1
CONFIDENTIAL TREATMENT EXHIBIT 10.8(a)
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
2
-2-
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
3
-3-
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
4
-4-
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:
5
-5-
(i) discounts, allowed and taken, in amounts customary in the
trade;
(ii) sales and/or use taxes and duties imposed upon and with
specific reference to particular SALES;
(iii) amounts allowed or credited on rejections or returns (not
exceeding the original billing) or retroactive price
reductions; and
(iv) outbound transportation prepaid or allowed.
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:
6
-6-
(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
7
-7-
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 * United
States Dollars * . * United States * 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 * United States
Dollars * of the Licence Issue Fee shall fall due on July 31, 1996.
(b) * of all Licence issue fees amounting to * United States Dollars *
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.
8
-8-
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 * Hundred United States Dollars (*).
4. MILESTONE PAYMENTS, ROYALTIES, RECORDS AND REPORTS
(a) LICENCEE shall pay to LICENSOR a milestone payment of * United
States Dollars (*) 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 * United
States Dollars (*) 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 * United
States Dollars (*) on first application for MARKETING AUTHORIZATION
for each LICENCED PRODUCT anywhere in the world.
(d) LICENCEE shall pay to LICENSOR a milestone payment of * United
States Dollars (*) 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 * United
States Dollars (*) in respect of royalties due on each LICENCED
PRODUCT.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
9
-9-
(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.
10
-10-
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
11
-11-
(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.
12
-12-
(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
13
-13-
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,
14
-14-
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.
15
-15-
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.
16
-16-
(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
17
-17-
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.
18
-18-
(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
19
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.
20
-20-
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.
21
-21-
(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
22
-22-
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.
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 concurrently with the expiration, invalidation or lapsing
of all issued patents within the PATENT RIGHTS
23
-23-
and/or the abandonment of all pending patent applications within the PATENT
RIGHTS.
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.
(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.
24
-24-
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
--------------