Exhibit 10.10
LICENSE AGREEMENT
This License
Agreement (the "Agreement") is made and entered into as of August
1, 2003 (the "Effective Date"), by and between MultiCell
Technologies, Inc., ("MULTICELL") a corporation organized under the
laws of the State of Rhode Island, having a place of business at 55
Access Road, Suite 700, Warwick, RI 02886, and XenoTech, LLC,
("XENOTECH") a limited liability corporation organized under the
laws of the State of Kansas, having a place of business at 16825
West 116 th Street, Lenexa, KS 66219. MULTICELL and
XENOTECH are sometimes each hereinafter referred to as a "Party" or
collectively as "Parties" to this Agreement.
Whereas, MULTICELL is the owner of certain patent rights,
trade secrets, know-how, materials, formulae and technology
relating to immortalized human hepatic cells and cell lines,
collectively hereinafter defined as "MultiCell
Technologies";
Whereas, MULTICELL desires that the above MultiCell
Technologies be developed and utilized to the fullest extent
possible so that products and services resulting therefrom may be
available for use and sale to the public;
Whereas, XENOTECH wishes to obtain, and MULTICELL is willing
to grant, a license to practice inventions and utilize and sell
products and services included within the MultiCell Technologies,
subject to the terms set forth below.
Now, Therefore, in consideration of the above premises and
the mutual covenants contained herein, the parties hereby agree as
follows:
1
Definitions.
When used in this
Agreement, the following terms shall have the meanings set out in
this Article 1. Except as otherwise explicitly provided, all
references to Articles and Sections shall refer to the Articles and
Sections of this Agreement.
1.1 The term
"Affiliate" shall mean any entity which is in control, is
controlled by or is under common control with a Party, where
"control" means beneficial ownership of more than fifty percent
(50%) of the outstanding shares or securities or the ability
otherwise to elect a majority of the board of directors or other
managing authority.
1.2 The term "Cell
Lines" shall mean the regenerative "immortalized" human hepatic
cells and cell lines designated by MULTICELL as "Fa2N4" and
"Ea1C35" and any subclones or derivatives of Fa2N4 and Ea1C35, or
any immortalized human hepatic cells and cell lines replacements,
successors, or alternatives to Fa2N4 and Ea1C35 (hereinafter
sometimes referred to as "Cell Line Improvements"), which are owned
by and/or licensed to MULTICELL.
1.3 The term "Cell Line
Technology" shall mean the trade secrets, know-how, procedures
and formulae reasonably necessary to culture, maintain, propagate,
cryopreserve and ship the Cell Lines.
1.4 The term "MFE
Formula" shall mean the formula and formulation details
reasonably necessary to manufacture and store multifunction
enhancing medium (" MFE ").
1.5 The term "MultiCell
Technologies" shall mean the Cell Lines, Cell Line Technology,
MFE Formula, MFE, Patent Rights, Trade Secrets, Know-How and
Permitted Improvements owned by and/or licensed to
MULTICELL.
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1.6 The term "Patent
Rights" shall mean United States Patent No. 6,107,043, issued
August 22, 2000, any later filed patent applications relating to
the cell lines, cell line improvements and MFE, and all related
patent applications and patents (including any provisional,
utility, continuations, continuations-in-part, continuing
prosecution, divisions, extensions, renewals, reissues, revivals,
re-examinations and foreign counterparts thereof); and all claims
of patents and patent applications in any country covering
inventions in the XenoTech Field, the practice of which would be
dominated by claims contained in such Patent Rights, to the extent
owned or controlled by MULTICELL.
1.7 The term "Trade
Secrets" shall mean and be defined in accordance with the
definition of Trade Secret found under California law in effect at
the time of the execution of this Agreement, including California
Civil Code Section 3426.1 and application of the Uniform Trade
Secrets Act as adopted in the State of California and amended from
time to time. Without limiting this definition, and for information
purposes only, a Trade Secret is the whole or any portion of any
technical or non-technical information, including a formula,
pattern, compilation, program, device, method, technique, drawing,
process, financial data, financial plan, product plan or customer
or supplier information that is actually or potentially valuable
because it is not generally known to others and that is subject to
reasonable efforts by MULTICELL to maintain its secrecy.
1.8 The term
"Improvements" shall mean any improvements, modifications,
assays, new products or the like made or derived from the MultiCell
Technologies. " MultiCell Improvements " shall mean any
Improvements made by MULTICELL alone or with third parties, "
Joint Improvements " shall mean, subject to Section 4.1
herein, any Improvements made by MULTICELL and XENOTECH jointly,
wherein each Party has provided a clearly demonstrated and
substantial contribution to the Improvement(s), " XenoTech
Improvements " shall mean, subject to Section 4.1 herein, any
Improvements made by XENOTECH alone, and " Cell Line
Improvements " shall mean any immortalized human hepatic cells
and cell lines made by MULTICELL, and/or its third party
collaborators, that are replacements, successors or alternatives to
the Fa2NF or Ea1C35 cell lines. Any and all Improvements,
including, but not limited to, MultiCell Improvements, Joint
Improvements, XenoTech Improvements and Cell Line Improvements,
shall only be considered " Permitted Improvements " that are
subject to the terms of this Agreement if, and only if, the terms
of Section 4.1 herein are fully satisfied.
1.9 The term "XenoTech
Field" shall mean application of the MultiCell Technologies and
Permitted Improvements to propagate, sublicense and sell Cell Lines
and Cell Line Improvements and to manufacture and sell MFE for any
use, including, but not limited to, drug discovery, drug
development and toxicology (including ADME-Tox), but specifically
excluding all uses or applications within the "MultiCell
Field".
1.10 The term "MultiCell
Field" shall mean all uses and applications of the MultiCell
Technologies and Improvements for (a) immortalization of
mammalian cells, including immortalization in a targeted fashion
(b) isolation of stem cells from mammalian livers, (c)
transplantation of immortalized cells (including human hepatocytes)
or stem cells for therapy and treatment of human and animal
diseases, (d) creation of an engineered human liver cell line for
the Sybiol™ BioArtificial Liver Assist Device or any other
extracorporeal liver assist or other device, (e) utilization of
immortalized mammalian cells for the production of therapeutic,
diagnostic or research-related proteins, other cellular components
or drug-like molecules, including small molecule chemical entities,
or (f) the right to engineer, modify, derivatize, combine, develop
or otherwise improve the Cell Lines, MFE, Permitted Improvements or
other MultiCell Technologies. XENOTECH or its Affiliates cannot
engineer, modify, derivatize, combine, develop or otherwise improve
the Cell Lines, MFE, Permitted Improvements or other MultiCell
Technologies unless and until the terms of Section 4.1 herein have
been fully satisfied.
1.11 The term "Licensed
Product" shall mean the Cell Lines, Cell Line Improvements, MFE
and Permitted Improvements to the same.
1.12 The term "Licensed
Service" shall mean any service offered to a third party that
utilizes or employs Cell Lines, Cell Line Improvements, MFE or
Permitted Improvements to the same, or that directly or indirectly
relies upon MCT Technologies and/or their Permitted
Improvements.
1.13 The term "Asian
Pacific Rim" shall mean the countries of Japan, Taiwan, the
People's Republic of China, North Korea, South Korea, Vietnam,
Thailand, Singapore, Malaysia, Indonesia and the
Philippines.
1.14 The term "Net
Sales" shall mean gross income including, but not limited
to, any and all consideration, license fees, milestones, royalties
and the like, actually paid to and received by XENOTECH or its
Affiliates from Sales and sublicenses of Licensed Products
and Licensed Services to independent third parties,
less:
1.14.1 shipping, storage,
packing and insurance expenses, each as actually paid or
allowed;
1.14.2 distributor
discounts;
1.14.3 amounts repaid or
credited by reason of rejections, defects or returns or because of
retroactive price reductions; and
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1.14.4 sales and other excise
taxes, use taxes, tariffs, export license fees and duties actually
paid or allowed.
1.15 The term "Sale"
shall mean any transaction that transfers to a purchaser, for
value, physical possession and title to a Licensed Product, after
which transfer the seller has no right or power to determine the
purchaser's resale price, if any, or that provides to a purchaser,
for specified value, Licensed Services. Transfer of possession and
title to an Affiliate or sublicensee shall not constitute a Sale
unless the Affiliate or sublicensee is an end user of the Licensed
Product.
1.16 The term "Term"
shall have the meaning set forth in Section 9.1.
1.17 The term "
Territory " shall mean worldwide.
2. Grant of
Rights and Transfer of Materials.
2.1 Licensed Patent Rights
and Technology. Subject to the terms and conditions hereof,
including MULTICELL's retained rights pursuant to Section 2.2
herein, MULTICELL hereby grants to XENOTECH and its Affiliates
during the Term, as defined below, an exclusive license under the
MultiCell Technologies within the XENOTECH Field and Territory to
develop, have developed, make, have made, use, have used, import,
have imported, Sell, offer for Sale and have Sold Licensed Products
and Licensed Services. XENOTECH'S right and license includes, but
is not limited to, the exclusive right to propagate, sub-license
and sell the Cell Lines, and Cell Line Improvements, and to
manufacture and sell the MFE and their Permitted Improvements. For
purposes of clarity, XENOTECH'S right and license will be used both
within XENOTECH for its internal research and development and for
contract research performed by XENOTECH for third parties, and by
XENOTECH, its distributors and sales representatives in
distribution, sales and sublicenses to third parties.
2.2 MULTICELL Retained
Rights. MULTICELL maintains all rights in the MultiCell
Technologies and Improvements within the MULTICELL Field. In
addition, MULTICELL shall have the retained right to continue its
research and development efforts within the XENOTECH Field,
including collaborative efforts with third parties, subject to the
rights of XENOTECH, if any, as provided herein, however, MULTICELL
shall not directly or indirectly license or sell the Cell Lines,
Cell Line Improvements or MFE and their Permitted Improvements
within the XENOTECH Field.
2.3 XENOTECH Retained
Rights . XENOTECH represents that it currently has the
technology and know-how to immortalize mammalian cells, isolate
stem cells from mammalian livers, and transplant immortalized cells
(including human hepatocytes) or stem cells for therapy and
treatment of human and animal diseases that does not involve the
use of the Cell Lines or other MultiCell Technologies. Accordingly,
XENOTECH retains the right to work by itself or with third parties
engaged in research in the immortalization of mammalian cells,
isolation of stem cells from mammalian livers, and transplantation
of immortalized cells (including human hepatocytes) or stem cells
for therapy and treatment of human and animal diseases, provided,
however, that such work is not based on the Confidential
Information, Trade Secrets, Know-How, Patent Rights or other
MultiCell Technologies or Improvements.
2.4 Sublicenses.
XENOTECH shall have the right to grant sublicenses, provided, that
any sublicenses granted by XENOTECH shall provide that relevant
obligations to MULTICELL contained in this Agreement shall be
binding upon the sublicensees. In this regard, MULTICELL AND
XENOTECH shall, within twenty (20) days of the Effective Date,
jointly develop a Limited License Agreement, a Limited Use
Agreement or other agreements (the "Form Agreements") to be
utilized by XENOTECH for any sublicense or other transfer of the
Cell Lines, Cell Line Technology, MFE, Permitted Improvements or
other MultiCell Technologies. XENOTECH shall utilize the Form
Agreements and provide MULTICELL with a true and accurate copy of
any and all executed Form Agreements from all clients and/or third
parties sublicensing, buying or obtaining access to the Cell Lines,
Cell Line Technology, MFE, Permitted Improvements or other
MultiCell Technologies, and any modification or termination
thereof, within thirty (30) days after execution, modification, or
termination. Any material variance from these Form Agreements must
be approved by MULTICELL prior to execution, which approval will
not be unreasonably withheld, conditioned or delayed. Any
sub-distributors, sales agents or the like employed by XENOTECH,
its Affiliates or sublicensees shall be bound by the same
conditions contained in this Agreement. Any sublicenses (or other
Form Agreements) shall survive termination of XENOTECH'S license
subject to such sublicensee's or other third party's agreement to
be bound directly to MULTICELL under the terms of such sublicense
or other Form Agreement.
2.5 Within fifteen (15) days
from the Effective Date, the Parties shall complete the transaction
associated with this Agreement (the "Closing"). Thereafter,
MULTICELL shall:
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2.5.1 Within five (5) days
from the Closing, provide for the transfer of reasonably sufficient
quantities of the Cell Lines to up to two locations acceptable to
XENOTECH, of which one is XenoTech's main offices in Lenexa,
Kansas. Within ten (10) business days after said transfer, XENOTECH
shall verify that the functional status (e.g., viability,
attachability and inducibility) of the Cell Lines after such
relocation is intact (the "Relocation"). The reasonable costs of
the Relocation shall be borne by XENOTECH.
2.5.2 Within thirty (30) days
from the Closing, conduct training utilizing the Cell Line
Technology for the benefit of XENOTECH. Such training shall be made
to the reasonable satisfaction of XENOTECH and at a reasonable
location within the United States chosen by XENOTECH (the "Cell
Line Training"). The reasonable costs associated with the Cell Line
Training shall be borne by XENOTECH.
2.5.3 At the Closing, deliver
to XENOTECH the MFE Formula. Within thirty (30) days after the
Closing, MULTICELL will assist in the training of two XENOTECH
scientists in the technology, know-how and procedures to prepare
the MFE, as reasonably necessary and as reasonably requested by
XENOTECH (the "MFE Training"). The reasonable costs of the MFE
Training shall be borne by XENOTECH.
2.5.4 At the Closing, deliver
into escrow a written "how to" manual describing the human hepatic
cell immortalization and selection procedures used to produce the
Cell Lines (the "Immortalization Technology Guide"). The escrow
agent will be MULTICELL'S outside legal counsel, and the Guide will
only be released from escrow and provided to XENOTECH if conditions
for the release provided in Section 14.6 herein are fully
satisfied.
3.
Payments.
3.1 License Fees.
XENOTECH has made, and will make, the following license fee
payments to MULTICELL in the following manner:
3.1.1 At the signing of the
existing Letter of Intent between XENOTECH and MULTICELL on July 8,
2003, XENOTECH paid MULTICELL the sum of fifty thousand dollars
($50,000), as a portion of the "Prepaid Royalties", for an
exclusive worldwide license during the Term (unless earlier
terminated along with license to Cell Lines as provided herein) in
the MFE Formula;
3.1.2 At the Closing, XENOTECH
shall pay to MULTICELL the sum of one hundred fifty thousand
dollars ($150,000) (the "Closing Payment"), said Closing Payment
being a portion of the "Prepaid Royalties" and place a
non-refundable eight hundred thousand dollar ($800,000) payment
(the "Relocation Payment") into a mutually agreeable escrow
account;
3.1.3 Within three (3)
business days after the Relocation, XENOTECH shall instruct the
escrow agent to release to MULTICELL the non-refundable Relocation
Payment from escrow. Once released, the Relocation Payment shall be
consideration for, and a guarantee of, Nosan's right of first
negotiation for distribution rights for the Asian Pacific Rim as
provided in Section 12.3 herein; and
3.1.4 Within ten (10) days
after the Cell Line Training, XENOTECH shall pay MULTICELL the sum
of five hundred thousand dollars ($500,000) (the "Training
Payment"). Once paid, the Training Payment shall be considered a
portion of the "Prepaid Royalties".
3.2 Running Royalty
Payments . XENOTECH shall pay MULTICELL (in accordance with
Article 7 herein) ongoing royalty payments (hereinafter "Running
Royalties") throughout the Term on Net Sales of Licensed Products
and Licensed Services Sold by XENOTECH or its Affiliates, and on
sublicenses and other agreements with third parties, as
follows:
3.2.1 thirty four percent
(34%) of Net Sales for use and/or propagation sublicenses of Cell
Lines or Cell Line Improvements to clients or third parties of
XENOTECH;
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3.2.2 seventeen and one-half
percent (17.5%) of Net Sales of Cell Lines or Cell Line
Improvements to third parties;
3.2.3 two and one-half percent
(2.5%) of Net Sales of in-house studies, using Cell Lines or Cell
Line Improvements, for the benefit of XENOTECH'S clients and/or
third parties;
3.2.4 ten percent (10%) of Net
Sales of MFE media, and Permitted Improvements to the MFE, to third
parties;
3.2.5 ten percent (10%) of Net
Sales of in-house studies, using Cell Lines or Cell Line
Improvements in studies of a type not currently performed by
XENOTECH and which type of study is enabled because of the Cell
Lines and/or Cell Line Improvements; and
3.2.6 fifteen percent (15%) of
Net Sales for any other sale, sublicense, transfer or other
permitted use of the MULTICELL Technology and Permitted
Improvements, other than as provided in paragraph 3.2.1 through
3.2.5 herein.
Running Royalty
payments will be made within forty-five (45) calendar days of the
close of each calendar quarter.
3.3 Running Royalty Credits .
The actual amount paid pursuant to Section 3.2 above, shall be
determined by the total Running Royalties for a given quarter, less
a credit from the Prepaid Royalties, until such credit is
exhausted, as follows. The maximum credit that XENOTECH shall be
entitled to offset against Running Royalties is $700,000 from the
Prepaid Royalties ("Maximum Credit"). The Relocation Payment is
nonrefundable and non-creditable without offset of any kind
. When Running Royalties are due from XENOTECH to MULTICELL,
XENOTECH will pay twenty five percent (25%) of the amount due in
said quarter in cash to MULTICELL and can offset the remaining
seventy five percent (75%) due MULTICELL against the Maximum
Credit. XENOTECH can continue to utilize the remaining portion of
the Maximum Credit in subsequent quarters, continuing at the rate
of seventy five percent (75%) of the amount due, until it is fully
exhausted. Thereafter, XENOTECH shall pay the full amount (100%) of
the Running Royalties in each quarter in cash without any further
credits or offsets due or applicable from License Fees paid
pursuant to Section 3.1.
3.4
Running Royalty Adjustments .
The Running Royalty rates of 3.2.1 to 3.2.6 provided above shall be
adjusted in the following situations: (i) for Permitted Joint
Improvements, the Running Royalty rates payable by XENOTECH shall
be reduced to seventy five percent (75%) of the rates shown therein
and (ii) for permitted XENOTECH Improvements, the Running Royalty
rates payable by XENOTECH shall be reduced to fifty percent (50%)
of the rates shown therein.
3.5 Guaranteed Minimum
Running Royalties . In order for XENOTECH to maintain its
exclusive license and right under this Agreement, XENOTECH shall
pay to MULTICELL guaranteed minimum Running Royalties ("Minimum
Running Royalties"), inclusive of any credits from the Maximum
Credit, as follows:
|
Time
Period
|
Minimum
|
|
First 16 months from the
Effective Date:
|
$ 800,000
|
|
Months 17 through 28 from the
Effective Date:
|
$ 2,100,000
|
|
Months 29 through 40 from the
Effective Date:
|
$ 2,600,000
|
|
Months 41 through 52 from the
Effective Date:
|
$ 3,000,000
|
|
Months 53 through 64 from the
Effective Date:
|
$ 3,300,000
|
|
Months 65 through 76 from the
Effective Date:
|
$ 3,630,000
|
|
Months 77 through 84 from the
Effective Date:
|
$ 2,662,000
|
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If, in any Time
Period listed above, the actual Running Royalties exceed the noted
Minimum Running Royalties for that Time Period, then XENOTECH shall
be entitled to credit that excess amount towards any shortfall in
next Time Period, but only to the extent that the actual Running
Royalties payable in said next Time Period fall short of the
guaranteed Minimum Running Royalties for that Time
Period.
In
the event that XENOTECH fails to meet the guaranteed Minimum
Running Royalties for any Time Period, then MULTICELL shall be
entitled to credit the shortfall against the remaining Maximum
Credits due XENOTECH, if any, provided, however, such credits shall
not exceed the Maximum Credit.
In
the event that XENOTECH fails to pay or have credited (against the
Maximum Credit) at least twenty five percent (25%) of the Minimum
Running Royalties for any Time Period provided above, then
MULTICELL shall have sixty (60) days, at its option, to notify
XENOTECH that any and all of XENOTECH'S license and rights under
this Agreement are terminated in accordance with Article 9 herein.
Upon said termination, XENOTECH shall, within thirty (30) days,
return all MultiCell Technologies, information, assets and other
materials to MULTICELL, including any and all Improvements, to sell
any remaining inventory, subject to the payment obligations to
MULTICELL noted herein, to cease any all further sales of Cell
Lines, Cell Line Improvements, MFE or its Permitted Improvements,
and to execute all instruments reasonably necessary, if any, to
re-vest said license and rights solely in MULTICELL. XENOTECH shall
have the right to complete its current contracts with existing
clients, subject to the payment obligations to MULTICELL noted
herein.
In
the event that XENOTECH fails to pay or have credited less than one
hundred percent (100%) but greater than twenty five percent (25%)
of the Minimum Running Royalties for any Time Period provided
above, then XENOTECH shall have the right to either increase its
royalty payments to MULTICELL or lose its exclusive license
hereunder. In addition, MULTICELL shall have sixty (60) days, at
its option, to notify XENOTECH that XENOTECH must, by the end of
the next Time Period, pay the Minimum Running Royalties for said
Time Period plus the shortfall (the "Shortfall Payment") from the
prior Time Period in order to maintain XENOTECH'S license
hereunder. Should XENOTECH fail to make the Shortfall Payment, then
MULTICELL shall have thirty (30) days, at its option, to notify
XENOTECH that any and all of XENOTECH'S license and rights
hereunder are terminated, provided, however, that XENOTECH shall
have 90 days to cure said breach as provided in Section 9.2
herein.
4.
Representations and Disclaimers.
4.1 XENOTECH
Representations . XENOTECH hereby represents, warrants and
agrees that it:
4.1.1 shall not reverse
engineer, modify, improve, derivatize or subclone the Cell Lines or
Cell Line Improvements or reverse engineer, modify or improve the
MFE or its Improvements without requesting permission from
MULTICELL in writing and obtaining the written approval of
MULTICELL;
4.1.2 shall not develop any
Joint Improvements or XENOTECH Improvements using the Cell Lines,
Cell Line Improvements or other MultiCell Technologies without
informing MULTICELL and obtaining prior written approval of
MULTICELL;
4.1.3 shall not use, sell, or
sublicense the Cell Lines or Cell Line Improvements for the
production of proteins, other cellular constituents or drug-like
molecules;
4.1.4 shall not use, sell, or
sublicense the Cell Lines or Cell Line Improvements for the
development of a device, such as an artificial liver or other liver
support devices, for the treatment of any human
diseases;
4.1.5 shall not use, sell, or
sublicense the Cell Lines or Cell Line Improvements for the purpose
of infecting and propagating viruses, including, but not limited
to, hepatitis B or C viruses;
4.1.6 shall not use, sell, or
sublicense the Cell Lines or Cell Line Improvements for the purpose
of transplanting the cells into animals, including
humans;
4.1.7 shall not sell,
sublicense or transfer the Cell Lines or Cell Line Improvements to
any and all companies, institutions, or the like that do not sign
one or more of the Form Agreements acceptable to XENOTECH and
MULTICELL;
4.1.8 shall not grant a
sublicense to a client or third party of more than (1) one year
without MULTICELL'S prior written permission, which shall not be
unreasonably withheld, conditioned or delayed;
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4.1.9 shall make a good faith
effort to promote the worldwide use and licensing of the Cell Lines
and Cell Line Improvements in a manner consistent with its other
sales and marketing efforts, but in any case no less than a
commercially reasonable effort;
4.1.10 is a limited liability
c