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Exhibit 99.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this "Agreement"), dated as
of
January 29, 2007 (the "Effective Date"), is made by and between
Critical
Therapeutics, Inc., a Delaware corporation ("Licensor"), and
Innovative
Metabolics, Inc., a Delaware corporation ("IMI"). Licensor and
IMI are sometimes
hereinafter referred to each as a "Party" and collectively as
the "Parties."
WHEREAS, Licensor has been engaged in the development of
certain
technology to stimulate the vagus nerve, and owns and otherwise
controls certain
patent rights and know-how with respect thereto;
WHEREAS, IMI desires to acquire exclusive rights under the
Licensed
Patents and Licensed Know-How in the Field (each as defined
below); and
WHEREAS, the Parties desire to enter into an agreement pursuant
to
which Licensor will grant an exclusive license to IMI under the
Licensed Patents
and Licensed Know-How for IMI to research, develop and
commercialize Licensed
Products & Methods (as defined below).
NOW, THEREFORE, the Parties hereby agree as follows:
Section 1. Definitions.
For the purpose of this Agreement, the following words and
phrases and
their correlatives shall have the meanings set forth below:
1.1 "Affiliate" of an entity means any other entity which
(directly or
indirectly) is controlled by, controls or is under common
control with such
entity. For the purposes of this definition, the term "control"
(including, with
correlative meanings, the terms "controlled by" and "under
common control with")
as used with respect to an entity means (i) in the case of a
corporate entity,
direct or indirect ownership of voting securities entitled to
cast at least
fifty percent (50%) of the votes in the election of directors or
(ii) in the
case of a non-corporate entity, direct or indirect ownership of
at least fifty
percent 50%) of the equity interests with the power to direct
the management and
policies of such entity, provided that if local law restricts
foreign ownership,
control shall be established by direct or indirect ownership of
the maximum
ownership percentage that may, under such local law, be owned by
foreign
interests.
1.2 "Confidential Information" shall have the meaning assigned
in the
Confidential Disclosure Agreement dated as of the Effective Date
by and between
CRTX and IMI (the "CDA").
1.3 "Controlled", when used in reference to Patent Rights or
other
intellectual property rights or Technology or tangibles
materials, means the
legal authority or right of a person or entity to grant a
license or sublicense
or covenant not to sue of Patent Rights or other intellectual
property rights to
another entity, or to disclose or provide Technology or tangible
materials to
such other entity, in each case by ownership, license,
sublicense, contract or
otherwise, without breaching the terms of any agreement with a
Third Party as of
the time that such person or entity would be first required
under this Agreement
to make such grant, disclosure or provision (subject in all
events to the terms
of Section 2.3(b)).
For clarity and without limitation, it is understood and agreed
that
because of Third Party agreements any of the foregoing may be
partially and not
fully "Controlled" for purposes of the licenses and other rights
granted herein,
such as, for example, Licensor only has a covenant not to sue or
other
non-exclusive right or license to a Patent Right or Technology,
or does not have
all the rights specified in the prosecution and enforcement
provisions set forth
in Section 6 for any Patent Right, and in any such case then the
applicable
Patent Right, other intellectual property rights, Technology or
tangible
materials shall be made available to IMI hereunder to the extent
and only to the
extent permitted by the applicable Third Party agreements.
1.4 "Excluded Field" means direct or indirect modulation by
a
pharmacological agent of the activity of a cholinergic receptor
(including the
nicotinic [alpha]7 cholinergic receptor). It is understood that
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EXCLUSIVE LICENSE AGREEMENT
change in a response to a pharmacological agent resulting solely
from use of any
medical device (including any Licensed Product & Method as
licensed hereunder)
is not in the Excluded Field.
1.5 "Field" means vagal nerve stimulation by any means, but does
not
include the Excluded Field. Exemplary vagal nerve stimulation
modalities within
the Field include mechanical (such as massage, needle, acoustic
or other
vibrational), electrical, thermal, magnetic, and
electromagnetic, or as produced
by any other energy source.
1.6 "First Financing" means one or more financing transactions
whereby
IMI first receives aggregate gross proceeds in excess of five
million dollars
(US$5,000,000).
1.7 "Licensed Know-How" means (i) the NS Licensed Know-How, and
(ii)
all Technology (other than the NS Licensed Know-How) Controlled
by Licensor or
any of its Affiliates as of the Effective Date or during the
term of this
Agreement, that in each case (1) is reasonably necessary or
useful to make, use,
sell, offer to sell, and/or import any Licensed Products &
Methods and (2)
qualifies as "Confidential Information" under the CDA.
1.8 "Licensed Methods" means any method that, absent the
licenses
granted hereunder, the practice of which would infringe one or
more Valid Claims
of the Licensed Patents in the Field.
1.9 "Licensed Patents" means (i) the NS Licensed Patents, and
(ii) all
Patent Rights (other than the NS Licensed Patents) Controlled by
Licensor or any
of its Affiliates as of the Effective Date or during the term of
this Agreement,
each of which Patent Rights under this clause (ii) is reasonably
necessary or
useful to make, use, sell, offer to sell, and/or import any
Licensed Products &
Methods. The Patent Rights under the foregoing clause (ii) that
are in existence
as of the Effective Date are listed in Exhibit A. For clarity,
all Patent Rights
that arise from, or otherwise claim priority (directly or
indirectly) to, any of
the Patent Rights listed as of the Effective Date or thereafter
on Exhibit A
shall be treated as "Licensed Patents" hereunder.
1.10 "Licensed Product" means any article or device that (i)
absent the
licenses granted hereunder, would infringe one or more Valid
Claims of the
Licensed Patents in the Field, (ii) is manufactured by using a
Licensed Method,
or (iii) when used as directed, practices a Licensed Method.
1.11 "Licensed Products & Methods" means Licensed Products
and Licensed
Methods. For clarity, "Licensed Products & Methods" and
those two subsidiary
definitions include, without limitation, combination products
discussed in the
last paragraph of the "Net Sales" definition, and those products
and services
described in Section 2.1(b).
1.12 "Material Adverse Effect" means a material adverse effect
on the
operations or proposed business of the other Party.
1.13 "Net Sales" means, with respect to any Licensed Product
or
Licensed Method, the amount received by IMI and its Sublicensed
Affiliates (but
no Sublicensed Third Parties) for bona fide sales of such
Licensed Product to,
or bona fide performances of such Licensed Method for, a Third
Party (other than
Sublicensees but including any Third Party distributors for
resale), less:
(a) discounts (including cash, quantity and patient program
discounts), retroactive price reductions, charge-back payments
and rebates
granted to managed health care organizations or to federal,
state and local
governments, their agencies, or to distributors and other trade
customers,
reimbursers and customers and purchasers to the extent actually
given or
allowed and consistent with industry standard practices for
products or
services similar to the applicable Licensed Product or Licensed
Method;
(b) credits or allowances actually granted upon claims,
damaged goods, rejections or returns of such Licensed Product or
Licensed
Method, including in connection with any recalls or
withdrawals;
2
<PAGE>
EXCLUSIVE LICENSE AGREEMENT
(c) freight out, postage, shipping and insurance charges
for delivery if and to the extent included in the amount
invoiced to the
Third Party; and
(d) taxes or duties levied on, absorbed or otherwise
imposed on such sale or performance, including value-added
taxes, or other
governmental charges otherwise imposed upon the billed amount,
as adjusted
for rebates and refunds, to the extent not paid by the Third
Party.
Net Sales shall not include any payments among IMI, its
Affiliates and
Sublicensed Third Parties. Net Sales shall be determined in
accordance with
generally accepted accounting principles, consistently applied.
Net Sales shall
not include sales or performances of Licensed Products &
Methods for clinical
studies (including post-approval studies), as donations to
non-profit
institutions or government agencies, for promotional or
demonstration purposes
(but not to exceed three percent (3%) of Net Sales in any
calendar year for such
purposes), or for research or development by IMI or any
Sublicensees.
In the event that a Licensed Product is sold, or a Licensed
Method is
performed, in any country in the form of a combination product
or service
containing or using, respectively, one or more articles,
devices, components or
methods that are not Licensed Products & Methods hereunder
(each, a "Non-Product
Component"), Net Sales of such combination product/service shall
be adjusted as
follows:
(1) First, actual Net Sales of such combination product/
service in such country for the applicable calendar quarter
calculated pursuant
to this Section 1.13 shall be multiplied by the fraction
A/(A+B), where A is the
average price in such country for such calendar quarter of the
Licensed Products
& Methods and B is the invoice price in such country for
such calendar quarter
of all Non-Product Components in such combination
product/service, provided that
all such Licensed Products & Methods and Non-Product
Components are
sold/performed separately in such country in such calendar
quarter.
(2) Second, if in a specific country over such calendar
quarter, such Non-Product Components in such combination
product/service are not
sold/performed separately in such country in such calendar
quarter, Net Sales
shall be calculated by multiplying actual Net Sales of such
combination
product/service calculated pursuant to this Section 1.13 by the
fraction A/C,
where A is the average price in such country for such calendar
quarter of such
Licensed Products & Methods and C is the average price in
such country for such
calendar quarter of such combination product/service.
(3) Third, if in a specific country over such calendar
quarter, such Licensed Products & Methods are not sold
/performed separately,
Net Sales shall be calculated by multiplying actual Net Sales of
such
combination product/service calculated pursuant to Section 1.13
by the fraction
(C-B)/C, where B is the average price in such country for such
calendar quarter
of all such Non-Product Components in such combination
product/service and C is
the average price in such country for such calendar quarter of
such combination
product/service
(4) Fourth, if, in a specific country over such calendar
quarter, both such Licensed Products & Methods and such
Non-Product Components
are not sold separately, a market price for such Licensed
Products & Methods and
all such Non-Product Components shall be negotiated by the
parties in good faith
based upon the costs, overhead and profit as are then incurred
for such
combination product/service, the apportionment of Net Sales as
provided in
clauses (1) to (3) above in other countries for such calendar
quarter if
available, and all other products, articles, devices, components
or methods then
being sold or performed by IMI and its Sublicensees and having
an ascertainable
market price.
1.14 "NS" means the Feinstein Institute for Medical Research,
formerly
known as North Shore Long Island Jewish Research Institute.
1.15 "NS License" means that certain Sponsored Research and
License
Agreement, effective as of January 1, 2003, by and between
Licensor and NS, as
amended by (i) that certain Amendment No. 1 dated June 1, 2006
and (ii) that
certain Amendment No. 2 dated January 8, 2007, and as may
further be amended,
restated, waived or changed as contemplated by Section
2.3(d).
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<PAGE>
EXCLUSIVE LICENSE AGREEMENT
1.16 "NS Licensed Patents" means all Patent Rights licensed as
of the
Effective Date or during the term of this Agreement to Licensor
under the NS
License, defined as of the Effective Date as the "North Shore
Patent Rights" in
the NS License, which Patent Rights in existence as of the
Effective Date that
contain Valid Claims that apply to the Field (in whole or in
part) are listed in
Exhibit B.
1.17 "NS Licensed Know-How" means all "North Shore Technology"
as
defined in the NS License.
1.18 "Patent Rights" mean (i) any patents and patent
applications, (ii)
any substitutions, divisionals, continuations,
continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations,
extensions,
supplementary protection certificates, term extensions (under
patent or other
law), certificates of invention and the like, of any patents or
patent
applications, and (iii) any foreign or international equivalents
of any of the
foregoing.
1.19 "Technology" means know-how, trade secrets, materials,
formulations, information, documents, studies, results, data
(including
pre-clinical, clinical and assay data), manufacturing processes
and data,
specifications, sourcing information, assays, and quality
control and testing
procedures, whether or not patented or patentable.
1.20 "Third Party" means any person or entity, other than IMI
or
Licensor or any of their Affiliates.
1.21 "Valid Claim" means a claim of (i) an issued and unexpired
patent,
which claim has not been revoked or held invalid or
unenforceable by a court or
other government agency of competent jurisdiction from which no
appeal can be or
has been taken and has not been held or admitted to be invalid
or unenforceable
through re-examination or disclaimer, reissue, opposition
procedure, nullity
suit or otherwise, or (ii) a pending patent application that was
filed in good
faith and has not been cancelled, withdrawn or abandoned without
the possibility
of appeal or refiling.
Section 2. License Grants by Licensor.
2.1 Exclusive License and Covenant Not to Sue. Licensor, for
itself and
on behalf of its Affiliates, hereby grants to IMI a
non-transferable (except in
accordance with Section 10.1), exclusive (even as to Licensor
and its
Affiliates, unless otherwise provided hereunder), worldwide
license or
sublicense (as the case may be), with the right to sublicense in
accordance with
Section 2.2, under the Licensed Patents and Licensed Know-How,
to practice and
otherwise exploit the same in the Field only, to make, have
made, use, sell,
offer to sell, and/or import Licensed Products & Methods. In
addition, Licensor,
for itself and on behalf of its Affiliates and licensees and
sublicensees,
hereby covenants not to sue, or cause or support any other
person or entity to
sue, IMI, any of its Affiliates or Sublicensees, or any of their
manufacturers,
suppliers, distributors or customers, for using Licensed
Know-How to develop and
commercialize products and services in the Field, which covenant
not to sue
shall apply to all activities occurring while the
license/sublicense granted in
the immediately previous sentence remains in force. For purposes
of this
Agreement, references to the "licenses granted above", "licenses
granted in
Section 2.1" and the like in this Agreement shall refer to both
the
license/sublicense and covenant not to sue contained in this
Section 2.1. For
clarity:
(a) with respect to the NS Licensed Patents and NS Licensed
Know-How, the licenses granted above shall grant all rights
available to
Licensor under the NS License, again only in the Field, and IMI
expressly
acknowledges that NS has retained rights under the NS License
for itself and
the US government and such retention of rights limits IMI's
rights under the
NS Licensed Patents and NS Licensed Know-How;
(b) the licenses granted above shall further cover Licensed
Products & Methods that act in the Field, as well as also
cause other
therapeutic effect(s) by acting outside of the Field (for
example, by
combining a pharmacological agent with a Licensed Product &
Method), provided
that the
4
<PAGE>
EXCLUSIVE LICENSE AGREEMENT
use or sale of the device, article, or pharmacological agent
responsible for
such other therapeutic effects, when sold or used alone without
the
applicable Licensed Product & Method, does not infringe any
Valid Claims of
the Licensed Patents outside of the Field (e.g., the
manufacture, use or sale
of such pharmacological agent alone does not infringe any such
Valid Claims);
and
(c) in all events, the licenses granted above shall not
apply to any pharmacological agents acting in the Excluded Field
that are
covered by any Valid Claims of the Licensed Patents or Licensed
Know-How,
whether or not used in combination with any Licensed Product
& Method,
provided that this exclusion in this clause (c) and the
foregoing clause (b)
shall not be understood to allow Licensor or any of its
Affiliates or
licensees or sublicensees to use any Licensed Product &
Method in the Field
in combination with any pharmacological agent acting in the
Excluded Field.
2.2 Sublicenses.
(a) The licenses granted in Section 2.1 include the right
to grant sublicenses (through multiple tiers) by IMI to its
Affiliates and
Third Parties (each such sublicensed Affiliate, a "Sublicensed
Affiliate",
each such Third Party sublicensee, a "Sublicensed Third Party",
and together
collectively the "Sublicensees"), provided that (i) any such
sublicense
agreement shall be subject to and subordinate to this Agreement,
(ii) IMI
shall remain responsible for the performance of its Sublicensees
hereunder,
and (iii) IMI shall have no right to sublicense unless and until
the payments
to Licensor set forth in Section 5.1 have been made in full.
(b) IMI shall provide to each of Licensor and NS timely
notification of each substantive negotiation to sublicense
rights hereunder
and shall thereafter keep each of Licensor and NS reasonably
informed as to
the substantive progress of such negotiations by providing each
of Licensor
and NS with significant drafts of term sheets, any final term
sheets and
drafts of any contracts or sublicense agreements prior to
execution thereof
so that each of Licensor and NS shall have any opportunity to
review the
same. All such information, drafts, term sheets, contracts and
agreements,
and the execution copies thereof referred to in Section 2.2(c),
shall be
treated as IMI's Confidential Information under the CDA.
(c) IMI shall provide to each of Licensor and NS an
unredacted execution copy of the sublicense agreement for its
Sublicensees
and any documents evidencing the consideration paid to IMI or
its Affiliates
within [**] business days of execution.
(d) Each sublicense granted to any Sublicensee hereunder
shall terminate immediately upon the termination of the licenses
granted in
Section 2.1, provided that any such sublicense shall not
terminate, on a
Sublicensee-by-Sublicensee basis, if, as of the effective date
of termination
of this Agreement pursuant to Section 9, (i) all outstanding
amounts owed
Licensor by IMI hereunder as of such date are paid in full
within [**] days
of such date (whether by IMI, its Affiliates or Sublicensees),
(ii) a
Sublicensee is not in material default of its obligations to IMI
under its
sublicense agreement, and (iii) within [**] days of such
termination the
Sublicensee agrees in writing to be bound directly to Licensor
under a
license agreement substantially similar to this Agreement with
respect to the
rights sublicensed to such Sublicensee hereunder, substituting
such
Sublicensee for IMI. Licensor and such Sublicensee shall
promptly memorialize
such direct license.
2.3 NS License and Other In-Licenses.
(a) NS License. During the term of this Agreement, IMI
hereby agrees to be responsible for those obligations of
Licensor under the
NS License that are set forth on Exhibit C attached hereto, and
to comply
with and otherwise satisfy those obligations as required by the
terms of the
NS License. Apart from those obligations, IMI and its Affiliates
shall not
assume any other obligations of Licensor under the NS License,
except and
only to the extent that IMI is a sublicensee of the rights
licensed to
Licensor thereunder.
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EXCLUSIVE LICENSE AGREEMENT
(b) Future Third Party Agreements.
(i) After the Effective Date, if (A) Licensor or any
of its Affiliates, in its sole discretion, determines to enter
into any
agreement with one or more Third Parties whereby IMI gains
rights in or
to any Patent Rights or Technology that would amount to
Licensed
Patents or Licensed Know-How, respectively, hereunder, and (B)
the
practice of such Patent Rights and Technology in the Field by
IMI or
any of its Sublicensees would give rise to royalties payable
by
Licensor or its applicable Affiliates, then such Patent Rights
and
Technology shall only be treated as "Controlled" and thus
Licensed
Patents and Licensed Know-How hereunder if and only if IMI
agrees by
amendment to this Agreement to reimburse Licensor and such
Affiliate
for the amount payable to such Third Party for activities by IMI
and
its Sublicensees.
(ii) Licensor shall notify IMI of any such Third
Party agreements, shall provide an unredacted copy of same to
IMI for
IMI to consider (subject to any applicable Third Party
confidentiality
requirements), and shall enter into any such amendment upon
IMI's
reasonable request.
(iii) For clarity, this Section 2.3(b) shall not
apply to the NS License or any NS Licensed Patents or NS
Licensed
Know-How, and further shall not apply to any Patent Rights
or
Technology owned in whole or in part by Licensor or any of
its
Affiliates (except to the extent Licensor or any of its
Affiliates are
required to account to any non-NS Third Party that jointly owns
such
Patent Rights or Technology for revenues generated from the
licensing
of such rights).
(c) Maintenance. Licensor shall take commercially
reasonable steps to maintain in full force and effect the NS
License and all
other Third-Party agreements whereby IMI gains rights hereunder
in or to any
of the Licensed Know-How or Licensed Patents, including subject
to and as
provided in Section 2.3(b) (collectively, "Third Party
In-Licenses").
Licensor shall provide IMI with prompt notice (and in any event
substantially
before the end of any applicable cure period under the
applicable Third Party
In-License) of any written claim of breach of any Third Party
In-License.
Subject to any applicable Third Party confidentiality
requirements (except
with respect to the NS License), Licensor shall provide IMI with
copies of
all notices and other documents Licensor receives or sends
pursuant to each
Third Party In-License that affects IMI's rights hereunder
(including any
termination notice).
(d) Amendment. Licensor shall not amend, restate, waive or
otherwise change any of the terms and conditions of the NS
License, nor shall
Licensor enter into any other agreement or understanding with
NS, that in
either case would have a material adverse impact on IMI's rights
under this
Agreement without the prior written consent of IMI.
(e) Bankruptcy. Licensor agrees that if any party to any
Third Party In-License seeks relief under any bankruptcy,
reorganization,
insolvency or similar laws, Licensor shall act in good faith to
take all
reasonably necessary action, at IMI's expense, to preserve the
rights granted
to IMI (via Licensor) hereunder (including seeking to preserve
Licensor's and
IMI's rights under any such laws, including under the US
Bankruptcy Code,
Title 11 of the U.S. Code). Should any Third Party In-License
terminate,
Licensor shall reasonably assist IMI, at IMI's expense, in
obtaining all
rights granted to IMI hereunder under such terminated agreement,
including by
having the licensor thereof treat IMI as a direct licensee
thereunder.
(f) Payments. Licensor shall be solely responsible for all
amounts owed to any Third Party arising from the NS License and
any other
Third Party In-License, except as provided in Section 2.3(a) for
the NS
License and subject to compliance with Section 2.3(b) as
applicable to any
such other Third Party In-License.
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EXCLUSIVE LICENSE AGREEMENT
(g) Proposed Letter Agreement with NS. Without limiting the
foregoing contained in this Section 2.3, with respect to the NS
License,
Licensor shall, at IMI's expense, assist IMI in its efforts to
negotiate and
execute a letter agreement with NS, and shall execute such
documents as IMI
may reasonably request amending the NS License, whereby, in the
event of
termination of the NS License, NS shall grant a direct license
to IMI in the
Field under the NS Licensed Know-How and NS Licensed Patents on
the same
terms as this Agreement with NS in place of Licensor hereunder,
provided that
IMI is then in good standing as a sublicensee under the NS
License.
2.4 Other Restrictions. Licensor shall not enter into any
agreement or
otherwise take any actions or omit to take any actions in
conflict with the
licenses granted in Section 2.1 and the other rights granted to
IMI hereunder.
2.5 License Limitations. No licenses or other rights are granted
by
Licensor hereunder to use any trademark, trade name, trade dress
or service mark
Controlled by Licensor or any of its Affiliates. All licenses
and other rights
are or shall be granted only as expressly provided in this
Agreement, and no
other licenses or other rights are or shall be created or
granted hereunder by
implication, estoppel or otherwise.
Section 3. Transfer of Licensed Know-How.
Within [**] days of the Effective Date, upon IMI's written
request
within [**] days of the Effective Date, Licensor shall provide
to IMI, at IMI's
expense, one (1) copy (in electronic form, if available) of all
documents in
Licensor's or its Affiliates' possession as of the Effective
Date to the extent
that such documents describe or contain Licensed Know-How, other
than NS
Licensed Know-How, which NS Licensed Know-How the Parties
acknowledge and agree
may be disclosed and provided by Dr. Kevin J. Tracey directly to
IMI and its
Sublicensed Affiliates instead of through Licensor, provided
that such NS
Licensed Know-How shall be treated as Confidential Information
of Licensor under
the CDA. Licensor shall provide and transfer to IMI all
additional Licensed
Know-How that may from time to time become available to
Licensor.
Section 4. Development and Commercialization.
4.1 Commercially Reasonable Efforts. IMI, or one of its
Sublicensees,
as applicable, shall use Commercially Reasonable Efforts to
develop and
commercialize at least one Licensed Product & Method prior
to [**], wherein
"Commercially Reasonable Efforts" means, with respect to
Licensed Products &
Methods, the carrying out of development and commercialization
activities in a
sustained manner using good faith commercially reasonable and
diligent efforts,
using the efforts and resources that a company within the
medical device
industry and similarly situated to IMI would reasonably devote
to a product of
similar market potential or profit potential resulting from its
own research
efforts, based on conditions then prevailing and taking into
account, without
limitation, issues of safety and efficacy, product profile, the
proprietary
position, the then current competitive environment for such
product and the
likely timing of such product's entry into the market, the
regulatory
environment and status of such product, and other relevant
scientific, technical
and commercial factors.
4.2 Responsibilities and Costs. As between the Parties:
(a) IMI and its Sublicensees shall have sole responsibility
for, and shall bear all their costs of conducting, all research,
development
and commercialization of Licensed Products & Methods
(including manufacturing
all materials required therefor);
(b) IMI and its Sublicensees shall own the results of all
such development and commercialization activities; and
(c) All regulatory filings and approvals for any Licensed
Products & Methods shall be obtained by, in the name of, and
solely owned by
IMI and its Sublicensees.
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EXCLUSIVE LICENSE AGREEMENT
Section 5. IMI Payments.
5.1 Initial License Fee.
(a) IMI shall pay to Licensor five hundred thousand US
dollars (US$500,000) in cash, which payment shall be due within
fifteen (15)
days of IMI or any of its Affiliates completing the First
Financing.
(b) In connection with the First Financing and at the same
time as shares of preferred stock of IMI are sold in the First
Financing (the
"Series A Preferred"), IMI shall issue to Licensor that number
of shares of a
series of preferred stock ("Junior Preferred") equal to the
number of shares
of Series A Preferred that could be purchased for $500,000 in
connection with
the First Financing, provided that prior to such issuance, upon
Licensor's
written instruction to IMI, IMI shall issue a portion of such
Junior
Preferred shares directly to NS. The Junior Preferred shares
shall have the
following rights:
(i) Dividend. Non-cumulative dividends shall be paid
on the Junior Preferred shares in an amount equal to eight
cents
(US$0.08) per share of Junior Preferred as, if and when declared
by the
board of directors of IMI.
(ii) Conversion. The Junior Preferred shares shall be
convertible into common stock of IMI by the holder at any time
at an
original conversion ratio of one share of such common stock per
share
of Junior Preferred, subject to anti-dilution protection as
provided
below.
(iii) Automatic Conversion. The Junior Preferred
shares shall automatically convert into common stock of IMI upon
the
closing of a firm underwritten public offering of common stock
with
proceeds of at least forty million US dollars (US$40,000,000) at
a
price per share of at least three US dollars (US$3.00) or, upon
the
conversion of all outstanding shares of Series A Preferred
shares.
(iv) Anti-dilution Protection. If IMI issues
additional shares (except for customary carve-outs such as
shares
issued under IMI equity plans and the like) at a purchase price
less
than the applicable conversion prices of the Series A Preferred
shares,
the Junior Preferred shares conversion prices shall be reduced,
based
on a broad-based weighted average formula (i.e., the total
number of
shares authorized for issuance under IMI equity plans are
included in
the numerator and the denominator of the adjustment
calculation), so
that in sum the Junior Preferred shall have essentially the
same
anti-dilution protection as the Series A Preferred.
(v) Liquidation Preference. In the event of a
Liquidation of IMI, the Series A Preferred shares shall receive,
in
preference to all other stockholders, an amount equal to the
number of
shares times the conversion price plus any declared but
unpaid
dividends. Next, the Junior Preferred shares shall receive
in
preference to all common stockholders an amount equal to the
number of
shares times the conversion price plus any declared but
unpaid
dividends (the "Liquidation Amount"). "Liquidation" means a
merger,
acquisition, consolidation, sale of the company, sale of
significant
assets of the company, or similar transaction.
(vi) Registration Rights. The Junior Preferred shall
receive from IMI piggyback (i.e., supplemental and not
demand)
registration rights equal to the piggyback rights held by
holders of
the Series A Preferred.
Licensor shall further agree in connection with receiving those
shares of Junior
Preferred (i) to have its shares of Junior Preferred treated for
all voting
purposes the same as the Series A Preferred, and (ii) to become
subject to the
following customary obligations contained in the applicable
financing agreements
on the same basis as the purchasers of Series A Preferred as a
whole: (1) voting
obligations related to the election of directors, (2) up to a
180 day lock-up in
connection with an initial public offering of IMI, and (3) a
drag-along right.
8
<PAGE>
EXCLUSIVE LICENSE AGREEMENT
5.2 Milestone Payment. IMI shall pay Licensor one million US
dollars
(US$1,000,000) upon IMI or any its Sublicensees first achieving
all regulatory
approvals from the United States Food and Drug Administration
(or any successor
agency thereto) or any foreign counterpart governmental agency
required for the
marketing and sale of any Licensed Product & Method in the
applicable country.
Such milestone payment shall be payable to Licensor within
thirty (30) days
after such achievement. Only one such milestone payment shall be
due under this
Agreement.
5.3 Royalties.
(a) Royalties from Net Sales of IMI and its Sublicensed
Affiliates. Subject to the terms and conditions of this
Agreement, IMI shall
pay to Licensor a flat royalty, of [**] percent ([**]%) based
upon worldwide
annual Net Sales made by IMI and its Sublicensed Affiliates (but
not
Sublicensed Third Parties) of any Licensed Products &
Methods sold or
performed in the Field while covered in the country of actual or
intended use
by a Valid Claim of the Licensed Patents.
(b) Sublicensed Third Party Payments. Subject to the terms
and conditions of this Agreement, IMI shall pay to Licensor [**]
percent
([**]%) of all sublicensing royalties, fees and payments
actually received by
IMI and its Affiliates from Sublicensed Third Parties in
consideration of
sublicenses granted under Section 2.2, excluding (i) the fair
market value of
any equity investments made in IMI and its Affiliates by
Sublicensed Third
Parties and their Affiliates, which fair market value shall be
determined
upon the written request of Licensor by a valuation firm
selected by IMI and
reasonably acceptable to Licensor (the cost of which firm shall
be shared
equally by IMI and Licensor, unless the valuation determined by
such firm is
more than [**]%) greater than the valuation proposed by IMI
before such firm
valuation, whereupon IMI shall pay such cost), with any premium
paid for such
equity investments over such fair market value subject to IMI's
[**]% payment
obligation above, (ii) payments by Sublicensed Third Parties and
their
Affiliates to pay or reimburse for out-of-pocket patent
prosecution,
maintenance, defense, enforcement and other related expenses of
IMI and its
Affiliates, (iii) payments by Sublicensed Third Parties and
their Affiliates
for full-time equivalents ("FTEs") of IMI and its Affiliates not
to exceed
more than [**] FTEs at a rate of [**] per FTE during the first
[**] years of
the applicable sublicense agreement, with any excess over such
FTE limits
subject to IMI's [**]% payment obligation above, and (iv)
payments by
Sublicensed Third Parties and their Affiliates for manufacturing
payments.
(c) Royalty Limitations. Royalties on sales and
performances of Licensed Products & Methods shall be payable
to or shared
with Licensor under Section 5.3(a) and Section 5.3(b) only for
those Licensed
Products & Methods that infringe a Valid Claim of the
Licensed Patents upon
sale or performance in the country of actual or intended use.
Only one
royalty shall be due with respect to the sale or performance of
the same unit
of Licensed Product & Method. Only one royalty shall be due
hereunder on the
sale or performance of any Licensed Product & Method, even
if the
manufacture, use, sale, offer for sale or importation of such
Licensed
Product & Method infringes more than one Valid Claim of the
Licensed Patents.
5.4 Minimum Royalties Payable.
(a) If and only if the amount payable by IMI to Licensor
for sales and performances of Licensed Products & Methods by
IMI and its
Sublicensees under Sections 5.3(a) and 5.3(b) is for any
calendar quarter
less than what Licensor owes to NS under the NS License
Agreement for those
same sales and performances (but not any other activities of
Licensor or any
other sublicensee under the NS License), IMI shall increase the
royalty
payment required by Section 5.5(b) to equal such amount owed NS
by Licensor.
Thereafter, in any subsequent royalty payment hereunder, IMI may
deduct from
the amount owed Licensor the amount required for such increase.
This Section
5.4(a) shall only apply while IMI has a sublicense to the NS
Licensed Patents
and NS Licensed Know-How from Licensor under the NS License.
9
<PAGE>
EXCLUSIVE LICENSE AGREEMENT
(b) Once IMI or any of its Sublicensees first sells or
performs any Licensed Product & Method that gives rise to
royalty payments
from Licensor to NS under the NS License Agreement, the Parties
shall meet
and agree on an appropriate means of monitoring payments owed NS
by Licensor
based on activities of IMI and its Sublicensees for each
calendar quarter and
upon any audit under Section 5.5(c) so as to comply with Section
5.4(a).
(c) All other payments, if any, required of Licensor or any
of its Affiliates for any Third Party In-Licenses other than the
NS License
shall be addressed by Section 2.3(b) and any amendment to this
Agreement.
5.5 Payment Terms.
(a) Manner of Payment. All payments to be made by IMI
hereunder shall be made in US dollars by wire transfer to such
bank account
as Licensor may designate.
(b) Reports and Royalty Payments.
(i) For as long as payments are due under Section
5.3(a) or 5.3(b), IMI shall furnish to Licensor a written
report,
within thirty (30) days after the end of each calendar quarter,
showing
the payments owed to Licensor for such calendar quarter.
Payments for
each calendar quarter shall be due at the same time as such
written
report for such calendar quarter.
(ii) The report shall include, at a minimum, the
following information for the applicable calendar quarter, each
listed
by Licensed Product & Method and by country of sale: (i) the
number of
units of Licensed Products & Methods sold and performed by
IMI and its
Sublicensed Affiliates on which royalties are owed Licensor
hereunder;
(ii) the gross amount received for such sales; (iii) deductions
taken
from Net Sales as specified in the definition thereof; (iv) Net
Sales;
(v) the gross amount of any payments received by IMI from
Sublicensed
Third Parties subject to sharing with Licensor under Section
5.3(b);
(vi) the royalties owed to Licensor under Section 5.3(a); (vii)
the
payments owed to Licensor under Section 5.3(b); (viii) the
computations
for any applicable currency conversions pursuant to Section
5.5(d); and
(ix) any other information expressly required by the terms of
this
Agreement. All such reports shall be treated as Confidential
Information of IMI.
(iii) IMI shall include terms in each sublicense
agreement it enters hereunder granting IMI permission from
each
Sublicensee to share with each of Licensor and NS the
information
listed in the numbered clauses of Section 5.5(b)(ii) as they
relate to
net sales of Licensed Products & Methods sold or performed
by such
Sublicensee.
(c) Records and Audits.
(i) IMI shall keep, and shall cause each of its
Sublicensees to keep, adequate books and records of accounting
for the
purpose of calculating all amounts payable to Licensor
hereunder. For
the [**] years next following the end of the calendar year to
which
each shall pertain, such books and records of accounting
(including
those of IMI's Sublicensees) shall be kept at each of their
principal
place of business and shall be open for inspection at
reasonab
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