1
EXHIBIT 10.2
THIS AGREEMENT is made the 3rd day of April, 1997 between PROTEUS MOLECULAR
DESIGN LIMITED having their registered office at House, Lyme Green Business
Park, Macclesfield, Cheshire, SK11 OJL, England (hereinafter called "Proteus")
of the First Part, ENFER TECHNOLOGY LIMITED whose registered office is at
Xxxxxxxxxxx, Xxxxxxxxx, Xxxxxx, Xx. Xxxxxxxxx (hereinafter called "Enfer") of
the Second Part and ENFER SCIENTIFIC LIMITED whose registered office is at
Xxxxxxxxxxx, Xxxxxxxxx, Xxxxxx, Xx. Xxxxxxxxx (hereinafter called "Enfer
Scientific") of the Third Part.
WHEREAS Proteus has agreed to grant to Enfer an exclusive licence to use the
Technology (as hereinafter defined) for the purpose of diagnostic testing of BSE
in cattle in the Territory (as hereinafter defined) within the Field of Use.
IT IS HEREBY AGREED as follows:
1. Definitions:
1.1 In this Agreement the following words and expressions shall have
the following meanings:
1.1.1 "EU Country" means each or any of the countries comprised
in the European Union at the date of this Agreement and
Switzerland provided that for the purpose of this
Agreement Benelux (Belgium, The Netherlands and
Luxembourg) shall be regarded as one country.
1.1.2 "Field of Use" means the carrying out of post-mortem
diagnostic tests for bovine spongiform encephalopathy by
means of any diagnostic test.
1.1.3 "Know-how" means the know-how and technical information at
the disposal of Proteus which is secret and substantial
and which are identified in protocols validated by Proteus
(and attached hereto as Annex 1) or which are identified
in any other appropriate form and which allow the
invention claimed in the Patents to be used within the
Field of Use.
1.1.4 "Net Sales Value" means the price as invoiced in the
Territory less VAT (or any equivalent sales tax), returns,
rebates and normal trade discounts actually granted in
respect of all diagnostic tests within the Field of Use
using all or part of the Technology carried out by Enfer
and/or its sub-licensees and means in relation to any such
tests carried out otherwise than in an arm's length
transaction exclusively for money the fair market price
(if higher) in the relevant country in which the test is
carried out less VAT (or any equivalent sales tax),
returns, rebates and normal trade discounts actually
granted Provided always "Net Sales Value" means nil value
in relation to any tests carried out by Enfer and/or its
sub-licensees for bona fide development or bona fide
provision of free samples to the intent however that Enfer
shall not offer such tests in conjunction with any other
product or service provided by Enfer to the detriment of
Proteus.
2
1.1.5 "Patents" means any patents which may be granted in the
Territory as a result of international patent application
No. PCT/GB/92/02246 and the national and regional
applications derived therefrom namely:
Country/Region Application Date of Status
Number Application
USA 244701 3/12/92 under examination
Canada 2124953 3/12/92 no action to date
Japan 5-509594 3/12/92 no action to date
Australia 30892/92 3/12/92 proceeding to acceptance
Europe (EPO) 92924777.3 3/12/92 under examination
New Zealand 246059 3/12/92 granted
South African patent application 92/9392 (granted)
including any extension of any such patent including any
protection under an SPC.
1.1.6 "Previous Agreement" means the Technology Transfer
Agreement dated the 1st May, 1996, made between Proteus of
the One Part and Enfer Scientific of the Other Part.
1.1.7 "SPC" means in relation to any product using all or part
of the Technology all Supplementary Protection
Certificates for medicinal products and their equivalents
provided under Council Regulation (EEC) No. 1768/92 of
18th June, 1992, or analogous extensions of patent/product
protection in any jurisdiction.
1.1.8 "Technology" means the Patents together with the Know-How.
1.1.9 "Term" means a period of 10 years from the date hereof.
1.1.10 "The Territory" means any country in the World.
1.1.11 "Year" means each calendar year commencing on the date of
this Agreement and each subsequent calendar year
commencing on an anniversary of the date of this
Agreement.
2. New Agreement:
The parties hereto acknowledge that this agreement shall
supercede the Previous Agreement which Previous Agreement shall
henceforth be of no effect save for the provisions relating to
confidentiality set out in clause 7 of the Previous
2
3
Agreement the provisions of which shall remain in full force and
effect save as may be varied by this agreement.
3. Grant of Licence:
3.1 Proteus hereby, for the consideration hereinafter provided,
grants to Enfer a full exclusive licence and authority for the
Term in the Territory to:
3.1.1 use the technology (or any part thereof) in the Territory
within the Field of Use; and
3.1.2 grant sub-licences to third parties to use, within the
Field of Use, the Technology (or any part thereof) within
the Territory, providing that such sub-licences do not
contain any terms which are less favourable to Proteus as
those contained in this Agreement and provided that Enfer
will notify Proteus of the appointment of any sub-licensee
within fourteen days of any appointment supplying full
details of such sub-licence;
which use, without limiting the generality of the foregoing,
shall include use for the production or provision of goods or
services.
3.2 Proteus shall at the request and cost of Enfer execute any
further document which may be necessary to give effect to this
Agreement in the Territory.
4. Obligations of Parties:
4.1 Enfer shall not use the Technology for any other purpose than the
Field of Use.
4.2 Enfer shall not use the Technology, in any Country within the
Territory, in respect of which this Agreement has terminated or
expired provided that it may utilize the invention claimed in the
Patents once the Patents have expired in such Country and it may
utilize the know-how once the know-how is no longer secret other
than if the Know-How is no longer secret by virtue of a breach by
Enfer of its obligations under Clause 7 or once the obligation
provided for in Clause 7.1 have ceased.
4.3 Proteus shall not, during the Term, licence or make available,
directly or indirectly, the Technology for use within the Field
of Use, to any other person resident or carrying on business in
any Country within the Territory and shall not during the said
Term exploit, either directly or indirectly, the Technology for
use within the Field of Use for any such Country, unless Enfer
has been requested by Proteus to do so and Enfer is unable or
unwilling to do so itself.
3
4
5. Payments:
Payments to Proteus shall be as follows:
5.1 Enfer has paid to Proteus prior to the date hereof the sum of
Pound Sterling 28,000 Stg. (twenty eight thousand pounds
sterling).
5.2 Payment of royalties shall be in sterling and shall be 12.5% of
the Net Sales Value in the Territory.
5.3 After the end of the second year of the Term, the aggregate
amount of the royalties paid by Enfer under this agreement for
any year shall not be less than Pound Sterling 65,000 (sixty five
thousand pounds).
5.4 Royalties shall be paid within 30 days of the end of each
calendar quarter to which they relate.
5.5 All royalties or other sums payable under this Agreement are
exclusive of value added tax or other applicable taxes or duties,
for which Enfer shall be additionally liable, and shall be paid
in pounds sterling in cleared funds to such bank account or in
such manner as Proteus may specify from time to time, without any
set-off, deduction or withholding except any tax which Enfer is
required by law to deduct or withhold, and if Enfer is required
by law to make any such tax deduction or withholding, Enfer shall
do all things in its power which may be necessary to enable or
assist Proteus to claim exemption for or (if that is 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 Proteus proper
evidence as to the deduction or withholding of any payment or of
the tax deducted or withheld.
6. Accounts:
6.1 Enfer shall keep (and/or procure that its sub-licensees keep)
true and accurate accounts and records in sufficient detail to
enable the amount of all royalties or other sums payable under
this Agreement to be determined.
6.2 Enfer shall submit to Proteus within 14 days of the end of each
quarter a statement setting forth with respect to the operations
of Enfer hereunder during that period the Net Sales Value.
6.3 Enfer shall upon Proteus giving reasonable notice allow Proteus
or its auditors (or procure that Proteus or its auditors is
allowed) to inspect those accounts and records referred to in
clauses 5.1 and 5.2 and to the extent that they relate to the
calculation of royalties or other sums to take copies of them.
6.4 If, following any inspection pursuant to clause 5.3 Proteus'
auditors certify to Proteus that the amount of the royalties paid
in respect of any period fall short of the amount of the
royalties which were properly payable in respect of the period
4
5
then, Enfer shall within 7 days of being served with a copy of
the certificate pay the shortfall plus interest thereon at the
rate of 4% above the base rate from time to time of National
Westminster Bank plc to Proteus. In the event that the shortfall
is greater than 5% of the amount actually paid for that period
then Enfer shall also pay to Proteus the reasonable costs and
expenses of Proteus in making the inspection.
7. Information and Improvements:
7.1 Proteus shall disclose to Enfer all information at its disposal
relating to the Technology in relation to the Field of Use and
allow Enfer to use such information for the purpose of exercising
its rights under this Agreement.
7.2 Any improvements made to the Technology by Proteus (which are
owned by Proteus and not subject to a duty of confidentiality in
favour of a third party) which could be of use to Enfer within
the Field of Use shall forthwith be disclosed to Enfer and deemed
to be included within the subject matter of the licence to Enfer
contained in clause 2 to the intent that Proteus shall grant to
Enfer, for the consideration already provided, an exclusive
licence to make use of such improvements in accordance with the
terms of this Agreement.
7.3 Enfer will supply Proteus with the results of field studies
carried out in respect of the use of Enfer's BSE assay in tests
undertaken in or on bovine carcasses including the results of the
study that has been completed by Enfer and validated by the
Veterinary Research Laboratory at Abbotstown, Ireland, which
information Proteus shall treat as secret and which Proteus shall
not use or exploit, PROVIDED HOWEVER that Proteus shall not be
entitled to be supplied by Enfer with any information about the
test protocols or methodology involved in such BSE tests.
7.4 Subject to clause 7.3 any improvements made to the Technology by
Enfer within the Field of Use shall forthwith be disclosed to
Proteus but Proteus shall have no right to use or exploit such
improvements.
8. Confidentiality:
8.1 Subject to the provisions of Clause 7.2 hereof, Enfer shall not
at any time during the Term, or within fifteen years from the
date of termination of the Agreement disclose to any other person
any Know-How or confidential information (whether it is marked as
such or not), disclosed to it by Proteus under or pursuant to
this Agreement, or use any Know-How or Patents, for any purpose
except as contemplated by this Agreement and in accordance
therewith and all Know-How and confidential information shall be
kept confidential by Enfer.
8.2 (i) Enfer shall cease to be under the obligations provided in
Clause 7.1 in respect of any Know-How or item of
confidential information (which has been disclosed to
Enfer since the 1st May 1996 or is disclosed to Enfer
under or pursuant to this Agreement) in the event that:
5
6
(a) Enfer can prove by documentary evidence produced to
Proteus within 28 days of disclosure that such
Know-How or confidential information is no longer
secret or substantial;
(b) any item of Know-How or confidential information
provided by Proteus under or pursuant to the
Agreement is or has become generally available to the
public in printed publications and general
circulation through no act, omission or default on
the part of Enfer or Enfer's agents, consultants,
sub-contractors, sub-licensees or employees;
(c) Enfer has obtained any item of Know-How or
confidential information by way of a disclosure,
without any obligations of confidence, to Enfer by a
third party who has not derived it directly or
indirectly from Proteus.
(ii) Any obligation on Enfer in relation to any particular
Patent shall cease on expiration of the said Patent.
8.3 Information shall not be regarded as being generally available to
the public for the purposes of clause 7.2(c) if, despite the
individual parts of the information being generally available,
the precise configuration of its constituent components are not
generally available.
9. Patents:
9.1 Proteus shall bear all costs of obtaining, maintaining and
renewing the Patents.
9.2 Proteus warrants that it has full power to enter into this
Agreement and that it has not granted any licences to use the
Technology in the Territory within the Field of Use.
10. Extension to Agreement:
10.1 Proteus grants Enfer the option exercisable by three months
notice in writing at any time during the ninth year of the Term
such notice to expire no later than the expiry of the ninth year
to renew this Agreement for a further term of five years
commencing at the expiry of the Term Provided that at the time
such notice is given Enfer has paid all royalties up to date and
has substantially performed its obligations hereunder.
10.2 In the event that this Agreement is renewed under clause 9.1 then
the Agreement shall be on the same terms and conditions as this
Agreement except for the option to renew contained in this clause
9.
6
7
11. Termination:
11.1 Either party may forthwith terminate this Agreement by giving
written notice to the other if the other party commits any breach
of this Agreement and, if the breach is capable of remedy, fails
to remedy it within 30 days after being given written notice
containing particuluars of the breach and requiring it to be
remedied.
11.2 Proteus may forthwith terminate this Agreement by giving written
notice to Enfer in the event that:
11.2.1 any royalties or other sums payable by Enfer under this
Agreement have not been paid by the due date for payment
and 30 days written notice has been given to Enfer; or
11.2.2 an incumbrancer takes possession or a receiver is
appointed over all or a substantial part of the property
or assets of Enfer; or
11.2.3 Enfer becomes subject to an administration order, makes
any voluntary arrangement with its creditors, goes into
liquidation or ceases or threaten not to carry on
business; or
11.2.4 anything analogous to the events described in clauses
10.2.2 and 10.2.3 above happens to Enfer in any
jurisdiction.
11.3 In the event that Proteus has the right to terminate this
Agreement it may, at its option, terminate this Agreement in
relation to specific Countries within the Territory and in this
event this Agreement shall continue in full force and effect in
relation to the remaining Countries in the Territory.
11.4 The rights given by clause 10.1 and 10.2 to terminate this
Agreement shall not prejudice any other right or remedy of either
party in respect of any breach of this Agreement.
12. Miscellaneous:
12.1 Each party agrees that it will be liable for the acts or
omissions of its subsidiaries, sub-licensees,
sub-contractors, agents and employees as if they were its
own acts or omissions under this Agreement.
12.2 This Agreement contains the entire Agreement between the parties
with respect to its subject matter and may not be modified except
by an instrument in writing signed by the duly authorised
representatives of the parties.
12.3 Each party acknowledges that, in entering into this agreement, it
does not do so in reliance on any representation, warranty or
other provision except as expressly provided in this Agreement,
and any conditions, warranties or other terms implied by statute
or common law are excluded to the fullest extent permitted by
law.
7
8
12.4 All payments and other obligations under this Agreement shall be
made and/or discharged without any right of set-off,
counterclaim, withholding or deduction other than as required by
law.
12.5 Enfer shall indemnify Proteus against any loss, damages, costs or
expenses which are awarded against or incurred by Proteus as a
result of any claim or threatened claim concerning the use by
Enfer of the Technology, or any defect in or otherwise in
connection with the Field of Use or the use of any part or all of
the Technology provided however that Enfer shall not be liable to
Proteus for any claims arising out of the negligence or breach of
duty of Proteus.
12.6 Each party shall not be liable to the other party for any damage
or loss to the extent that the other party is compensated under
any policy of insurance.
12.7 In the event that Enfer fails to pay any monies due to Proteus
under this Agreement by the due date then Enfer will pay to
Proteus interest on such sum at the rate of 4% above the base
rate from time to time of the National Westminster Bank plc until
payment in full. Any monies received shall be applied first
towards discharging interest and secondly towards discharging the
principal monies owed.
12.8 This Agreement shall be governed by the Laws of England and the
parties hereby agree that the Courts of Law in England shall have
non-exclusive jurisdiction to entertain any action in respect
hereof.
12.9 Any notice required or permitted to be given under this Agreement
by either party to the other shall be in writing and shall be
served by sending the same by registered or recorded delivery
post to the address of the other party as given herein or to such
other address as that party may have previously notified the
party giving notice as its address for such service.
12.10 Either party may notify this Agreement to the European Commission
under Article 85 of the Treaty of Rome and/or to the relevant
competition authority in any Country within the Territory as
required by law. If either party elects to notify this Agreement
as aforesaid, the other party shall give all reasonable
assistance that may be required in order to complete the
notification including, without limitation, preparation of all
responses to queries raised by the European Commission or such
competition authority as the case may be. Each party shall bear
their own costs incurred in connection with such notifications
and each party agrees to any modification to the Agreement
required by the European Commission, to ensure compatibility with
Article 85, and further agrees to modify the Agreement in
relation solely to any Country within the Territory to the extent
8
9
necessary to make the Agreement compatible with the competition
laws of such Country.
IN WITNESS whereof the parties have entered into this Agreement the day and year
first above written.
Signed for and on behalf of Proteus Molecular
Design Limited in the presence of: ______________________________
Director
Signed for and on behalf of Enfer Technology
Limited in the presence of: ______________________________
Director
Signed for and on behalf of Enfer Scientific
Limited in the presence of: ______________________________
Director
9
10
Dated the 3rd day of April 1997
PROTEUS MOLECULAR DESIGN LIMITED
FIRST PART
ENFER TECHNOLOGY LIMITED
SECOND PART
ENFER SCIENTIFIC LIMITED
THIRD PART
TECHNOLOGY TRANSFER AGREEMENT
Xxxxxxx Xxxxxxx & Co.,
Solicitors,
Xxxxxxx Xxxxx,
Xxxxxx,
Xx. Xxxx.
10
11
[LOGO]
PCT WORLD INTELLECTUAL PROPERTY ORGANIZATION
International Bureau
INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
-----------------------------------------------------------------------------------------------------------------------------------
(51) INTERNATIONAL PATENT CLASSIFICATION 5: (11) INTERNATIONAL PUBLICATION NUMBER: WO 93/11155
C07K 7/06, 7/08, 7/10
C07K 15/00, A61K 37/02, 39/00 A1
G01N 33/68 (43) INTERNATIONAL PUBLICATION DATE: 10 June 1993 (10.06.93)
-----------------------------------------------------------------------------------------------------------------------------------
(21) INTERNATIONAL APPLICATION NUMBER: PCT/GB92/02246 (74) AGENT: XXXXX X. XXXX & CO.; Xxxxxxxx Xxxxx, 00-00
Xxxxxxxx, Xxxxxx XX0X 0XX (GB)
(22) INTERNATIONAL FILING DATE 3 December 1992 (81) DESIGNATED STATES: AU, BG, BR, CA, Fl, HU, JP. MN, NO,
(03.12.92) NZ, R_, RU, UA, US, European patent (AT, BE, CH, DE,
DR, ES, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE).
(30) PRIORITY DATA:
9125747.7 3 December 1991 (03.12.91) GB PUBLISHED
9214663.8 10 July 1992 (10.07.92) GB With international search report.
Before the expiration of the time limit for amending
the claims and to be republished in the event of the
receipt of amendments.
(71) APPLICANT (for all designated States except US): PROTEUS
MOLECULAR DESIGN LIMITED [GB/GB]; Xxxxxxx Xxxxx, 00
Xxxxxxxxx Xxxx, Xxxxxx, Xxxxxxxx XX0 0XX (XX)
(72) INVENTORS; AND
(75) INVENTORS/APPLICAMS (for US only): XXXXXXXXX, Xxxxxx, Xxxxxxx [GB/GB];
Xxxxxxx Xxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxx, Xxxxxxxx XX00 0XX (XX).
XXXXXX, Xxxxx [GB/GB]; The Old Bakery, 00X Xxxx Xxxxxx, Xxxxxx Xxxxxx,
Xxxxxxxx XX0 0XX (GB). XXX, Xxxxx, Xxxx [GB/GB]; 0 Xxxx Xxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxxxx X00 0XX (XX).
-----------------------------------------------------------------------------------------------------------------------------------
(54) TITLE: FRAGMENTS OF PRION PROTEINS
(57) ABSTRACT
Synthetic polypeptides having at least one antigenic site of a prion protein are disclosed together with methods for their
use and manufacture and antibodies raised against such polypeptides. Diagnostic kits using the polypeptides and/or antibodies are
also disclosed.
ANNEX I
OF ENFER
Agreement
-----------------------------------------------------------------------------------------------------------------------------------
