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Title: |
Collaboration and License Agreement |
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2006 |
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$79 |
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#1022341 |
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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 One Amgen Center Drive, Thousand Oaks, California 91320 ("AMGEN"), and, on
the other hand, MEMORY PHARMACEUTICALS CORP., a Delaware corporation, having its
principal place of business at 100 Philips Parkway, Montvale, New Jersey 07645
("MEMORY").
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
<PAGE>
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
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<PAGE>
(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
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<PAGE>
(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
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<PAGE>
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 OF PHASE 2A 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 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
<PAGE>
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
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