Confidential Treatment Confidential treatment has been requested for portions of this document marked with asterisks.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
EXHIBIT
10.11
Monoclonal
Antibody
This
AGREEMENT
FOR THE PURCHASE AND SALE OF MONOCLONAL ANTIBODIES
(the
“Agreement”),
dated
and effective as of December 26, 2006 (the “Effective Date”) is by and between
INTELLECT
NEUROSCIENCES, INC.,
a
Delaware corporation with offices at 0 Xxxx 00xx
Xxxxxx,
Xxx Xxxx, XX 00000, XXX (“Intellect”),
and
IMMUNO-BIOLOGICAL
LABORATORIES CO., LTD.,
a
Japanese corporation with offices at 0-0 Xxxxxxxx, Xxxxxxxx-xxx, Xxxxx 000-0000,
Xxxxx (“IBL”).
Intellect and IBL shall each be a “Party”
and
together the “Parties”.
WHEREAS,
IBL
provides various medicines and in-vitro diagnostic products used to promote
the
fight against disease and to assist human welfare and is engaged in the business
of selling antibodies for both biomedical research and diagnostic use;
WHEREAS,
Intellect is engaged in research to produce therapeutic monoclonal antibodies
for the prevention and treatment of Alzheimer’s disease; and
WHEREAS,
Intellect desires to obtain certain monoclonal antibodies and related materials
from IBL and IBL desires to sell such antibodies and related materials to
Intellect;
NOW,
THEREFORE,
in
consideration of the mutual promises and agreements contained herein, and for
other good and valuable consideration, the receipt and sufficiency of which
are
hereby acknowledged, the Parties agree as follows:
ARTICLE
1: DEFINED TERMS
1.1
“Accounting
Standards” shall mean United States Generally Accepted Accounting Principles
(“US GAAP”).
1.2
“Affiliate”
shall mean, with respect to any Person, any other Person which directly or
indirectly controls, is controlled by or is under common control with such
Person. A Person shall be deemed to control another Person if such Person
possesses the power to direct or cause the direction of the management, business
and policies of such Person, whether through the ownership of fifty percent
(50%) or more of the voting securities of such Person, voting capacity at
management meetings, by contract or otherwise.
1.3
“Antibodies”
shall have the meaning set out in Article 2.
1.4
“Approval”
shall mean any approval (including Price Approvals), registration, license
or
authorization from any Governmental Authority required for the manufacture,
Development, Commercialization, distribution, sale, storage or transport of
the
Product in any country of the Territory, and shall include, without limitation,
an approval, registration, license or authorization granted in connection with
any Approval Application.
1.5
“Approval
Application” shall mean the submission to the relevant Governmental Authority of
an appropriate application seeking any approval (including Price Approval),
registration, license or authorization from any Governmental Authority required
for the manufacture, development, commercialization, distribution, sale, storage
or transport of the Product in any country of the Territory, and shall include,
without limitation, a marketing authorization application, supplementary
application or variation thereof, NDA, or any equivalent applications in any
country of the Territory.
1.6
“Business
Day” shall mean a day which is not a Saturday, Sunday or public holiday in
Japan, Israel or New York.
1.7 “Commercially
Reasonable Efforts” shall mean the efforts and resources customarily used in the
pharmaceutical industry for a compound which is of similar market potential
and
at a similar stage in its product life.
1.8 “Confidential
Information” shall have the meaning set out in Article 12
1.9 “Control”
in the context of intellectual property, shall mean possession of the ability
to
grant the license or other access provided for herein without violating the
terms of any agreement or other arrangement with a Third Party.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
1.10 “Effective
Date” shall mean the earliest date on which this Agreement has been executed by
both Parties.
1.11 “EMEA”
shall mean the European Agency for the Evaluation of Medicines or any successor
agency thereto.
1.12 “EU”
shall mean the then current member states of the European Union.
1.13 “FDA”
shall mean the United States Food and Drug Administration and any successor
agency thereto.
1.14 “Final
Approval” shall mean, (i) in relation to the United States, receipt by Intellect
or Intellect Licensee of the official approval letter from the FDA approving
the
marketing and sale of the Product in the United States under an NDA or
supplemental NDA, as applicable, or (ii) in relation to the EU, receipt by
Intellect or Intellect Licensee of the EMEA’s or relevant national regulatory
authority’s written decision granting marketing authorization for the Product in
one or more countries in the EU, or (iii) in relation to any other countries
in
the Territory, receipt of an equivalent approval to distribute, market and
sell
the Product in such country(ies) by Intellect or Intellect Licensee.
1.15 “Governmental
Authority” shall mean any court, agency, authority, department, regulatory body
or other instrumentality of any government or country or of any national,
federal, state, provincial, regional, county, city or other political
subdivision of any such government or any supranational organization of which
any such country is a member.
1.16
“IBL
Know-How” shall mean, to the extent Controlled by IBL on the Effective Date or
during the Term, Know-How that is necessary for the manufacture, use,
Development, sale, offer for sale or importation of the Product, including,
without limitation, Inventions owned solely by IBL or jointly by IBL and a
Third
Party and all Know-How Controlled by IBL in relation to the
Antibodies.
1.17
“IBL
Patents and Corresponding Applications” shall mean, to the extent Controlled by
IBL as of the Effective Date or during the term of this Agreement, all Patent
Rights and patent applications that claim the manufacture, use, development,
sale, offer for sale or import of Product, and all divisional, continuations,
continuations-in-part, reissues, extensions, reexaminations, extensions and
renewals of such patents in all foreign jurisdictions, including, without
limitation, Inventions owned solely by IBL or jointly by IBL and a Third Party
with respect to the “82E1
Antibody”
and the
“1A10
Antibody”,
each
as defined in Article 2 hereof, and all of which are listed on Schedule
3
attached
hereto.
1.18
“IBL
Technology” shall mean the IBL Patents and Corresponding Applications and IBL
Know-How.
1.19
“Intellect
Patents and Corresponding Applications” shall mean, Japanese patent (No 0000000,
granted 06/16, 0000), Xxxxxxxxx (Patent No. 743827, granted 5/23/02), China
(Patent No. 1177616, granted 12/1/04) New Zealand (Patent No. 337765, granted
1/10/02 and all divisional, continuations, continuations-in-part, reissues,
extensions, reexaminations and renewals and extensions of such patents, US
application no 09/402,820 and all divisional, continuations,
continuations-in-part, reissues, extensions, reexaminations, extensions and
renewals of such patents in all foreign jurisdictions.
1.20 “Invention”
shall mean any invention, whether or not patentable, or other Know-How,
conceived in the course and as part of the development together with all Patent
Rights and other intellectual property rights therein.
1.21 “Know-How”
shall mean any and all proprietary unpatented technical information, data,
ideas, test results, inventions, instructions, processes, knowledge, techniques,
discoveries, formulae, specifications, designs, regulatory filings, and
biological or other materials (including, without limitation, biological,
chemical, toxicological, physical and analytical, safety, manufacturing and
quality control data and information) and other information (whether or not
patentable) which are now or hereafter during the Term of this Agreement are
owned, licensed (with the right to sublicense) or otherwise held by a Party
or
its Affiliates related to the Antibodies, or the development, manufacture,
use,
or sale thereof.
1.22 “Laws”
shall mean all laws, statutes, rules, regulations, orders, judgments,
injunctions and/or ordinances of any Governmental Authority in the
Territory.
1.23 “Loss”
or
“Losses” shall mean all losses, obligations, liabilities, penalties and damages
(including but not limited to compensatory damages), settlements, costs and
expenses, including, without limitation, reasonable attorneys’ fees, of whatever
kind or nature, in each case incurred by a party or an Affiliate and paid to
a
Third Party, before and without giving effect to any insurance
proceeds.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
1.24 “Major
Market Country” shall mean each of Japan, China, France, Germany, Italy, Spain,
the United Kingdom and the United States.
1.25 “Management
Change of Control” shall mean any of the following events: (i) the acquisition
by a Third Party (other than a Third Party controlling a Party as of the
Effective Date) of more than fifty percent (50%) of the shares of such Party’s
capital stock, the holders of which have general voting power under ordinary
circumstances to elect at least a majority of such Party’s board of directors
(the “Voting Stock”), but excluding any such acquisition that is a bona fide
equity financing of such Party with arm’s-length financial investors where such
an investor is not within the top 20 globally ranked pharmaceutical companies
(as ranked by annual sales); (ii) the approval by a Party’s stockholders of a
merger, share exchange, reorganization, consolidation or similar transaction
of
IBL or Intellect (a “Transaction”), other than a Transaction which would result
in the Voting Stock of IBL or Intellect outstanding immediately prior thereto
continuing to represent (either by remaining outstanding or by being converted
into voting securities of the surviving entity) more than fifty percent (50%)
of
the Voting Stock of IBL or Intellect or such surviving entity immediately after
such Transaction; or (iii) approval by a Party’s stockholders of a complete
liquidation of such Party or a sale or disposition of all or substantially
all
of the assets of such Party.
1.26 “NDA”
shall mean a new drug application and all amendments and supplements thereto
filed with the EMEA, the FDA or an equivalent Governmental Authority, requiring
such filing, and including all documents, data and other information concerning
a pharmaceutical product which is necessary for the gaining of Approval seeking
permission to market and sell the applicable Product in a country.
1.27 “Net
Sales” with respect to any Product shall mean the gross amount invoiced by or on
behalf of Intellect and any Intellect Affiliate, licensee or sublicensee
(“Intellect
Licensee”)
for
that Product sold to Third Party customers, less the following deductions,
determined in accordance with Intellect’s or Intellect Licensee’s standard
accounting methods as generally and consistently applied by Intellect or
Intellect Licensee, to the extent included in the gross invoiced sales price
of
any Product or otherwise directly paid or incurred by Intellect or Intellect
Licensee (or affiliates) with respect to the sale of such Product:
|
(a)
|
normal
and customary trade and quantity discounts actually allowed and properly
taken directly with respect to sales of the
Product;
|
|
|
(b)
|
amounts
repaid or credited by reasons of defects, rejection, recalls, returns,
rebates and allowances of goods or because of retroactive price reductions
specifically identifiable to the
Product;
|
|
(c)
|
charge
backs and other amounts paid on sale or dispensing of such
Product;
|
|
(d)
|
amounts
payable resulting from Governmental (or agency thereof) mandated
rebate
programs;
|
| (e) |
Third-Party
cash rebates and chargeback related to sales of the finished Product,
to
the extent actually allowed;
|
|
(f)
|
tariffs,
duties, excise, sales, value-added and other taxes (other than taxes
based
on income);
|
| (g) |
retroactive
price reductions that are actually allowed or
granted;
|
|
(h)
|
cash
discounts for timely payment;
|
| (i) |
delayed
ship order credits;
|
|
(j)
|
discounts
pursuant to indigent patient programs and patient discount
programs;
|
|
(k)
|
all
freight, postage and insurance included in the invoice price;
and
|
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
|
(l)
|
amounts
repaid or credited for uncollectible amounts on previously sold
Products.
|
Any
of
the items set forth above that would otherwise be deducted from the invoice
price in the calculation of Net Sales but which are separately charged to Third
Parties shall not be deducted from the invoice price in the calculation of
Net
Sales.
Sales
from Intellect to its Affiliates or from an Intellect Licensee to its Affiliates
shall be disregarded for purposes of calculating Net Sales. In the case of
any
sale or other disposal of a Product between or among Intellect and its
Affiliates, or between or among an Intellect Licensee and its Affiliates, for
resale, Net Sales shall be calculated as above only on the value charged or
invoiced on the first arm’s-length sale thereafter to a Third
Party.
In
the
case of any sale which is not invoiced or is delivered before invoice, Net
Sales
shall be calculated at the time of shipment or when the Product is paid for,
if
paid for before shipment or invoice.
In
the
case of any sale or other disposal for value, such as barter or counter-trade,
of any Product, or part thereof, other than in an arm’s length transaction
exclusively for money, Net Sales shall be calculated as above on the value
of
the non-cash consideration received or the fair market price (if higher) of
the
Product in the country of sale or disposal.
1.28 “Patent
Rights” shall mean (a) United States patents and patents of other countries,
including, without limitation, re-examinations, reissues, renewals, extensions,
term restorations, confirmations, registrations, re-validations, patents of
addition, supplementary protection certificates and the like, and (b) pending
applications for United States patents and patents of other countries,
including, without limitation, provisional applications, continuations,
continuations-in-part, divisional and substitute applications, including,
without limitation, inventors’ certificates.
1.29 “Person”
shall mean any individual, partnership, joint venture, limited liability
company, corporation, firm, trust, association, unincorporated organization,
governmental authority or agency, or any other entity not specifically listed
herein.
1.30 “Phase
I”
means any study conducted in any country to determine, among other things,
safety of a Product in a target patient population.
1.31 “Phase
II” means any study conducted in any country to determine, among other things,
dose response, duration of effect, preliminary efficacy and safety of a Product
in a target patient population.
1.32 “Phase
III” means any study conducted in any country to confirm, with statistical
significance, the efficacy and safety of a Product in a large, targeted
population, performed to obtain Regulatory Approval of such
Product.
1.33 “Price
Approval” shall mean, in countries in the Territory where Governmental
Authorities may approve or determine pricing or pricing reimbursement for
pharmaceutical products, such approval or determination.
1.34
“Pre-clinical study” shall mean any study conducted in any country to determine,
among other things, safety of a Product in animals for the purpose of
NDA.
1.35 “Product”
shall mean a pharmaceutical product, utilizing a free end specific antibody
drug
product to position 1 or 40 of A Beta that is made with the
Antibodies.
1.36
“Regulatory
Approval” in the United States shall mean Final Approval of a new drug
application pursuant to United States code as published at 21 CFR ss. 314,
permitting marketing of the applicable Product in interstate commerce in the
United States; in the European Union shall mean Final Approval of the marketing
authorization application pursuant to Council Directive 75/319/EEC, as amended,
or Council Regulation 2309/93/EEC or such approval as granted by a relevant
national Regulatory Authority, as amended; or with respect to any other country
not included in the foregoing, all authorizations by the appropriate
Governmental Authority necessary for the commercial sale of a Product in that
country including, without limitation and where applicable, approval of
labeling, price, reimbursement and manufacturing.
1.37 “Regulatory
Authority” shall mean the FDA, EMEA or any other counterpart or additional
governmental or regulatory agencies responsible for applicable Regulatory
Approvals.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
1.38
“Term” shall have the meaning set out in Article 9.
1.39 “Territory”
shall mean all the countries in the world.
1.40 “Third
Party” shall mean any Person other than Intellect or IBL or any Affiliate of
either Party.
ARTICLE
2: Sale and Purchase of Monoclonal Antibodies
| 2.1 |
(a)
As of the Effective Date, IBL hereby sells to Intellect and Intellect
purchases, the humanized monoclonal
|
antibody
referred to as 82E1, all cells or cell lines that secrete such antibody,
the cDNA sequence of the antibody, the cDNA sequence of the murine hybridoma
antibody from which the 82E1 humanized antibody is derived and any IBL Patents
and Corresponding Applications and Know How related to the antibody, the cell
lines and the method of making the antibody and cloning the cell lines (the
“82E1 Antibody”) all as set forth on Schedule
1 attached hereto.
(b)
As of
the Effective Date, IBL hereby sells to Intellect and Intellect purchases the
IBL murine monoclonal antibody referred to as 1A10, the cDNA sequence of the
antibody from which the 1A10 murine antibody is derived and any IBL Patents
and
Corresponding Applications and Know How related to the antibody, the cell lines
and the method of making the antibody and cloning the cell lines (the
“1A10
Antibody”)
all as
set forth on Schedule
2
attached
hereto. (The 82E1
Antibody
and the
1A10
Antibody
are
hereinafter referred to as the “Antibodies”.)
(c)
Except as set forth in this Agreement, IBL retains no rights with respect to
the
Antibodies, the cells or cell lines that secrete such antibodies, the cDNA
sequence of the antibodies, the cDNA sequence of the murine hybridoma antibodies
from which the antibodies are derived and any IBL Patents and Corresponding
Applications and Know How related to the Antibodies.
2.3 In
consideration of the sale and purchase of the Antibodies, Intellect agrees
to
pay a total of US $2,125,000 to IBL upon the achievement of certain milestones
plus royalties ***, as described below in Article 4.
2.4
Intellect
hereby grants IBL a worldwide, exclusive, paid up license under the Intellect
Patents and Corresponding Applications to make, use and sell murine monoclonal
antibodies that are free end specific for the amino-terminus of beta amyloid
peptides at position 1 and also for the C-terminus at position 40 solely for
diagnostic and/or laboratory research purposes. The license granted herein
shall
automatically terminate if IBL sells or transfers the Antibodies to any Third
Party for any purpose other than diagnostic and/or laboratory research purposes.
Intellect expressly reserves for itself the right to make, have made, import,
transfer, purchase and use the Antibodies for the purpose of research and/or
development of a Product without payment or accounting to IBL.
2.5 IBL
shall
deliver the Antibodies to the location(s) specified by Intellect at the expense
of Intellect.
2.6 Intellect
shall return the Antibodies, cell lines, cDNA sequences, Patents and
Corresponding Applications transferred to Intellect by IBL in the event that
Intellect has not initiated the pre-clinical study with a free end specific
antibody drug product to position 1 or 40 of A Beta that is made with the
Antibodies, within three (3) years after the Effective Date.
ARTICLE
3: Development and Manufacture
3.1 Intellect
shall be solely responsible for all development of the Antibodies, including
all
pre-clinical and clinical development activities. Intellect (and its Affiliates
where appropriate) shall retain authority and responsibility for ensuring and
maintaining compliance with applicable Laws. IBL and its Affiliates shall
co-operate and provide to Intellect any assistance reasonably required by
Intellect for the purposes of obtaining Regulatory Approvals for the Antibodies
without further compensation, but with the understanding that reasonable
expenses incurred by IBL and as are previously agreed to in writing by IBL
and
Intellect in connection therewith will be reimbursed by Intellect. IBL will
make
fully available to Intellect such of the IBL Technology as is necessary for
Intellect to fully exploit the Antibodies consistent with this Agreement.
3.2 The
Antibodies will be manufactured by Intellect or a Third Party manufacturer
of
Intellect’s sole choice.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
ARTICLE
4: Payment
4.1 Intellect
shall provide IBL with written notice of the achievement of each of the
milestone events listed below promptly (and in any event within thirty (30)
days) following such achievement. In consideration of the sale of the
Antibodies, Intellect shall make the following payments on the achievement
of
the milestone events listed below, where “Initiation”
is
defined as the first dose given to the first subject or patient, within thirty
(30) days of the receipt by Intellect of the invoice from IBL:
|
***
|
***
|
|
|
***
|
***
|
|
|
***
|
***
|
|
|
***
|
***
|
|
|
***
|
***
|
|
|
***
|
***
|
|
|
Total
|
$2,125,000
|
4.2 The
above
milestones shall be payable to IBL for the first free end specific antibody
drug
product to A beta position 1 or 40 developed by Intellect using the Intellect
monoclonal free-end specific antibody technology.
4.3 As
further consideration for the sale of the Antibodies, Intellect will pay IBL
a
royalty ***; provided that if Intellect is required to obtain a license from
a
Third Party in order to manufacture, use, or sell the Antibodies or the Product,
then Intellect may deduct the royalties paid to the Third Party from the
royalties payable to IBL, ***.
4.4 Royalties
will be paid to IBL on a semi annual basis within 60 days after the end of
each
semi-annual period during which this Agreement is in effect.
.
4.5 Intellect
shall provide to IBL semi annual reports detailing its Net Sales (and
adjustments thereto) with respect to the Antibodies.
4.6
With
respect to sales of Antibodies in United States Dollars, all royalty
calculations and amounts due to IBL shall be expressed in United States Dollars.
With respect to sales of Antibodies in a currency other than United States
Dollars, all royalty calculations and amounts due to IBL shall be expressed
both
in the currency of such sales and in the United States Dollar equivalent. The
United States Dollar equivalent shall be calculated using Intellect’s
then-current standard exchange rate methodology applied in its external
reporting for the conversion of foreign currency sales into United States
Dollars.
ARTICLE
5: Books, Records and Inspections
5.1
Intellect shall, and shall cause its Affiliates to, keep proper books of record
and account in which full, true and correct entries (in conformity with the
Accounting Standards and all requirements of Law) shall be made of all dealings
and transactions in relation to this Agreement. Intellect will keep such books
and records for at least three (3) years following the end of the calendar
quarter to which they pertain. Such books of accounts shall be kept at
Intellect’s principal place of business.
5.2
No
more
than once in any calendar year this Agreement is in force, and for one year
thereafter, Intellect shall, and shall cause its Affiliates to, permit
independent auditors, to visit and inspect, during regular business hours and
under the guidance of officers of Intellect, and to examine the books of account
of Intellect or such Affiliate solely to determine the correctness of any sales
records and payments made or required to be made by Intellect under this
Agreement.
ARTICLE
6: Intellectual Property
6.1 All
Inventions by Intellect, whether or not patentable, that are generated,
identified, discovered, conceived created or made or reduced to practice solely
by Intellect or its Affiliates, employees and agents or others acting on its
or
their behalf in connection with Intellect’s activities under this Agreement, or
are owned or controlled by Intellect or its Affiliates and that are necessary
to
use, research, develop, seek regulatory approval, manufacture or sell
antibodies, including, without limitation, various chemical and physical forms,
formulations, combinations, back-ups, modes of delivery and methods of use
for
the Antibodies (collectively, “Intellect
Inventions”)
and
all Patents Rights claiming such Intellect Inventions shall be the sole property
of Intellect.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
6.2 Intellect
shall have the right to bring suit under the Intellect Patents and Corresponding
Applications licensed to IBL under this Agreement without joining IBL as a
party. At the request of Intellect, and at Intellect’s sole cost and expense,
IBL shall join as a party plaintiff in any lawsuit for infringement of the
Patents and Corresponding Applications licensed to IBL under this Agreement.
IBL
shall not have the right to bring suit for infringement of the Intellect Patents
and Corresponding Applications licensed to IBL hereunder.
ARTICLE
7: Representations and Warranties
7.1 Due
Incorporation.
Each of
the Parties hereto hereby represents and warrants to the other that it is duly
incorporated under the relevant Laws of incorporation and each has full
corporate authority to enter into and to perform its obligations under this
Agreement.
7.2
Due
Authorization.
Each of
the Parties hereto hereby represents and warrants to the other that this
Agreement has been fully authorized, executed and delivered by it and it has
full legal right, power and authority to enter into and perform this Agreement,
which shall constitute a valid and binding agreement between the Parties upon
due execution and that it does not conflict with or result in a breach of the
terms of any agreement to which such Party is a party.
7.3 IBL
Representations and Warranties
All
representations and warranties of IBL contained in this Agreement shall be
true
and correct in all respects (in the case of any warranty containing any
materiality qualification) or in all material respects (in the case of any
warranty without any materiality qualification) on the date hereof. IBL
represents and warrants to Intellect to the best of its knowledge as of the
Effective Date, subject to disclosure in agreed form against the representations
and warranties in an annex to this Agreement, that:
|
(a)
|
IBL
is not engaged in any litigation or arbitration, or in any dispute
or
controversy reasonably likely to lead to litigation, arbitration
or other
proceeding, which would materially affect the validity of this Agreement
or such Party’s ability to fulfill its respective obligations under this
Agreement;
|
| (b) |
IBL
Controls the entire right, title and interest in the IBL Technology,
free
and clear of all material charges, encumbrances, restrictions, liens,
disputes, options, royalty obligations, proceedings or claims relating
to,
affecting, or limiting its rights or the rights of Intellect to IBL
Patents and Corresponding Applications or IBL Know-How under this
Agreement;
|
| (c) |
the
execution, delivery and performance of this Agreement by IBL does
not
violate any material law, regulation, orders, judgments or decrees
of any
court, governmental body or administrative or other agency having
authority over it nor any other material agreement or arrangement,
whether
written or oral, by which it is
bound;
|
| (d) |
this
Agreement is a legal, valid and binding obligation, enforceable in
accordance with the terms and conditions hereof (subject to applicable
Laws of bankruptcy and moratorium);
|
| (e) |
the
rights granted to Intellect and its Affiliates hereunder do not conflict
with rights granted by IBL to any Third
Party;
|
| (f) |
neither
IBL nor any of its Affiliates has received any notice concerning
the
institution or possible institution of any interference, reexamination,
reissue, revocation or nullification involving any IBL Patents and
Corresponding Applications or any administrative proceeding challenging
the validity of any IBL Patents and Corresponding
Applications;
|
|
(g)
|
no
representation or warranty made in this Agreement contains any untrue
statement of a material fact or omits to state a material fact necessary
in order to make the statements contained herein or therein not false
or
misleading;
|
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(h)
|
IBL
owns or has all necessary licenses or rights within its jurisdiction
for
the Territory to the subject matter claimed by the IBL Patents and
Corresponding Applications.
|
7.4 Intellect
Representations and Warranties
All
representations and warranties of Intellect contained in this Agreement shall
be
true and correct in all respects (in the case of any warranty containing any
materiality qualification) or in all material respects (in the case of any
warranty without any materiality qualification) on the Effective Date. Intellect
represents and warrants to IBL to the best of its knowledge as of the Effective
Date, subject to disclosure in agreed form against the representations and
warranties in an annex to this Agreement, that:
|
(a)
|
Intellect
is not engaged in any litigation or arbitration, or in any dispute
or
controversy reasonably likely to lead to litigation, arbitration
or other
proceeding, which would materially affect the validity of this Agreement
or Intellect’s ability to fulfill its obligations under this
Agreement;
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(b)
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Intellect
Controls the entire right, title and interest in the Intellect Patents
and
Corresponding Applications, free and clear of all material charges,
encumbrances, restrictions, liens, disputes, options, royalty obligations,
proceedings or claims relating to, affecting, or limiting its rights
or
the rights of IBL to the Intellect Patents and Corresponding Applications
under this Agreement;
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(c)
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the
execution, delivery and performance of this Agreement by Intellect
does
not violate any material law, regulation, orders, judgments or decrees
of
any court, governmental body or administrative or other agency having
authority over it nor any other material agreement or arrangement,
whether
written or oral, by which it is
bound;
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(d)
|
this
Agreement is a legal, valid and binding obligation, enforceable in
accordance with the terms and conditions hereof (subject to applicable
Laws of bankruptcy and moratorium);
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(e)
|
the
rights granted to IBL and its Affiliates hereunder do not conflict
with
rights granted by Intellect to any Third
Party;
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(f)
|
neither
Intellect nor any of its Affiliates has received any notice concerning
the
institution or possible institution of any interference, reexamination,
reissue, revocation or nullification involving any Intellect Patents
and
Corresponding Applications or any administrative proceeding challenging
the validity of any Intellect Patents and Corresponding
Applications;
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(g)
|
no
representation or warranty made in this Agreement contains any untrue
statement of a material fact or omits to state a material fact necessary
in order to make the statements contained herein or therein not false
or
misleading;
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(h)
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Intellect
owns or has all necessary licenses or rights within its jurisdiction
for
the Territory to the subject matter claimed by the Intellect Patents
and
Corresponding Applications.
|
DISCLAIMER. EXCEPT
AS EXPRESSLY SET FORTH HEREIN, NO PARTY MAKES ANY EXPRESS OR IMPLIED WARRANTIES,
STATUTORY OR OTHERWISE, CONCERNING THE VALUE, ADEQUACY, FREEDOM FROM INRINGEMENT
OF THIRD PARTY PATENTS, FREEDOM FROM FAULT OF, OTHER QUALITY, EFFICIENCY,
STABILITY, CHARACTERISTICS OR USEFULNESS OF, OR MERCHANTABILITY, OR FITNESS
FOR
A PARTICULAR PURPOSE OF, ANY ANTIBODY.
ARTICLE
8: IBL Covenants
IBL
agrees that its shall use the rights granted to it under the Intellect Patents
and Corresponding Applications solely for the manufacture, use and sale for
diagnostic and/or laboratory research purposes of murine monoclonal antibodies
that are free end specific for the amino-terminus of beta amyloid peptides
at
position 1 and also for the C-terminus at position 40 and that it shall not
transfer, make use or sell the Antibodies for any other purpose.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
ARTICLE
9: Termination
9.1 The
Agreement shall be effective from the Effective Date and terminate upon the
last
to expire of the Intellect Patents unless terminated prior to such time pursuant
to this Article 9 (the “Term”).
9.2
Either
Party shall have the right to terminate this agreement upon ninety (90) days
written notice if the other Party commits a breach of this Agreement that is
material to the transactions contemplated by this Agreement taken as a whole.
Any such notice of breach shall set forth the details of the alleged breach
and
the breaching Party shall have the opportunity to cure the breach during the
ninety (90) days notice period, or with respect to matters not capable of being
cured with ninety (90) days, to initiate steps reasonably expected to cure
the
breach during such ninety (90) day period. The non-breaching Party may terminate
the Agreement forthwith in the event that a material breach is incurable or
the
breaching party has not initiated steps to cure the breach.
9.3 Either
Party shall have the right to terminate this Agreement if, at any time,
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(a)
|
the
other Party shall file in any court or agency pursuant to any statute
or
regulation of any state or country, a petition in bankruptcy or insolvency
or for reorganization or for an arrangement or for the appointment
of a
receiver or trustee of the Party or of its assets,
or
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(b)
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if
the other Party proposes a written agreement of composition or extension
of its debts, or
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(c)
|
if
the other Party shall be served with an involuntary petition against
it,
filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof,
or
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(d)
|
if
the other Party shall propose or be a party to any dissolution or
liquidation, or
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(e)
|
if
the other Party shall make an assignment for the benefit of creditors,
or
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|
(f)
|
there
is a change of Management Change of Control of the other
Party.
|
9.4 In
the
event that this Agreement is terminated or rejected by Intellect or its receiver
or trustee under applicable bankruptcy Laws due to Intellect’s bankruptcy, then
all rights and licenses granted under or pursuant to this Agreement by Intellect
to IBL, shall otherwise be deemed to be, for purposes of Section 365(n) of
the
U.S. Bankruptcy Code and any similar Laws in any other country in the Territory,
licenses of rights to “intellectual property” as defined under Section 101(35A)
of the U.S. Bankruptcy Code. The Parties agree that all intellectual property
rights licensed hereunder, including, without limitation, any patents or patent
applications in any country of a party covered by the license grants under
this
Agreement, are part of the “intellectual property” as defined under Section
101(35A) of the Bankruptcy Code subject to the protections afforded the
non-terminating Party under Section 365(n) of the Bankruptcy Code, and any
similar law or regulation in any other country.
9.5 In
the
event that IBL is or becomes subject to the operation of Section 365(n) of
the
U.S. Bankruptcy Code and any similar Laws in any other country in the Territory,
then IBL shall grant to Intellect the right to commence action against Third
Party infringers of the IBL Patents in the event that IBL fails to commence
such
action within seven (7) Business Days of becoming aware of such a Third Party
infringer of the IBL Patents.
9.6
Survival
of Obligations.
Notwithstanding the expiration or termination of this Agreement, neither
Intellect nor IBL shall be relieved of any obligations incurred by such Party
prior to such termination and such termination shall be without prejudice to
the
rights and remedies of a Party with respect to any antecedent breach of any
of
the provisions of this Agreement. All other provisions which by their nature
are
intended to survive any such termination shall survive and continue to be
enforceable.
9.7 Notice
of
termination served by a Party upon the other Party shall be binding on the
Parties’ Affiliates. Both Parties and their respective Affiliates shall
immediately cease their activities under this Agreement and shall pay all sums
due and owing to one another.
Confidential
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asterisks.
ARTICLE
10: Indemnity
10.1 Intellect
shall indemnify, defend and hold harmless IBL, its Affiliates, agents,
directors, officers and employees from and against any loss, damage, action,
proceeding, expense or liability, including attorney’s fees (“Loss”)
for
personal injury or lawsuit for infringement of Third Parties’ Intellectual
Property arising from or in connection with use of the Antibodies by Intellect
or any Intellect Licensee, except, in each case, to the extent such Losses
result from the gross negligence or willful misconduct of IBL or its Affiliates.
10.2
In
the
event a party seeks indemnification under this Article, it shall inform the
other party (the “Indemnifying
Party”)
of a
claim as soon as reasonably practicable after it receives notice of the claim,
shall permit the Indemnifying Party to assume direction and control of the
defense of the claim (including the right to settle the claim solely for
monetary consideration), and shall cooperate as requested (at the expense of
the
Indemnifying Party) in the defense of the claim.
10.3 NOTWITHSTANDING
ANY OTHER PROVISION OF THIS AGREEMENT AND UNDER NO CIRCUMSTANCES WILL EITHER
PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL OR
PUNITIVE DAMAGES OR LOSS OF PROFITS, WHETHER BASED ON CONTRACT OR TORT, OR
ARISING UNDER APPLICABLE LAW OR OTHERWISE.
10.4
All
claims for indemnification (“Indemnity
Claims”)
by any
indemnified party with respect to this Agreement (the “Indemnified
Party”)
hereunder shall be asserted and resolved as set forth in this Article 9. In
the
event that any written claim or demand for which a party (the “Indemnifying
Party”)
would
be liable to any Indemnified Party hereunder is asserted against or sought
to be
collected from any Indemnified Party by a Third Party, such Indemnified Party
shall promptly, but in no event more than ten (10) days following such
Indemnified Party’s receipt of such claim or demand, notify the Indemnifying
Party of such claim or demand and the amount or the estimated amount thereof
to
the extent then feasible (the “Claim
Notice”).
All
indemnity claims by any Indemnified Party which do not involve Third Party
claims shall be communicated via a Claim Notice to the other party promptly
following discovery of such claim. The failure to provide such notice will
not
affect any rights under this Agreement except to the extent that the
Indemnifying Party is materially prejudiced by such failure.
10.5
The
Indemnifying Party shall have twenty (20) days from the delivery or mailing
of
the Claim Notice (the “Notice
Period”)
to
notify the Indemnified Party whether or not it desires to defend the Indemnified
Party against such claim or demand. An election to assume the defense of such
claim or demand shall not be deemed to be an admission that the Indemnifying
Party is liable to the Indemnified Party in respect of such claim or demand.
All
costs and expenses incurred by the Indemnifying Party in defending such claim
or
demand shall be a liability of, and shall be paid by, the Indemnifying Party;
provided, however, that the amount of such expenses shall be subject to the
limitations set forth in this Article 10.
10.6
In
the
event that it is ultimately determined that the Indemnifying Party is not
obligated to indemnify, defend or hold the Indemnified Party harmless from
and
against any Third Party claim, the Indemnified Party shall reimburse the
Indemnifying Party for any and all costs and expenses (including without
limitation, attorney’s fees and court costs) incurred by the Indemnifying Party
in its defense of the Third Party claim. In the event that the Indemnifying
Party notifies the Indemnified Party within the Notice Period that it desires
to
defend the Indemnified Party against such claim or demand, the Indemnifying
Party shall have the right to defend the Indemnified Party by appropriate
proceedings. If any Indemnified Party desires to participate in, but not
control, any such defense or settlement, it may do so at its sole cost and
expense.
10.7
The
Indemnified Party shall not settle a claim or demand without the consent of
the
Indemnifying Party, which shall not be unreasonably withheld. The Indemnifying
Party may settle any claim or demand for monetary damages; it being understood
that the Indemnifying Party shall not, without the prior written consent of
the
Indemnified Party, which shall not be unreasonably withheld, settle, compromise
or offer to settle or compromise any such claim or demand on a basis which
would
result in the imposition of a consent order, injunction or decree that would
restrict the future activity or conduct of the Indemnified Party or any
subsidiary or Affiliate thereof.
10.8 To
the
extent the Indemnifying Party shall control or participate in the defense or
settlement of any Third Party claim or demand, the Indemnified Party will give
the Indemnifying Party and its counsel access to, during normal business hours,
the relevant business records and other documents, and shall permit them to
consult with the employees and counsel of the Indemnified Party. The Indemnified
Party shall use its commercially reasonable efforts to assist in the defense
of
all such claims.
Confidential
Treatment
Confidential
treatment has been
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asterisks.
10.9
If
the
Indemnifying Party shall fail to undertake in a timely manner the defense of
any
Third-Party claim or it is reasonably determined that representation by the
Indemnifying Party’s counsel of both the Indemnifying Party and the Indemnified
Party may present a conflict of interest, the Indemnified Party shall have
the
right to undertake the defense or settlement thereof at the Indemnifying Party’s
expense. If the Indemnified Party assumes the defense of any such claim or
proceeding pursuant to this Article 10.9 and proposes to settle such claim
or
proceeding prior to a final judgment thereon or to forgo any appeal with respect
thereto, then the Indemnified Party shall give the Indemnifying Party timely
written notice and the Indemnifying Party shall have the right to participate
in
the settlement or assume or reassume the defense of such claim or proceeding.
No
settlement that the Indemnifying Party is responsible for paying may be entered
into without the approval of the Indemnifying Party.
10.10 Any
notice of a claim by reason of any of the warranties contained in this Agreement
shall state specifically the warranty with respect to which the claim is made,
the facts giving rise to an alleged basis for the claim, and the amount of
the
liability asserted against the Indemnifying Party by reason of the
claim.
10.11 The
Indemnified Party shall take and shall cause its Affiliates to take all
reasonable steps to mitigate any Loss upon becoming aware of any event which
would reasonably be expected to, or does, give rise thereto, including incurring
costs only to the minimum extent necessary to remedy a breach that gives rise
to
the Loss.
ARTICLE
11: Dispute Resolution
11.1 The
Parties agree that except as specified in Articles 11.3(f) and 11.3(i), in
no
event shall any dispute, controversy or claim arising under this Agreement
be
the subject of private litigation between the Parties. To the extent that a
dispute, controversy or claim is related to compliance with the terms of this
Agreement, or the validity, breach, termination or interpretation of this
Agreement, such dispute, controversy or claim shall be resolved in accordance
with Article 11.2.
11.2 Each
Party shall have the right to refer any dispute, controversy or claim related
to
compliance with the terms of this Agreement, or the validity, breach,
termination or interpretation of this Agreement, to the senior management within
each Party for resolution. The senior management shall have thirty (30) days
in
which to meet in good faith to resolve the dispute, controversy or claim. In
the
event that the senior management of both Parties are unable to resolve the
matter within such thirty (30) day period the dispute, controversy or claim,
shall be promptly submitted to the to the Chief Executive Officer of IBL or
its
designee and the Chief Executive Officer of Intellect or its designee (together,
the “Senior Officers”) for resolution. In the event the Senior Officers are
unable to resolve the dispute, controversy or claim within fifteen (15) days,
such dispute, controversy or claim shall be resolved through binding arbitration
pursuant to Article 11.3.
11.3
Arbitration
|
(a)
|
In
the event that the Senior Officers are unable to resolve any dispute,
controversy or claim between the Parties referred to them pursuant
to
Article 11.2 arising out of or in connection with compliance with
this
Agreement, or the validity, breach, termination or interpretation
of this
Agreement, the dispute, controversy or claim (other than a dispute,
controversy or claim relating to patent scope, validity or infringement)
shall, at the request of either Party be finally settled by binding
arbitration in accordance with the then current Rules of Arbitration
of
the International Chamber of
Commerce.
|
| (b) |
The
arbitration panel shall consist of three (3) arbitrators, each of
whom
must have legal or business experience in pharmaceutical licensing
matters. The arbitrators are to be selected as follows: Intellect
shall
nominate one (1) such qualified arbitrator; IBL shall nominate one
(1)
such qualified arbitrator; and the two arbitrators so nominated shall
nominate a third such qualified arbitrator, who shall be the presiding
arbitrator, in each case subject to confirmation by the International
Court of Arbitration of the International Chamber of Commerce (the
“ICC
Court”). In the event either Intellect or IBL shall have failed to
nominate a qualified arbitrator as provided above within fifteen
(15) days
after the other Party shall have nominated its arbitrator, or the
two
arbitrators so nominated shall fail to agree on a third arbitrator
as
provided above within thirty (30) days, the presiding arbitrator
shall be
appointed by the ICC Court.
|
Confidential
Treatment
Confidential
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asterisks.
| (c) |
The
place of arbitration shall be New York and the language of the arbitration
shall be English.
|
| (d) |
Except
as otherwise provided in this Agreement, the arbitration procedure
set
forth in this Article 11.3 shall be the sole and exclusive means
of
settling or resolving any dispute referred to in this Article
11.3.
|
| (e) |
Within
sixty (60) days after the third and presiding arbitrator has been
confirmed by the ICC Court, the Parties shall exchange all documents
in
their respective possession that are relevant to the issues in dispute
and
not protected from disclosure by attorney-client privilege or other
immunity. Each Party shall also be permitted to take sworn oral deposition
of individuals, such depositions to be scheduled by mutual agreement
and
concluded within forty-five (45) days after the exchange of documents
described above. At least fifteen (15) days prior to the first scheduled
hearing date, the Parties shall identify the witnesses that they
intend to
present at the arbitration hearing and the documentation on which
they
intend to rely. The Parties shall use their commercially reasonable
efforts to conclude the arbitration hearings within ten (10) months
following the confirmation of the third and presiding arbitrator.
The
arbitrators shall issue their decision (including grounds and reasoning)
in writing no later than sixty (60) days following the conclusion
of the
last arbitration hearing.
|
| (f) |
The
award of the arbitrators shall be final and binding on the Parties
and may
be presented by either of the Parties for enforcement in any court
of
competent jurisdiction, and the Parties hereby consent to the jurisdiction
of such court solely for purposes of enforcement of this arbitration
agreement and any order or award entered
therein.
|
| (g) |
Each
Party shall bear its own attorney’s fees, costs, and disbursements arising
out of the arbitration, and shall pay an equal share of the fees
and costs
of the arbitrators; provided, however, the arbitrators shall be authorized
to determine whether a Party is the prevailing party, and if so,
to award
to that prevailing Party reimbursement for its reasonable attorneys’ fees,
costs and disbursements and/or the fees and costs of the
arbitrators.
|
| (h) |
Provided
the Agreement has not terminated, the Parties covenant to continue
the
performance under the Agreement in accordance with the terms thereof,
pending the final resolution of the
dispute.
|
|
(i)
|
Notwithstanding
the foregoing, either Party shall have the right to pursue an action
in a
court of competent jurisdiction to obtain injunctive or other equitable
remedy.
|
ARTICLE
12: Confidentiality
12.1 Each
Party will maintain in strictest confidence, and will ensure that its Affiliates
and its and their consultants, employees, agents and representatives maintain
in
strictest confidence, and not publish, use or disclose for any purpose other
than as set forth in this Agreement, all proprietary and confidential
information or materials possessed or developed which has been or is provided
by
each Party to the other and whether developed before or after the Effective
Date
(“Confidential Information”). For the avoidance of doubt, Confidential
Information shall include, but not be limited to, information or materials
on
substances, formulations, technology, equipment, data, reports, know-how,
sources for supply, patent position and business plans inventions, discoveries,
improvements and methods, business plans, marketing techniques or plans,
manufacturing and other plant designs, location of operations, and any other
information regarding the business operations of a Party or in relation to
development, manufacture or commercialization of any Antibody hereunder. Each
Party agrees that it will not use for any purpose other than the completion
of
the Agreement, and will not publish, disseminate, or disclose, in any manner,
to
any person not subject to restrictions of confidentiality at least as strict
as
those contained within this Agreement, any Confidential Information, except
that
a Party may disclose any portion of the Confidential Information that: (i)
that
Party is legally required to disclose, (ii) that Party can demonstrate by
competent evidence has entered or enters the public domain through no act or
fault of that Party, (iii) that Party can demonstrate by competent evidence
was
already known by that Party before receipt from the disclosing Party, or (iv)
that Party can demonstrate by competent evidence was received by that Party,
without restriction on disclosure, from a Third Party under no confidentiality
obligation to the other Party.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
12.2.
Each
party will use at least the same standard of care as it uses to protect
proprietary or confidential information of its own to ensure that its employees,
agents, consultants and other representatives do not disclose or make any
unauthorized use of the Confidential Information but in no event less than
reasonable care. Each Party will promptly notify the other upon discovery of
any
unauthorized use or disclosure of the Confidential Information. Each Party
shall
ensure that any agent, consultant or representative shall only receive such
Confidential Information under restrictions of confidentiality at least as
strict as those contained within this Agreement.
12.3
Each
Party acknowledges that damages resulting from disclosure of the Confidential
Information would be an inadequate remedy and that, notwithstanding the
provisions of Article 11.1(a), in the event of any such disclosure or any
indication of an intent to disclose such information, a Party (or its
Affiliates) owning such information shall be entitled to seek, by way of private
litigation, injunctive relief or other equitable relief in addition to any
and
all remedies available at law or in equity.
12.4
The
provisions of this Article 12 will survive for ten (10) years after the
termination or expiration of this Agreement.
ARTICLE
13: Miscellaneous
13.1 Press
Releases.
The
Parties agree that they may disclose publicly through press releases, upon
signing this Agreement, the nature and scope of this Agreement in the form
as
mutually agreed by the Parties. Thereafter, the Parties may make such public
disclosures regarding this Agreement as are reasonably necessary to comply
with
Laws or regulations or for appropriate market disclosure, and based on the
advice of external securities law counsel. All press releases shall be approved
in writing in advance by both Parties, except for such disclosures permitted
pursuant to the preceding sentence, such approval not to be unreasonably
withheld or delayed.
13.2 Amendment.
No
amendment, waiver or consent to this Agreement shall be effective unless in
writing and signed by both Parties hereto.
13.3 Assignment.
Neither
this Agreement nor any rights or obligations hereunder may be assigned or
otherwise transferred by IBL to a Party which is not an Affiliate of IBL without
the prior written consent of Intellect; provided, however, that IBL may assign
this Agreement and its rights and obligations hereunder without Intellect’s
consent in connection with the transfer or sale of all or substantially all
of
the business of IBL to a Third Party, whether by merger, sale of stock, sale
of
assets or otherwise. Any purported assignment in contravention of this Article
13.3 shall, at the option of Intellect, be null and void and of no effect.
No
assignment shall release either Party from responsibility for the performance
of
any accrued obligation of such Party hereunder. This Agreement shall be binding
upon and enforceable against the successor to or any permitted assignees of
IBL.
13.4 Intellect
shall consult with IBL prior to an assignment by it of the rights or obligations
hereunder to a Party which is not an Affiliate of Intellect; however Intellect
may assign this Agreement without the consent of IBL. Intellect shall give
IBL
written notice within five Business Days of such assignment. No assignment
shall
release either Party from responsibility for the performance of any accrued
obligation of such Party hereunder. This Agreement shall be binding upon and
enforceable against the successor to or any permitted assignees of
Intellect.
13.5 In
the
event that an Affiliate to which a Party has assigned any of its rights or
obligations under this Agreement ceases to be an Affiliate of that Party, the
Affiliate shall assign back to that Party all such rights and obligations prior
to it ceasing to be an Affiliate.
13.6
Merger,
Acquisition and Sale of Company.
In the
event that Intellect merges with a Third Party or is acquired by a Third Party
at the will of Intellect, or sells the company to a Third Party, no such merger,
acquisition or sale of the company shall release either Party from
responsibility for the performance of any accrued obligation of such Party
hereunder,. This Agreement shall be binding upon and enforceable against the
merged company, the acquiring company or purchasing company.
13.7 Entire
Agreement.
This
Agreement (including the Annexes hereto) constitutes the entire agreement of
the
Parties with respect to the Antibodies and supersedes any and all prior
negotiations, correspondence and understandings between the Parties with respect
to the subject matter hereof, whether oral or in writing.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
13.8 Governing
Law.
This
Agreement shall be governed by, construed and enforced in accordance with the
Laws of the State of New York and the United States of America without regard
to
the conflicts of Laws principles thereof.
13.9 Notices.
All
notices and other communications pursuant to this Agreement shall be in writing,
shall be effective when received, and shall be deemed to have been received
on
the date of delivery if delivered personally; or on the second business day
after the business day of deposit with Federal Express or other similar courier
for overnight delivery, freight prepaid; in each such case, addressed as follows
(until any such address is changed by notice duly given):
To
Intellect:
Intellect
Neurosciences, Inc
0
Xxxx
00xx
Xxxxxx
Xxx
Xxxx,
XX 00000
Attention:
Xxxxxx Xxxx
Executive
Vice President and Chief Financial Officer
Fax:
000-000-0000
with
a
copy to:
Xxxxxxx
Xxxxxxx, Esq.
Xxxxx
Xxxxxxx Xxxxxxx Israels
Xxx
Xxxxxxxxx Xxxxxx
Xxxxxx,
XX 00000
Fax:
(000) 000-0000
To
IBL:
Immuno-Biological
Laboratories Co., Ltd.
0-0
Xxxxxxxx, Xxxxxxxx-Xxx, Xxxxx
000-0000,
XXXXX
Attention:
Tsutomu Seito, President
Fax:
x00
00-000-0000
13.10 Counterparts.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
13.11
No
Agency.
It is
understood and agreed that nothing in this Agreement shall be construed as
authorization for either Party to act as agent for the other.
13.12 Force
Majeure.
Each
Party hereto shall be relieved of its obligations hereunder to the extent that
fulfillment of such obligations shall be prevented by acts beyond its reasonable
control.
13.13 Titles.
The
titles of the Articles of this Agreement are for general information and
reference only, and this Agreement shall not be construed by reference to such
titles.
13.14 Severability.
Each
Party agrees that, should any provision of this Agreement be determined by
a
court of competent jurisdiction to violate or contravene any applicable law
or
policy, such provision will be severed or modified by the court to the extent
necessary to comply with the applicable law or policy, and such modified
provision and the remainder of the provisions hereof will continue in full
force
and effect.
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
13.15 Waiver.
Failure
by either Party to enforce any rights under this Agreement shall not be
construed as a waiver of such rights nor shall a waiver by either Party in
one
or more instances be construed as constituting a continuing waiver or as a
waiver in other instances.
13.16
Third
Party Beneficiaries.
This
Agreement is neither expressly nor impliedly made for the benefit of any party
other than those executing it.
13.1 Expenses.
Except
as otherwise specified in this Agreement, all costs and expenses, including
fees
and disbursements of counsel, financial advisors and accountants, incurred
in
connection with this Agreement and the transactions contemplated hereby will
be
paid by the party incurring such costs and expenses.
13.18 Specific
Performance.
The
parties hereto agree that irreparable damage would occur in the event any
provision of this Agreement were not performed in accordance with the terms
hereof and that the parties hereto will be entitled to specific performance
of
the terms hereof, in addition to any other remedy at law or in equity without
the necessity of demonstrating the inadequacy of monetary damages and without
the posting of a bond.
Confidential
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Confidential
treatment has been
requested for portions of this document marked with
asterisks.
IN
WITNESS WHEREOF,
the
undersigned have executed this Agreement on the day and year first above
written.
Immuno-Biological
Laboratories Co., Ltd.
__________________________
Name:
Tsutomu Seito
Title:
President
Date:
_______________
Intellect
Neurosciences, Inc
__________________________
Name:
Title:
Date:
_______________
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
SCHEDULE
1
82E1
ANTIBODY DELIVERABLES
| 1. |
The
humanized monoclonal antibody referred to as
82E1
|
| i) |
The
secreting CHO cell lines
|
|
ii)
|
The
cDNA sequence in variable region of the
antibody
|
| iii) |
Expression
vector
|
| 2. |
The
murine monoclonal antibody referred to as
82E1
|
| i) |
The
secreting Hybridoma cell
lines
|
| ii) |
The
cDNA sequence in variable region of the
antibody
|
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
SCHEDULE
2
1A10
ANTIBODY DELIVERABLES
| 1. |
The
murine monoclonal antibody referred to as
1A10
|
| i) |
The
secreting Hybridoma cell lines
|
| ii) |
The
cDNA sequence in variable region of the
antibody
|
Confidential
Treatment
Confidential
treatment has been
requested for portions of this document marked with
asterisks.
SCHEDULE
3
IBL
PATENTS AND CORRESPONDING APPLICATIONS
| 1. |
PCT/JP2004/13536(Filed
09/16/2004), entered into Japan (Application No. 2006-510156), US
(Application No.10/589,969) and EP (Application
No.04821687.3)
|
|
“MONOCLONAL
ANTIBODY AND USE THEREOF”
|
| 2. |
PCT/US2006/031517(Filed
08/11/2006)
|
|
“METHODS
TO EVALUATE AB-LOWERING AGENTS USING WILDTYPE
MICE
|
| 3. |
US60/843,460(Filed
09/08/2006)
|
|
“DEGLYCOSYLATED
ANTI-AMYLOID BETA ANTIBODIES INDUCE AMYLOID BETA SEQUESTRATION WITH
REDUCED MICROGLIAL PHAGOCYTOSIS AND CYTOKINE
RELEASE”
|
