50
SCHEDULE 1.41
MEMORY PATENT RIGHTS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1.42
MEMORY SCREENING TECHNOLOGY
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1.48
PDE10 AMINO ACID SEQUENCE
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1.57
RESEARCH WORKPLAN
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1.60
MEMORY IDENTIFIED
SECONDARY COMPOUNDS
None.
SCHEDULE 1.65-A
TRIGGERING EVENT
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 1.65-B
CENTRAL NERVOUS SYSTEM EFFECTS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 2.6
SHORT FORM LICENSE AGREEMENT
This Exclusive License Agreement (this "AGREEMENT") entered into as of the ___th
day of ______, 2005 by and between MEMORY PHARMACEUTICALS CORP., a Delaware
corporation, having its principal place of business at 000 Xxxxxxx Xxxxxxx,
Xxxxxxxx, Xxx Xxxxxx 00000 ("MEMORY"), and AMGEN INC., a Delaware corporation,
having its principal place of business at Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx,
Xxxxxxxxxx 00000 ("AMGEN").
Whereas, Memory owns all right title and interest in and to the patents
and patent applications set forth on Schedule 1 hereto (the "LICENSED PATENTS");
Whereas, Amgen and Memory are parties to that certain Collaboration and
License Agreement dated October ___, 2005 (the "LICENSE AGREEMENT");
Whereas, Memory desires to grant Amgen an exclusive license to the
Licensed Patents on the terms and conditions set forth in the License Agreement.
NOW, THEREFORE, in consideration of the mutual representations, warranties
and covenants contained herein and for other good and valuable consideration,
and intending to be legally bound, the parties hereby agree as follows:
1. Grant of License. Memory hereby grants Amgen an exclusive license to the
Licensed Patents for all uses, including prophylaxis, palliative, diagnostic,
and therapeutic, on the terms and conditions set forth in the License Agreement.
2. Further Assurances. Memory shall take all actions and execute all documents
necessary for Amgen to perfect its rights hereunder. Amgen shall reimburse
Memory for any out of pocket costs incurred in connection therewith.
3. Recordal. Amgen shall have the right to record this Agreement as necessary to
perfect its interest herein, including with the United States Patent and
Trademark Office and similar offices in other countries throughout the world.
IN WITNESS WHEREOF, the parties hereto have each caused a duly authorized
officer to sign this Agreement.
AMGEN INC. MEMORY PHARMACEUTICALS CORP.
By: __________________________ By:__________________________
Title: Title:
SCHEDULE 7.1
MEMORY LEAD SERIES
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 7.3(f)
APPROVED SUBCONTRACTORS
None.
SCHEDULE 9.2-A
MEMORY PDE10 CHEMICAL FAMILIES
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 9.2-B
REQUIRED PATENT PROSECUTIONS
[*]
[*] CONFIDENTIAL TREATMENT IS REQUESTED
SCHEDULE 13.2
FORM OF PRESS RELEASE
[MEMORY SCIENCE WORKING FOR THE MIND LOGO]
FOR MORE INFORMATION:
Jzaneen Xxxxxx Xxxxx Xxxxx
Vice President, Legal Affairs Xxxxx Investor Relations, Inc.
(000) 000-0000 (000) 000-0000
MEMORY PHARMACEUTICALS ANNOUNCES COLLABORATION TO DEVELOP PDE10 INHIBITORS
FOR CENTRAL NERVOUS SYSTEM DISORDERS WITH AMGEN
Montvale, NJ - October __, 2005 - Memory Pharmaceuticals Corp. (NASDAQ: MEMY)
today announced that it has entered into an exclusive worldwide collaboration
and license agreement with Amgen to develop PDE10 inhibitors as human
therapeutics, including as a potential treatment for certain neurological and
psychiatric disorders. The collaboration will focus on the optimization of lead
compounds that the Company has identified and that have demonstrated
effectiveness in the selective inhibition of PDE10 activity in several animal
models.
Under the collaboration, Memory Pharmaceuticals will receive an upfront payment
of $5.0 million, and the Company could also receive significant milestone
payments for the successful achievement of research, development, approval and
sales events for compounds that progress under the collaboration. In addition,
Memory Pharmaceuticals is eligible to receive royalties that will increase with
increasing sales levels on worldwide sales of marketed products from the
collaboration. Over the next two years of the collaboration, Memory
Pharmaceuticals could receive research funding of $5.1 million.
"PDE10 is a very compelling target for treating certain central nervous system
disorders, and we are delighted to have Amgen as a partner in our effort to
aggressively pursue this target and address the pervasive unmet needs of
patients with these disorders," said Xxx Xxxxx, President and Chief Executive
Officer of Memory Pharmaceuticals. "In addition, we believe this collaboration
is further validation of Memory Pharmaceuticals' solid discovery capabilities."
PDE10 is a class of phosphodiesterases that degrades cAMP and cGMP, molecules
that are responsible for improving the function of many different cells in the
body, including neurons. By inhibiting PDE10 activity, levels of cAMP and cGMP
are increased within neurons, and the ability of these neurons to function
properly is thereby improved. PDE10 has been shown to be present at high levels
in neurons in areas of the brain that are closely associated with many
neurological and psychiatric disorders.
ABOUT THE COMPANY
Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on
developing innovative drugs for the treatment of debilitating CNS disorders such
as Alzheimer's disease, schizophrenia, depression, vascular dementia, mild
cognitive impairment, Xxxxxxxxx'x disease and memory impairments
associated with aging. For additional information, please visit our website at
xxxx://xxx.xxxxxxxxxxxx.xxx.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject to risks and
uncertainties. All statements, other than statements of historical facts,
regarding management's expectations, beliefs, goals, plans or Memory
Pharmaceuticals' prospects, future financial position, future revenues and
projected costs should be considered forward-looking. Readers are cautioned that
actual results may differ materially from projections or estimates due to a
variety of important factors, including the risks and uncertainties associated
with: obtaining additional financing to support Memory Pharmaceuticals' R&D and
clinical activities and operations; Memory Pharmaceuticals' ability to enter
into and maintain collaborations with third parties for its drug development
programs; Memory Pharmaceuticals' dependence on its collaborations with Roche
and its license relationship with Bayer; conducting preclinical and clinical
trials of Memory Pharmaceuticals' drug candidates that demonstrate these
candidates' safety and effectiveness; obtaining regulatory approvals to conduct
clinical trials and to commercialize Memory Pharmaceuticals' drug candidates;
achieving milestones under Memory Pharmaceuticals' collaborations; Memory
Pharmaceuticals' dependence on third- party preclinical or clinical research
organizations, manufacturers and consultants; and protecting the intellectual
property developed by or licensed to Memory Pharmaceuticals. These and other
risks are described in greater detail in Memory Pharmaceuticals' filings with
the Securities and Exchange Commission. Memory Pharmaceuticals may not actually
achieve the goals or plans described in its forward-looking statements, and
investors should not place undue reliance on these statements. Memory
Pharmaceuticals disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of this press
release.
# # #
