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Exhibit 10.8 (a)
CONFIDENTIAL TREATMENT
LICENCE AGREEMENT
(DOCUMENT IDENTIFICATION CODE: LEUKOSITE/IC/NHLI/0012/LICENCE)
THIS AGREEMENT (hereinafter called the "LICENCE AGREEMENT") is made effective
the Thirty First day of January, 1996 (hereinafter called the "EFFECTIVE DATE").
BY AND BETWEEN:
THE IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY & MEDICINE of ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (hereinafter called the "COLLEGE"); and
IMPERIAL EXPLOITATION LIMITED, a company organised under English law and having
a registered office at ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (hereinafter
called the "LICENSOR");
OF THE FIRST PART,
AND:
LEUKOSITE INCORPORATED, a company organised under the laws of the state of
Delaware, United States of America, having a principal office at ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America (hereinafter called the
"LICENCEE")
OF THE SECOND PART.
WITNESSETH:
A. WHEREAS, ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ and ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter called the
"INVENTORS"), have made certain discoveries and inventions in the field
of Eosinophil Chernotactic Cytokines (hereinafter called the
"INVENTION"); and
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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B. WHEREAS, ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇ and ▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ as employees The National Heart & Lung Institute of
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (hereinafter "NHLI") at the
time of the making of the INVENTION have assigned their right, title and
interest in the invention to NHLI; and
C. WHEREAS, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ as an employee of The ▇▇▇▇▇▇ Institute for
Cancer Research formerly of ▇▇▇▇▇▇ House, ▇▇▇-▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (hereinafter the "▇▇▇▇▇▇") at the time of the making of
the INVENTION has assigned his right, title and interest in the
invention to ▇▇▇▇▇▇; and
D. WHEREAS, applications have been filed in the United Kingdom and other
territories in the joint names of NHLI and ▇▇▇▇▇▇ for the granting of
letters patent relating to the said the INVENTION, further described in
Schedule A hereto (hereinafter all collectively called the "PATENT
APPLICATIONS"); and
E. WHEREAS, NHLI on August 1, 1995 ceased to be an independent legal entity
and became a constituent part of the COLLEGE; and
F. WHEREAS, ▇▇▇▇▇▇ have by deed of assignment, appended hereto as Schedule
B, assigned its entire right, title and interest in and to the INVENTION
and the PATENT APPLICATIONS to the COLLEGE; and
G. WHEREAS, the COLLEGE has appointed the LICENSOR to act as its agent for
the purpose of granting Licences under the PATENT RIGHTS, as hereinafter
defined, relating to the INVENTION; and
H. WHEREAS, LICENSOR represents that COLLEGE is the true, sole and rightful
owner of the said INVENTION; and
I. WHEREAS, COLLEGE and LICENSOR desire that the INVENTION be developed and
made available to the public; and
J. WHEREAS, LICENCEE is willing to make a commitment to develop products
embodying the INVENTION for use by and for the general public; and
K. WHEREAS, LICENCEE represents that it is engaged in the business of
research and development of products in fields related to the INVENTION;
and
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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L. WHEREAS, LICENCEE is prepared to undertake a programme for the
development, manufacture and sale of LICENCED PRODUCTS, as hereinafter
defined, provided that LICENCEE is able to obtain a Licence under the
PATENT RIGHTS with exclusivity to protect its investment in such
programme; and
M. WHEREAS, LICENSOR recognises that LICENCEE requires such a Licence in
order to justify the investment in funding and personnel needed to
develop and market LICENCED PRODUCTS; and
N. WHEREAS, LICENCEE desires to obtain such a Licence under the PATENT
RIGHTS; and
O. WHEREAS, LICENSOR is willing to grant to LICENCEE such a Licence under
the PATENT RIGHTS;
NOW, THEREFORE, in consideration of the premises and the performance of the
covenants herein contained, IT IS AGREED AS FOLLOWS:
1 DEFINITIONS
For the purposes of this LICENCE AGREEMENT, and solely for such purposes, the
terms hereinafter set forth shall have the following respective meanings:
(a) "PATENT RIGHTS" shall mean rights to and in the PATENT APPLICATIONS as
identified in Schedule A hereof and in respect of letters patent,
Patent Co-operation Treaty applications, European Patent Convention
applications or applications under similar administrative international
conventions, patent applications in the listed or designated countries,
together with any divisional, continuation, continuation-inpart,
substitute, reissue, extension, supplementary protection certificate or
other application based thereon and all letters patent resulting
therefrom.
(b) "VALID CLAIM" shall mean a claim of an issued, unexpired patent within
the PATENT RIGHTS or a mutually agreed claim being prosecuted in a
pending application within the PATENT RIGHTS. A claim of an issued,
unexpired patent shall be presumed to be valid unless and until it has
been held to be invalid by a final judgement of a court or
administrative body of competent jurisdiction from which no appeal can
be or is taken. A claim being prosecuted in a pending
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separately with the Commission.
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application shall be presumed to be mutually agreed and valid unless
LICENSOR is notified by LICENCEE in writing that said claim should no
longer be regarded as such. For the purposes of royalty determination
and payment under Article 4 hereof, any mutually agreed claim being
prosecuted in a pending patent application shall be deemed to be the
equivalent of a valid claim of an issued, unexpired patent.
(c) "CONTROL", "CONTROL(S)" or "CONTROLLED" shall refer to ownership of at
least fifty percent (50%) of the stock of a corporation or Organisation
entitled to vote upon election of directors thereof.
(d) "AFFILIATE" or "AFFILIATES" shall mean any company(ies), corporations
or organisation(s) which ▇▇▇▇) directly or indirectly CONTROLLED by
LICENCEE.
(e) "SUBLICENCEE" or "SUBLICENCEES" shall mean company(ies), corporations
or organisation(s) to whom or which the LICENSOR shall Licence PATENT
RIGHTS, LICENCED PRODUCTS, marketing rights, SALES rights or any other
form of right of whatsoever kind, rights to which are conferred herein
by the LICENSOR upon the LICENCEE.
(f) "SOLD", "SALE", "SALES", "SELL", "SELLING" and "SELLS" shall refer to
the act of selling or disposing of for value.
(g) "USE", "USES" and "USED" shall refer to the act of using for any
commercial purposes whatsoever.
(h) "SELLER" shall mean one who SELLS.
(i) "LICENCED PRODUCT" shall mean any product covered by a VALID CLAIM of
the PATENT RIGHTS or made by a method covered by a VALID CLAIM of the
PATENT RIGHTS or that is SOLD by LICENCEE. or an AFFILIATE under
conditions or circumstances which, if unLicenced, would amount to
infringement or contributory infringement or inducement of infringement
of the PATENT RIGHTS.
(j) "NET SALES VALUE" shall mean actual ▇▇▇▇▇▇▇▇ by the SELLER (LICENCEE or
AFFILIATE or SUBLICENCEE) for SALE of LICENCED PRODUCT less the
following deductions where they are factually applicable:
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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No allowance or deduction shall be made for commissions or collections,
by whatever name known.
The NET SALES VALUE of any LICENCED PRODUCT that is USED by LICENCEE or
AFFILIATE or SUBLICENCEE or SOLD by LICENCEE or AFFILIATE or
SUBLICENCEE to any person, firm or corporation controlling, controlled
by, or under common control with LICENCEE or an AFFILIATE or enjoying a
special course of dealing with LICENCEE or an AFFILIATE, shall be
determined for the LICENCED PRODUCT so USED or SOLD by reference to the
NET SALES VALUE thereof which would apply hereunder in an arm's length
SALE to a third party other than such person, firm or corporation.
(k) "FINAL PRODUCT FORM" shall mean a LICENCED PRODUCT in a dosage form
suitable for final usage by the administering physician or other
consumer.
(l) "BULK PRODUCT FORM" shall mean a LICENCED PRODUCT in a form other than
FINAL PRODUCT FORM.
(m) "LICENCED FIELD" shall mean the making or SELLING Of LICENCED PRODUCT
for therapeutic treatment of or diagnosis of disease in humans
employing such LICENCED PRODUCTS.
(n) "MARKETING AUTHORISATION" shall mean allowance granted by the
appropriate national body within a country to market and SELL LICENCED
PRODUCT for therapeutic use in the LICENCED FIELD.
2. LICENCE
LICENSOR hereby grants to LICENCEE and LICENCEE hereby accepts from LICENSOR,
upon the terms and conditions herein specified:
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separately with the Commission.
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(a) An exclusive, as hereinafter specified in Article 10 hereof, and
non-assignable Licence under the PATENT RIGHTS to make, to have made,
to USE and to SELL LICENCED PRODUCTS for use in the LICENCED FIELD,
including a Licence to USE processes covered by the PATENT RIGHTS, in
all countries in which the PATENT RIGHTS are or shall be in effect and
in their respective territories and possessions, to the full end of
their term or terms on a country-by-country basis for which the PATENT
RIGHTS are issued, unless sooner terminated as hereinafter provided.
(b) The right to extend to its AFFILIATES and SUBLICENCEES the Licence and
rights granted pursuant to Article 2 hereof, provided LICENCEE promptly
notifies LICENSOR in writing of each such extension.
(c) LICENCEE agrees to be responsible for the performance hereunder by its
AFFILIATES and SUBLICENCEES to which the Licence and rights shall have
been extended pursuant to Article 2 hereof.
(d) For the purposes of reporting and making payments of earned royalties
under this LICENCE AGREEMENT, the manufacture, SALE or USE of LICENCED
PRODUCTS by any AFFILIATE or SUBLICENCEE to which the Licence and
rights shall have been extended pursuant to Article 2 hereof shall be
considered the manufacture, SALE or USE of such LICENCED PRODUCTS by
LICENCEE; however, provided LICENCEE shall so notify LICENSOR in
advance thereof in writing, any such AFFILIATE or SUBLICENCEE may make
the pertinent reports and royalty payments specified in Article 4
hereof directly to LICENSOR on behalf of LICENCEE, otherwise, such
reports and payments on account of SALES or USES of LICENCED PRODUCTS
by each AFFILIATE or SUBLICENCEE shall be made by LICENCEE; and, in any
event, the SALES or USES of LICENCED PRODUCTS by each such AFFILIATE or
SUBLICENCEE shall be separately shown in the reports to LICENSOR if
such information is readily available to LICENCEE.
(e) No other, further or different Licence or right and, except as
expressly provided in Article 2 hereof, no further power to subLicence
is hereby granted or implied.
(f) LICENSOR grants to LICENCEE a sole and exclusive option to add to the
PATENT RIGHTS the entire right, title and interest of COLLEGE or an
affiliate, to any invention conceived solely by
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separately with the Commission.
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employees of COLLEGE or an affiliate or jointly with employees of
LICENCEE and/or another third party, or first actually reduced to
practice, on a programme of research support provided by LICENCEE to
COLLEGE or an affiliate thereof and mutually agreed at the time of
agreeing on the terms of a research agreement covering said research as
falling within the scope of this Article 2(f), said option to continue
for as long as such support is being provided by LICENCEE and for three
(3) months thereafter. Upon written notice by LICENCEE, these rights to
such inventions shall automatically be added to the PATENT RIGHTS at no
additional fee or cost to LICENCEE and all other terms and conditions
of this LICENCE AGREEMENT shall apply; providing, however, that if any
LICENCED PRODUCT sold by LICENCEE or an affiliate is covered only by a
patent jointly owned by COLLEGE or an affiliate, the royalty rate,
milestone payments and all other payments due to LICENSOR hereunder
shall be reduced by fifty percent (50%).
(g) LICENSOR, COLLEGE and their AFFILIATES additionally grant LICENCEE on a
royalty free, paid-up, worldwide basis:
(i) a non-exclusive Licence to use all know-how, data and other
technical information relating to the PATENT RIGHTS and/or
developed under a programme of research supported by LICENCEE;
and
(ii) an exclusive right and Licence to receive, use and/or sell all
biological materials created by LICENSOR, COLLEGE and their
AFFILIATES and relating to the PATENT RIGHT'S and/or created
on a programme of research supported by LICENCEE.
3. LICENCE ISSUE FEES
(a) LICENCEE shall pay to LICENSOR a Licence issue fee of *****************
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***************************************** of the Licence Issue Fee
shall be paid within thirty (30) days following execution and delivery
of this LICENCE AGREEMENT and payment of the remaining ****************
************************************************ of the Licence issue
Fee shall fall due on July 31, 1996.
(b) ******************* of all Licence issue fees amounting to ********
******************************************************* shall be
creditable once and once only against royalties payable under this
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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LICENCE AGREEMENT on SALES of LICENCED PRODUCT subject to a maximum
reduction in any royalties due in each quarterly reporting period of
********************* of the total due pursuant to Article 4 herein.
Such reduction in royalties shall continue until Licensor has reduced
cumulative royalties payable be the said ******************************
***********************************
4. MILESTONE PAYMENTS, ROYALTIES, RECORDS AND REPORTS
(a) LICENCEE shall pay to LICENSOR a milestone payment of *****
************************************************ on first entry of the
each LICENCED PRODUCT into its first phase I clinical trial anywhere in
the world.
(b) LICENCEE shall pay to LICENSOR a milestone payment of *******
******************************************** on first entry of the each
LICENCED PRODUCT into its first phase HI clinical trial anywhere in the
world.
(c) LICENCEE shall pay to LICENSOR a milestone payment of *****
******************************************************** on first
application for MARKETING AUTHORIZATION for each LICENCED PRODUCT
anywhere in the world.
(d) LICENCEE shall pay to LICENSOR a milestone payment of ******
******************************************************** on first
issuance of MARKETING AUTHORIZATION for each LICENCED PRODUCT anywhere
in the world.
(e) ******************* of all milestone payments for each LICENCED PRODUCT
made pursuant to Articles 4(a), 4(b), 4(c) and 4(d) herein shall be
creditable once and once only against royalties payable under this
LICENCE AGREEMENT on SALES of all LICENCED PRODUCTS subject to a
maximum reduction in any royalties due in each quarterly reporting
period of ******************** of the total due pursuant to Article 4
herein. Such reduction in royalties in respect of each LICENCED PRODUCT
shall continue until Licensor has reduced cumulative royalties payable
by the ****************************************************************
********************* in respect of royalties due on each LICENCED
PRODUCT.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(f) For the rights and privileges granted under this LICENCE AGREEMENT,
LICENCEE shall pay to LICENSOR, in the manner provided herein, to the
end of the term or terms of the PATENT RIGHTS or until this LICENCE
AGREEMENT is terminated as hereinafter provided, earned royalties
computed as a percentage of the NET SALES VALUE of all LICENCED
PRODUCTS that are made, USED or SOLD by or for LICENCEE or AFFILIATES
or SUBLICENCEES under this LICENCE AGREEMENT; the percentage of NET
SALES VALUE to be as follows:
(i) ******************* of the NET SALES VALUE of annual SALES of
LICENCED PRODUCTS SOLD for therapeutic use; and
(ii) ********************** of the NET SALES VALUE of annual SALES
of LICENCED PRODUCTS SOLD for diagnostic use); and
(g) Earned royalty shall be paid pursuant to Article 4 hereof on all
LICENCED PRODUCTS made, SOLD or USED under this LICENCE AGREEMENT;
however, earned royalty shall be payable hereunder as to a given
LICENCED PRODUCT only when a Licence right granted herein is utilised
in the manufacture or SALE or USE thereof, and the earned royalty
payable on a given LICENCED PRODUCT made hereunder shall not become due
and owing until such LICENCED PRODUCT is SOLD or USED.
Any LICENCED PRODUCT made under a Licence granted pursuant to this
LICENCE AGREEMENT prior to the termination or expiration of the
applicable PATENT RIGHTS and not SOLD or USED prior to the termination
or expiration of such PATENT RIGHTS shall be subject to the payment of
royalties hereunder when SOLD or USED, even though such SALE or USE
occurs after the termination or expiration of all pertinent Licences or
rights granted hereunder.
The earned royalty for any particular LICENCED PRODUCT shall be due
upon the first bona fide arm's length SALE or USE thereof and any
subsequent SALE or USE of such LICENCED PRODUCT by other than LICENCEE
or an AFFILIATE shall be royalty free.
(h) Notwithstanding the provisions of Article 4 hereof, in the case of
transfers or SALES of any LICENCED PRODUCT between LICENCEE, AFFILIATES
and SUBLICENCEES, one and only one royalty shall be payable thereon and
such royalty shall become
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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payable upon the final SALE thereof to a third party or final USE
thereof by LICENCEE or AFFILIATE.
(i) LICENCEE shall keep full, true and accurate books of account containing
all particulars which are necessary for the purpose of showing the
amount payable to LICENSOR by way of royalty as aforesaid or by way of
any other provision hereunder. Said books of account shall be kept at
LICENCEE's principal place of business. Said books and the supporting
data shall be maintained and kept open at all reasonable times, for
three (3) years following the end of the calendar year to which they
pertain (and access shall not be denied thereafter, if reasonably
available), to the inspection of an independent accountant retained by
LICENSOR and reasonably acceptable to LICENCEE for the purpose of
verifying LICENCEE's royalty statements, or LICENCEE's compliance in
other respects with this LICENCE AGREEMENT. Such inspections shall not
be conducted more than once per year. Names of customers and other
confidential information shall not be disclosed to LICENSOR by such
independent accountant. Such accountant shall be retained at LICENSOR's
sole expense, unless during any such inspection a deficiency in
payments to LICENSOR of five percent (5%) or more is determined to
exist in which event LICENCEE shall within thirty (30) days reimburse
LICENSOR for the full expense of retaining such accountant, including
but not limited to professional and administrative fees, travel and
subsistence costs.
(j) LICENCEE within thirty (30) days after the first day of January, April,
July and October of each year shall deliver to LICENSOR a true and
accurate report, giving such particulars of the LICENCED PRODUCTS made,
USED and SOLD by LICENCEE and AFFILIATES and SUBLICENCEES during the
preceding three (3) months under this LICENCE AGREEMENT as are
pertinent to an accounting for royalty under this LICENCE AGREEMENT.
These shall include at least the following, separately stated as to the
LICENCED PRODUCTS in FINAL PRODUCT FORM and those in BULK PRODUCT FORM:
(i) the quantity of LICENCED PRODUCTS invoiced by LICENCEE and
AFFILIATES and SUBLICENCEES during those three (3) months and
the ▇▇▇▇▇▇▇▇ therefor; and
(ii) the allowable deductions therefrom; and
(iii) the calculation of royalties thereon; and
(iv) the amount of LICENCED PRODUCTS USED or SOLD during those
three (3) months; and
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separately with the Commission.
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(v) the calculation of royalties thereon; and
(vi) the total royalties so calculated.
Simultaneously with the delivery of each such report, LICENCEE shall
pay to LICENSOR the royalty and any other payments due under this
LICENCE AGREEMENT for the period covered by such report. If no
royalties are due, it shall be so reported. Royalties shall be paid to
LICENSOR at LICENSOR's office specified for the purposes of giving
notice in Article 12 hereof.
(k) All amounts payable hereunder by LICENCEE to LICENSOR shall be payable
in United States Dollars. In the event any LICENCED PRODUCT shall be
SOLD by LICENCEE or an AFFILIATE or SUBLICENCEE for currency other than
United States Dollars, the earned royalty payable as to such LICENCED
PRODUCT under Article 4 hereof shall first be determined in the
currency for which the LICENCED PRODUCT was SOLD and then converted
into its equivalent in United States Dollars, as follows:
(i) the average rate applicable to the transfer of funds arising
from royalty payments as established by the exchange control
authorities of the country of which the currency of such funds
is the national currency for the accounting period for which
payment is thus made; or
(ii) if there is no applicable rate so established, then the
average selling rate for United States Dollars as published by
leading commercial banks in the major city of the country of
which such foreign currency is the national currency for such
accounting period; or
(iii) if there is no rate so published, then the average buying rate
for such foreign currency as published by leading United
States banks for such accounting period.
If the law or regulations of any country shall at any time operate to
prohibit the transfer of funds therefrom to the United Kingdom,
LICENCEE shall have the right to pay royalties hereunder on account of
the SALES or USE in such country by depositing local currency to the
account of LICENSOR in a bank in such country and notifying LICENSOR to
such effect. LICENCEE shall thereafter co-operate with LICENSOR by all
lawful means to obtain the lawful release of said funds to LICENSOR but
shall have no further responsibility therefor.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(l) In the event that any payment required under this LICENCE AGREEMENT
shall be overdue, LICENCEE shall pay interest thereon at an annual rate
equivalent to the United Kingdom Clearing Bank Base Lending Rate
computed from the date when the payment became due; provided, however,
that if such rate shall be in excess of that allowed by applicable law,
then the highest rate permitted by law shall apply. Payment shall be
deemed to have been made when received by LICENCEE.
(m) In the event that royalties are to be paid by LICENCEE to a party who
is not an AFFILIATE of LICENCEE for LICENCED PRODUCT for which
royalties are also due to LICENSOR pursuant to Article 4(f) hereof then
the royalties to be paid to LICENSOR by LICENCEE pursuant to Article
4(f) hereof shall be reduced by one-third of the amount of such other
royalties. In addition, in the event that the royalty paid to LICENSOR
is a significant factor in the return realised by LICENCEE so as to
diminish LICENCEE's capacity to respond to competitive pressures in the
market, LICENSOR agrees to consider a reasonable reduction in the
royalty paid to LICENSOR as to each such LICENCED PRODUCT for the
period during which such market condition exists. Factors determining
the size of the reduction will include profit margin on LICENCED
PRODUCT and on analogous products, prices of competitive products, and
LICENCEE's expenditures in LICENCED PRODUCT development.
5. DILIGENCE
LICENCEE shall exercise reasonable diligence in developing, testing,
manufacturing, promoting, advertising and SELLING LICENCED PRODUCTS under this
LICENCE AGREEMENT. the course of such diligence LICENCEE shall, either directly
or through an AFFILIATE or SUBLICENCEE to which the Licence shall have been
extended pursuant to Article 2 hereof, take appropriate steps including the
following:
(a) Diligently upon entering into this LICENCE AGREEMENT, establish and
maintain a research and development programme or programmes in the
LICENCED FIELD, or continue to conduct an existing programme or
programmes, reasonably designed, funded and resourced to obtain
information useful in enabling LICENCEE or AFFILIATE to prepare and
file all necessary documentation, data and other evidence required for
MARKETING AUTHORISATION in at least the United States of America, one
country in Europe and Japan. Such submission shall in the case of
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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the United States of America be a New Drug Application (hereinafter
called a "NDA") or its equivalent with the Food and Drug Administration
of the United States Government.
(b) When sufficient technical and marketing data have been obtained in the
sole discretion of the LICENCEE, file with an appropriate and properly
empowered national regulatory authority for approval to commence,
conduct or continue clinical trials of LICENCED PRODUCTS in the
LICENCED FIELD in patients. Such filing shall in the case of the United
States of America be an Investigational New Drug Application
(hereinafter called an "IND").
(c) Proceed diligently following the granting of national approval to
commission and conduct such clinical trials, associated studies and all
other works as are reasonably deemed to be required for subsequent
inclusion in the filing for MARKETING AUTHORISATION for such LICENCED
PRODUCT.
(d) Providing the results of the clinical trials warrant it, and at the
sole discretion of the LICENCEE, proceed diligently to file submissions
for MARKETING AUTHORISATION in at least the United States of America or
one country in Europe or Japan of at least one LICENCED PRODUCT in the
LICENCED FIELD. Such submission in the case of the United States of
America shall be an NDA.
(e) After such submissions are filed, diligently prosecute such submissions
and file all necessary reports and respond to all reasonable requests
from the pertinent regulatory authorities for information, data,
samples, tests and the like; and exhaust all administrative remedies
reasonably available in instances of adverse action by the pertinent
regulatory authorities.
(f) In respect of all countries, proceed diligently following issue of
MARKETING AUTHORISATION as follows:
(i) use reasonable efforts to make and SELL LICENCED PRODUCT'S in
the LICENCED FIELD;
(ii) advertise, promote the SALE of and otherwise employ marketing
and sales technique reasonably designed to develop a public
demand for LICENCED PRODUCTS in the LICENCED FIELD and satisfy
such public demand;
(ii) upon reasonable written request of LICENSOR, furnish LICENSOR
with representative copies of all advertising,
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separately with the Commission.
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sales and promotional material relating to such LICENCED
PRODUCTS.
(g) In order to keep LICENSOR apprised of the progress of the research and
development programme or programmes submit progress reports as to its
activities in the LICENCED FIELD, the first such report to be submitted
one (1) year from the EFFECTIVE DATE of this LICENCE AGREEMENT and
further such reports to continue to be submitted annually thereafter
until the SALE of LICENCED PRODUCTS within the LICENCED FIELD is
approved and LICENCED PRODUCTS are being marketed on a regular
commercial basis in the United States and such approval and marketing
is reported in writing to LICENSOR,
(h) Within three (3) years of the EFFECTIVE DATE of this LICENCE AGREEMENT
and every year thereafter until first SALE, LICENCEE shall provide
LICENSOR with the following:
(i) a written statement of LICENCEE's best estimate or forecast of
its projected annual SALES for each of the first three (3)
years of SALES of each product in each country in which it
intends to market a LICENCED PRODUCT under this LICENCE
AGREEMENT; and
(ii) a written statement of LICENCEE's forecast of the anticipated
marketing date in each country for each such product that it
intends to market as a LICENCED PRODUCT, based upon the
assumption that no unexpected technical or regulatory problems
will arise.
(i) Subject to necessary generally sequential performance of the acts
specified in Article 5 hereof, each of them is separately agreed upon
and performance of one of them shall not excuse non-performance of
another.
(j) Non-performance of this Article 5, or any subparagraph thereof, shall
be a breach of or default under this LICENCE AGREEMENT, subject to
LICENSOR's right to terminate this LICENCE AGREEMENT pursuant to
Article 6 hereof.
(k) LICENSOR agrees to maintain information in such reports in confidence
to the same extent that it maintains like information of its own in
confidence, subject to LICENSOR's obligation to report information to
LICENCEE.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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6. TERMINATION
(a) Subject to Article 12 hereof, if LICENCEE shall become bankrupt or
insolvent and/or if the business of LICENCEE shall be placed in the
hands of a Receiver, Assignee, or Trustee, whether by the voluntary act
of LICENCEE or otherwise, this LICENCE AGREEMENT shall immediately
terminate.
(b) Upon any material breach of or default under this LICENCE AGREEMENT by
LICENCEE, LICENSOR may terminate this LICENCE AGREEMENT by forty-five
(45) days written notice by registered mail to LICENCEE. Said notice
shall become effective at the end of said period, unless during said
period LICENCEE shall cure such breach or default.
(c) LICENCEE may terminate this LICENCE AGREEMENT at any time on three (3)
months' written notice to LICENSOR.
(d) Upon termination of this LICENCE AGREEMENT for any reason, all rights
granted hereunder shall revert to LICENSOR for the benefit of LICENSOR.
(e) LICENCEE's obligations to report to LICENSOR and to pay royalties to
LICENSOR as to any LICENCED PRODUCT made or USED under a Licence or an
immunity granted . pursuant to this LICENCE AGREEMENT prior to
termination or expiration of this LICENCE AGREEMENT shall survive such
termination or expiration and any termination of this LICENCE AGREEMENT
shall be subject to this Article 6.
(f) Notwithstanding any other remedy provided for herein, if LICENCEE shall
not make the payment provided for herein, when due, LICENSOR shall have
the option, in its discretion, to terminate the Licence and rights
granted under this LICENCE AGREEMENT on forty-five (45) days written
notice to LICENCEE, whereupon the Licence and rights granted under this
LICENCE AGREEMENT shall be terminated unless LICENCEE shall have made
such payment to LICENSOR within such forty-five (45) days from the date
of such notice.
(g) Upon any termination of this LICENCE AGREEMENT its provisions shall
continue in force and effect to the extent necessary to effectuate any
provision which by its terms clearly shall continue beyond such
termination.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(h) Upon termination of this LICENCE AGREEMENT other than by expiry of the
PATENT RIGHTS, LICENCEE shall have no Licence to make or USE LICENCED
PRODUCTS.
7. ASSIGNMENT
This LICENCE AGREEMENT shall not be assigned by LICENCEE, except as part of a
sale or transfer of all or substantially all of LICENCEE's business and subject
to LICENSOR's right of termination as provided for in Article 6 herein, and, in
such event, only in its entirety and upon prior written approval by LICENSOR;
and, the term "LICENCEE" where used in this LICENCE AGREEMENT shall thereafter
mean such assignee of LICENCEE.
8. INFRINGEMENT
(a) LICENSOR agrees to enforce its patents within the PATENT RIGHTS from
infringement and ▇▇▇ infringers when in its sole judgement such action
may be reasonably necessary, proper and justified.
(b) Notwithstanding the provisions of Article 8(a) above, provided LICENCEE
shall have supplied LICENSOR with evidence comprising a prima facie
case of infringement of the PATENT RIGHTS by a third party hereto
SELLING significant quantities of products in competition with
LICENCEE's or an AFFILIATE's or a SUBLICENCEE's SALE of LICENCED
PRODUCTS hereunder, LICENCEE shall be entitled to notify LICENSOR in
writing requesting LICENSOR to take steps to enforce the PATENT RIGHTS
and LICENSOR shall within three (3) months of the receipt of such
written request either:
(i) cause said infringement to terminate (including termination
for whatever cause); or
(ii) initiate legal proceedings against the infringer; or
(iii) grant LICENCEE the right, at LICENCEE's sole expense, to bring
suit against the infringer for infringement of the PATENT
RIGHTS.
(c) In no event shall LICENCEE be entitled to invoke Article 8(b) above
with respect to more than two alleged infringers in any one country
listed with the PATENT RIGHTS at any given time even though there be
more than two such infringers in such country and
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
17
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the provisions of Article 8(b) hereof shall not come into effect or
continue in effect as to such country while LICENSOR is carrying on any
such legal proceeding against two such parties therein.
(d) In the event either party hereto shall initiate or carry on legal
proceedings to enforce the PATENT RIGHTS against an alleged infringer,
as provided herein, the other party hereto shall fully co-operate with
the party initiating or carrying on such proceedings.
(e) In the event LICENSOR shall institute suit or other legal proceedings
to enforce the PATENT RIGHTS, it shall have sole control of such suit.
(f) In the event LICENCEE shall institute suit or other legal proceedings
under Article 8(b) above to enforce the PATENT RIGHTS, LICENSOR shall
be entitled to be represented by counsel of its choosing, at its sole
expense, and LICENCEE shall be entitled to retain all damages. LICENCEE
shall not discontinue or settle any such proceedings brought by it
without obtaining the concurrence of LICENSOR, not to be unreasonably
withheld, and giving LICENSOR a timely opportunity to continue such
proceedings in its own name, under its sole control, and at its sole
expense.
9. STATUS OF THE PATENT RIGHTS
(a) LICENSOR shall diligently maintain and prosecute the patent
applications filed within the PATENT RIGHT'S to obtain patents thereon.
LICENSOR does not represent or warrant that any such patent will be
obtained and LICENSOR shall in its sole discretion be responsible for
determining whether to abandon any or all of said patent applications.
Notwithstanding the aforementioned, LICENSOR shall provide LICENCEE
with adequate opportunity to comment upon filing, maintenance and
prosecution of the PATENT RIGHTS and the opportunity to assume the
maintenance and/or prosecution of any part of the PATENT RIGHTS which
LICENSOR decides to abandon.
(b) LICENCEE shall on receipt of invoices from LICENSOR reimburse LICENSOR
for all reasonable costs incurred by LICENSOR in prosecuting and
maintaining the PATENT RIGHTS before International and National Patent
Offices. Such costs shall include but not be limited to official fees,
professional services of patent agents and attorneys, renewal fees and
extension fees.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(c) LICENSOR shall be responsible for maintaining the patents obtained on
the patent applications referred to in Article 9(a) hereof.
(d) Subject to Article 9(a) hereof, nothing in this LICENCE AGREEMENT shall
be construed to require LICENSOR to file or prosecute any patent
application or to maintain any patent.
(e) LICENSOR will advise LICENCEE regularly of the status of all patent
applications and patents within the PATENT RIGHTS.
(f) Unless mutually agreed to in writing in advance, following notification
by LICENSOR of the deadline for entry of a patent application under the
PATENT RIGHTS, filed under the Patent Co-operation Treaty into its
National and Regional Phase, LICENCEE shall give LICENSOR thirty (30)
days written notice should it wish to abandon seeking protection in any
territories designated or retrospectively designated in the Patent
Co-operation Treaty application.
(g) From the date of notification by LICENCEE of its wish to abandon the
seeking of patent protection pursuant to Article 9(f) hereof all said
applications shall cease to form a part of the PATENT RIGHTS.
(h) From the date of notification by LICENCEE of its wish to abandon the
seeking of patent protection pursuant to Article 9(f) hereof LICENSOR
shall cease to have any obligation whatsoever under rights embodied in
said applications.
(i) LICENCEE shall co-operate with LICENSOR in seeking any extension that
is available or that becomes available in respect of the term of any
patent within the PATENT RIGHTS including any patent that may issue on
a patent application within the PATENT RIGHTS and LICENCEE shall
diligently advise LICENSOR in a timely manner of approval by the Food
and Drug Administration of the United States of America to USE, SELL or
market LICENCED PRODUCTS or any other governmental approval obtained by
or on behalf of LICENCEE or an AFFILIATE or SUBLICENCEE that is
pertinent to any such extension and LICENCEE shall supply LICENSOR with
any pertinent information and data in its possession or control or that
is in the possession or control of any AFFILIATE or SUBLICENCEE of
LICENCEE and shall cooperate
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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fully in assisting LICENSOR to obtain any such extension that it may
seek and LICENCEE shall supply LICENSOR in a timely manner with any
information and data and any supporting affidavits or documents
required to comply with 35 USC 156 Extension of Patent Term (and any
successor legislation) and any administrative rules or regulation
thereunder or required to comply with any corresponding laws and
regulations that are or shall be in effect in any country within the
PATENT RIGHTS, all without further consideration. LICENCEE shall
require its AFFILIATES and SUBLICENCEES to comply with this Article 9.
10. EXCLUSIVITY
Subject to Articles 2, 6 and 12 hereof, the Licence and rights granted to
LICENCEE under Article 2 hereof shall be sole and exclusive to LICENCEE in each
country within the PATENT RIGHTS in that LICENSOR shall neither make nor SELL
LICENCED PRODUCTS nor grant another concurrently effective Licence for LICENCED
PRODUCTS for USE in the LICENCED FIELD under the pertinent PATENT RIGHTS, or any
of them, during the period extending from the EFFECTIVE DATE of this LICENCE
AGREEMENT until either:
(i) the end of the term or terms of the pertinent patents in each
country within the PATENT RIGHTS; or
(ii) termination of this LICENCE AGREEMENT; whichever is first to
occur.
11. NON-USE OF NAMES
(a) LICENCEE shall not use the name of any inventor of the PATENT RIGHTS,
or of any institution with which he has been or is connected, or of
LICENSOR, or any adaptation of any of them, in any advertising,
promotional or sales literature, without prior written consent obtained
from LICENSOR in each case, which shall not be unreasonably withheld.
LICENCEE shall require its AFFILIATES and SUBLICENCEES to comply with
this Article 11 to the same extent that it applies to LICENCEE.
(b) LICENSOR shall not use the name of LICENCEE or its AFFILIATES or its
SUBLICENCEES or any adaptation thereof, in any advertising, promotional
or sales literature or in any press release without prior written
consent of LICENCEE in each case, which shall not be unreasonably
withheld.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
20
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12. GENERAL
(a) This LICENCE AGREEMENT, including the Schedules hereto attached,
constitutes the entire agreement and understanding between the parties
as to the PATENT RIGHTS. All prior negotiations, representations,
agreements, contracts, offers and earlier understandings of whatsoever
kind, whether written or oral between LICENSOR and LICENCEE in respect
of the PATENT RIGHTS, are superseded by, merged into, extinguished by
and completely expressed by this LICENCE AGREEMENT.
No aspect, part or wording of this LICENCE AGREEMENT may be modified
except by mutual agreement between the LICENSOR and LICENCEE taking the
form of an instrument in writing signed and dated by duly authorised
representatives of both LICENSOR and LICENCEE.
(b) Any notice required or permitted to be given by this LICENCE AGREEMENT
shall be given by post-paid, first class, registered or certified mail
addressed to:
LEUKOSITE INC.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
(marked for attention of the Chief Executive Officer)
or
IMPERIAL EXPLOITATION LTD
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇
(marked for attention of the Company Secretary)
Such addresses may be altered by notice so given. If no time limit is
specified for a notice required or permitted to be given by this
LICENCE AGREEMENT, the time limit therefor shall be ten (10) full
business days, not including the day of mailings
(c) This LICENCE AGREEMENT and its effect are subject to and shall be
construed and enforced in accordance with English law, except as to any
issue which by English law depends upon the validity, scope or
enforceability of any patent within the PATENT RIGHTS, which issue
shall be determined in accordance with the applicable patent laws of
the country of such patent.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(d) LICENSOR and LICENCEE shall endeavour to settle amicably any disputes
arising under this LICENCE AGREEMENT. If the parties are unable to
settle any dispute by themselves, then any such dispute arising in
connection with this LICENCE AGREEMENT shall be submitted first to
alternative dispute resolution proceedings and, if that fails, then
such dispute shall be finally settled by arbitration conducted in
England, by and in accordance with the rules then obtaining of the
London Court of Arbitration and judgement upon the award rendered may
be entered in the highest court of the forum having jurisdiction. The
provisions of this Article 12(d) shall not apply to any dispute or
controversy as to which any treaty or law prohibits settlement as
contemplated under this Article.
(e) Nothing in this LICENCE AGREEMENT shall be construed so as to require
the commission of any act contrary to law, and wherever there is any
conflict between any provision of this LICENCE AGREEMENT or concerning
the legal right of the parties to contract and any statute, law,
ordinance or treaty, the latter shall prevail, but in such event the
affected provisions of this LICENCE AGREEMENT shall be curtailed and
limited only to the extent necessary to bring it within the applicable
legal requirements.
(f) Notwithstanding anything to the contrary in this LICENCE AGREEMENT,
nothing herein contained shall be construed as a representation by
LICENSOR that the PATENT RIGHTS can be or will be used to prevent the
importation by a third party hereto of a product into or the SALE or
USE by a third party hereto of a product in any country within the
PATENT RIGHTS where such product shall have been placed in commerce
under circumstances which preclude the USE of the PATENT RIGHTS to
prevent such importation or SALE or USE by reason of any applicable law
or treaty.
(g) LICENCEE shall take all reasonable and necessary steps to register this
LICENCE AGREEMENT in any country where such is required to permit the
transfer of funds and/or payment of royalties to LICENSOR hereunder or
is otherwise required by the government or law of such country to
effectuate or carry out this LICENCE AGREEMENT. Notwithstanding
anything contained herein, but subject to Article 12(e) hereof,
LICENCEE shall not be relieved of any of its obligations under this
LICENCE AGREEMENT by any failure to register this LICENCE AGREEMENT in
any country, and, specifically, LICENCEE shall not be relieved of its
obligation
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
22
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to make any payment due to LICENSOR hereunder at LICENSOR's address
specified in Article 12(b) of this LICENCE AGREEMENT.
(h) It shall be the full and sole responsibility of LICENCEE and its
AFFILIATES and its SUBLICENCEES to use appropriate care in the practice
of any process and the manufacture and USE of any product pursuant to
any Licence or immunity granted hereunder and LICENSOR shall have no
right to control the manner in which or the material with which or upon
which any process Licenced hereunder is practised and LICENSOR shall
not be required to provide any know-how or operating instructions or
other information with respect to any such process or product and
LICENSOR makes no representation or warranty whatsoever with respect to
any such process or product.
(i) Nothing in this LICENCE AGREEMENT shall be construed as a
representation or a warranty by LICENSOR as to the validity or scope of
any patent within the PATENT RIGHTS or that any process practised or
anything made, USED or SOLD under any Licence or immunity granted under
this LICENCE AGREEMENT is or will be free from infringement of patents
of third parties.
(j) LICENCEE agrees to indemnify and hold harmless INVENTORS, LICENSOR,
COLLEGE and their respective officers, directors, employees and agents
from and against any and all claims, damages and liabilities asserted
by third parties, both government and private, arising from LICENCEE's
and AFFILIATES' and SUBLICENCEES' practice of any method covered by the
PATENT RIGHTS or manufacture, USE or SALE of LICENCED PRODUCTS or the
USE thereof by others including ultimate consumers.
(k) As used in this LICENCE AGREEMENT, singular includes the plural and
plural includes the singular, wherever so required by the context. The
headings appearing at the beginning of the numbered Articles hereof
have been inserted for convenience only and do not constitute a part of
this LICENCE AGREEMENT.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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13. EFFECTIVE DATE AND TERM
This LICENCE AGREEMENT shall become effective on the day and year first above
written and shall, unless terminated earlier by one of the parties in accord
with its terms, expire *********************************************************
********************************************************************************
********************************************************************************
***********************
14. GOVERNMENT RIGHTS
(a) LICENCEE shall comply in all respects with the applicable provisions of
any applicable law, requirement, regulation or determination by any
Government relating to the PATENT RIGHTS and shall provide LICENSOR
with any information or report required to comply with any such law,
requirement, regulation or determination.
(b) Any inconsistency between this LICENCE AGREEMENT and the pertinent
provisions of any law, requirement, regulation or determination by a
Government shall be resolved by conforming this LICENCE AGREEMENT to
such provisions of any such law, requirement, regulation or
determination.
(c) Any agreement or arrangement relating to the PATENT RIGHTS between
LICENCEE and any third party hereto shall be made expressly subject to
the terms and conditions of this Article 14 and LICENCEE shall require
such other party to comply therewith to the same extent that LICENCEE
is required to comply.
(d) Any Licence or other right granted or to be granted pursuant to this
LICENCE AGREEMENT and any term of exclusivity applicable to such
Licence or right shall be subject to any and all applicable
governmental laws and regulations relating to compulsory licensing.
15. TAXATION
(a) All payments due under this LICENCE AGREEMENT are quoted herein as
exclusive of any United Kingdom Value Added Tax or similar tax which
shall be payable, or shall become payable during the term of this
LICENCE AGREEMENT, in addition on rendering by LICENCEE of an
appropriate invoice.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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(b) All payments under this LICENCE AGREEMENT are quoted herein as
exclusive of any Japanese withholding tax or similar tax in other
countries which shall be payable, or shall become payable during the
term of this LICENCE AGREEMENT, in addition on rendering by LICENCEE of
an appropriate invoice.
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and duly
executed this LICENCE AGREEMENT on the date(s) indicated below, to be effective
the day and year first above written.
For and on Behalf of IMPERIAL EXPLOITATION LIMITED
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
--------------------
▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Company Secretary
Date: 11 March 1996
-------------
For and on Behalf of IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY & MEDICINE
By /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
-------------------
▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Pro-▇▇▇▇▇▇ (Research Contracts)
Date: 11 March 1996
-------------
For and on Behalf of LEUKOSITE INCORPORATED
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
----------------------
▇▇. ▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
Title: Chief Executive Officer
Date: March 25, 1996
--------------
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.