EXHIBIT 10.1
DATED 5th November 1998
INTRACELL VACCINES LIMITED
and
UNIVERSITY OF BIRMINGHAM
LICENCE
AGREEMENT
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LICENCE AGREEMENT
THIS LICENCE is made the 5th day of November one thousandnine hundred and ninety
eight
BETWEEN: Intracell Vaccines Ltd,
1 Sydney Mount, Circular Road,
Xxxxxxx, Isle of Man IM1 3DB (hereinafter referred to as
"the Licensee")
AND: XXXXXXXXXX XX XXXXXXXXXX,
Xxxxxxxxx,
Xxxxxxxxxx X00 0XX (hereinafter referred to as "the
Licensor").
WHEREAS
(1) The Licensor has applied for patents ("the Patents") in respect of an
invention relating to RNA Vaccines, including HIV ("the Invention") in a number
of countries worldwide short particulars of which are set forth in Schedule I
hereto.
(2) The Licensor has agreed to grant to the Licensee an exclusive worldwide
licence ("the Licence") on the terms detailed herein to make, use exercise and
vend the Invention in all pharmaceutical forms and in all fields of application.
(3) It is agreed that the Licence should supersede and replace all previous
licence agreements relating to the Invention between the parties.
NOW THIS LICENCE WITNESSETH THAT:
1.0 GRANT
1.1 The Licensor hereby grants to the Licensee an exclusive worldwide licence
to make use exercise and vend the Invention in all pharmaceutical forms and in
all fields of application.
1.2 The Licensor shall not xxx the Licensee under any other patent know how
copyright registered design or other intellectual property owned by or licensed
to the Licensor alone or jointly or in common with others in respect of any
activity which would but for the Licence amount to infringement.
1.3 The Licensor owns US Patent Nos 4816250 and 5219567 relating to the
manufacture of a Herpes Vaccine which could provide protection
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for the Licensees intended manufacture of vaccines under this Licence. The
Licensor will provide reasonable assistance to the Licensee, at the Licensees
cost, in enforcing US Xxxxxx Xxx 0000000 and 5219567 where the Licensee believes
that such enforcement will enable it to protect its vaccine manufacture and sale
in the USA.
ROYALTY
2.1 Upon execution of this Licence, the Licensee shall be obliged to pay to
the Licensor a non-refundable payment of (pound)60,000. (pound)10,000 shall be
payable upon the date of execution of this Licence, (pound)20,000 shall be
payable by 30 November 1998 and the balance shall be payable by 31 December
1998.
2.2 For sales in the territories listed in Schedule I and in all other
territories where a valid patent or similar enforceable protection (eg, pipeline
protection) with regard to the Invention exists or becomes available a royalty
of 5% of the net sales shall be paid to the Licensor.
2.3 For sales in countries other than those listed in Schedule I and where no
patent or similar enforceable protection in respect of the Invention exists the
Licensee shall pay to the Licensor a royalty of 3% of the net sales value per
annum.
2.4 The royalties detailed above in Clauses 2.2 and 2.3 shall be payable in
all countries until the expiry of the last valid patent or similar enforceable
protection in respect of the Invention. After such time the Licensee shall pay
to the Licensor a royalty of 3% of the net sales value per annum in all
countries. This royalty shall cease after a period of 10 years from the first
commercial sale in each country and thereafter no further royalty will be
payable.
2.5 The Licensee shall be permitted to grant sub-licences to third parties,
subject to the prior approval of the Licensor, where such approval shall not be
unreasonably withheld. The Licensee shall pay to the Licensor a 15% share of all
sub-licensee payments in lieu of running royalty as detailed in clauses 2.2 and
2.3 3 (including downpayments or running royalties). These payments shall
continue until the Licensee ceases to receive payments from its sub-licensee(s).
2.6 On the I st of January 2002 and in each year thereafter, the Licensee
shall pay to the Licensor an advance minimum royalty of (pound) 50,000. The
minimum royalty shall be recoverable from running royalty due to the Licensor
for the same annual period.
2.7 The net sales value shall mean the Licensee's invoice price on the first
act of sale hereunder to an independent third party after deduction of the usual
trade discounts and returns and excluding the costs of packing transport
insurance and tax.
2.8 The Licensee shall within 30 days after the 30th June and 31st December
in every year of the Licence render to the Licensor a statement showing the
amount of sub-licence income received and the net value (as defined above) on a
country by country basis and the sum of royalties due in respect of the period
ending on such 30th June or 3 1 st December and the Licensee shall at the same
time pay to the Licensor the sum due.
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2.9 Royalty payments shall be made in pounds sterling subject to deduction of
any applicable withholding taxes but with the addition of any applicable Value
Added Tax. Net sales value shall be calculated initially in the currency of the
country where the sales were made and if necessary shall be converted to pounds
sterling at the midmarket spot exchange rate indicated by the Financial Times on
the final day of the period to which the royalty payment relates.
2.10 The Licensee shall keep proper books of account and record and the
supporting documentation showing all matters connected with the manufacture sale
and disposition of its products and the amount due in respect of royalties and
shall allow the Licensor by its duly appointed officers or accountants at all
reasonable times to inspect and take copies of or extracts from such books
records and documentation and any other relevant or apparently relevant book
account record or voucher as may be reasonably necessary for the sole purpose of
verifying the amount due in respect of royalties. Such inspection may be made
notwithstanding termination of this Agreement whilst any outstanding claim
remains unsettled in the view of any par-ties hereto.
3.0 THE PATENTS
3.1 The Licensor shall not amend the specification of the Patents without the
p or approval writing of the Licensee which approval shall not be unreasonably
withheld.
3.2 Nothing herein shall impose an obligation on the Licensor to defend any
action or proceeding in which a claim or counter-claim is made for revocation of
any of the Patents but should the Licensor decide to defend the Patents it shall
do so at its own cost.
4.0 LICENSORS OBLIGATIONS
4.1 The Licensee shall reimberse the Licensor for the costs of prosecution
and maintenance of the patents from the date of this Licence. The Licensor will
on demand produce to the Licensee at its principal office the renewal
certificate three days at least before the last day for payment of each renewal
fee.
4.2 The Licensor shall if and whenever required by the Licensee give it or
its agent and servants in confidence all such explanations and information as
are now or in the future in its possession to enable the Licensee to manufacture
its products under the Licence to the best advantage.
5.0 IMPROVEMENTS
5.1 Each of the parties hereto shall forthwith on the discovery thereof
communicate to the other full information concerning any improvements relating
to the Invention and the other shall treat such information as confidential.
5.2 Any patents existing or granted in the future to the Licensor in respect
of any application relating to an Improvement shall be deemed to be included in
the expression "the Patents" for the purpose of this Agreement and the Licensor
undertakes to endorse hereon a suitable memorandum of the extension of the
Licence to such patents for the purpose of registration at the appropriate
Patent Office or to execute such other document as may be necessary therefore.
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5.3 Each party shall treat as confidential all the data pertaining to the
Invention and shall not disclose any of them to any third party by publication
or otherwise which obligations shall last for a period of five (5) years after
the date of execution of this agreement except:
(a) data which at the time of disclosure is in the public
domain;
(b) data which after disclosure becomes part of the public
domain by publication or otherwise except by breach of this
Agreement by the Licensee.
6.0 INFRINGEMENT
6.1 Each of the parties hereto shall forthwith give notice in writing to the
other party of any infringement or threatened infringement of any of the patents
which shall at any time come to its knowledge.
6.2 In the event that there shall be any substantial infringement of the
Patents ("substantial infringement" meaning sales by third parties in any
country of products infringing the Patents or any of them exceeding in unit
terms five per centum of the unit sales of the Licensee of Products in such
country) in any twelve month period and the Licensor does not within forty-five
days after written notice from the Licensee of such prejudicial effect institute
proceedings to prevent such infringement the Licensee may at its option
forthwith so far as it extends to that country on notice in writing to the
Licensor institute such proceedings at its own expense in the name of the
Licensor giving to the Licensor an indemnity in respect of the costs of any such
proceedings and shall be entitled to retain all damages in any recovered in such
proceedings.
6.3 Payment of royalties as from the commencement of any such substantial
infringement shall continue so long as the Licensee is able to sell products
without either reduction in price or a reduction in volume of ten per centum or
more. In the event that such reductions are necessary royalty payments shall be
reduced in a ratio to the reductions in volume or price as the case may be.
7.0 TERMINATION
7.1 If the royalties due hereunder in respect of any half-year have not been
paid within the time allowed or within 30 days of the due date by the Licence or
if The Licensee shall commit or allow to be committed a breach of any of the
other covenants promises or undertakings herein contained and shall not have
remedied such breach within 60 days after notice is given to it by the Licensor
or either of them requiring such remedy or if the Licensee shall have a receiver
appointed of the whole or any part of its asses or any order is made or a
resolution passed for winding up the Licensee (unless such receiver is appointed
or such order or resolution is passed as part of a scheme for reconstruction or
amalgamation of the Licensee) then the Licensor may forthwith by notice in
writing terminate the Licence without being required to give any or any further
notice in advance of such termination but such termination shall 1 be without
prejudice to the remedy of the Licensor to xxx for and recover any royalties
then due and to pursue any remedy in respect of any previous breach of any of
the. covenants or agreement herein contained.
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8.0 ANCULLARY PROVISIONS
8.1 The Licensee may have products manufactured by third parties on a toll
manufacture basis provided that obligations of confidentiality are imposed upon
the toll manufacturer.
8.2 The Licensee shall carry out all clinical trials in relation to its
products as may be required for registration purposes in the various countries
and shall pursue with due diligence applications for the registration of its
products for sale in any country where such registration is a requirement.
8.3 Any notice required or permitted to be given hereunder may (without
prejudice to the use of any other method) be given by sending the same by
prepaid post of facsimile to the following address and contact:
For the University of Birmingham to:
Xxxxxxxxxx xx Xxxxxxxxxx
Xxxxxxxxx
Xxxxxxxxxx
X00 0XX
XX
FAO: Mrs G Ball, Director of Finance
Tel: 0121414 6083
Fax: 0121414 6056
For Intracell Vaccines Limited to:
00 Xxxxxx Xxxxx
Xxxxxxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
FAO: Xx X X Xxxxxx
Tel: 000 000 0000
Fax: 000 000 0000
8.4 Invalidation for whatever reason at present or due to circumstances
somewhere in the future of any clause in the Licence or occurrence of a gap in
the Licence shall not have effect on the legal effectiveness of other clauses.
Such ineffective clause due to invalidation as mentioned above shall be replaced
or such gap as mentioned above shall be filled by an adequately formulated
provision which comes closest to the intentions of the contracting parties and
would have been properly expressed by them, had they taken such flaw or gap into
due consideration in the first place.
8.5 The Licence shall be interpreted in all respects in accordance with the
Laws and Courts of England.
8.6 It is agreed that the Licence should supersede and replace all previous
licence agreements between the parties.
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SCHEDULE 1
----------
Country Patent Application No Date of Filing
Application
Australia* 637114 12 June 0000
Xxxxxx 2060198 12 June 0000
Xxxxxxxxxxx* 0477240 12 June 1990
Germany* 69021879.6 12 June 0000
Xxxxx* 0477240 12 June 1990
France* 0477240 12 June 1990
GB* 0477240 12 June 0000
Xxxxx 508641/90 12 June 1990
* Patent granted
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IN WITNESS WHEREOF the parties hereto have executed this Licence Agreement on
the date and year first above written.
/s/ Xxxxx X Xxxxx
-----------------
for and on behalf of
UNIVERSITY OF BIRMINGHAM
/s/ Xxxxx Xxxxxx
-----------------
for and on behalf of
INTRACELL VACCINES LIMITED
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