[Confidential treatment has been requested for portions of this Exhibit. The
confidential portions have been redacted and are denoted [***]. The confidential
portions have been separately filed with the Commission.]
MEDICAL RESEARCH COUNCIL
- and -
ALEXION PHARMACEUTICAL INC.
L I C E N S E
for
Winter Patent
THIS AGREEMENT is made the 27th day of March One thousand nine hundred and
ninety six between MEDICAL RESEARCH COUNCIL of 00 Xxxx Xxxxxxxx, Xxxxxx XXX 0XX
(hereinafter called "MRC" which expression includes its successors and assigns)
of the one part and ALEXION PHARMACEUTICALS, INC. of 00, Xxxxxxx Xxxx, Xxxxx
000, Xxx Xxxxx, Xxxxxxxxxxx 00000, XXX (hereinafter called "THE LICENSEE" which
expression includes its successors and permitted assigns) of the other part.
W H E R E A S:
MRC is the proprietor of certain patent rights in respect of the genetic
engineering of monoclonal antibodies comprising the replacement in whole or in
part of the complementary determining regions of one antibody by those of
another.
NOW IT IS HEREBY AGREED as follows:
1. Definitions
(1) IN this Agreement the following words and expressions shall be
construed as follows:
'THE EFFECTIVE DATE' shall mean the date specified above.
-2-
"THE RESHAPING PROCESS" shall mean the [***].
"THE PRODUCTS" shall mean end products produced either directly or
indirectly from antibodies which have been modified using the Reshaping
Process and which are in a form capable of being marketed or sold upon a
commercial basis.
"AFFILIATE" shall mean any corporation, company, partnership or other
entity which directly or indirectly controls, is controlled by or is under
common control with either party to this Agreement.
"CONTROL" means the ownership of more than 50% of issued share capital or
the legal power to direct or cause the direction of the general management
and policies of the party in question.
"FIELDS" [***].
"NET RECEIPTS" shall mean all monies received by Licensee in respect of the
sale of the Products, less the following items to the extent that they are
paid or allowed and included in the invoice price:
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normal discounts actually granted;
credits allowed for Products returned or not accepted by customers;
packaging, transportation and prepaid insurance charges on shipments
or deliveries to customers;
taxes actually incurred and paid by Licensee in connection with the
sale or delivery of Products to customers.
"THE WINTER PATENT" shall mean the patents and applications therefor set
out in Schedule I hereto and any divisions, renewals, continuations,
extensions or reissues thereof and any patent granted thereon.
"THE BOSS PATENTS" shall mean the patents and patent applications therefore
set out in Schedule 3 hereto in [***] and any patent granted on such
patent applications including but without prejudice to the generality of
the foregoing author certificates, inventor certificates, improvement
patents, utility certificates and models and certificates of addition and
including any divisions, renewals, continuations, extensions or reissues
thereof.
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(2) IN this Agreement the singular shall where the context so permits
include the plural and vice versa.
2. Commencement
THIS Agreement shall be deemed to have come into force on the Effective
Date and shall be read and construed accordingly.
3. Grant of Rights
(1) MRC agrees to grant to the Licensee the following licenses under the
Winter Patent:
(i) a non-exclusive world-wide license to exploit the Winter Patent
commercially in any way whatsoever by the use of the Reshaping
Process in the Fields and by the commercial exploitation in the
Fields of any resulting antibodies provided always that any such
exploitation does not involve the antibodies detailed in the
Second Schedule hereto;
(ii) a non-exclusive sub-license under the Boss Patents to the extent
required to enable the licensee to use the Reshaping Process in
-5-
accordance with (i) above to produce Products from mammalian
cells and for no other purpose.
(2) The Licensee shall not be entitled to grant sub-licenses of the rights
granted to it under this Agreement except with the prior written
consent of MRC. Such consent shall not be unreasonably withheld or
delayed to requests to sublicense rights to the Winter Patent in
respect of antibodies modified by the Licensee itself using the
Reshaping Process. MRC and Licensee acknowledge that it is not the
intention that Licensee should offer a contract service to third
parties in the use of the Reshaping Process. In cases where MRC gives
consent to the grant of a sublicense under the Winter Patent MRC shall
also not unreasonably withhold consent from requests by Licensee for
MRC to grant to the sublicensee a sublicense under the Boss Patent, in
accordance with the limitations specified in Clause 3 (1) (ii) above
and restricted to the modified antibodies sublicensed by Licensee. The
Licensee shall use its best endeavors to ensure that any sub-licensee
performs its obligations under any such sub-license.
(3) The following arrangements shall not require the prior consent of MRC:
(i) The appointment of any person as agent or distributor to market
sell use or otherwise dispose of the Products in any part of the
world.
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(ii) The sub-contracting of the development of new Products for the
Licensee .
(iii) The sub-contracting of manufacture for the Licensee of Products
or intermediates for Products.
4. Payments
(1) IN CONSIDERATION for the non-exclusive license granted pursuant to
Clause 3.1 hereof the Licensee shall pay to MRC the sum of [***] upon
signature of this Agreement.
(2) IN FURTHER consideration of the licenses granted by MRC to Licensee
under this Agreement, Licensee shall pay to MRC a royalty at the rate
of [***] of Net Receipts on all sales of Products by Licensee or any
Affiliate where the Products are either manufactured and/or sold in a
country where the Winter and/or the Boss Patent is granted valid and
subsisting at the date of such sale. The royalty payments shall be
exclusive of any applicable value added tax ("VAT").
(3) If MRC shall hereafter license another party under the Winter Patents
in the Fields at a lower royalty rate than is payable by Licensee by
virtue of
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this license agreement, or with another substantial term more
favorable to such party than the corresponding term of this license
agreement, then Licensee shall have an option to convert this license
agreement so that the royalty rate payable thereunder. or other
corresponding term, is the same as the rate of term that applies to
the third party; PROVIDED that if the third party's license imposes
upon that party any other obligation (including any restriction as to
product or territory) which is associated with that party's operations
as patent licensee and which is more onerous than an obligation of
corresponding category on the part of Licensee under this agreement,
then any exercise of the option by Licensee shall operate so that
Licensee assumes an obligation as patent licensee corresponding to
such other obligation of the third party, either as a substitute in
place of Licensee's obligation(s) of corresponding category, or if
there is no such obligation or corresponding category, then as an
additional obligation.
This clause shall not entitle a Licensee to a license in respect of
any of the restricted antibodies set out in Schedule 2.
(4) Licensee agrees to keep true and accurate records and books of account
containing all data necessary for the calculation of the royalties
payable to MRC under Clause 4(2). Such records and books of account
shall upon reasonable notice having been given by MRC be open at all
reasonable
-8-
times during business hours for inspection by MRC or its duly
authorized representative.
(5) Licensee shall prepare a statement in respect of each calendar quarter
of this Agreement which shall show for the calendar quarter in
question Licensee's Net Receipts on sales by it of the Products on a
country by country basis. details of the quantities of Products
manufactured and sold in each country and the royalty and, if
applicable, VAT due to MRC thereon pursuant to Clause 4(2) above. Such
statement shall be submitted to MRC within 60 days following the end
of the calendar quarter or part thereof to which it relates together
with a remittance for the royalties and, if applicable, VAT due to
MRC. If MRC shall give notice to Licensee within 30 days of the
receipt of any such statement that it does not accept the same such
statement shall be certified by an independent chartered accountant
appointed by agreement between the parties or, in default of agreement
within 14 days, by the President for the time being of the Institute
of Chartered Accountants of England and Wales in London. Licensee
shall make available all books and records required for the purpose of
such certification at reasonable times during normal business hours
and the statement so certified shall be binding between the parties.
The costs of such certification shall be the responsibility of MRC if
the certification shows the original statement to have been accurate
(i.e. the certification shows a deficiency of 5% or less of the total
amount in fact
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payable by the Licensee) and otherwise shall be the responsibility of
Licensee. Following any such certification the parties shall make any
adjustments necessary in respect of the royalties already paid to MRC
in relation to the year in question.
(6) The Licensee shall pay royalties to MRC 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 imposed by or under the authority
of any government or public authority and in particular but without
limitation where any sums due to be paid to MRC hereunder are subject
to any withholding or similar tax, the Licensee shall pay such
additional amount as shall be required to ensure that the net amount
received by MRC hereunder will equal the full amount which would have
been received by it had not such tax been imposed or withheld. The
Licensee and, without prejudice to the foregoing, MRC shall use their
best endeavors to do all such lawful acts and things and to sign all
such lawful deeds and documents as will enable the Licensee to take
advantage of any applicable legal provision or any double taxation
treaties with the object of paying the sums due to MRC without
imposing or withholding any tax.
-10-
Sums are expressed in this agreement as exclusive of VAT. MRC agrees
to provide Licensee with a VAT invoice in respect of every payment
affected by VAT.
(7) Where MRC does not receive payment of any sums due to it within the
period specified hereunder in respect thereof interest shall accrue on
the sum outstanding at the rate of 1% per month calculated on a daily
basis without prejudice to MRC right to receive payment on the due
date therefor.
5. Term and Termination
(1) SUBJECT as hereinafter provided this Agreement and the licenses
granted pursuant thereto shall continue in force in each territory
during the subsistence of the last to expire of the Winter or Boss
Patents.
(2) MRC may terminate this Agreement and the said licenses forthwith by
notice to the Licensee to that effect upon the happening of any of the
following events:
(A) if the Licensee fails to perform or observe any of the
obligations on its part to be performed or observed and if the
breach is one
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capable of remedy has not been remedied within three (3) months
of the giving of a notice informing the Licensee of such breach;
(B) if the Licensee files a voluntary petition in bankruptcy or
applies to any Tribunal for a Receiver Trustee or similar officer
to be appointed by any Court or Executive Department to liquidate
or conserve the Licensee or any substantial part of its property
or assets due to insolvency or to the threat thereof or if the
Licensee suffers any trusteeship or receivership to continue
undischarged for a period of sixty days or suffers any similar
procedure for the relief of distressed debtors entered into by
the Licensee voluntarily or involuntarily or if the Licensee is
otherwise divested of its assets for a period of sixty days or
makes a general assignment for the benefit of its creditors;
(3) The Licensee may terminate this Agreement and the Licenses granted
pursuant hereto by giving to MRC 6 months notice to that effect if the
Licensee considers that substantial unlicensed competition is
seriously interfering with Licensee's exploitation of the Reshaping
Process under this Agreement and that MRC is not taking appropriate
steps to seek to prevent or reduce such unlicensed competition. Such
termination shall be without prejudice to the right of MRC to enforce
the Winter Patents in the event of subsequent manufacture of Products
by the Licensee.
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(4) TERMINATION of this Agreement or of the said Licenses shall be without
prejudice to any rights of either party against the other which may
have accrued up to the date of such termination and the Licensee shall
pay to MRC the appropriate royalties hereunder on all stocks of the
Products (on which royalties have not already been paid) held at the
date of termination by the Licensee or any person engaged by the same
to manufacture the Products and shall thereafter be free to sell such
products on which royalty has been paid.
6. Warranties
(1) MRC hereby represents and warrants that MRC owns the Winter Patents or
is otherwise authorized to license the Winter Patents to the Licensee.
(2) MRC hereby represents and warrants that MRC is entitled or authorized
to grant a sub-license under the Boss Patents in conjunction with a
license to the Licensee to use the Reshaping Process for the
production of Products from mammalian cells and for no other purpose.
(3) NOTHING in this Agreement or in any licenses to be granted pursuant
thereto shall be construed as a representation or warranty that any of
the said Patents are valid or that any manufacture use sale or other
disposal
-13-
of the Products is not an infringement of any patents or other rights
not vested in the MRC.
(4) THE Licensee shall promote the sale of the Products of good marketable
quality and shall use reasonable endeavors to meet the market demand
therefore.
7. Infringement
IF the Licensee becomes aware of a suspected infringement of the Winter
Patents it shall notify MRC giving full particulars thereof. If the alleged
infringement consists of any act which (if done by the Licensee) would be
within the scope of the licenses granted under this Agreement MRC and the
Licensee shall (within a reasonable time of the said notification) consult
together with a view to agreeing upon a course of action to be pursued.
8. Waiver
THE waiver by MRC of any breach default or omission in the performance or
observance of any of the terms of this Agreement by the Licensee shall not
be deemed to be a waiver of any other such breach default or omission.
-14-
9. Notices
ANY notice consent or other communication authorized or required to be
given hereunder or for the purposes hereof shall be in writing and be
deemed to be duly given to MRC if left at or sent by recorded delivery or
registered post addressed to its principal office and to the Licensee if
left at or sent by recorded delivery or registered post to its principal
place of business. Any such notice consent or other communication if served
by post shall be deemed to have been given at the time when it would have
been received in due course of the post.
10. Non-assignability
Save for an assignment to an Affiliate of the Licensee, the Licensee shall
not be entitled to assign the benefit of this Agreement or any rights
granted or to be granted under the Agreement.
11. Law and Jurisdiction
THIS Agreement is to be read and construed in accordance with and governed
by the Laws of England so far as the subject matter allows and the parties
hereby submit to the jurisdiction of the English courts in relation to any
dispute arising out of this Agreement.
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IN WITNESS whereof the parties hereto have caused this Agreement to be
executed in the matter legally binding upon them by causing authorized
representatives to sign this Agreement.
MEDICAL RESEARCH COUNCIL ALEXION PHARMACEUTICALS, INC.
Signed:_____________________________ _____________________________
Name and Position:
_____________________________ _____________________________
_____________________________ _____________________________
Date: _____________________________ _____________________________
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SCHEDULE ONE above referred to
Inventor: [***]
Applicant: [***]
Title: [***]
UK Priority Application: [***]
Final Application
Territory Application number Date of filing
(Publication number) (Publication date)
*(Patent number) (Grant date)
--------------------------------------------------------------------------------
[***]
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SCHEDULE TWO above referred to
ANTIBODIES EXCLUDED FROM THE LICENSE
[***]
-18-
SCHEDULE THREE above referred to
Title: [***]
Subject matter: [***]
Inventors: [***]
[***]
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