Exhibit 10.1
PATENT LICENCE
AGREEMENT
(ADAIR PATENT
RIGHTS)
(MEDI-493)
between
CELLTECH THERAPEUTICS
LIMITED
and
MEDIMMUNE INC.
THIS AGREEMENT is made the 19 day of
January 1998
BETWEEN
1.
CELLTECH THERAPEUTICS LIMITED
(registered in England No. 1472269) whose principal place of
business is at 216 Bath Road, Slough, Berkshire SL1 4EN, England
(“Celltech”); and
2.
MEDIMMUNE INC. of 35 West Watkins
Mill Road, Gaithersburg, MD 20878, USA
(“Licensee”).
WHEREAS
A.
Celltech claims John Robert Adair,
Diljeet Singh Athwal and John Spencer Emtage whilst employees of
Celltech in or about December 1989 developed certain processes
and products in the field of genetic engineering of monoclonal
antibodies which are the subject of the Adair Patent Rights,
and
B.
Celltech has filed and prosecuted
patent applications and/or been granted patents in the Patent
Offices of the United Kingdom and elsewhere in respect of such
processes and products, and
C.
Celltech wishes to grant and the
Licensee wishes to accept a licence under the Adair Patent Rights
on the terms set out below.
NOW IT IS HEREBY AGREED as follows:
1.
DEFINITIONS
In this Agreement the following
words and phrases shall have the following meanings unless the
context otherwise requires:
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1.1
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“Adair Patent Rights”
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shall mean the Patent Rights short particulars
of which are set out in Schedule 1 hereto and sometimes
referred to collectively or individually as “the Adair
Patent”.
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1.2
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“Affiliate”
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shall mean any company, partnership or other
entity which directly or indirectly Controls, is Controlled by or
is under common Control with the relevant party to this
Agreement.
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1.3
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“Control”
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shall mean ownership of more than 50%
of the issued share capital or the legal power to
direct or cause the direction of the general management and
policies of the party in question.
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1.4
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“Commencement Date”
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shall mean the date hereof;
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1.5
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“Field”
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shall mean the field of human therapy and
prophylaxis.
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1.6
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“Net Receipts”
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shall mean all monies received by or on behalf
of the Licensee or by or on behalf of its sub-licensees in respect
of the sale of Product(s), less the following items to the extent
that they are paid or allowed and included in the invoice
price:
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i)
normal discounts actually
granted;
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ii)
credits allowed for Products
returned or not accepted by customers: disallowed
reimbursements;
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iii)
packaging, transportation and
pre-paid insurance charges on shipments or deliveries to
customers;
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iv)
sales, customs, and excise taxes
actually incurred and paid by the Licensee or its sub-licensees in
connection with the sale or delivery of Product to
customers.
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Upon any sale or other disposal of Product by or
on behalf of Licensee or its sub-licensee other than a bona fide
arms length transaction exclusively for money or upon any disposal
of the Product for purposes which do not result in a disposal of
such Product in consideration of sales revenue customary in the
country of use, such sale, other disposal or use shall be deemed to
constitute a sale at the then current maximum selling price in the
country in which such sale, other disposal or use
occurs.
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For the avoidance of doubt, the supply of
Product free of charge for use in clinical studies or to third
parties for research evaluation purposes shall not be included in
this provision.
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1.7
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“Patent Rights”
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shall mean patent applications or patents,
inventor certificates, utility certificates, improvement patents
and models and certificates of addition and includes any divisions,
renewals, continuations, extensions or re-issues thereof anywhere
in the Territory and supplementary protection
certificates.
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1.8
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“Product”
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shall mean antibodies or fragments thereof or
any formulation containing the same of which the Licensee is the
proprietor or is otherwise licensed to develop, make, have made,
use or sell, and which bind to the respiratory syncitical virus
(MEDI-493).
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1.9
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“Territory”
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shall mean worldwide.
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1.10
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“Valid Claim”
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shall mean a claim of an issued, unexpired
patent included within the Adair Patent Rights which has not been
held invalid or unenforceable in an unappealed or unappealable
decision of a court or competent body having jurisdiction
thereof.
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2.
GRANT OF
RIGHTS
2.1
Celltech hereby grants to the
Licensee with effect from the Commencement Date a non-exclusive
licence under the Adair Patent Rights to develop, make, have made,
use and sell Products in the Field and Territory;
2.2
Licensee shall be entitled to
sublicense the rights granted in clause 2.1 on terms which are
subject and subordinate to the terms of this Agreement and at least
14 days prior to the execution of any sublicence, Licensee shall
give written notice to Celltech of the identity of the sublicensee
together with details of the antibody covered by the sublicence and
Licensee shall provide Celltech with a redacted copy (excluding
financial and other relevant terms) of any sub-licence granted
pursuant to this Clause 2.2 promptly after its
execution.
3.
PAYMENT
3.1
In consideration of the Licences
granted in clause 2 the Licensee shall pay to Celltech an initial
sum of [***] against Celltech’s invoice to be issued on the
Commencement Date.
3.2
In further consideration of the
licenses granted in Clause 2 the Licensee shall pay to Celltech
annually upon each anniversary of the Commencement Date [****]
which amount may be offset in each year up to a maximum of [***]
against up to half the amount of any royalties payable under Clause
3.3 by the Licensee in the same year.
3.3
In further consideration of the
licences granted in Clause 2 the Licensee shall pay to Celltech a
royalty at the rate of [***] of Net Receipts from all Products sold
where the manufacture or sale of the Product in a country of the
Territory would, but for the licence granted hereby, infringe a
Valid Claim.
3.4
Payments due under Clause 3.3 shall
be made within 30 days of the end of each calendar quarter in
respect of royalties accruing on Net Receipts during
that
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calendar quarter. Payments due
under Clause 3.2 shall be made within 30 days of each anniversary
of the Commencement Date.
3.5
All payments due under this
Agreement:
3.5.1
are exclusive of any Value Added Tax
or similar tax which shall be payable in addition by the
Licensee.
3.5.2
shall be made in pounds sterling or
to the credit of a bank account to be designated in writing by
Celltech. Payments due to Celltech in a currency other than
pounds sterling shall first be calculated in the relevant foreign
currency and then converted to pounds sterling at the rate of
exchange of the currency in the country in which such payments fall
due, as determined by the Financial Times Spot Rate for the pound
in London first published on the day after the last business day of
the calendar quarter in respect of which the royalties are
payable.
3.5.3
shall be made in full without
set-off and free and clear of and without any deduction or
withholding for or on account of taxes, duties, levies, imposts,
fees or charges and other duties that may be imposed by or under
the authority of any government or public authority as far as is
legally possible save with regard to withholding tax. Where
any sum due to be paid to Celltech hereunder is subject to any
withholding or similar tax the parties shall take all reasonable
steps to do all such acts and things and to sign all such deeds and
documents as will enable them to take advantage of any applicable
double taxation agreements with the object of paying the sums due
to Celltech and on a gross basis. In the event there is no
applicable double taxation agreement the Licensee shall pay such
withholding or similar tax, deduct the relevant amount from the
payment due to Celltech, and secure and send to Celltech proof of
such withholding or similar tax in a form satisfactory to Celltech
as evidence of such payment.
3.6
Where Celltech 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 2% above the “Base Rate” from time to time
of Midland Bank Plc calculated on a daily basis without prejudice
to Celltech’s right to receive payment on the due date
therefor.
3.7
If restrictions on the transfer of
currency exist in any country of the Territory such as to prevent
the Licensee from making payments in the United Kingdom, the
Licensee shall take all reasonable steps to obtain a waiver of such
restrictions or otherwise enable the Licensee to make such payments
failing which the Licensee may make the royalty payments due upon
sales in such country in local currency and deposit such payments
in a local bank or other depository designated by
Celltech.
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4.
RECORDS AND
STATEMENTS
4.1
The Licensee agrees to keep true and
accurate records and books of account containing all data necessary
for the calculation of the royalties payable to Celltech under
clause 3.3. At Celltech’s request and expense the
Licensee shall permit a representative of a firm of independent
accountants, appointed by Celltech and acceptable to the Licensee
(such acceptance not to be unreasonably withheld or delayed), upon
reasonable notice and at reasonable times, to inspect such books
and records for the purposes of verifying the royalties payable to
Celltech by the Licensee. If the royalties are found to be in
error such that royalties were underpaid, then the Licensee shall
promptly make good any deficiency including making payments of
interest on outstanding sums in accordance with the current rate
subsisting pursuant to clause 3.6 and if any deficiency of 5% or
more is found to have arisen the costs of the said inspection shall
be borne by the Licensee.
4.2
The Licensee shall prepare a
statement in respect of each calendar quarter of this Agreement
which shall show for the calendar quarter in question the Net
Receipts of sales by it or any sub-licensee of Products on a
country by country basis, details of the quantities of Products
manufactured and/or sold in each country in respect of which there
are Adair Patent Rights licensed under this Agreement and the
royalty and VAT due to Celltech thereon pursuant to clause 3
above. Such statement shall be submitted to Celltech within
30 days of the end of each calendar quarter to which it relates
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