RESEARCH COLLABORATION AGREEMENT
Exhibit
10.1
CONFIDENTIAL
TREATMENT REQUESTED:
Certain
portions of this document have been omitted pursuant to a request for
confidential treatment and, where applicable, have been marked with an asterisk
(“[*****]”) to denote where omissions have been made. The confidential material
has been filed separately with the Securities and Exchange
Commission.
This
Research Collaboration Agreement is ("Agreement") entered into and effective
this day of August 6, 2007 (hereinafter the "Effective Date"), by and between
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(1)
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MRC
Technology, whose principal place of business is situated at 0-0
Xxxxxxxxxx Xxxx, Xxxx Xxxx, Xxxxxx XX0 xXX, Xxxxxxx (hereinafter
also
called "MRCT"); and:
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(2)
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INTELLECT
NEUROSCIENCES, Inc. whose principal place of business is located
at 0 Xxxx
00& Xxxxxx, Xxx Xxxx, XX 00000 (hereinafter also called "Intellect");
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Recitals
WHEREAS,
Intellect has identified, developed and has know-how and proprietary rights
to
certain monoclonal antibodies, including two murine monoclonal antibodies
against amyloid beta, designated by Intellect as Antibody IN-NO1 and Antibody
IN-C02; and
WHEREAS,
Intellect has research expertise, know-how, and proprietary rights relating
to
discovery research leading toward new therapeutic products based on Intellect
monoclonal antibodies; and
WHEREAS,
MRCT has genetic engineering expertise to modify murine antibodies wherein
certain regions of the immunoglobulin are changed from mouse to human, which
modification is sometimes, in one aspect, referred to as "humanising" or
"humanisation"; and
WHEREAS,
MRCT has developed processes and vectors to humanise murine antibodies and
has
the right to grant licenses to third parties under the Licensed Patent Rights
as
hereinafter defined; and
WHEREAS,
Intellect is desirous of modifying its Antibody IN-NO1 and Antibody IN- C02
and
of having MRCT perform such modification, and MRCT is desirous of carrying
out
such modification;
NOW,
THEREFORE, in consideration of the foregoing promises and of the mutual
covenants and obligations hereinafter set forth, the parties agree as follows:
ARTICLE
I -Definitions
As
used
in this agreement, the following terms when used with initial capital letters,
shall have the following meanings, the singular shall include the plural and
vice versa:
1.1
"Affiliate"
shall mean any entity that directly or indirectly controls, is controlled by,
or
is under common control with a party, and for the purposes of this Section
1.3,
"control" shall mean ownership of more than fifty percent (50%) of the voting
interest, or such lower maximum amount allowed by the law governing the
ownership of said organisation.
1.2
"Antibody"
shall mean either Antibody IN-NO1 or Antibody IN-C02 (as the context requires)
and "Antibodies" shall mean both Antibody IN-NO1 and Antibody IN-C02.
1.3
"Business
Day" means any day, except Saturday and Sunday, on which commercial banking
institutions are open for business (i) in the USA in the case of Intellect
and
(ii) in London, U.K., in the case of MRCT. Any other reference in this Agreement
to "day" whether or not capitalized shall refer to a calendar day, not a
Business Day.
1.4
"Commercial
Introduction" shall mean the date upon which Intellect or one or more Affiliates
or Licensees (as defined hereunder) first achieves Net Sales following the
final
issuance of all required licenses and approvals by the United States Food and
Drug Administration ("FDA") (or equivalent licenses and approvals in a country
other than the United States) allowing for the manufacture and sale of a
Licensed Product for human use.
1.5
"Commercial
Sale" means, with respect to a Licensed Product in a particular country, the
sale to a third party purchaser by Intellect, its Affiliates, and or its
Licensees of Licensed Products in such country after all required Regulatory
Approvals have been obtained in such country and, if Regulatory Approval is
not
required in such country, any commercial sale of Licensed Products in such
country.
1.6
"Confidential
Information" means all secret, confidential, or proprietary information or
data,
whether provided in written, oral, video, computer, or other form or format,
provided by one party ("the Disclosing Party") to the other party (the
"Receiving Party") pursuant to this Agreement or generated pursuant to this
Agreement, including, but not limited to, information relating to the Disclosing
Party's existing or proposed research and development efforts, patent
applications, business or products, the terms of this Agreement, and any other
materials that have not been made available by the Disclosing Party to the
general public. Notwithstanding the foregoing sentence, Confidential Information
shall not include any information or materials that:
(i)
are
already known to the Receiving Party (other than under obligation of
confidentiality) at the time of disclosure by the Disclosing Party, to the
extent the Receiving Party has documentary evidence to that effect;
(ii)
are
generally available to the public or otherwise part of the public domain at
the
time of its disclosure to the Receiving Party;
(iii)
become
generally available to the public or otherwise part of the public domain after
its disclosure or development, as the case may be, and other than through any
act or omission of a party in breach of such party's confidentiality obligations
under this Agreement;
(iv)
are
subsequently lawfully disclosed to the Receiving Party by a third party who
had
no obligation to the Disclosing Party not to disclose such information to
others;
(v)
are
independently discovered or developed by or on behalf of the Receiving Party
without the use of the Disclosing Party's Confidential Information, to the
extent the Receiving Party has documentary evidence to that effect;
(vi)
are
approved for release by the Disclosing Party in writing; or
(vii)
are
required by law to be disclosed.
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1.7
"Designated
Antibody" shall mean a Humanised Antibody for which Intellect seeks regulatory
approval through the conduct of human clinical trials, or a US BLA, or an
equivalent regulatory approval in any country.
1.8
"Humanised
Antibody" shall mean an antibody that binds to amyloid beta and is made by
MRCT
under this Agreement, the antibody comprising murine complementarity determining
regions ('CDRs' as identified in Exhibit Al. Winter Patent") derived from
Antibody IN-NO1 together with human framework regions, or derived from Antibody
IN-C02 together with human framework regions, and in each case any modifications
thereof.
1.9
"Intellect
Invention" shall mean any discovery or invention to the extent (i) made or
conceived or reduced to practice by or on behalf of MRCT, whether alone or
jointly with Intellect, in the performance of the humanisation of Intellect's
Antibody IN-NO1 and Antibody IN-C02, whether or not patentable, and (ii) not
an
MRCT Invention. For the purpose of clarity, Intellect Inventions shall include
without limitation all of the DNA sequences encoding Humanised Antibody genes
included in the MRCT Deliverables as defined in Section 2.2 but otherwise
excluding DNA sequences encoding for MRCT'S proprietary expression vectors.
1.10
"Intellect
IP" shall mean any and all patented and non-patented proprietary technology
and
information, in any form whatsoever, that is necessary or useful for making
and
using Humanised Antibodies, without regard to whether or not the technology
or
information is patentable, which is (i) owned with the right to disclose or
otherwise controlled by Intellect as of the Effective Date or hereafter during
the term of this Agreement and is first disclosed by Intellect to MRCT, or
(ii)
is assigned, or is obliged hereunder to be assigned, to Intellect by MRCT,
including, without limitation, processes, techniques, methods, products,
transformed cells, other biological materials and compositions which are
necessary or useful for making or using the Humanised Antibodies. Intellect
IP
shall not include MRCT IP or MRCT Inventions.
1.11
"Licensed
Patent Rights" shall mean the patents and patent applications licensed to MRCT
and with respect to which MRCT has the right to authorise and grant sublicenses,
as detailed in Exhibit A hereto, including any divisions, renewals,
continuations, extensions, reexaminations, reissues, or continuations-in-part
(to the extent that any such continuation-in- part claims subject matter as
disclosed in the patents and applications listed in Exhibit A) thereof, as
well
as any patent that issues from any of the foregoing.
1.12
"Licensed
Product" shall mean a product comprising a Humanised Antibody, the manufacture,
use, offer for sale, sale, or importation of which by an unlicensed third party
would infringe one or more Valid Claims of the Licensed Patent Rights, or which
incorporates MRCT IP or MRCT Inventions. The term "Licensed Product" does not
include chimeric antibodies or murine antibodies.
1.13
"Licensee"
shall mean any organisation licensed by Intellect to manufacture or sell
Licensed Products. For clarity, the term "Licensee" shall include any
Sublicensee of Intellect under the Licensed Patent Rights as herein defined.
1.14
"MRCT
Invention" shall mean any discovery or invention to the extent (i) made or
conceived or reduced to practice by or on behalf of MRCT in the performance
of
the humanisation of Intellect's Antibody IN-NO1 and Antibody IN-C02 under this
Agreement, whether or not patentable, and (ii) covering a generally applicable
method or technique for humanising antibody proteins or for constructing a
vector or reagent used to humanise or express an antibody.
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1.15
"MRCT
IP"
shall mean (i) any MRCT Invention and (ii) all patented and non- patented
proprietary technology and information, in any form whatsoever, that is: (a)
necessary or useful for making and using the Licensed Products, without regard
to whether or not the technology or information is patentable; (b) owned,
controlled, or developed by MRCT, as of the Effective Date or hereafter during
the term of this Agreement; and (c) provided by MRCT to Intellect hereunder,
including, but not limited to discoveries, formulae, materials, practices,
methods, knowledge, know-how, processes, trade secrets, ideas, concepts,
manufacturing, engineering, standard operating procedures, flow diagrams and
charts, quality assurance, quality control data, technical data, manufacturing
technology, research data and records, and all other confidential or proprietary
technical and business information relating to the humanisation of murine
antibodies, generation of chimeric antibodies, or any gene expression vectors
used in such methods and all improvements or modifications thereto. For purposes
of clarity, MRCT IP includes MRCT Inventions that satisfy (a), (b) and (c),
above, while MRCT IP does not include Licensed Patent Rights as defined
hereunder.
1.16
"Net
Sales" shall mean the gross amount invoiced by Intellect, its Affiliates and/or
Licensees for the sale of Licensed Products, less the following amounts: (i)
discounts or rebates actually allowed or granted; (ii) credits or allowances
actually granted on rejections or returns (not exceeding the original billing);
(iii) outbound freight, postage, shipping, and insurance charges prepaid or
allowed; (iv) sales, tariff duties, surcharges, and/or use or excise taxes,
levies, or other similar governmental charges included in the invoiced amount;
and (v) any similar and customary deductions taken in accordance with U.K.
generally accepted accounting principles (GAAP) consistently applied. Provision
of Licensed Products for promotional, sampling, or educational purposes, or
for
use in pre-clinical studies or clinical trials, shall not be considered in
determining Net Sales, provided that no consideration (monetary or non-monetary
other than incidental) is received in exchange therefor. No allowance or
deduction shall be made for commissions or collections or overhead, by whatever
name known.
1.17
"Regulatory
Approval" in a country means any and all approvals (including price and
reimbursement approvals), licences, registrations, or authorisation of any
governmental agency, necessary for the manufacture, use, storage, import,
transport, and/or sale of a Licensed Product in such country.
1.18
"Research
Collaboration" means the research activities undertaken by the parties in
accordance with the Research Plan.
1.19
“Research
Plans” shall mean the plan of research activites as set forth in Annex A
hereto.
1.20
“Sublicense”,
Sublicense Agreement” and “Sublicensee” shall mean, and include, without
limitation, any relationship in which Intellect grants a third party a licence,
option, right of first refusal, or other such right under any of the licences
granted by MRCT to Intellect under this Agreement for the purpose of allowing
such third party to develop and commercialise one or more Licensed Products.
1.21
"Term"
shall have the meaning set out in Section 8.1.
1.22
"Valid
Claim" shall mean a claim in any unexpired issued patent within the Licensed
Patent Rights or MRCT IP which has not been held invalid by a non-appealed
or
unappealable decision by a court or other appropriate body of competent
jurisdiction.
ARTICLE
I1 -Research Collaboration
2.1
Upon
the
execution of this Agreement and the receipt from Intellect of the necessary
materials and information as specified in Section 2.2, below, MRCT will
undertake the humanisation of Intellect's Antibody IN-NO1 and Antibody IN-C02
in
accordance with the Research Plan set forth in Annex A hereto. The Research
Plan
may be amended as mutually agreed to by the parties. The parties agree to use
commercially reasonable efforts to perform their respective responsibilities
under the Research Collaboration.
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2.2
Under
the
Research Plan, MRCT shall provide the following biological materials, including
gene cloning vectors for research purposes only, data (including copies of
raw
data) information, and reports to Intellect (collectively, the "MRCT
Deliverables"):
[*****].
2.3
After
the
Effective Date, Intellect shall, at its expense and without charge to MRCT,
deliver to MRCT at least one cell line that produces Intellect's Antibody IN-NO1
and Antibody IN-C02 and such Intellect know-how including related technical
information as sufficient (in the reasonable judgment of both parties) to enable
MRCT to carry out its humanisation obligations under this Agreement (the
"Intellect Deliverables"). The Intellect Deliverables shall be deemed to be
Confidential Information of Intellect. The transfer from Intellect to MRCT
of
the cell line(s) producing Intellect's Antibody IN-NO1 and Antibody IN-C02
is
solely for the purpose of MRCT conducting its humanisation obligations under
this Agreement, and for no other purpose, and MRCT shall hold the Intellect
Deliverables in strict confidence.
2.4
MRCT
shall maintain an appropriate secure work site for conducting its activities
under the Research Plan. MRCT shall cause its research teams performing the
activities under the Research Plan to keep detailed contemporaneous records
and
data in connection with the Research Plan, and to prepare reports detailing
work
to date, which shall be furnished to Intellect in a timely manner upon
completion of each research milestone specified in the Research Plan or as
otherwise agreed between the parties. MRCT shall permit duly authorised
employees of Intellect to have access to MRCT's laboratories from time to time
at mutually agreeable times and upon reasonable notice for the purpose of
reviewing the work conducted by MRCT pursuant to this Agreement.
2.5
Any
MRCT
personnel performing work pursuant to the Research Plan shall be obligated
under
hislher terms and conditions of employment to (i) assign hisher entire worldwide
right, title, and interest in and to any discovery, invention, improvement,
or
technological advance, including any MRCT Invention, and any associated
intellectual property, including any MRCT IP, to MRCT and (ii) comply at all
times with the confidentiality obligations imposed on MRCT under this Agreement.
2.6
Upon
completion of its research activities hereunder or the earlier termination
of
the Research Collaboration in accordance with Article VIII, MRCT shall provide
to Intellect samples of all Humanised Antibodies, as agreed to by the parties,
and MRCT shall issue a final written report to Intellect. The final written
report shall set forth in reasonable detail the results of MRCT'S humanisation
of Intellect Antibody IN-NO1 and Antibody IN-C02 including, without limitation,
the synthesis information (including, but not limited to, the DNA and amino
acid
sequence information, and including final and intermediate sequences) for all
Humanised Antibodies.
2.7
All
worldwide right, title, and interest in Humanised Antibodies, Intellect
Inventions and Intellect IP shall belong solely to Intellect. At the request
and
expense of Intellect, MRCT shall execute such documents as Intellect may
reasonably request in order to reflect Intellect's ownership of Humanised
Antibodies, Intellect Inventions and Intellect IP, and to reasonably cooperate
with and assist Intellect with regard to Intellect's efforts to register
Intellect's rights in and to the Humanised Antibodies.
2.8
MRCT
shall maintain, within its sole possession and control, samples of Humanised
Antibodies and samples of any vectors containing Humanised Antibodies and MRCT
shall not distribute, transfer, or sell any such Humanised Antibodies or vectors
(or any MRCT Deliverable) to any third party for any purpose whatsoever without
the prior written consent of Intellect.
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2.9
Notwithstanding
anything to the contrary herein, MRCT retains all worldwide right, title, and
interest in the Licensed Patent Rights and MRCT IP used or developed in the
performance of MRCT's obligations under this Agreement. Intellect is granted
(under Section 4.1, below) a limited licence to use any vectors and sequences
included in the MRCT IP only insofar as such vectors and sequences are used
in
conjunction with the expression of Intellect's Antibody IN-NO1 and Antibody
IN-C02 and Humanised Antibodies derived therefrom by MRCT subject to the terms
of this Agreement. MRCT shall not, except in the event of termination of this
Agreement by MRCT pursuant to Sections 8.4 or 8.5 hereof, exercise any of its
proprietary rights arising hereunder or otherwise restrict Intellect from
commercialising any Humanised Antibody produced hereunder in any manner. All
MRCT Inventions shall be owned by MRCT and shall be deemed to be included in
the
MRCT IP and the Licensed Patent Rights, as applicable.
ARTICLE
111 -Payments for the Research Collaboration
3.1
Intellect
shall pay to MRCT for undertaking to perform the humanisation work pursuant
to
the Research Collaboration the sum of [*****] United Kingdom Pounds (UK£[*****])
for each Antibody (the "Initial Payment"). The Initial Payment for each Antibody
is non-refundable and shall be made
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(i)
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within
sixty (60) days after the Effective Date in relation to Antibody
IN-N01;
and
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(ii)
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within
thirty (30) days of the receipt by MRCT of the cell line producing
Antibody IN-C02 from Intellect (as set out in Section 2.3) in relation
to
Antibody IN-C02.
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3.2
Intellect
will pay MRCT in United Kingdom Pounds for its research efforts carried out
in
accordance with the Research Plan the research milestone payments (the "Research
Milestone Payments") as set forth in the cost schedule attached as Annex B
within thirty (30) days following the documented completion of, and delivery
by
MRCT of the relevant MRCT Deliverable and Intellect's receipt of an invoice
from
MRCT for, each research milestone specified in Annex A. The Initial Payment
and
the Research Milestone Payments shall be paid by wire transfer in United Kingdom
Pounds (UU)within thirty (30) days of the date of invoice by wire transfer
to
the account of MRCT. at [*****], or such other bank and or account as may be
notified to Intellect by MRCT from time to time, and the transaction identified
as "Agreement dated [Effective Date] between MRC Technology and Intellect".
For
the avoidance of doubt the Research Milestone Payments set out in Annex B shall
be payable by Intellect in relation to each of Antibody IN-NO1 and Antibody
IN-C02.
3.3
In
the
event that Intellect does not agree that any one of the Research Milestones
has
been met, Intellect shall notify MRCT within fifteen (15) Business Days from
the
date of delivery of MRCT Deliverable required by said Milestone. Intellect
shall
be deemed to have accepted a particular MRCT Deliverable unless it notifies
MRCT
of any defect or non-conformity within fifteen (15) Business Days after it
receives the particular MRCT Deliverable. On receipt of any such notification,
Intellect and MRCT will each use best efforts to reach agreement on the
clarification and redefinition of the Milestone(s) and (if applicable)
corresponding cost schedule. In the event of a dispute arising under this
Section 3.3, Intellect shall pay the disputed amount to MRCT and payment so
made
will be without prejudice to either party's right to seek resolution of the
dispute under Section 1 1.13, below.
3.4
Except
as
otherwise expressly provided herein or agreed to by the parties in writing,
all
payments hereunder shall be made free and clear of and without deduction or
deferment in respect of any demand, set-off, counterclaim, or other dispute,
and
so far as is legally possible, such payment shall be made free and clear of
any
taxes payable on said payments imposed by or under the authority of government
or any public authority, and, in particular, but without limitation where any
sums due to be paid to MRCT hereunder are subject to any withholding or similar
tax, Intellect shall pay such additional amount as shall be required to ensure
that the net amount received by MRCT hereunder will equal the full amount which
would have been due to MRCT hereunder had no such tax been imposed or required
by law to be withheld, unless said tax is withheld for the benefit of MRCT.
Intellect and, without prejudice to the foregoing, MRCT shall use their best
endeavours to do all such lawful acts and to sign all such lawful documents
as
will enable Intellect to take advantage of any applicable legal provision or
any
double taxation treaty with the object of paying the sums due MRCT without
imposing or withholding any tax.
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ARTICLE
IV -License Grant and Payments
4.1
MRCT
hereby grants to Intellect (i) a non-exclusive worldwide sublicense, with the
right to grant further Sublicenses, under the Licensed Patent Rights to make,
have made, use, import, offer for sale, and/or sell Licensed Products; and
(ii)
an exclusive worldwide licence, with the right to grant Sublicenses, under
the
MRCT IP to make, have made, use, import, offer for sale, and/or sell Licensed
Products.
4.2
Granting
of Sublicenses
(i)
Intellect,
without being required to obtain the consent of MRCT, shall be entitled to
grant
further non-exclusive Sublicenses to its Licensees to make, have made, use,
import, offer for sale, and/or sell Licensed Products.
(ii)
Intellect
undertakes upon the execution of any Sublicense Agreement under sub-section
4.1
(i) above promptly to advise MRCT of the identity of the Sublicensee and nature
of the rights so licensed.
4.3
The
following arrangements shall not require the prior consent of MRCT:
(i)
The
appointment of any person as agent or distributor to market, sell, use, or
otherwise dispose of the Licensed Products in any part of the world.
(ii)
The
subcontracting of manufacture of Licensed Products by Licensee.
4.4
Regulatory
Milestone Payments. In consideration of the rights, privileges and licences
granted herein, Intellect shall pay to MRCT in United States Dollars (US
Dollars) each of the following regulatory milestone payments in respect of
each
Designated Antibody ("Regulatory Milestone Payments"):
[*****]
Each
of
the above Regulatory Milestone Payments shall become due and payable forthwith
upon the corresponding payment becoming due and payable to Intellect by a
development partner or Licensee or, where no such payment is payable to
Intellect, on Intellect first receiving notification from the relevant
regulatory authority of the granting of the Regulatory Approval upon which
it is
contingent, as specified above in this Section 4.2. In the event that each
of
the Designated Antibodies is subject to separate clinical trials the payments
set out in Sections 4.4(i) and (ii) shall be due in respect of each Designated
Antibody. In the event that the Designated Antibodies are tested in the same
clinical trial the payments set out in Section 4.4(i) and (ii) shall be payable
only once.
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4.5
Royalties.
In consideration of the rights, privileges and licence granted herein, Intellect
shall pay to MRCT on a country-by-country, Licensed Product-by-Licensed Product
basis an earned royalty of [*****] of the Net Sales of Licensed Products.
All
royalties payable by Intellect to MRCT shall be paid on a country-by-country
basis from the date of the first Commercial Sale by Intellect, its Affiliates
and/or Licensees of each Licensed Product in each country until ten (10) years
after the first Commercial Sale of the applicable Licensed Product in said
country (the "Royalty Period") provided that any time following such first
Commercial Sale during which the Licensed Product is withdrawn from the market
for any reason shall not count towards such ten year period.
On
a
country-by-country basis and on a Licensed Product-by-Licensed Product basis,
upon the scheduled expiration of the obligation to pay royalties with respect
to
the sale of such Licensed Product in such country, Intellect shall have a fully
paid-up, royalty free, perpetual and irrevocable license to make, have made,
use, import, offer for sale and/or sell Licensed Products in said country.
4.6
Sales
between Intellect, its Affiliates and Licensees shall not be subject to a
royalty, but in such cases the royalty specified in Section 4.2 shall be
calculated upon Intellect's, its Affiliates' and/or Licensees' Net Sales to
independent third parties in arm's-length transactions. An agreement between
Intellect and an Affiliate shall not be a sublicense under the Licensed Patent
Rights. The obligation to pay royalty to MRCT under this Article IV is imposed
only once with respect to the same unit of Licensed Product regardless of the
number of Valid Claims concerning the same.
4.7
Intellect
agrees that any sublicenses under the Licensed Patent Rights granted by it
shall
provide that the obligations owed by Intellect to MRCT under Articles IV, V,
VIII and X of this Agreement (save for Section 8.6, which shall apply only
to
Intellect) shall be reflected in the wording of the sublicense with obligations
no less onerous for the sublicensee than those set forth in this Agreement
with
respect to Intellect which Intellect shall use its best endeavours to enforce
to
the benefit of MRCT in the event of any breach thereof. In particular Intellect
shall ensure that MRCT can monitor payment of all royalties due to it in
consequence of this Agreement.
4.8
Intellect
agrees to forward to MRCT in a timely manner a copy of any and all fully
executed License agreements entered into with any Licensee, and further to
forward to MRCT annually a copy of such reports (or the relevant portions
thereof) received by Intellect from its Licensees during the preceding twelve
(12) month period under the sublicenses as shall be pertinent to a royalty
accounting under said License agreements.
4.9
The
above
Regulatory Milestone Payments and royalties due shall be paid by Intellect
to
MRCT in US Dollars (USD) by electronic transfer to the account of MRCT at
[*****] or such other bank and/or account as may be notified to Intellect by
MRCT from time to time.
4.10
If
a sum
payable under this Agreement shall be overdue for thirty (30) days, Intellect
shall pay MRCT interest on the sum outstanding at the rate of six percent (6%)
per annum above the base rate of the Royal Bank of Scotland plc applying and
calculated on a daily basis from the date that payment became due in respect
of
said sum; provided however, that if such interest rate shall be in excess of
that allowed by applicable law, then the highest rate permitted by law shall
apply. The payment of such interest shall not prevent MRCT from exercising
any
other rights it may have a consequence of the lateness of any payment.
4.11
The
aggregate amount of the Net Sales of the Licensed Products used for computing
the amounts payable hereunder shall be computed in U.S. Dollars, and all royalty
payments shall be made in U.S. Dollars. For purposes of determining the amount
of payments due, the amount of the Net Sales of the Licensed Products in any
foreign currency shall be computed by converting such amounts into U.S. Dollars
at the prevailing commercial rate of exchange for purchasing same quoted in
The
Wall Street Journal, New York edition, on the last Business Day of the period
with respect to which such payment is payable hereunder.
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ARTICLE
V -Reports and Records
5.1
Intellect
shall keep, and shall cause its Affiliates and Licensees to keep, full true
and
accurate books of account containing all particulars that may be necessary
for
the purpose of showing the amounts payable to MRCT pursuant to Sections 4.5,
4.6
and 4.7 above, and the accuracy of the reports made to MRCT hereunder. Such
records shall be retained by Intellect for five (5) years following the end
of
the calendar year to which they pertain. Upon thirty(30) days advance notice
to
Intellect, MRCT shall have the right to direct an independent, certified public
accountant selected by MRCT and reasonably acceptable to Intellect to inspect
Intellect's books of account no more frequently than once per year during
Intellect's normal business hours for the sole purpose of verifying the accuracy
of the reports made to MRCT pursuant to Section 5.2, below. MRCT shall be
responsible for the costs of any such inspection, except in the event that
the
results of the inspection reveal a discrepancy to be corrected in MRCT's favour
of five percent (5%) or more for the period under inspection, in which case
the
entire costs of such inspection shall be paid by Intellect. Any such
discrepancies will be promptly corrected by a payment or refund, as appropriate.
5.2
Intellect,
within ninety (90) days after June 30 and December 31 of each year after
Commercial Introduction, shall deliver to MRCT true and accurate reports, giving
such particulars of the business conducted by Intellect, its Affiliates and
Licensees during the preceding half year as shall be pertinent to a royalty
accounting hereunder. These reports shall include at least the following:
(i)
the
number of Licensed Products manufactured and sold;
(ii)
total
xxxxxxxx for Licensed Products sold on a country-by-country basis;
(iii)
deductions
applicable as provided in Section 1.15, above;
(iv)
the
total
royalties due;
(v)
the
names
and addresses of all Affiliates and Licensees of Intellect under this Agreement.
5.3
With
each
such report submitted, Intellect shall pay to MRCT the royalties due and payable
under this Agreement. If no royalties shall be due, Intellect shall so report.
ARTICLE
VI -Warranties and Representations
6.1
As
of the
Effective Date, each of Intellect and MRCT hereby represents and warrants to
the
other party hereto as follows:
(i)
it
is a
corporation or entity duly organised and validly existing under the laws of
the
state, country or other jurisdiction of its incorporation or
formation;
(ii)
it
has
the power and authority to execute and deliver this Agreement and to perform
its
obligations hereunder;
9
(iii)
the
execution, delivery, and performance by such party of this Agreement and its
compliance with the terms and provisions hereof does not and will not conflict
with or result in a breach of any terms and provisions of or constitute a
default under (a) a loan agreement, guaranty, financing agreement, agreement
affecting a product, or other agreement or instrument binding or affecting
it or
its property, (b) the provisions of its charter or operative documents or
bylaws, or (c) any order, writ, injunction, or decree of any court or
governmental authority entered against it or by which any of its property is
bound;
(iv)
it
has
the full right and authority to enter into this Agreement, and that it is not
aware of any impediment that would inhibit its ability to perform its
obligations hereunder and comply with the terms and conditions imposed on it
by
this Agreement; and
(v)
it
has
the full right, power, and authority to grant all of the rights, including
all
right title and interest in the licences, granted to the other party under
this
Agreement.
6.2
Intellect
acknowledges that it may require licences to third party patents not owned
or
controlled by MRCT in addition to the rights granted under this Agreement.
For
the avoidance of doubt, Intellect hereby accepts and agrees that it has the
sole
responsibility to pursue and enter into any third party licences that may be
necessary for this purpose.
6.3
Except
as
otherwise expressly set forth in Section 6.1 above, MRCT makes no representation
and extends no warranty of any kind, either express or implied, in respect
of
Humanised Antibodies or any information or materials provided to Intellect
hereunder, including, but not limited to, warranties of merchantability, fitness
for a particular purpose, and validity of Licensed Patent Rights claims, issued
or pending, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.
6.4 NOTWITHSTANDING
ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NO PARTY SHALL BE LIABLE TO ANOTHER
PARTY BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION, OR OTHER TERM
OR
ANY DUTY OF COMMON LAW, OR, UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR
ANY
CONSEQUENTIAL, SPECIAL, OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR
LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE, OR OTHERWISE),
AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES,
OR AGENTS OR OTHERWISE.
6.5
Neither
party shall be liable for failure or delay in performing any of its obligations
hereunder, excepting any payment obligations, to the extent such failure or
delay is occasioned by compliance with any governmental regulation, request,
or
order, or by circumstances beyond the reasonable control of the party so failing
or delaying, including, without limitation, Acts of God, war, insurrection,
fire, flood, accident, labour strikes, work stoppage or slowdown (whether or
not
such labour event is within the reasonable control of the parties), or inability
to obtain raw materials, supplies, power, or equipment necessary to enable
such
party to perform its obligations hereunder. Each party shall (a) promptly notify
the other party in writing of any such event of force majeure, the expected
duration thereof, and its anticipated effect on the ability of such party to
perform its obligations hereunder, and (b) make reasonable efforts to remedy
any
such event of force majeure.
ARTICLE
VII -Confidential Information
7.1
Confidentialitv.
During the Term and for a period of five (5) years following the expiration
or
earlier termination hereof, each party shall maintain in confidence Confidential
Information of the other party, and shall not disclose, use or grant to a third
party the right to use any of the Confidential Information of the other party
except on a need-to-know basis to such party's directors, officers and
employees, such party's Affiliates' directors, officers, and employees, and
to
such party's consultants or advisors, to the extent such disclosure is
reasonably necessary in connection with such party's activities as expressly
authorised by this Agreement. To the extent that disclosure to any person,
other
than an employee of a party with a pre-existing confidentiality obligation,
is
authorised by this Agreement, prior to disclosure, the party wishing to disclose
any Confidential Information of the other party shall obtain written agreement
of such person to hold in confidence and not disclose, use, or grant the use
of
the Confidential Information of the other party except as expressly permitted
under this Agreement. Each party shall notify the other party promptly in
writing upon discovery of any unauthorised use or disclosure of the other
party's Confidential Information.
10
7.2
No
party
shall disclose any terms or conditions of this Agreement to any third party
without the prior written consent of the other party; provided, however, that
a
party, without such consent, may disclose the terms or conditions of this
Agreement: (a) on a need-to-know basis to its legal and financial advisors
who
are obligated to maintain such information in confidence, and (b) to a third
party (who is obligated to maintain such information in confidence) in
connection with (i) a prospective equity investment by such third party, which
investment is reasonably expected to be in excess of three percent (3%) of
such
party's market capitalisation at such time, (ii) a merger, consolidation, or
similar transaction by such party, (iii) the sale or licence of all or
substantially all of the assets of such party relating to the subject matter
of
this Agreement, or (iv) a proposed Sublicensee under this Agreement.
Notwithstanding the foregoing, prior to execution of this Agreement, the parties
have agreed upon the substance of information that can be used to describe
the
terms and conditions of this transaction, and each party may disclose such
information, as modified by mutual written agreement of the parties, without
the
consent of the other party.
7.3
The
confidentiality obligations under this Article VII shall not apply (a) to the
extent that a party is required to disclose information by applicable law,
regulation, or order of a governmental agency or a court of competent
jurisdiction, or (b) to the extent necessary to allow Intellect or MRCT (where
possible, with adequate safeguards for confidentiality) to defend against
litigation, to prosecute patent applications, to obtain Regulatory Approvals,
or
as otherwise required under this Agreement; provided, however, except with
respect to such litigation in defence, patent prosecution, and Regulatory
Approvals, or where such disclosure is required pursuant to this Agreement,
such
disclosure shall not occur until the Disclosing Party shall provide written
notice thereof to the other party, consult with the other party with respect
to
such disclosure, and provide the other party sufficient opportunity to object
to
any such disclosure or to request that the Disclosing Party seek confidential
treatment thereof, in which event the Disclosing Party shall use all reasonable
efforts to accommodate the other party's requests and in any event to limit
such
disclosure to the maximum extent possible under the circumstances.
7.4
During
the Term, a party ("Publishing Party") shall submit to the other party
(''Reviewing Party") for review and approval all proposed academic, scientific,
and medical publications and public presentations relating to Licensed Products
for review in connection with preservation of intellectual property rights
andlor to determine whether Confidential Information should be modified or
deleted; provided, however, that after the approval of an academic, scientific,
or medical publication, andlor after an approved public presentation has been
given, then the Publishing Party shall not have to resubmit any such information
for re-approval should it be republished or publicly disclosed in another form.
Written copies of such proposed publications and presentations shall be
submitted to the Reviewing Party not less than fifteen (15) Business Days prior
to submission for publication or presentation and the other party shall provide
comments with respect to such publications and presentations within five (5)
Business Days following its receipt of such written copy. Notwithstanding the
foregoing, no such publication or presentation shall be made until such
publication or presentation has been approved by the Reviewing Party's
respective patent counsel. Intellect and MRCT shall each comply with standard
academic practice regarding authorship of scientific publications and
recognition of contribution of other parties in any publications relating to
Licensed Products.
11
7.5
Each
party agrees that there shall be no public announcement of the execution of
this
Agreement without prior written consent of the other party, which consent shall
not be unreasonably withheld or delayed.
7.6
Upon
termination of this Agreement, the Receiving Party shall promptly return, or
destroy at the Disclosing Party's option, all of the Disclosing Party's
Confidential Information, including all reproductions and copies thereof in
any
medium, except that the Receiving Party may retain one copy for its legal files
for the sole purpose of complying with, and evidencing compliance with the
terms
of this Agreement and any disclosure required by applicable law, regulation,
or
order of a governmental agency or a court of competent jurisdiction.
7.7
If
either
party becomes aware or has knowledge of any unauthorised use or disclosure
of
the other party's Confidential Information, it shall promptly notify in writing
the Disclosing Party of such unauthorised use or disclosure.
ARTICLE
VIII -Term and Termination
8.1
Unless
earlier terminated in accordance with the subsequent Sections of this Article
VIII, the term of this Agreement ("Term") shall commence on the Effective Date
and shall continue on a country-by-country basis until the end of the Royalty
Term in a given country.
8.2
The
Research Collaboration shall commence on the Effective Date and shall conclude
upon the completion of the Research Collaboration, or at such time as mutually
agreed by the parties.
8.3
Either
party may, subject to applicable law and to the provisions set forth herein,
terminate this Agreement by giving the other party written notice of termination
if, at any time, the other party shall: (i) file in any court pursuant to any
statute a petition for bankruptcy or insolvency, or for reorganisation in
bankruptcy, or for an arrangement or for the appointment of a receiver, trustee
or administrator of such party or of its assets; (ii) propose a written
agreement of composition or extension of its debts; (iii) 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;
(iv) propose or be a party to any dissolution; or (v) make an assignment for
the
benefit of its creditors.
8.4
Should
Intellect fail to pay MRCT the sums payable under Article I11 hereof and all
payments due and payable under Article IV hereof, MRCT shall have the right
to
terminate this Agreement sixty (60) days from the date of giving Intellect
written notice to such effect, and unless Intellect shall pay MRCT within the
sixty (60) day period all such undisputed sums, royalties, and interest as
are
due and payable hereunder, thereafter MRCT may, at its sole discretion,
terminate this Agreement, effective immediately upon providing Intellect written
notice to such effect, always provided that either party may refer the matter
to
the English courts in accordance with the provisions of Section 11.12,
below
8.5
Upon
any
material breach or default of this Agreement by either party, other than those
occurrences set out in Sections 8.3 and 8.5, which shall always take precedence
in that order over any material breach or default referred to in this Section
8.6, the non-breaching party shall have the right to terminate this Agreement
and the rights, privileges, and licences granted hereunder ninety (90) days
after providing written notice of such alleged breach to the allegedly breaching
party. If the party alleged to be in breach does not dispute or cure such breach
within such ninety (90) day period, the non-breaching party shall thereafter
have the right to terminate this Agreement, effective immediately on providing
written notice to such effect to the allegedly breaching party. If the party
alleged to be in breach disputes the alleged breach, it shall have the right
to
submit the matter for resolution in accordance with Section 11.13, below, in
which event the ninety (90) day period for curing the alleged breach shall
be
stayed pending completion of any proceedings in respect thereof pursuant to
Section 1 1.12 or 1 1.13, below.
12
8.6
Notwithstanding
any other provision herein, Intellect may terminate this Agreement in its
entirety at any time by giving MRCT three (3) month's prior written notice
and
upon payment of all amounts due to MRCT through the effective date of
termination.
8.7
For
the
avoidance of doubt, this Agreement may be terminated upon mutual written consent
signed by the duly authorised representatives of both parties.
8.8
Upon
expiration or termination of this Agreement for any reason, nothing herein
shall
be construed to release either party from any obligation that matured prior
to
the effective date of such expiration or termination. Intellect and its
Affiliates and Licensees may, however, after the effective date of such
termination, sell all Licensed Products, and complete Licensed Products in
the
process of manufacture at the time of said termination and sell the same,
provided that Intellect shall have paid MRCT in full all research payments
due
under Article I11 hereof and provided that Intellect shall pay to MRCT in full
the royalties due under Article IV hereof and shall submit the reports required
by Article V hereof on the sales of Licensed Products which shall survive said
termination.
8.9
Upon
termination of this Agreement for any reason, but not the expiration of the
same, all cell lines, materials, and information belonging to Intellect,
including, but not limited to Intellect Antibody IN-NO1 and Antibody IN-C02
and
any Humanised Antibodies shall be returned to Intellect within thirty (30)
days
except that, in the event that Intellect shall have failed to pay MRCT in full
the payments required under Sections 3.1 and 3.2 hereof, MRCT reserves the
right
to withhold any materials created during any stage of the Research Plan in
respect of which payment has not been made in full unless an alternative payment
has been agreed by the parties and paid in full pursuant to the provisions
for
early termination set out in Section 8.9, below, and except that MRCT may retain
one sample of all cell lines, materials and information, including laboratory
notebooks, research reports and data, for the purpose of complying with
regulatory requirements or evidentiary requirements in the event of litigation.
Notwithstanding the foregoing, MRCT shall not dispose of any Intellect materials
without first providing reasonable notice to Intellect of its intention to
do
so.
8.10
Intellect
may terminate this Agreement at any time in respect of the Research Plan
specified in Annex A on one (1) month's prior written notice to MRCT, except
that Intellect shall not be permitted to terminate the Research Collaboration
prior to completion of Milestone 1 (at Annex A), and provided that if Intellect
for any reason terminates this Agreement during any subsequent stage of the
Research Collaboration (i.e., before completion of Milestone 2 or 3 at Annex
A),
then Intellect shall pay MRCT for that stage forthwith when such termination
by
Intellect pursuant to this Section 8.9 takes effect. MRCT shall use its
reasonable endeavours to mitigate and reduce the costs borne by it in respect
of
the incomplete stage. Unless Intellect has terminated this Agreement as provided
hereunder, Intellect shall be deemed to have approved the commencement of each
stage of the Research Collaboration specified in Annex A without intermission
on
the completion of the previous stage, unless Intellect specifically notifies
MRCT of its intention to terminate this Agreement. Said completion shall not
be
deemed conditional upon Intellect agreeing that the relevant Milestone has
been
met.
8.11
The
right
of either party to terminate this Agreement shall not be affected in any way
by
its waiver of or failure to take action with respect to any previous
default.
8.12
Termination
of this Agreement for any reason shall be without prejudice to any party's
right
to receive all payments to which such party is entitled under this Agreement
and
obtain performance of any obligations provided for in this Agreement which
survive termination by their terms or by fair interpretation of this Agreement;
and any other remedies which any party may then or thereafter have
hereunder.
13
ARTICLE
IX –Patents
9.1
Any
and
all patents and patent applications in respect of MRCT Inventions or relating
to
the production of antibodies other than Humanised Antibodies hereunder shall
be
owned by MRCT, which shall have the sole right to prosecute such applications
and patents and will meet all costs in relation thereto. Intellect will assign
and hereby does assign any and all rights as necessary to vest such ownership
of
MRCT Inventions and MRCT IP in MRCT and cause its employees, officers, and
agents to execute any necessary documents for such assignment.
9.2
Any
and
all patents and patent applications in respect of Intellect Inventions or
relating specifically to Humanised Antibodies and their use shall be owned
by
Intellect, which shall have the sole right to prosecute such applications and
patents and will meet all costs in relation thereto. MRCT will assign and hereby
does assign any and all rights as necessary to vest such ownership of Intellect
Inventions and Intellect IP in Intellect and cause its employees, officers,
and
agents to execute any necessary documents for such assignment.
9.3
The
parties shall consult and co-operate fully on patent filings pursuant to
Sections
9.1
and
9.2, which consultation and co-operation shall not delay timely filing of patent
applications by either party. Each party shall assist the other in the
prosecution of patent applications and patents arising from the Research
Collaboration. Each party shall supply the other in a timely manner with copies
of relevant prosecution-related documents.
9.4
The
parties shall cooperate, if necessary and appropriate, with each other in
gaining patent term extensions, including, without limitation, supplementary
protection certificates, and any other extensions that are now available or
become available in the future wherever applicable to MRCT Inventions and/or
Intellect Inventions covering Licensed Products or any process relating to
the
manufacture thereof or any element thereof. The parties shall, if necessary
and appropriate, use reasonable efforts to agree upon a joint strategy relating
to patent term extensions, but, in the absence of mutual agreement with respect
to any extension issue, a patent shall be extended if a party elects to extend
such patent. All filings for such extension shall be made by the party to whom
the patent is assigned; provided, however, that in the event that MRCT elects
not to file for an extension, MRCT shall (i) inform Intellect of its intention
not to file and (ii) effective immediately upon such election, hereby grants
Intellect the right to file for such extension.
9.5
For
the
avoidance of doubt, it is hereby stated that Intellect will not assert any
of
its claims to intellectual property arising out of the Research Collaboration
pursuant to this Agreement against MRCT in a manner which would inhibit MRCT's
freedom to work in the general area of antibody engineering and production
excluding Humanised Antibodies. During the term of this Agreement, MRCT will
not
assert MRCT IP or Licensed Patent Rights or any of its claims to intellectual
property arising out of the Research Collaboration against Intellect in a manner
which would prevent Intellect from making, having made, using, offering for
sale, selling, importing, or otherwise commercialising any Hurnanised Antibody
produced hereunder.
ARTICLE
X -Infringement
10.1
Third
Partv Infringement of the Licensed Patent Rights
(i)
If
either
party becomes aware of any infiingement of the Licensed Patent Rights by a
third
party, such party shall promptly notify the other party of the infringement
in
writing and provide a summary of the relevant facts and circumstances known
to
such Party relating to such infringement. Intellect shall not notify any third
party of the infringement of any of the Licensed Patent Rights without first
obtaining the written consent of MRCT.
14
(ii)
The
parties will cooperate to the extent possible and MRCT shall consult with its
licensor in order to determine the course of action.
10.2
Third
Party Infringement of Intellectual Property Rights. Each party shall have the
right, at its sole discretion, on its own behalf and expense, to institute,
prosecute, and control any action or proceeding to restrain infringement by
a
third party of any of its rights in respect of Inventions, know-how, and
intellectual property owned by such Party.
ARTICLE
XI –Miscellaneous
11.1
Any
notice required to be given hereunder shall be deemed given if communicated
in
the English language and delivered to the party to be notified at its address
shown below or at such other address as may be furnished from time to time
by
the party to be notified to notifying party in writing either (a) by registered
air mail, postage prepaid, which notice shall be effective five (5) days after
the date of mailing or (b) in person, by telefax (with proof of transmission
and
confirmation by first class mail postage paid) or overnight courier, which
notice shall be effective on the Business Day immediately following the date
of
such delivery.
If
to
Intellect Neurosciences:
Address:
0 Xxxx 0 0xxXxxxxx,
Xxx
Xxxx,
XX 00000
Attention:
Chief Executive Officer
If
to
MRCT:
MRC
Technology
0-0
Xxxxxxxxxx Xxxx,
Xxxx
Xxxx,
Xxxxxx,
XX0 0XX. U.K
Attention:
Chief Executive Officer
11.2
Each
of
the parties shall contribute, to the extent reasonable, facilities, supplies,
personnel, and other resources without charge or expense to the other as may
be
necessary for proper performance of the respective obligations under this
Agreement and that are consistent with Annex A. To the extent reasonable and
except as may otherwise be expressly provided, each party shall bear its own
out-of-pocket costs and disbursements incurred in the performance of this
Agreement.
11.3
Nothing
contained in this Agreement, or otherwise, shall constitute the parties as
partners with one another or render either liable for the debts or accounts
of
the other. Furthermore, nothing in this Agreement shall be construed to
constitute, create, give affect to or otherwise imply ajoint venture or formal
business organisation of any kind.
11.4
Intellect
agrees to indemnify and hold harmless MRCT, and its respective officers,
employees, and agents from and against any and all claims, damages, and
liabilities asserted by third parties arising from the manufacture, use, or
sale
by Intellect, its Affiliates andlor its Licensees, or by any other party
authorised by Intellect, its Affiliates or its Licensees, of Licensed Products
and services licensed under this Agreement or the use thereof by others, except
to the extent that such claims, damages or liabilities arise from the gross
negligence or willful misconduct of MRCT.
15
11.5
This
Agreement and the rights and licence granted herein shall be binding upon and
shall inure to the benefit of successors of the parties hereto, or to an
assignee of all of the goodwill and entire business and assets of a party
hereto, but shall not otherwise be assignable without the prior written consent
of the other party, which consent will not be unreasonably withheld but shall
be
conditional, inter alia, upon the formal acceptance by the assignee of the
payment obligations and terms and conditions of this Agreement.
11.6
The
parties hereto acknowledge that this Agreement, including Exhibit A, Annex
A and
Annex B attached hereto, sets forth the entire Agreement and understanding
of
the parties hereto as to the subject matter hereof, and shall not be subject
to
any change or modification except by the execution of a written instrument
subscribed to by the parties hereto.
11.7
The
failure of any party to exercise or enforce any right granted in this Agreement
shall not be deemed to be a waiver of such right or operate to bar the exercise
of enforcement thereof at any time or times thereafter.
11.8
Except
where required by law, neither party shall use the name of any other party
or
make specific reference to the terms of this Agreement in any press release,
advertisement or other public statement without the prior written consent and
approval of the other party.
11.9
The
provisions of this Agreement are severable, and in the event that any provisions
of this Agreement shall be determined to be invalid or unenforceable under
any
controlling body of the law, such invalidity or unenforceability shall not
in
any way affect the validity or enforceability of the remaining provisions
hereof.
11.10
All
headings herein are for convenience only, and shall not be interpreted as having
any substantive effect.
11.11
This
Agreement shall be construed, governed, interpreted, and applied in accordance
with the laws of England, except that questions affecting the construction
and
effect of any patent shall be determined by the law of the country in which
the
patent was granted. Any and all disputes between the parties relating to the
interpretation, implementation, or application of this Agreement, or any other
matter in connection with it, shall be subject to the exclusive jurisdiction
of
the English courts.
11.12
Except
with respect to breaches of Articles IV, V, VII or X, if there is any dispute
between the parties relating to the interpretation, implementation, or
application of this Agreement,
or any other matter in connection with it, they will first attempt in good
faith
to negotiate a settlement. If the matter is not resolved by negotiation, the
parties will refer the dispute to mediation in accordance with CDR (Centre
for
Dispute Resolution, London) procedures ("ADR"). If the parties fail to agree
on
a settlement within 28 days of the initiation of the ADR procedure, either
party
may refer the matter to the English courts in accordance with the provisions
of
Section 11.11, above.
11.13
The
terms
of Sections 3.1 and 3.2, and Articles IV, V, VII, and XI shall survive the
expiration or termination for any reason of this Agreement and continue for
as
long as necessary to permit their full discharge.
11.14
This
Agreement may be signed in two (2) counterparts, each of which shall be deemed
an original, with the same effect as if the signatures thereto and hereto were
upon the same instrument.
*
* * *
*
16
IN
WITNESS THEREOF, the parties hereto have caused this Agreement to be duly
executed in duplicate by their authorised officers effective as of the date
first written above.
Signed:-For
and on behalf of MRC Technology.
|
By
:
|
|
|
Name:
|
|
|
Title:
|
Xxxxx Xxxxx
|
|
Director Licensing and Agreements
|
|
|
Medical Research Council Technology
|
Signed:-For and on
behalf of Intellect Neurosciences
|
By:
|
|
|
Date:
|
17
|
MRCT
|
CONFIDENTIAL
|
EXHIBIT
A
|
|
Inventor:
|
Xxxxxxx
Xxxx Winter
|
|
Applicant:
|
Medical
Research Council
|
|
Title:
|
Recombinant
DNA Products and Methods
|
|
UK
Priority Application:
|
UK
PA 8607679 (27.03.86)
|
Final
Application
|
Territory
|
Application
number
(Publication
number)
*(Patent
number)
|
|
Date
of filing
(Publication
date)
(Expiry
date)
*(Grant
date)
|
|
|
UK
|
8707252
|
26.03.87
|
||
|
(GB
2188638A)
|
(7.10.87)
|
|||
|
*(GB
2188638B)
|
*(23.05.90)
|
|||
|
EUROPE
|
87/02620.7
|
26.03.87
|
||
|
Austria,
Belgium,
|
(EP
0239400A)
|
(30.09.87)
|
||
|
France,
Germany,
|
*(239400)
|
*(03.08.94)
|
||
|
Greece,
Italy, Liechtenstein,
|
(25.03.2007)
|
|||
|
Luxembourg,
Netherlands,
|
||||
|
Spain,
Sweden,
|
||||
|
Switzerland)
|
||||
|
CANADA
|
533071
|
26.03.87
|
||
|
*(1,340,879)
|
*(25.01.2000)
|
|||
|
(24.01.2017)
|
||||
|
USA
(Parent) 07/782717
|
25.10.91
|
(continuation
of
|
||
|
903776
filed 04.09.86)
|
||||
|
*(5,225,539)
|
*(06.07.93)
|
|||
|
(05.07.2010)
|
||||
|
USA
(Continuation-in-part)
|
08/452,000
|
00.00.00.
|
||
|
(Continuation
application
|
||||
|
derived
from continuation- in-part 07/189814
|
||||
|
filed
03.05.88)
|
||||
|
*(6,548,640)
|
*(15.04.2003)
|
|||
|
(07.12.2015)
|
||||
|
JAPAN
|
73970/00
|
00.00.00
|
||
|
(296890/87)
|
(24.12.87)
|
|||
|
*(2912618)
|
*(09.04.99)
|
|||
|
(26.03.2007)
|
||||
18
Exhibit
A-1
|
MRCT
|
CONFIDENTIAL
|
EXHIBIT
A
|
|
Title
|
Multichain
Polypeptides or Proteins and Processes for their
Production
|
|
Subject
Matter:
|
Expression
of multichain proteins, such as antibodies, in single host
cells
|
|
Inventors
|
Xxxxxxx
Xxxx Xxxx
|
|
Xxxx
Xxxxx Xxxxxx
|
|
|
Xxxx
Xxxxxxx Xxxxxx
|
|
|
Xxxxx
Xxxx Xxxx
|
|
Priority
Applications Date:
|
25
March 1983
|
|
Earliest
Publication Date/No:
|
27
September 1984/W0841037 12
|
|
Territory
|
Application
Date
|
Application
No.
|
Patent
No
|
Expiry
Date
|
||||
|
*Europe
|
23.03.84
|
84301966.9
|
0120694
|
23.03.04
|
||||
|
*Europe
(divisional)
|
23.03.84
|
|
92202982.2
|
|||||
|
Japan
|
23.03.84
|
501609/84
|
2594900
|
23.03.04
|
||||
|
Japan
(divisional)
|
23.03.84
|
228332/94
|
3186463
|
23.03.04
|
||||
|
Japan
(divisional)
|
23.03.84
|
000000/00
|
||||||
|
Xxxxx
(divisional)
|
23.03.84
|
2001-063448
|
||||||
|
USA
(divisional 1)
|
23.04.84
|
08/320381
|
||||||
|
USA
(divisional 2)
|
23.04.84
|
08/450727
|
||||||
|
USA
(divisional 3)
|
23.04.84
|
08/453449
|
||||||
|
USA
(divisional 4)
|
23.04.84
|
08/452420
|
||||||
|
United
Kingdom
|
23.03.84
|
8407571
|
213763 | 23.03.04 |
* includes:
Austria, Belgium, France, Germany, Italy, Liechtenstein, Luxembourg,
Netherlands, Sweden,
Switzerland, and United Kingdom.
19
Exhibit
A-2
|
CONFIDENTIAL
|
ANNEX
A
|
Research
Plan for the Humanisation of the IN-NO1 and IN-C02 Mouse Monoclonal
Antibodies
A.
Humanisation
of Mouse Antibody IN-NO 1:
Al.
Project
Milestone 1: [*****]
[*****]
A2.
Project
Milestone 2: [*****]
[*****]
Annex
A-3
|
CONFIDENTIAL
|
ANNEX
A
|
A3.
Project
Milestone 3: [*****]
[*****]
B.
Humanisation
of Mouse Antibody IN-C02:
B
1. Project
Milestone 4: [*****]
[*****]
B2.
Project
Milestone 5: [*****]
[*****]
Annex
A-4
|
CONFIDENTIAL
|
ANNEX
A
|
B3.
Project
Milestone 6: [*****]
[*****]
Annex
A-5
ANNEX
B
Payment
Terms for Antibody IN-NO1
[*****]
20
Payment
Terms for Antibody IN-CO1
[*****]
Payments
Schedule
The
payments specified in Annex A and Annex B (Payment Terms) above will be invoiced
to Intellect, and paid in British Pounds (UKE) as provided in the Agreement,
according to the following schedule:-
Antibody
IN-NO 1
|
Contract
Signature:
|
[*****]
|
|
Milestone
1 completion:
|
[*****]
|
|
Milestone
2 completion:
|
[*****]
|
|
Milestone
3 completion:
|
[*****]
|
|
Total Contract Payments
for Antibody IN-NO1:
|
[*****]
_________________
|
|
Antibody
IN-C02
|
|
|
Receipt
of Intellect Deliverable:
|
[*****]
|
|
Milestone
4 completion:
|
[*****]
|
|
Milestone
5 completion:
|
[*****]
|
|
Milestone
6 completion:
|
[*****]
|
|
Total
Contract Payments for Antibody IN-C02:
|
[*****]
|
Annex
B-6
21
