<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
( X ) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarter ended September 30, 1997
OR
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________________ to ______________________
Commission file number 1-13768
ONCORMED, INC.
------------------------------------------------------
(Exact name of registrant as specified in its charter)
DELAWARE 52-1842781
------------------------ ------------------------------------
(State of Incorporation) (I.R.S. Employer Identification No.)
205 PERRY PARKWAY
GAITHERSBURG, MARYLAND 20877
----------------------------------------
(Address of principal executive offices)
(Zip code)
(301) 208-1888
----------------------------------------------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
YES x NO
----- -----
At October 31, 1997, there were 7,869,688 shares of Common Stock outstanding at
a par value of $.01.
<PAGE> 2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
ONCORMED, INC.
<TABLE>
<S> <C>
Date: April 13, 1998 /s/ DR. TIMOTHY J. TRICHE
-------------------------------------------------------------------------------------
Dr. Timothy J. Triche, Chairman and Chief Executive Officer
Date: April 13, 1998 /s/ DR. DOUGLAS DOLGINOW
-------------------------------------------------------------------------------------
Dr. Douglas Dolginow, President and Chief Operating Officer
Date: April 13, 1998 /s/ L. ROBERT JOHNSTON, JR.
-------------------------------------------------------------------------------------
L. Robert Johnston, Jr., Vice President and Chief Financial Officer
</TABLE>
26
<PAGE> 3
ONCORMED, INC.
<TABLE>
<CAPTION>
EXHIBIT INDEX
Exhibit No. Description Page No.
- ----------- ----------- --------
<S> <C> <C>
EX-11 Calculation of Earnings Per Share 28
EX-27 Financial Data Schedule 29
(in EDGAR transmission only)
10.36 * License Agreement, dated July 7, 1997, between the Company,
Cancer Research Campaign Technology Limited and Duke University
</TABLE>
27
* Confidential treatment has been granted. The omitted portions have been
separately filed with the Securities and Exchange Commission.
<PAGE> 1
LICENSE AGREEMENT
BETWEEN
(1) CANCER RESEARCH CAMPAIGN TECHNOLOGY LIMITED
and
(2) DUKE UNIVERSITY
and
(3) ONCORMED, INC.
FOR
DIAGNOSTIC RIGHTS
TO THE BRCA2 GENE
CONFIDENTIAL TREATMENT HAS BEEN GRANTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. THE OMITTED PORTIONS HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
<PAGE> 2
THIS AGREEMENT is made the 7th day of July 1997
BETWEEN:
CANCER RESEARCH CAMPAIGN TECHNOLOGY LIMITED of Cambridge
House, 6-10 Cambridge Terrace, Regent's Park, London NW1 4JL, UK ("CRCT");
DUKE UNIVERSITY, a non-profit institution having a place of
business at 230 North Building, Durham, North Carolina 27708, USA ("DUKE"); and
ONCORMED, INC. of 205 Perry Parkway, Gaithersburg, Maryland
20877, USA ("ONCORMED")
WHEREAS:
A) Certain employees of the Institute of Cancer Research: Royal Cancer
Hospital ("ICR"), of 17A Onslow Gardens, London SW7 3AL (the "ICR
Inventors"), and an employee of DUKE (the "DUKE Inventor") jointly
characterised a DNA sequence encoding a gene known as "BRCA2" (as
hereinafter defined) which is associated with inherited susceptibility
to breast cancer.
B) During the period in which BRCA2 was characterised, the ICR Inventors
were funded by the Cancer Research Campaign of 10 Cambridge Terrace,
Regent's Park, London NW1 4JL ("CRC"), a major UK cancer research
charity.
C) Under an agreement between CRC, ICR and CRCT dated 15 May 1995, all
rights to the results of CRC-funded research undertaken at ICR vest in
CRCT. Pursuant to that agreement, ICR and the ICR Inventors formally
assigned their rights in and to the invention subsisting in the said
BRCA2 characterisation to CRCT by way of a deed of assignment dated 6
June 1996.
D) The DUKE Inventor carried out the characterisation of BRCA2 during the
normal course of his employment.
E) Patent applications ("BRCA2 Patent Applications", as hereinafter
defined) have been filed for the invention subsisting in the aforesaid
characterisation of BRCA2 in the joint names of CRCT and DUKE.
F) Pursuant to an agreement dated 28 August 1996, CRCT and DUKE have
agreed that CRCT is exclusively responsible for the filing,
prosecution and exploitation of the said BRCA2 Patent Applications and
any patents granted therefrom ("BRCA2 Patents", as hereinafter
defined).
G) It is the desire of both CRCT and DUKE that the rights subsisting in
the BRCA2 Patent Applications and BRCA2 Patents are exploited so as to
ensure the widest possible availability of tests for inherited
susceptibility to breast cancer. In this regard, ONCORMED acknowledges
the not-for-profit status of DUKE and the charitable status of CRC.
<PAGE> 3
H) CRCT and DUKE have agreed to grant ONCORMED an exclusive worldwide
licence to the BRCA2 Patent Applications and BRCA2 Patents subject to
the terms and conditions of this Agreement.
NOW IT IS HEREBY AGREED as follows:-
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement and in the Schedules to this Agreement the following
words and phrases shall have the following meanings unless the context
requires otherwise:
"Affiliate" any company, partnership or other entity
which directly or indirectly Controls, is controlled by or is
under common Control with a Party.
"Agreement" this agreement and any and all schedules,
appendices and other addenda to it as may be varied from time
to time in accordance with the provisions of this agreement.
"Approval" permission to use or offer for sale or sell
as granted by the Food and Drug Administration of the United
States of America, or any other authority in the United States
of America or elsewhere, which has been given Federal or State
legal powers to grant such permission.
"BRCA2 Gene" the gene which is associated with inherited
susceptibility to breast cancer and which is encoded, in whole
or part, by the nucleotide sequence set out in the BRCA2
Patent Applications and/or BRCA2 Patents.
"BRCA2 Information" information in a recorded form which
is proprietary to and possessed by either CRCT and/or DUKE and
which arose prior to the date hereof and that which arises
within three (3) years thereafter, where said information
directly relates to the BRCA2 Gene and/or BRCA2 Protein
Products and, where such information specifically concerns the
provision of Diagnostic Services and/or Diagnostic Products.
"BRCA2 Patents Applications" the patent applications
listed in Schedule 1 and any national, international or
regional patent applications derived therefrom, either in
whole or in part.
"BRCA2 Patents" all patents granted and issued from BRCA2
Patent Applications and all continuations,
continuations-in-part, divisions, re-issues, renewals,
substitutions, thereof, as well as any supplementary
protection certificates (or equivalents thereof) in relation
thereto.
"BRCA2 Protein Product" the protein produced after
transcription and translation of the BRCA2 Gene, either in
whole or in part.
<PAGE> 4
"Business Day" 9.30 am to 5.30 pm London time on a day other
than a Saturday, Sunday, bank or other public holiday in
either the UK or the USA.
"Code Of Practice" the code of practice for providing a
Diagnostic Service as set out in Schedule 2 as may be revised
by the Parties, from time to time.
"Competent Authority" any local or national agency,
authority, department, inspectorate, minister, ministry
official or public or statutory person (whether autonomous or
not) of any government of any country having jurisdiction over
this Agreement or any of the Parties or over the development,
validation, provision, and marketing of the Diagnostic
Service.
"Control" the ownership of more than 50% of the issued
share capital or the legal power to direct or cause the
direction of the general management and the policies of the
Party in question.
"Diagnostic Service" a service for diagnosing
susceptibility to breast cancer through determining:
(i) the nucleotide sequence of the BRCA2 Gene in
a sample of DNA from a test recipient and identifying
any Mutations therein; and/or
(ii) determining the presence or absence of BRCA2
Protein Product, either in whole or in part, from a
sample from a test recipient.
"Diagnostic Product" a product, kit, instrument, tool,
reagent or material which has received regulatory approval in
the country of use or sale, and/or which is being used or sold
by ONCORMED, its Sub-licensees or Affiliates or their
customers for the clinical analysis of the BRCA2 Gene or BRCA2
Protein Product for the purposes of determining any Mutations
therein.
"Documents" paper, notebooks, books, files, ledgers,
records, tapes, discs, diskettes, CD-ROM and any other media
on which Know How can be permanently stored.
"Force Majeure" in relation to any Party, any event or
circumstance which is beyond the reasonable control of that
Party, which event that Party could not have reasonably been
expected to have taken into account at the date of this
Agreement and which results in or causes the failure of that
Party to perform any or all of its obligations under this
Agreement including act of God, lightning, fire, storm, flood,
earthquake, accumulation of snow or ice, lack of water arising
from weather or environmental problems, strike, lockout or
other industrial disturbance, act of the public enemy, war
declared or undeclared, threat of war, terrorist act,
blockade, revolution, riot, insurrection, civil commotion,
public demonstration, student disorder, sabotage, act of
vandalism, prevention from or hindrance in obtaining in any
way materials, energy, or other supplies, explosion, fault or
failure of plant or machinery (which could not have been
<PAGE> 5
prevented by good practice), government restraint, act of
legislature and Directive or requirement of a Competent
Authority governing either Party provided that lack of funds
shall not be interpreted as a cause beyond the reasonable
control of that Party.
"Know How" unpatented technical and other information
which is not in the public domain including ideas, concepts,
experience, data, specifications, procedures for experiments
and tests and results of experimentation and testing as
related to the BRCA2 Gene, BRCA2 Protein Product and/or
development and provision of the Diagnostic Service or
Diagnostic Product.
"Mutations" alterations in the normal wild-type
nucleotide sequence of the BRCA2 Gene or BRCA2 Protein Product
which have been shown to result in an increased genetic
susceptibility to breast cancer.
"Major Countries" those countries listed in Schedule 3.
"Net Sales Revenue" gross income accruing to ONCORMED
and/or its Sub-licensees and Affiliates through the provision
of Diagnostic Services and/or sales or other disposals of
Diagnostic Products and Research Products less the following
items to the extent they are paid or allowed and included in
the invoice price whether or not such costs are invoiced
separately to the purchaser;
a) quantity, trade and/or cash discounts
actually granted;
b) amounts repaid or credited and allowances
including cash, credit or free goods allowances and
amounts given by reason of chargebacks, retroactive
price reductions or billing errors and rebates
(including government-mandated rebates), actually
allowed or paid;
c) amounts refunded or credited for any
Diagnostic Service or Diagnostic Product or Research
Product which was rejected, or in any other way
deemed invalid;
d) freight, shipment and insurance costs in
providing Diagnostic Services and/or transporting
Diagnostic Products and/or Research Products; and
e) non-recoverable taxes, tariffs, customs
duties and surcharges and other governmental charges
incurred in connection with the provision of
Diagnostic Services and/or use, sale or disposal of
Diagnostic Products and/or Research Products.
"Non-Cash Compensation" any value ONCORMED receives from
Sub-licensees and Affiliates appointed by ONCORMED pursuant to
this Agreement which is not directly calculable in monetary
terms.
"Parties" CRCT, DUKE and ONCORMED.
<PAGE> 6
"Research Product" any product marketed specifically
for use in the research market for detection purposes related
to the BRCA2 Gene, protein products and mutations thereof,
where the use, sale, disposal, marketing or any other dealing
of such product is encompassed by any claim of any BRCA2
Patent Applications and/or any BRCA2 Patents. In the event
that a product falls within the definitions of both Diagnostic
Products and Research Products, such product shall be taken as
falling solely within the definition of Diagnostic Products.
"Sub-licence" a sub-licence granted pursuant to Clause 2.2.
"Sub-licensee" any person granted a Sub-licence pursuant to
Clause 2.2.
"Sub-licence Fees" all consideration other than royalty
payments (which are dealt with hereunder by separate payment
arrangements), that accrue to ONCORMED under any Sub-licence.
Where such consideration takes a Non-Cash Compensation form, a
monetary value for that consideration shall be determined
pursuant to Clause 4.3 and such sum shall be deemed to have
been received by ONCORMED for the purposes of Clause 4.3.
Notwithstanding the foregoing, payments received by ONCORMED
or an Affiliate of ONCORMED for the performance of research
and/or development, where such research and/or development
specifically and solely relates to obtaining Approval for a
Diagnostic Service and/or a Diagnostic Product and is not an
extension of any programmes being undertaken by ONCORMED as at
the date hereof, then:
(i) to the extent that such payments cover the
actual cost of such research and/or development; and
(ii) provided that CRCT has given its prior
written approval to the execution of the Sub-Licence
in question;
that portion of such payments which is equal to, or less than,
(***) of the aggregate amounts received (other than royalty
payments) for the grant of the Sub-Licence in question shall
not constitute consideration for the purposes of this
definition.
"Therapeutic Rights" rights to develop, make, have made,
use and sell products and/or services to treat, prevent,
ameliorate, reduce the symptoms of or delay the occurrence of
breast and any other cancers in any way and by any means.
"Valid Claim" a claim in any issued BRCA2 Patent which has
not expired, been revoked or otherwise held to be
unenforceable or invalid by a decision of a court or other
governmental agency or Competent Authority, as determined on a
country-by-country basis.
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 7
1.2 Unless the context otherwise requires, all references to a particular
Clause or Schedule shall be a reference to that Clause or Schedule in
or to this Agreement as it may be amended from time to time pursuant
to this Agreement.
1.3 The table of contents and headings are inserted for convenience only
and shall be ignored in construing this Agreement.
1.4 Unless the contrary intention appears, words importing the masculine
gender shall include the feminine, and vice versa, and words in the
singular include the plural, and vice versa.
1.5 Unless the contrary intention appears, words denoting persons shall
include any individual, partnership, company, corporation, joint
venture, trust, association, organisation or other entity, in each
case whether or not having a separate legal personality.
1.6 Reference to the words "include" or "including" are to be construed
without limitation to the generality of the preceding words.
1.7 Reference to any statute or regulation includes any modification or
re-enactment of that statute or regulation.
2. GRANT OF LICENCE
2.1 CRCT and DUKE hereby grant ONCORMED:
2.1.1 an exclusive, worldwide licence under the BRCA2 Patent
Applications and BRCA2 Patents to:
(i) provide Diagnostic Services; and
(ii) make, have made, use, offer for sale, and sell
Diagnostic Products;
2.1.2 an exclusive, worldwide licence under the BRCA2 Patent
Applications and BRCA2 Patents to make, have made, use, offer for
sale, and sell Research Products;
2.1.3 a non-exclusive, worldwide licence under the BRCA2 Patent
Applications, BRCA2 Patent and BRCA2 Information to undertake research
on the BRCA2 Gene and BRCA2 Protein Product for the purposes of
providing a Diagnostic Service or Diagnostic Product and/or Research
Product; and
2.1.4 a non-exclusive, worldwide licence under BRCA2 Information for
the purposes of providing a Diagnostic Service and/or making a
Diagnostic Product and/or making a Research Product to the extent that
ONCORMED can demonstrate to CRCT's reasonable satisfaction that the
BRCA2 Information in question is necessary to carry out the service or
make the product.
2.2 ONCORMED shall be entitled to grant sub-licences under the rights
granted to it pursuant to Clause 2.1 to any third party, provided
that:
<PAGE> 8
2.2.1 ONCORMED has given prior written notice of the same to CRCT
and provided CRCT with a draft of the proposed Sub-Licence at least
fifteen (15) Business Days prior to its execution, with a copy
substantially the same as the version that is to be executed (the
"Execution Copy") and has allowed CRCT at least five (5) Business Days
to provide ONCORMED with its comments on the terms set forth in the
Execution Copy. ONCORMED shall give due consideration to all comments
received from CRCT prior to execution of the Sub-Licence, but ONCORMED
shall have absolute discretion as to whether to accept or act on any
of CRCT's comments;
2.2.2 in the case of intended Sub-licences where the consideration
is to comprise, in part or whole, payments in respect of research
and/or development where the same specifically and solely relate to
Diagnostic Services or Diagnostic Products, and would constitute an
extension of a programme(s) being undertaken by ONCORMED as at the
date hereof, such Sub-licences will not be entered into without the
prior written consent of CRCT;
2.2.3 the terms of the Sub-licence, in ONCORMED's reasonable
opinion, reflect the full market value of the rights being
sub-licensed, having used all reasonable endeavours to secure this,
and that the rate at which royalties are to be paid to ONCORMED by the
Sub-licensee is not less than the rate at which royalties are payable
by ONCORMED to CRCT under this Agreement;
2.2.4 the Sub-licence contains undertakings by the Sub-licensee to
observe and perform provisions substantially similar to those
contained in this Agreement with regard to confidentiality,
non-assignability, adherence to the Code of Practice and termination
and an undertaking by the Sub-licensee to make payments to ONCORMED
within thirty (30) Business Days of the date when they fall due and,
in addition, that the terms of any such Sub-licence prohibit, in the
field of Diagnostic Services, any further sub-licensing; and
2.2.5 the Sub-licence is expressed to terminate automatically on the
termination of this Agreement for any reason.
2.3 Subject to the conditions set out in Clause 2.2, ONCORMED shall use
its best efforts to grant at least one Sub-licence under the rights
granted to it pursuant to Clause 2.1.1 (i).
2.4 ONCORMED shall, at its own expense:
2.4.1 provide CRCT with a true copy of any Sub-licence entered into,
within twenty (20) Business Days of the grant thereof; and
2.4.2 at all times, ensure the observance and performance by every
Sub-licensee of the provisions of the Sub-licence and indemnify both
CRCT and DUKE against any loss, damage, costs, claims or expenses
which are awarded against or incurred by either CRCT or DUKE as a
result of:
(i) any breach by any Sub-licensee of any of the
provisions of the Sub-licence, or
(ii) any Diagnostic Product or Diagnostic Service provided
by any Sub-licensee.
<PAGE> 9
2.5 CRCT and DUKE shall notify ONCORMED of any improvements, discoveries
or inventions, arising within five (5) years from the date hereof,
where the subject matter of the same is the BRCA2 Gene and protein
products and mutations thereof, and said improvements, discoveries and
inventions have applicability to Diagnostic Products and Diagnostic
Services and the rights thereto vest in CRCT and/or DUKE. (***)
3. GRANT BACK
3.1 In acknowledgement of the public funds used in the development of the
invention which underlies the licences granted to ONCORMED hereunder,
ONCORMED hereby grants back to CRCT and DUKE the following licences:
3.1.1 to CRCT, a non-exclusive, royalty free sub-licence, with the
right to grant sub-licences under the licence granted pursuant to
Clause 2.1, to the BRCA2 Patent Applications and BRCA2 Patents to
provide Diagnostic Services at its sole discretion and without
reference to ONCORMED, but only on a not-for-profit basis and only to
any UK National Health Service ("NHS") Hospital to:
(i) provide Diagnostic Services to NHS patients of NHS
Hospitals; and/or
(ii) provide Diagnostic Services in relation to NHS
patient samples where said samples have been obtained from NHS
patients and referred to the NHS Hospital in accordance with
NHS practice.
3.1.2 to DUKE, a non-exclusive, royalty free sub-licence under the
licence granted pursuant to Clause 2.1 to the BRCA2 Patent
Applications and BRCA2 Patents to pursue DUKE's own educational,
teaching, and research activities; (***)
3.2 Except as provided for in Clause 3.1, CRCT and DUKE acknowledge and
agree that neither shall have any right or licence to provide
Diagnostic Services and/or Diagnostic Products, either directly or
indirectly, to any third party and that neither shall have the right
to license or to provide Research Products to a third party, except
for research purposes only. (***)
3.3 In the event that a sub-licence has been granted in accordance with
Clause 3.1.1 and the sub-licensee provides a Diagnostic Service where
the majority of the patients who are the subject of the said service
are required to make a specific financial contribution/payment for the
service they receive, the Sub-licence shall, in respect of the NHS
hospital concerned, be terminable at ONCORMED's option.
3.4 DUKE and ONCORMED agree that should DUKE desire to provide Diagnostic
Services beyond the provisions of Clause 3.1.2, DUKE will take a
Sub-licence from ONCORMED, such Sub-licence to be offered to DUKE on
terms to be negotiated in good faith by DUKE and ONCORMED.
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 10
4. PAYMENTS FOR LICENCES
4.1 In consideration of the rights granted to ONCORMED under this
Agreement, ONCORMED shall pay to CRCT:
4.1.1 (***)
4.1.2 (***)
4.1.3 (***)
4.1.4 (***)
4.1.5 (***)
4.1.6 (***)
4.1.7 (***)
4.1.8 (***)
4.2 In the event that it is necessary for ONCORMED to pay royalties to
third parties (other than Oncor or an affiliate thereof) on sales of
Diagnostic Services, Diagnostic Products or Research Products the
royalty rates specified in Clause (***) shall, on a country-by-country
and product/service basis, be reduced by the total cumulative
royalties payable to third parties (other than Oncor (or an affiliate
thereof), Affiliates of ONCORMED and/or Sub-licensees), divided by the
number of said third parties, subject always to a minimum royalty rate
payable to CRCT of one-half of the applicable rate specified in
Clauses 4.1.6, 4.1.7 or 4.1.8 as the case may be.
(***)
Reduction of CRCT's royalties under this Clause 4.2 shall only occur
on the payment by ONCORMED of additional royalties where such
additional royalties are due in respect of patented technology whose
claims cover the provision of the Diagnostic Service, Diagnostic
Product or Research Product. Only one royalty shall be payable on each
unit of Diagnostic Service, Diagnostic Product or Research Product.
4.3 ONCORMED shall pay to CRCT (***) of all Sub-license fees. In the event
that ONCORMED wishes to conclude a Sub-licence for Non-Cash
Compensation, in part or whole, ONCORMED shall, prior to the execution
of such Sub-licence, agree with CRCT a true and fair monetary value
for the same. Payment shall be made within ten (10) Business Days of
such Sub-licence Fees being actually received by ONCORMED (having used
its reasonable endeavours to secure such Sub-licence Fees).
4.4 For the avoidance of doubt, all sums due to CRCT pursuant to this
Clause 4 shall be non-refundable and non-creditable against any other
payments due to CRCT hereunder and DUKE also hereby agrees and
confirms that the payments made to CRCT hereunder are for the benefit
of both CRCT and DUKE.
4.5 ONCORMED shall pay all royalties due to CRCT hereunder, in respect of
Net Sales Revenue of ONCORMED and its Affiliates in a given quarter or
in respect of royalties actually received from a Sub-licensee in a
given quarter, quarterly in arrears within forty (40) Business Days of
31 March, 30 June, 30 September and 31 December in each year.
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 11
4.6 All payments due to CRCT under this Agreement shall be made in US
dollars and to the account of "Cancer Research Campaign Technology
Limited" and forwarded to Mr Roger Feather, or any other appointed
nominee of CRCT, at the following address:
Cancer Research Campaign Technology Limited
Cambridge House
6-10 Cambridge Terrace
Regent's Park
London
NW1 4JL
United Kingdom
4.7 All royalties or other sums payable to CRCT hereunder are stated
exclusive of all applicable withholding taxes, sales taxes and other
similar taxes or duties, for which ONCORMED shall be additionally
liable, and shall be paid in cleared funds without any set-off,
deduction or withholding except for any such tax or duty which
ONCORMED is required by law to deduct or withhold. If ONCORMED is
required by law to make any such tax deduction, or withholding or
payment, ONCORMED shall use its reasonable endeavours to enable or
assist CRCT to claim exemption from or, if not possible, a credit for
the deduction or withholding under any applicable double taxation or
similar agreement from time to time in force, and shall from time to
time give CRCT proper evidence as to the deduction or withholding and
payment of the tax deducted or withheld.
4.8 Where CRCT does not receive payment of any sums due to it within
thirty (30) Business Days of the due date, interest shall accrue on
the sum due and owing to CRCT at the rate equivalent to an annual rate
of (***) over the then current base rate of Lloyds Bank plc, for the
UK, calculated on a daily basis, without prejudice to CRCT's right to
receive payment on the due date.
4.9 ONCORMED shall prepare a quarterly statement showing for the
immediately preceding quarter the number of Diagnostic Service tests
carried out and the number of Diagnostic Products sold, each on a
country-by-country basis, the Net Sales Revenue accruing therefrom and
the calculation of Sub-licence Fees and royalties due to CRCT
hereunder. Such statement shall be submitted to CRCT within forty
(40) Business Days of the relevant quarter date.
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 12
4.10 ONCORMED shall, and shall procure that its Sub-licensees shall, keep
true and accurate records and books of account containing all data
necessary for the calculation of the amounts payable by it to CRCT
pursuant to this Agreement. Such records and books of account shall be
kept for three (3) years following the end of the calendar year to
which they relate and shall, upon reasonable notice having been given
by CRCT, be open at all reasonable times on Business Days for
inspection, under the terms of confidentiality contained in this
Agreement, by an independent firm of accountants appointed by
agreement between the Parties or, failing such agreement within thirty
(30) Business Days, the President for the time being of the Institute
of Chartered Accountants of England and Wales in London. Any such
examination shall take place not later than three (3) years following
the expiration of the period to which it relates and there shall be no
more than one examination per year. The costs and expenses relating
to such inspection shall be borne by CRCT unless it is established
that as a result of an error ONCORMED has failed to pay at least
ninety-five percent (95%) of the full amount due and owing under this
Agreement, in which event the costs and expenses of such inspection
shall be borne by ONCORMED. In addition any outstanding payments due
to CRCT which are identified as a result of carrying out the
investigation shall be made over to CRCT immediately.
5. INTELLECTUAL PROPERTY
5.1 The ownership of BRCA2 Patent Applications and BRCA2 Patents shall at
all times remain vested in CRCT and DUKE unless otherwise agreed
between CRCT and DUKE.
5.2 CRCT shall be responsible for the filing, prosecution, appeal
proceedings and maintenance of BRCA2 Patent Applications and BRCA2
Patents in the Major Countries and such other countries and
jurisdictions that ONCORMED agrees to fully fund in accordance with
Clause 5.4, unless otherwise agreed in writing by CRCT, DUKE and
ONCORMED and shall at all times use all reasonable endeavours to
accommodate the reasonable requirements of ONCORMED in relation to
matters of filing, prosecution and maintenance.
5.3 Notwithstanding the provisions of Clause 5.2, CRCT and ONCORMED shall
within sixty (60) Business Days of the signing of this Agreement cause
their respective patent agents to agree upon an appropriate course of
action for the filing and prosecution or BRCA2 Patent Applications in
the United States of America (US) including agreement on the identity
of a firm of patent attorneys to be appointed in the US.
5.4 ONCORMED shall pay (***)
5.5 ONCORMED shall (***) at its own cost and expense, give all due
assistance to CRCT in the prosecution of BRCA2 Patent Applications and the
maintenance of BRCA2 Patents as CRCT may reasonably request. Should CRCT elect
not to prepare and file patent applications, pursuant to Clause 5.2, in any
given country or jurisdiction where ONCORMED requires such filing, CRCT shall
notify ONCORMED in writing within a reasonable period of time prior to the
expiration of any applicable time bars and any public disclosure of the
inventions that are subject of CRCT's decision. After receipt of such notice,
ONCORMED may file patent applications covering the aforsaid inventions, in the
countries and jurisdictions identified, at ONCORMED's sole discretion and
expense. If CRCT elects not to prosecute any BRCA2 Patent Application it has
filed, or elects not to maintain any BRCA2, Patent, CRCT shall notify
ONCORMED in writing within a reasonable period prior to the expiration of any
applicable time bars. After receipt of such notice, ONCORMED may elect to
prosecute or maintain such applications or patents identified in such notice at
ONCORMED's sole discretion and expense. CRCT and DUKE agree to provide, at
ONCORMED's sole cost and expense, reasonable cooperation to ONCORMED in
relation to any BRCA2 Patent Applications filed or prosecuted by ONCORMED or
BRCA2 Patents maintained by ONCORMED pursuant to the Clause 5.5.
5.6 CRCT shall keep ONCORMED fully informed of the progress of the
prosecution of BRCA2 Patent Applications and maintenance of the BRCA2
Patents and shall furnish copies of such documents as received from
CRCT's patent agents relating thereto.
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 13
5.7 If any claim is made or threatened against CRCT, DUKE, ONCORMED or a
Sub-licensee (in the case of the latter, where this is made known to
ONCORMED) by any third party that the exercise by ONCORMED or a
Sub-licensee, as the case may be, of the rights granted pursuant to
this Agreement infringes any patent or other rights of any other
person, the Party first notified shall fully notify CRCT, and DUKE or
ONCORMED, as the case may be, as soon as possible. ONCORMED shall
have the right to defend such claims and shall be given all reasonable
assistance by CRCT and DUKE (***) as ONCORMED may reasonably request.
5.8 ONCORMED at its own cost and expense shall have the right to bring
suit against any party which infringes the rights granted to ONCORMED
pursuant to this Agreement. In such circumstances, ONCORMED shall
notify CRCT and DUKE of the steps which ONCORMED proposes to take in
enforcing its rights prior to taking any such action. CRCT and DUKE
shall provide ONCORMED, at ONCORMED's sole cost and expense, with such
assistance in connection therewith as ONCORMED may reasonably request.
In the event that ONCORMED takes action against infringers of the
rights granted to it hereunder, any and all financial remuneration
awarded to ONCORMED in relation to such action shall be shared equally
with CRCT after ONCORMED has recouped any and all legal, litigation
and patent costs, expenses, disbursements paid by ONCORMED to third
parties, directly incurred in taking such action (including, but not
limited to the fees and expenses of legal counsel, investigators and
expert witnesses).
6. OBLIGATIONS
6.1 Subject to the regulations of any applicable regulatory body, or of
any applicable State or Federal laws in the United States, or any
applicable laws of any jurisdiction in which OncorMed or a
sub-licensee is doing business, ONCORMED shall, and shall procure that
its Sub-licensees shall, use reasonable endeavours to provide
Diagnostic Services in accordance with the guidelines set out in the
Code of Practice, and to provide Diagnostic Services in accordance
with the guidelines set out in the Code of Practice.
6.2 ONCORMED shall use its reasonable endeavours to provide the Diagnostic
Services in at least the Major Countries, either directly or by
sub-licensing the rights granted to it under this Agreement.
6.3 ONCORMED shall use its reasonable endeavours to develop, use, offer
for sale and sell the Diagnostic Products in at least the Major
Countries, either directly or by sub-licensing the rights granted to
it under this Agreement.
6.4 In the event that CRCT concludes an agreement with a third party
covering the Therapeutic Rights under any BRCA2 Patent Application
and/or BRCA2 Patent, CRCT shall pay over to ONCORMED, within thirty
five (35) Business Days of receipt by CRCT from said third party:
6.4.1 (***)
6.4.2 (***)
6.4.3 (***)
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 14
7. CONFIDENTIALITY
7.1 Each Party undertakes and agrees not at any time for any reason
whatsoever to disclose or permit to be disclosed to any third party or
otherwise make use of or permit to be made use of, any trade secrets
or confidential information relating to another Party's technology or
the business affairs or finances of another Party or of an Affiliate,
Sub-licensee or of any suppliers, agents, distributors, or customers
of another Party which come into its possession pursuant to this
Agreement. For the purposes of this Clause 7, BRCA2 Information
constitutes confidential information of CRCT and/or DUKE, as the case
may be, and the quarterly statements provided by ONCORMED pursuant to
Clause 4.9, to either CRCT or DUKE shall constitute confidential
information of ONCORMED.
7.2 It is expected that DUKE will not receive confidential technical or
scientific information under this Agreement. Therefore, it is agreed
that the reception of any such confidential technical and scientific
information by DUKE from ONCORMED shall be provided for under a
separate agreement.
7.3 The obligations of confidence set out in this Clause 7 shall not
extend to any information which:
7.3.1 is, or shall become, generally available to the public
otherwise than by reason of a breach by the recipient Party of the
provisions of this Clause; or
7.3.2 is known to the recipient Party and is at its free disposal
prior to its receipt from another Party, as can be shown by written
record; or
7.3.3 is subsequently disclosed to the recipient Party without
obligations of confidence by another party owing no such obligations
in respect thereof; or
7.3.4 is required to be disclosed by any applicable law or any
regulatory authority to which a Party is from time to time subject to;
or
7.3.5 is independently developed by a person or persons with no
access to the confidential information disclosed by a Party, as
demonstrated by written records.
7.4 Except as specified in 7.2 herein, the obligations of each Party under
this Clause 7 shall survive the expiration or termination of this
Agreement for whatever reason.
7.5 ONCORMED shall procure that the Sub-licensees and its Affiliates, and
CRCT and DUKE shall procure that their Affiliates and those third
parties which have been granted Therapeutic Rights, shall, to the
extent that any of the same have access to any trade secrets or
confidential information proprietary to another Party, are informed of
the secret and confidential nature of the same and are made aware of
and subject to equivalent obligations of confidentiality to those set
out under this Clause 7.
7.6 Each Party agrees to keep the terms and conditions of this Agreement
confidential and not disclose the same to any third party unless, and
to the extent, required by any applicable law or regulation.
Notwithstanding the foregoing, ONCORMED may disclose the terms and
conditions and copies of this
<PAGE> 15
Agreement to third parties that are subject to a confidentiality
obligation covering the same, provided that such third parties are
potential or current Sub-Licensees or investors. ONCORMED shall
endeavour to give CRCT written notice of any disclosures to potential
or current Sub-licensees or investors, but any failure to provide such
notice shall not be a material breach of this Agreement for the
purposes of Clause 9.
8. WARRANTIES, INDEMNITY AND LIABILITY
8.1 CRCT and DUKE each represent that to the best of their knowledge and
belief they are the sole owners of BRCA2 Patent Applications and the
inventions claimed therein and that they are free to enter into this
Agreement.
8.2 ONCORMED represents that it is free to enter into this Agreement.
8.3 (***)
8.4 (***)
8.5 Neither CRCT nor DUKE shall be liable to ONCORMED or its Sub-licensees
nor shall ONCORMED and/or its Sub-licensees be liable to CRCT or DUKE
in contract, tort, negligence, breach of statutory study or otherwise
for any loss, damage, cost or expense of any nature whatsoever of an
indirect or consequential nature (including any economic loss or other
loss of turnover, profits, business or goodwill) arising out of or in
connection with this Agreement or the subject matter of this
Agreement.
8.6 ONCORMED shall maintain in force at its sole cost and expense, with
reputable insurance companies, general liability insurance and
products liability insurance coverage in an amount reasonably
sufficient to protect against liability (***) CRCT and/or DUKE shall
have the right to ascertain from time to time that such coverage
exists, such right to be exercised in a reasonable manner.
8.7 Except for the representations made by CRCT and DUKE in Clause 8.1,
nothing in this Agreement shall be deemed to be a representation or
warranty by either CRCT or DUKE of the validity of any BRCA2 Patents
or the accuracy, safety, efficacy, or usefulness, for any purpose, of
any BRCA2 Information, BRCA2 Patent Applications, or BRCA2 Patents.
CRCT and DUKE shall have no obligation, express or implied, to
supervise, monitor, review or otherwise assume responsibility for the
production, manufacture, testing, marketing or sale of any licensed
product nor any liability whatsoever to ONCORMED or any third party
for or on account of any injury, loss, or damage of any kind or
nature, sustained by, or damage assessed or asserted against, or any
other liability incurred by or in connection with or resulting from:
8.7.1 the production, use or sale of any BRCA2 Protein Product,
Research Product, Diagnostic Product or Diagnostic Service; or
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 16
8.7.2 the use of BRCA2 Information, BRCA2 Patent Applications or
BRCA2 Patents; or
8.7.3 any advertising or other promotional activities with respect
to any of the foregoing.
8.8 Under no circumstances shall CRCT or DUKE's liability to ONCORMED
under this Agreement, together, in total exceed the sums paid by
ONCORMED from time to time to CRCT pursuant to Clause 4.
8.9 The provisions of this Clause 8 shall survive the expiration or
termination of this Agreement, for whatever reason.
9. TERM AND TERMINATION
9.1 This Agreement shall come into effect on the Commencement Date and
shall expire, on a country by country basis, on the date of expiration
of the last to expire BRCA2 Patent in that country or, if no BRCA2
Patent is granted in a given country, ten (10) years after the first
commercial provision of BRCA2 Diagnostic Service or sale or disposal
of BRCA2 Diagnostic Product.
9.2 If ONCORMED and all the permitted Sub-licensees no longer wish to
undertake the provision of Diagnostic Services and/or the development,
use or sale of Diagnostic Products, ONCORMED shall so notify CRCT in
writing and this Agreement shall terminate ninety (90) Business Days
from receipt of such notice.
9.3 Either CRCT and DUKE acting together on the one hand or ONCORMED on
the other hand ("the Terminating Party") shall have the right to
terminate this Agreement forthwith upon giving written notice of
termination to ONCORMED on the one hand or CRCT and DUKE together on
the other hand, as the case may be, ("the Defaulting Party"), upon the
occurrence of any of the following events at any time during this
Agreement:
9.3.1 the Defaulting Party commits a material breach of this
Agreement which in the case of a breach capable of remedy shall not
have been remedied within forty (40) Business Days of the receipt by
it of a notice identifying the breach and requiring its remedy;
9.3.2 the Defaulting Party for a period of longer than sixty (60)
Business Days suspends payment of its debts or otherwise ceases or
threatens to cease to carry on its business or becomes bankrupt or
insolvent (including without limitation being deemed to be unable to
pay its debts);
9.3.3 a proposal is made or a nominee or supervisor is appointed for
a composition in satisfaction of the debts of the Defaulting Party or
a scheme or arrangement of its affairs, or the Defaulting Party enters
into any composition or arrangement for the benefit of its creditors,
or proceedings are commenced in relation to the Defaulting Party under
any law, regulation or procedure relating to the re-construction or
re-adjustment of debts (including where a petition is filed or
proceeding commenced seeking any reorganisation, arrangement,
composition or re-adjustment under any applicable bankruptcy,
insolvency, moratorium, reorganisation or other similar law affecting
creditor's rights or where the Defaulting Party consents to, or
acquiesces in, the filing of such a petition);
<PAGE> 17
9.3.4 the Defaulting Party takes, without the consent of the
Terminating Party (such consent not to be unreasonably withheld), any
action, or any legal proceedings are started or other steps taken by a
third party, with a view to:
(i) the winding up or dissolution of the Defaulting Party
(other than for the reconstruction of a solvent company for
any purpose, including the inclusion of any part of the share
capital of the Defaulting Party in the Official List of the
London Stock Exchange or in the list of the New York or
American Stock Exchange or quotation of the same on the
National Association of Securities Dealers Automated Quotation
System or an application by the Defaulting Party for
registration as a public company in accordance with the
requirements of the Companies Act 1985); or
(ii) the appointment of a liquidator, trustee, receiver,
administrative receiver, receiver and manager, interim
receiver custodian, sequestrator or similar officer of the
Defaulting Party against the Defaulting Party or a substantial
part of the assets of the Defaulting Party, or anything
analogous to any of the foregoing occurs under the laws of any
country.
9.3.5 Notwithstanding the foregoing provisions of this Clause 9.3,
ONCORMED shall only be deemed to be a Defaulting party in relation to
any of the events set for in Clauses 9.3.2, 9.3.3 and 9.3.4, if
ONCORMED has failed to cure or terminate the event or arrangements
within a period of sixty (60) days from the date of the first
occurrence of such event or arrangements. In any event the provisions
of this Clause 9.3 shall not apply to ONCORMED in respect of any
proceedings under Chapter 11 of the United States Bankruptcy Code made
by or against ONCORMED which contemplate ONCORMED continuing its
operations.
9.4 CRCT and DUKE, acting together and not separately, shall, unless both
have given their prior written approval, have the right to terminate
this Agreement forthwith should any third party, which falls within
one or more of the categories set forth in (***) acquire Control
of ONCORMED. The Parties agree that CRCT and DUKE may add further
categories of third parties to Schedule 4 from time to time by
providing written notice thereof to ONCORMED. However, only Schedule
4 as updated prior to the date on which the Board of Directors of
ONCORMED approves the sale of the "controlling interest" to a third
party, shall be considered when applying the provisions of this Clause
9.4.
10. CONSEQUENCES OF TERMINATION
10.1 Upon expiry or termination of this Agreement for whatever reason:
10.1.1 the licence rights granted by CRCT and DUKE to ONCORMED
pursuant to Clause 2 shall terminate immediately;
10.1.2 ONCORMED shall pay to CRCT within thirty (30) Business Days
all sums due to CRCT and/or DUKE which have accrued prior to the date
of termination or expiry; and
10.1.3 ONCORMED shall return, and shall procure that its Affiliates
and Sub-licensees shall return, to CRCT or as CRCT shall direct all
Documents which embody and pertain to BRCA2 Patent Applications and
BRCA2 Patents and
<PAGE> 18
their use thereof and make no further use of the same for any reason
whatsoever provided however, that ONCORMED shall be entitled to keep
one set, in strict confidence, for legal retention records purposes
only.
10.2 Termination or expiry of this Agreement for whatever reason shall not
affect the accrued rights of the Parties arising in any way out of
this Agreement as at the date of termination and in particular but
without limitation the right to recover damages and interest, and all
provisions which are expressed to survive this Agreement shall remain
in full force and effect.
10.3 Notwithstanding the provisions of Clause 10.1.1, termination or expiry
of this Agreement for whatever reason shall be without prejudice to
the right of ONCORMED or its Affiliates and/or Sub-licensees to fulfil
orders received prior to the termination subject to the payment of
royalties on any Net Sales Revenue accruing in respect thereof at the
rates set out in Clause 4.
11. ASSIGNMENT
11.1 Save as otherwise provided in this Agreement, no Party shall without
the prior written consent of the other Parties, assign the benefit
and/or burden of this Agreement nor sub-contract any of its
obligations hereunder unless otherwise permitted by the terms hereof.
12. FORCE MAJEURE
12.1 If a Party (the "Non-Performing Party") is unable to carry out any of
its obligations under this Agreement due to Force Majeure this
Agreement shall remain in effect but the Non-Performing Party's
relevant obligations under this Agreement and the relevant obligations
of the other Parties ("the Innocent Parties") under this Agreement
shall be suspended for a period equal to the duration of the
circumstance of Force Majeure provided that:
12.1.1 the suspension of performance is of no greater scope than is
required by the Force Majeure;
12.1.2 the Non-Performing Party gives the Innocent Parties prompt
notice describing the circumstance of Force Majeure, including the
nature of the occurrence and its expected duration, and continues to
furnish regular reports during the period of Force Majeure;
12.1.3 the Non-Performing Party uses all reasonable efforts to remedy
its inability to perform and to mitigate the effects of the
circumstance of Force Majeure; and
12.1.4 as soon as practicable after the event which constitutes Force
Majeure the Parties shall discuss how best to continue their
operations as far as possible in accordance with this Agreement.
12.2 If Force Majeure is continuing at the expiry of three (3) months
either of the Innocent Parties may give thirty (30) Business Days
written notice to terminate this Agreement to the Non-Performing Party
and termination shall occur if the Force Majeure is continuing at the
end of that thirty (30) Business Day notice period.
13. GOVERNING LAW
<PAGE> 19
13.1 The validity, construction and performance of this Agreement shall be
governed by the laws of England and subject to the non-exclusive
jurisdiction of the English Courts.
14. ARBITRATION
14.1 Any dispute concerning the validity, construction or performance of
this Agreement shall first be promptly considered in good faith
discussions by senior executive officers of the Parties in an attempt
to resolve the dispute and if such discussions should fail to resolve
the dispute it shall be subject, upon written notice from any Party to
each of the other Parties, to arbitration to be resolved by a panel of
three arbitrators as expeditiously as possible in accordance with the
Rules of Conciliation and Arbitration of the International Chamber of
Commerce (ICC), unless the Parties agree otherwise. For disputes
related to patent matters, the dispute shall be in accordance with the
then current ICC Patent Arbitration Rules. For all other disputes,
the dispute shall be in accordance with the then current ICC
Commercial Arbitration Rules. The decision and award rendered by the
arbitrators shall be final and binding upon the Parties. Each Party
shall bear its own costs and expenses, including attorney's fees, in
connection with the arbitration. Judgement upon the award may be
entered in any court having jurisdiction thereof. Any arbitration
pursuant to this Clause 14 shall be held in London, England.
15. WAIVER
15.1 No Party shall be deemed to have waived any of its rights or remedies
whatsoever unless the waiver is made in writing and signed by a duly
authorised representative of that Party. In particular, no delay or
failure of any Party in exercising or enforcing any of its rights or
remedies whatsoever shall operate as a waiver of those rights or
remedies so as to preclude or impair the exercise or enforcement of
those rights or remedies nor shall any partial exercise or enforcement
of any right or remedy by any Party preclude or impair any other
exercise or enforcement of that right or remedy by that Party.
16. SEVERANCE OF TERMS
16.1 If the whole or any part of this Agreement is or becomes or is
declared illegal, invalid or unenforceable in any jurisdiction for any
reason (including both by reason of the provisions of any legislation
and also by reason of any court or Competent Authority which either
has jurisdiction over this Agreement or has jurisdiction over any of
the Parties):
16.1.1 in the case of the illegality, invalidity or un-enforceability
of the whole of this Agreement it shall terminate only in relation to
the jurisdiction in question; or
16.1.2 in the case of the illegality, invalidity or un-enforceability
of part of this Agreement that part shall be severed from this
Agreement in the jurisdiction in question and that illegality,
invalidity or un-enforceability shall not in any way whatsoever
prejudice or affect the remaining parts of this Agreement which shall
continue in full force and effect.
<PAGE> 20
16.2 If in the reasonable opinion of any Party any severance under this
Clause 16 materially affects the commercial basis of this Agreement,
the Parties shall discuss, in good faith, ways to eliminate the
material effect.
17. ENTIRE AGREEMENT AND VARIATIONS
17.1 Except for the agreements referred to in Recitals C and F, this
Agreement embodies and sets forth the entire agreement and
understanding of the Parties and supersedes all prior oral or written
agreements, understandings or arrangements relating to the specific
subject matter of this Agreement. No Party shall be entitled to rely
on any agreement, understanding or arrangement which is not expressly
set forth in this Agreement. It is agreed that should any grant of a
right to ONCORMED by CRCT or DUKE be found to be in conflict with or
otherwise further limited by any previous agreement between CRCT and
DUKE in a way not contemplated by the Parties, that this Agreement
shall be controlling in the interpretation of the grant of rights.
17.2 No director, officer, employee or agent of any Party is authorised to
make any representation or warranty to another Party not contained in
this Agreement, and each Party acknowledges that it has not relied on
any such oral or written representations or warranties.
17.3 No variation, amendment, modification or supplement to this Agreement
shall be valid unless made in writing in the English language and
signed by a duly authorised representative of each Party.
18. NOTICES
18.1 Any notice or other document to be given under this Agreement shall be
in writing in the English language and shall be deemed to have been
duly given if left at or sent by courier, fax (provided a confirmation
copy is sent by mail) recorded mail or registered mail to a Party at
the addresses set out below for such Party or such other addresses as
the Party may from time to time designate by written notice to the
others.
Address of CRCT
Cambridge House
6-10 Cambridge Terrace
Regent's Park
London NW1 4JL
United Kingdom
For the attention of the Chief Executive
Fax No. +44(0) 171 487 4637
Address of ONCORMED, Inc.
205 Perry Parkway
Gaithersburg
Maryland 20877
United States of America
For the attention of Dr Doug Dolginow
Fax No. (+)1 301 527 1539
<PAGE> 21
A copy of any notice to ONCORMED under this Agreement shall be sent
to the law firm of:
Brobeck Phleger & Harrison LLP
1633 Broadway
47th Floor
New York, NY 10019
United States of America
For the attention of Nigel L Howard
Fax No. (+)1 212 586 7878
Address of Duke University
Office of Science and Technology
Duke University
PO Box 90083
230 North Building
Durham
North Carolina 27708
United States of America
For the attention of Dr Andrew Balber
Fax No. (+)1 919 681 7559
19. COUNTERPARTS
19.1 This Agreement may be executed in any number of counterparts and by
the different Parties by separate counterparts, each of which when so
executed shall be the original, and all of which shall constitute one
and the same instrument. Complete sets of counterparts shall be lodged
with each Party.
20. THIS AGREEMENT NOT TO CONSTITUTE A PARTNERSHIP
20.1 None of the provisions of this Agreement shall be deemed to constitute
a partnership between the Parties and none of the Parties shall have
any authority to bind the others in any way except as provided in this
Agreement.
21. COSTS
21.1 Each Party shall bear its own legal costs, legal fees and other
expenses incurred in the preparation and execution of this Agreement.
22. PUBLIC STATEMENTS
22.1 Except as provided in Clause 22.2, no Party will, without the prior
written consent of each other Party:
22.1.1 use in advertising, publicly or otherwise, any trade-name,
personal name, trademark, trade device, service mark, symbol, or any
abbreviation, contraction or simulation thereof, owned by another
Party; or
22.1.2 represent, either directly or indirectly, that any product or
service of another Party is a product or service of the representing
Party or that it is made in accordance with or utilises the
information or documents of another Party.
<PAGE> 22
22.2 The restrictions in Clause 22.2 shall not apply to the following:
22.2.1 a press release, in a form agreed to by all the Parties,
publicly announcing this Agreement; or
22.2.2 use as required by any applicable law or governmental
regulation.
<PAGE> 23
IN WITNESS whereof this Agreement has been executed by duly authorised officers
of the Parties on the date first above written.
Signed by: /s/ DR S E FODEN
------------------------
For and on behalf of
CANCER RESEARCH CAMPAIGN
TECHNOLOGY LIMITED
Dr S E Foden
Chief Executive
Signed by: /s/ ROBERT L. TABER
------------------------
For and on behalf of
DUKE UNIVERSITY
Robert L. Taber
Associate Vice Chancellor
Signed by: /s/ DOUG DOLGINOW
------------------------
For and on behalf of
ONCORMED, INC.
Doug Dolginow
President
<PAGE> 24
SCHEDULE 1
BRCA2 Patent Applications
(***)
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 25
SCHEDULE 2
CODE OF PRACTICE FOR COMPANIES SEEKING A LICENCE OR SUB-LICENCE TO THE
DIAGNOSTIC RIGHTS OF THE BRCA2 PATENT
(***)
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 26
SCHEDULE 3
MAJOR COUNTRIES
(***)
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
<PAGE> 27
SCHEDULE 4
THIRD PARTIES FOR PURPOSES OF CLAUSE 4
(***)
*** Denotes language for which confidential treatment has been granted
pursuant to the rules and regulations of the Securities Exchange Act
of 1934, as amended.
