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EXHIBIT 10.1
DATED MARCH 27, 1996
CONFIDENTIAL
***Portions of the Exhibit have been omitted pursuant to a request for
Confidential Treatment under rule 406 of the Securities Act of 1933, as amended.
The complete Exhibit, including the portions for which confidential treatment
has been requested, has been filed separately with the Securities and Exchange
Commission.
(1) PROTEUS MOLECULAR DESIGN LIMITED
(2) ML LABORATORIES PLC
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TECHNOLOGY LICENSE AGREEMENT
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XXXX & CO
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THIS AGREEMENT is made the day of 1996
BETWEEN:
(1) PROTEUS MOLECULAR DESIGN LIMITED whose registered office is at Proteus
House, Lyme Xxxxx Xxxxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxx, XX00 0XX
("Proteus");
(2) ML LABORATORIES PLC whose registered office is at Marcol House, 000
Xxxxxx Xxxxxx, Xxxxxx, X0X 0XX ("ML").
1. RECITALS
Whereas Proteus has developed know-how and patentable matter relating to
GnRH Immunotherapeutic. ML wishes to utilize this technology to develop,
manufacture, use and sell products in the Territory for the treatment of
human prostate and breast cancer.
Whereas Proteus is willing to grant a License to ML to do so, on the
terms and conditions of this Agreement.
Whereas Proteus will be contracted to supply the Conjugate to be
incorporated in the finished products.
IT IS AGREED, as follows:
2. INTERPRETATION
2.1 In this Agreement:
"Competing Product" means a third party product for
application within the Field of Use of
which all or part falls within the
claims of United States Patent
Application No. 07/177,730 filed 5th
April 1988 in the form of its claims
or any of them as existing immediately
prior to the decision to grant or not
grant the patent other than a product
in relation to which the invention in
the said claims forms an immaterial or
insubstantial part. In the event that
the parties are unable to agree
whether a particular third party
product is a Competing Product the
matter shall be resolved in accordance
with Schedule G;
"Completion" means either:
(a) the entry into the next stage of
development being in relation to Phase
II
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the date of commencement of Phase III
of clinical trials or in relation to
Phase III making the application for
Registration (as appropriate) as
outlined in the relevant clinical
development plan; or
(b) such other date as the parties may
agree having regard in particular to
the supply of Conjugate or regulatory
issues or changes to the Programme;
and "Completed" shall have a
corresponding meaning;
"Conjugate" means the biologically active material
(including any improvements thereto
made pursuant to clause 6.3) formed by
linking the GnRH analogue, referred to
in the claims of United States Patent
Application No. 07/177,730 filed 5th
April 1988 in the form of its claims
existing immediately prior to the
decision to grant or not grant the
patent, to a tetanus toxoid by means
of a chemical linker;
"Field of Use" means the treatment of human prostate
and breast cancer and other human
ailments;
"Formulation" means the mixing and dilution of the
Conjugate with salts, water and
adjuvants;
"Group" means in relation to any company, that
company and any other company which,
at the relevant time, is that
company's holding company or
subsidiary (as defined by s736 of the
Companies Act 1985), or the subsidiary
of any such holding company (as so
defined), and a "Member" of a Group
has a corresponding meaning;
"Improvement" means any improvement made (whether
patentable or not) to the Technology
and which would make the Technology
cheaper, more effective, more useful
or
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more valuable, or would in any other
way render the Technology preferable
in commerce;
"Indication" means a use for a product for the
treatment of a particular condition or
for a particular purpose in relation
to which Registration has been
obtained;
"Interest" means interest at the rate of 4 per
cent per annum above the base rate
from time to time of National
Westminster Bank Plc;
"Know-How" means the experience and knowledge of
the appropriate methodologies and
processes and the supporting technical
data, drawings, specifications for the
information (howsoever stored,
recorded or embodied including on
magnetic media) brief details of which
are set out in Schedule B but
excluding anything relating to the
Conjugate;
"Patents" means the patents and patent
applications listed in Schedule A and
any patent obtained in pursuance of
any such application including any
extension of any such patent including
any protection under an SPC;
"Product(s)" all products or materials of ML (or
Members of its Group or its
sub-licensees) of which all or part
are developed, produced, made, utilize
or use all or any part of the
Technology and/or the Conjugate for
application within the Field of Use
other than products or materials of
which the non patented Technology
forms an immaterial or insubstantial
part;
"Programme" means a programme of clinical,
development, stability and/or other
trials conducted in relation to a
particular Product and/or the
application for Registration for that
particular Product
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with the intention of obtaining a
particular Indication or Indications
for that Product;
"Net Sales Value" means, in relation to any of the
Products:
(a) where the Products are sold on
arm's length terms, the price charged
to the purchaser less;
(i) any value added tax or other
sales tax;
(ii) any freight, warehousing,
carriage and carriage insurance
charges,
to the extent that any of those items
are included in the price, and after
deducting any allowances for lost or
damaged merchandise or returns and any
normal trade discounts or rebates
actually given;
(b) where the Products are sold
otherwise than on arm's length terms,
but are subsequently sold on arm's
length terms, the price charged under
the first such arm's length sale,
calculated in accordance with
sub-clause (a) above;
(c) where the Products are not sold on
arm's length terms but are used or
otherwise disposed of on a commercial
basis, the price that would have been
charged on the first arm's length
sale, calculated in accordance with
sub-clause (a) above provided that
Products reasonably supplied as
samples shall not be treated as being
disposed of on a commercial basis and
shall be ignored for the purposes of
calculating Net Sales Value;
"Quarter" means each period of three months
ending on the last day of March, June,
September and December, and any
shorter period to the date of
termination
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of this Agreement, and "Quarterly" has
a corresponding meaning;
"Registration" means approval issued by a designated
regulatory authority of any country to
grant marketing authorization for that
country for a product;
"SPC" means in relation to any Product 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;
"Start Date" means the date upon which a
contract with an investigator is made
to start clinical trials under a
Programme which has not been
terminated under clause 8.5;
"Technology" means the Patents and the Know-How; .
"Term" means the period during which this
Agreement continues in force pursuant
to clause 14.1;
"Territory" means the world;
"Year" means each calendar year.
2.2 Any reference in this Agreement to:
(a) a statute or a provision of a statute is a reference to
that statute or provision as amended or re-enacted at
the relevant time; and
(b) "writing" or any cognate expression includes a reference
to any communication effected by telex, facsimile
transmission or similar means.
2.3 The headings in this Agreement are for convenience only and
shall not affect its interpretation.
3. GRANT OF LICENSE
3.1 Proteus hereby grants to ML, subject to the provisions of this
Agreement, an exclusive world-wide license under the Technology
to:
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(a) develop and manufacture Products in the Territory other
than the Conjugate;
(b) use, deal in and sell the Products and otherwise to use
the Technology in the Territory within the Field of Use;
and
(c) have the Products (other than the Conjugate)
manufactured in the Territory for ML by a
sub-contractor, subject to ML obtaining from the
sub-contractor a binding written undertaking to comply
with all the applicable provisions of this Agreement,
and procuring that the subcontractor complies in all
respects with those provisions.
3.2 ML shall be liable for and indemnify Proteus against the acts or
omissions of its sub-contractors appointed under this Agreement
as though they were the acts or omission of ML under this
Agreement.
3.3 During the Term Proteus, except as otherwise provided in this
Agreement, shall not:
(a) develop or manufacture Products other than the
Conjugate;
(b) use, sell or otherwise deal in any of the Products or
make any other use of the Technology in the Field of Use
in the Territory save for the supply of Conjugate in
accordance with ML's instructions;
(c) supply any Products (other than supply of the Conjugate)
to any person in the Territory; or
(d) develop or manufacture any products (other than the
Conjugate) which reduces directly or indirectly the
level of sex hormones in humans without the prior
written consent of ML (to be given in ML's absolute
discretion);
(e) grant to any other person a license to do anything
specified by sub-clauses 3.3(a), (b), (c) or (d) above;
or
(f) encourage or assist any third party to do anything
specified by subclauses 3.3(a), (b), (c) or (d) above.
3.4 ML shall not (and procure that the Members of ML's Group and
each of its sub-licensees shall not) use the Technology outside
the Field of Use.
3.5 Proteus acknowledges and accepts that the restriction on it set
out in clause 3.3(d) is a necessary commercial and practical
restriction having regard to the nature of the patented
invention the subject of the Patents and the Know-How together
with the legitimate need of ML to protect the substantial
consideration payable by ML in order to obtain the exclusive
rights in respect of the said invention and the Know-How as well
as the legitimate need for ML to minimize
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the substantial commercial risk being taken by ML in order to
commercialize the said invention and the Know-How.
4. SUB-LICENSING
4.1 ML shall be entitled to grant sub-licenses of its rights under
this Agreement to any person, provided that:
(a) the sub-license contains undertakings by the
sub-licensee to observe and perform provisions
substantially similar to those contained in this
Agreement with regard to use, restrictions,
confidentiality, access to records, non-assignability
and termination, so far as the same are capable of
observance and performance by the sub-licensee, and
prohibits any further sub-licensing;
(b) the sub-license is expressed to terminate automatically
on the termination of this Agreement for any reason.
4.2 Proteus agrees that any sub-license granted by ML pursuant to
this Agreement may include as an alternative to the provision
referred to in clause 4.1(b) above a right for the sub-licensee
to novate their sub-license to Proteus in the event that this
Agreement does terminate. Proteus will take such a novation
provided that:
(a) Proteus was notified of the identity of the sub-licensee
by ML within 30 days of the grant of the sub-license;
(b) Proteus receives a written confirmation of the novation
from the sub-licensee within 30 days from the
termination of this Agreement;
(c) the sub-license is on normal commercial terms;
(d) the sub-licensee has not been in breach of the terms of
their sub-license; and
(e) the sub-licensee is not and has not been a Member of
ML's Group.
4.3 ML shall:
(a) within 30 days of the grant of any sub-license notify
Proteus in writing, and
(b) at all times during the Term ensure the observance and
performance by every sub-licensee under this Agreement
of the provisions of the sub-license and indemnify
Proteus against any loss, damages, costs, claims or
expenses which are awarded against or incurred by
Proteus as a result of any breach by any sub-licensee
under this Agreement of any of the provisions of the
sub-license.
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4.4 In the event that ML grants any sub-licenses under this
Agreement ML shall remain responsible for and indemnify Proteus
against all acts and omissions of such sub-licensees as though
they were acts or omissions of ML under this Agreement.
4.5 ML shall not grant any sub-licenses under this Agreement for a
consideration other than money at full value without Proteus'
prior written consent
5. DEVELOPMENT
5.1 Save as provided in clause 5.2 ML or its sub-licensees shall be
wholly responsible for the further development of the Products
(other than Conjugate) including planning, conducting and
funding all necessary Programmes leading to Registration of the
Products to the maximum extent commercially practicable. ML
undertakes to Proteus that it shall use its reasonable
commercial endeavours to progress such Programmes and
Registration in a timely manner keeping Proteus fully informed
during such period of development.
5.2 Proteus shall be responsible for the Phase IIa study for the
first Product including planning, conducting and funding the
study. Proteus shall be entitled to sub-contract the work for
the Phase IIa study to a sub-contractor approved by ML. The
results and data from the Phase IIa study shall be included
within the definition of Technology for the purposes of this
Agreement and licensed to ML in accordance with clause 3.1.
5.3 Forthwith on receipt from ML of the initial payment due pursuant
to subclause 8.1(a) below Proteus will supply ML with all
information in its possession that has not previously been
disclosed relating to the Technology,
5.4 Proteus shall supply sufficient Conjugate to ML to allow ML to
conduct Programmes for Products at a price to be agreed.
6. IMPROVEMENTS
6.1 Any Improvement made by ML shall belong to ML. Proteus shall
have no rights to such Improvement other than as provided in
clauses 15.2 and 15.3.
6.2 Any Improvement developed by Proteus shall belong to Proteus.
Any such Improvement shall be included within the definition of
Technology for the purposes of this Agreement and licensed to ML
in accordance with clause 3.1.
6.3 Proteus shall use its reasonable endeavours to improve the
Conjugate to make it cheaper, more effective, more useful, more
valuable or to render the Conjugate preferable in commerce.
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7. METHODS OF MANUFACTURE AND SALE
7.1 ML shall ensure that all Products manufactured by or for ML
comply with any methods of manufacture, specifications,
formulae, designs, standards of quality and quality control
procedures laid down by any regulatory authorities from time to
time and with all applicable standards and legal requirements,
and are free from defects in workmanship and materials.
7.2 ML shall use its reasonable endeavours at all times during the
Term to promote the sale of the Products and to satisfy market
demand for them.
7.3 Except as otherwise provided in this Agreement, ML shall be
entitled to promote and market the Products in the Territory in
such manner as ML may, in accordance with sound commercial
principles, think fit, and in particular ML shall be entitled to
use such trade marks in respect of the Products and to sell the
Products to its customers at such prices as it may determine.
7.4 ML shall not be (and shall procure that any of its Group Members
and/or sub-licensees are not) during the Term involved directly
or indirectly in the research, development, manufacture,
production, marketing, sale or otherwise of any product which:
(a) is the same as the Products; or
(b) reduces directly or indirectly the level of sex hormones
in humans;
without the prior written consent of Proteus (which shall be in
Proteus' absolute discretion).
7.5 ML acknowledges and accepts that the restriction on it set out
in clause 7.4 is a necessary commercial and practical
restriction having regard to the nature of the patented
invention the subject of the Patents and the Know-How together
with the need to keep the use and disclosure of the said
invention and the Know-How strictly limited to the purposes of
ML performing its obligations and exercising its rights under
this Agreement.
8. MILESTONE PAYMENTS
8.1 ML shall pay to Proteus:
(a) the sum of *** on the day of execution of this
Agreement; and
(b) the sum of *** payable on the commencement of Phase IIa
clinical trials for the first Product.
8.2 There shall also be paid to Proteus by ML development milestones
as follows:
(a) the sum of ***:
(i) on the first Completion of a Phase IIa study under
any Programme (with credit to be given for any
installments already paid under (ii) below); or
(ii) *** with the first installment paid on the second
anniversary of a Start Date and the second
installment paid on the third anniversary of a
Start Date;
whichever of the events in (i) and (ii) above shall be
the sooner.
(b) the sum of ***:
(i) on the first Completion of a Phase III study under
any Programme (with credit to be given for any
installments already paid under (ii) below); or
(ii) *** with the first installment paid on the fourth
anniversary of a Start Date and the second
installment paid on the fifth anniversary of a
Start Date;
whichever of the events in (i) and (ii) above shall be
the sooner.
8.3 There shall also be paid to Proteus by ML regulatory milestones
as follows:
(a) *** on the first Registration for any Product in any
country in the European Union;
(b) *** on the first Registration for any Product in Japan;
(c) *** on the first Registration for any Product in the
United States of America; and
(d) *** on the first Registration for any Product in any
country referred to in Schedule C.
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8.4 Each of the milestone payments referred to in clauses 8.2 and
8.3 above shall be payable only once. It shall be paid upon the
first occurrence of the particular event to which each milestone
relates regardless of which Programme the event occurs under.
8.5 ML shall have the right to terminate any Programme upon giving 2
months written notice to Proteus. On the termination of any
particular Programme:
(a) ML will cease all work in relation to that Programme;
and
(b) that Programme will cease to be of effect in triggering
the payment of future milestones or installments of
milestones.
8.6 The milestone payments referred to in this Section 8 shall not
be creditable against ML's royalty obligations and shall apply
regardless of whether it is ML, a Member of its Group, any
sub-licensee or any sub-contractor who completes the relevant
study, phase or obtains Registration as appropriate.
8.7 Payment of the milestone payments referred to in this Section 8
shall be made by telegraphic transfer to a bank account
nominated from time to time by Proteus.
9. ROYALTIES
9.1 In consideration of the rights granted under this Agreement, ML
shall, subject to the following provisions, pay to Proteus:
(a) royalties in respect of all Products sold, or used or
otherwise disposed of on a commercial basis by ML and/or
any Member of its Group at the rate of *** of the Net
Sales Value of those Products calculated in accordance
with Schedule D;
(b) royalties at the rate of *** of all royalties or other
sums (other than those referred to in clause 9.5)
received by ML and/or any Member of its Group from any
third party (other than those referred to in sub-clause
9.1(c) below) in consideration of the grant to it of a
sub-license under all or any part of ML's rights under
this Agreement; and
(c) royalties at the rate of *** of all royalties or other
sums (other than those referred to in clause 9.5)
received by ML and/or any Member of its Group from any
third party in consideration of the granting to it of a
sub-license under all or any part of ML's rights under
this Agreement which relate to the United Kingdom and/or
Ireland;
provided that the amount of royalties payable to Proteus under
b) and (c) above in relation to the grant of a particular
sub-license shall not be less than *** of the Net Sales Value of
the particular sub-licensee in any country for so long as a
patent within the Patents remains in force in that country. ML
shall make up the amount of any shortfall in royalties paid to
Proteus, in relation to such sub-license to this minimum level.
9.2 The royalties payable pursuant to clause 9.1 shall be due:
(a) in relation to Proteus' royalty on royalties payable to
ML and/or ML's Group under sub-clauses 9.1(b) and (c)
above with the same frequency as the royalties are due
to be paid to ML and/or ML's Group under each of such
sub-licenses; and
(b) in relation to Proteus' royalty on sales of Products
made by ML and/or ML's Group under sub-clause 9.1(a)
they shall be paid Quarterly.
9.3 Within 30 days after any payment of royalties is due to Proteus
ML shall send to Proteus a written statement showing, for the
period since the last such written statement, details of the
following:
(a) the quantity of the Products sold or otherwise disposed
of on a commercial basis by ML and/or any Member of its
Group;
(b) the Net Sales Value in respect of that quantity of
Products sold or otherwise disposed of on a commercial
basis by ML and/or any Member of its Group;
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(c) the amount of the royalties payable under sub-clause
9.1(a);
(d) the amount of royalties or other sums received by ML
and/or Members of its Group under any sub-licenses; and
(e) the amount of any royalties payable pursuant to
sub-clauses 9.1(b) and 9.1(c).
9.4 On the same day as providing the written statement referred to
in clause 9.3 ML shall send to Proteus a telegraphic transfer
for the total amount of royalties shown as payable on the
written statement.
9.5 The calculation of royalties payable to Proteus under
sub-clauses 9.1(b) and (c) shall not take into account any
initial up front payments which ML and/or a Member of its Group
receives in relation to the grant of any sub-license for a
territory provided:
(a) such payments are due to ML prior to or upon the first
Registration or launch of a Product in that territory;
and
(b) in addition the sub-license provides for royalties to be
paid at a full commercial rate; and
(c) the payment does not contain any element which is
attributable to a prepayment of royalties (in the event
such element does exist then only that element shall be
subject to the calculation of royalties).
10. GENERAL FINANCIAL
10.1 All royalties or other sums payable under this Agreement shall
be paid in pounds sterling. Where any royalties or other sums
falling due in any period covered by the written statements
referred to in clause 9.3 are calculated in a currency other
than pounds sterling, they shall be converted into pounds
sterling by reference to:
(a) the exchange rate applying when the monies are actually
converted into pounds sterling if this occurs during the
period covered by the written statement referred to in
clause 9.3; or
(b) in the event the monies are not actually converted into
pounds sterling, the exchange rate of the National
Westminster Bank plc ruling in London on the last day of
the period covered by the written statement referred to
in clause 9.3.
10.2 All royalties of other sums payable under this Agreement are
exclusive of value added tax or other applicable taxes or
duties, for which ML shall be additionally liable, and shall be
paid 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
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withholding except any tax which ML is required by law to deduct
or withhold, and if ML is required by law to make any such tax
deduction or withholding, ML shall do all things in its power
which may be necessary to enable or assist Proteus to claim
exemption from 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 any payment over of the tax deducted or withheld.
10.3 If ML fails to pay in full any royalties or other sums payable
under this Agreement on the date or within the period specified
for payment, the amount outstanding shall bear Interest, both
before and after any judgement, from that date or the last day
of that period until that amount is paid in full to Proteus.
10.4 ML shall remain liable to pay royalties:
(a) on Net Sales Value of Products which ML and/or any
Member of its Group sells or otherwise disposes of or
deals in Products on a commercial basis for a period
equal to the longer of:-
(i) the duration of the Patents; or
(ii) the period during which all or part of the
Technology remains subject to duties of
confidentiality under clause 13.1; and
(b) on royalties and other sums received from sub-licensees
under this Agreement for so long as ML and/or Members of
its Group receive or are entitled to receive such
monies.
11. ACCOUNTS
11.1 ML shall keep (and procure that each other Member of its Group
and each of its sub-licensees keeps) 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.
11.2 ML 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
clause 11.1 and, to the extent that they relate to the
calculation of royalties or other sums, to take copies of them
provided that Proteus shall not exercise such right more than
once in any Year).
11.3 ML shall at its own expense, obtain and submit to Proteus,
within 30 days of ML's auditors having produced ML's statutory
accounts for each financial year, a certificate by ML's auditors
that the statements submitted during that financial year to
Proteus pursuant to clause 9.3 were true and accurate.
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11.4 If, following any inspection pursuant to clause 11.2, Proteus'
auditors certify to Proteus that the amount of the royalties
paid in respect of any period falls short of the amount of the
royalties which were properly payable in respect of that period
then, ML shall within 7 days of being served with a copy of the
certificate pay the shortfall plus Interest thereon to Proteus.
In the event that the shortfall is greater than 5% of the amount
actually paid for that period then ML shall also pay to Proteus
the reasonable costs and expenses of Proteus in making the
inspection.
11.5 The provisions of this Section 11 shall remain in full force and
effect after the termination of this Agreement for any reason
until the settlement of all subsisting claims of Proteus under
this Agreement.
12. INTELLECTUAL PROPERTY PROTECTION AND PROCEEDINGS
12.1 Proteus shall:-
(a) use its reasonable endeavours to prosecute any patent or
other forms of protection subsisting in the Territory in
respect of the Technology;
(b) make all necessary filings, and pay all requisite
renewal fees to maintain the Patents in the Territory;
and
(c) appeal against the first instance decision of the
European Patent Office in the event that the European
patent application referred to in Schedule A shall not
be granted at first instance. Proteus shall not be
obliged to continue with such appeal if leading counsel
is of the opinion that Proteus has a less than a 50%
chance of obtaining grant of such patent upon appeal;
and in the event that Proteus shall not comply with clauses
12.1(a), (b) or (c) above then Proteus shall immediately notify
ML and ML shall be entitled to take over the conduct of the
prosecution or maintenance of such patent (including the said
appeal) as appropriate.
12.2 If ML does take over the conduct of prosecution or maintenance
of a patent (including the said appeal) under clause 12.1 then
ML shall be entitled to deduct ML's expenses in fulfilling the
duty placed upon Proteus in 12.1(a), (b) and (c) from royalties
payable to Proteus by virtue of such patent. Any patent or other
protection obtained pursuant to any such application shall be or
remain the absolute property of Proteus.
12.3 ML undertakes that it will (or procure that its sub-licensees or
agents will) apply for and use its reasonable endeavours to
obtain SPC's in relation to each Product in as many countries as
possible for which it obtains Registration. Proteus will provide
all reasonable assistance in applying for and obtaining such
SPC's.
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12.4 The parties shall, at the request of either of them and at joint
expense but for no further consideration, enter into such formal
licenses relating to the Patents as may be necessary or
desirable in accordance with the relevant law and practice in
each part of the Territory for the protection of either of the
parties or the Patents.
12.5 Proteus shall have no liability to ML in respect of any claim
for infringement of any patent or other rights of any person
which is based on the manufacture, use or sale of or any other
dealing in any of the Products otherwise than in accordance with
this Agreement.
12.6 Each party shall fully notify the other as soon as practicable
after it becomes aware of:-
(a) any actual, threatened or suspected infringement of any
of the Patents; or
(b) any proceedings commenced against it in which the
validity or Proteus' ownership of any of the Patents is
challenged or it is alleged that use of the Technology
pursuant to this Agreement infringes the patent or other
rights of any third party.
12.7 As soon as practicable after any notification has been given
pursuant to clause 12.6, the parties shall meet to decide
whether:
(a) in the circumstances referred to in clause 12.6(a),
proceedings shall be commenced; or
(b) in the circumstances referred to in clause 12.6(b), the
proceedings shall be defended.
12.8 If the parties are unable to agree within 28 days of the meeting
referred to in clause 12.7 upon the steps which should be taken,
then:
(a) in the circumstances referred to in clause 12.6(a), the
party which considers that proceedings should be brought
may, at its own expense:
(i) if it is the owner of the Patents, bring such
proceedings; or
(ii) if the other party is the owner, require the
other party to lend its name to such
proceedings; or
(b) in the circumstances referred to in clause 12.6(b), the
party against whom the proceedings are brought may
defend such proceedings and, if it does so, require that
the other party provides it with assistance in defending
such proceedings.
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12.9 If either party is required to lend its name to proceedings or
required to assist in defending proceedings as contemplated by
clause 12.8, the party requiring it to do so shall:
(a) indemnify it against any damages, costs or expenses
which are awarded against or incurred by it or which,
with the consent of the party requiring it to do so, are
agreed to be paid by it in settlement of the claim;
(b) be entitled to any damages, costs or expenses which are
awarded against or which are agreed to be paid by the
claimant in settlement of the claim;
(c) if it is requiring the other party to lend its name to
proceedings, specify the court in which they shall be
brought; and
(d) to the extent that the circumstances permit, give
directions as to the conduct of the proceedings.
12.10 Each party shall do all such things and execute all such
documents as may reasonably be required of it by the other party
for the purpose of assisting the other party in bringing or
defending any such proceedings, and the party receiving the
assistance shall, unless it has been required by the other party
to lend its name to bring or to assist in defending the
proceedings, bear the cost of providing it.
12.11 In the event that MIL wishes to commence or defend proceedings
in relation to the Technology (and Proteus does not wish to do
so) then ML may deduct an amount equal to legal expenses
actually incurred by ML in commencing or defending such
proceedings from the royalties payable to Proteus by virtue of
the patent within the Patents which may be subsisting in the
country to which the proceedings relate on condition that:
(a) ML has obtained a written opinion from leading counsel
(who shall be jointly instructed by ML and Proteus) that
it has a reasonable prospect of success in such
proceedings and a copy of such opinion has been provided
to Proteus; and
(b) ML does not fail to properly complete or take any
procedural step in such proceedings; and
(c) the opinion of leading counsel is sought on a regular
basis that such proceedings continue to have a
reasonable prospect of success; and
(d) ML keeps Proteus fully informed as to the conduct of the
proceedings on a regular basis and provides any
information which may be requested by Proteus or its
advisors; and
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(e) ML does not settle any such proceedings without the
prior written consent of Proteus as to the terms of any
such settlement;
and in the event that ML shall fail at any time to satisfy any
one of the conditions contained in (a), (b), (c), (d) or (e)
above then the total amount of royalties deducted pursuant to
this clause shall become immediately repayable to Proteus
together with Interest.
12.12 Upon any monies being received by ML and/or any Member of ML's
Group by virtue of any proceedings in relation to which amounts
have been deducted from Proteus' royalties under clause 12.11
(provided that those amounts have not already been repaid under
clause 12.11) then such monies shall be applied in the order as
follows:
(a) in repaying to ML its legal expenses plus Interest
(other than those legal costs met out of Proteus'
royalties) and repaying to Proteus the amount of
royalties deducted under clause 12.11 above plus
Interest. Such repayment to ML and Proteus shall be made
pro rata to the amounts to be repaid to each of them;
and
(b) any balance of such monies remaining after the repayment
referred to in clause 12.12(a) above shall be
apportioned between the parties in accordance with their
respective losses provided that if any damages awarded
under such proceedings did not include any element which
was attributable to lost sales of Products or lost
profit upon which Proteus would have received a royalty
then Proteus shall not share in such damages.
12.13 The preceding provisions state the entire obligation and
liability of Proteus arising out of or in connection with this
Agreement with respect to the infringement of any patent or
other rights of any person subject to clause 19.4.
13. CONFIDENTIALITY
13.1 Each party shall not, at any time during the Term or within 15
years from the date of termination of this Agreement, disclose
to any other person, or use for any purpose except as
contemplated by this Agreement, any information which has been
disclosed to it by the other party under or pursuant to this
Agreement, and it shall keep all such information confidential
(whether it is marked as such or not), except as provided by
clauses 13.3 and 15.2 below.
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13.2 Any information which is disclosed to ML under or pursuant to
the Agreement may be:
(a) disclosed by ML to:
(i) any regulatory body to the extent required to
achieve the sale of Products; or
(ii) any person, to the extent required by law; or
(b) disclosed by ML to:
(i) any actual or potential sub-licensee or
sub-contractor of ML or any person carrying out
research or development on its behalf; or
(ii) any employee of ML or any other Member of its
Group or of any of the persons mentioned in
sub-clause (b) (i) above.
to the extent necessary for the purposes of the manufacture and
sale of, and any other dealings in, the Products (other than the
Conjugate), subject in each case to ML first obtaining a written
undertaking from the person in question, as nearly as
practicable in the terms of this clause, to keep the information
confidential and to use it only for the purposes for which the
disclosure is made.
13.3 Any information which is disclosed to a party under or pursuant
to this Agreement shall cease to be subject to the duty of
confidentiality contained in clause 13.1 in the event that:
(a) that party to whom it is disclosed can prove by
documentary evidence, produced to the other party within
28 days of disclosure, was information already in its
possession and at its free disposal before the
disclosure hereunder to it, or
(b) such information is hereafter disclosed without any
obligations of confidence to that party by a third party
who has not derived it directly or indirectly from the
other party and/or a Member of the other party's Group;
or
(c) such information is or becomes generally available to
the public in printed publications in general
circulation through no act, omission or default on the
part of that party or any Member of that party's Group
or that party's agents, consultants, sub-contractors,
sub-licensees or employees.
13.4 Information shall not be regarded as being generally available
to the public for the purposes of clause 13.3(c) if, despite the
individual parts of the information
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being generally available, the precise configuration of its
constituent components are not generally available.
13.5 Each party agrees that it will be liable for the acts or
omissions of its Group Members, agents and employees as if they
were its own acts or omissions.
14. DURATION AND TERMINATION
14.1 This Agreement shall, unless terminated earlier for any reason,
continue in force for not less than 10 years and thereafter for
so long as ML is liable to pay royalties to Proteus.
14.2 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 a
written notice containing full particulars of the breach and
requiring it to be remedied.
14.3 For the purposes of clause 14.2 a breach shall be considered
capable of remedy if the party in breach can comply with the
provision in question in all respects other than as to the time
of performance (provided that the time of performance is not of
the essence).
14.4 Proteus may forthwith terminate this Agreement by giving written
notice to ML in the event that:
(a) if any royalties or other sums payable by ML under this
Agreement are not paid within 30 days of a written
demand made by Proteus after the due date for payment;
or
(b) an encumbrancer takes possession, or a receiver is
appointed, over all or a substantial part the property
or assets of ML; or
(c) (except for the purposes of a bona fide amalgamation or
reconstruction and so that the resulting company
effectively agrees to be bound by or assume the
obligations imposed on ML under this Agreement) where ML
becomes subject to an administration order, makes any
voluntary arrangement with its creditors (with the
meaning of the Insolvency Act 1986), goes into
liquidation or ceases, or threatens to cease, to carry
on business.
14.5 In the event that Proteus shall have the right to terminate this
Agreement it may, at its option, terminate this Agreement in
relation to specific countries in the Territory and in this
event this Agreement shall continue in full force and effect in
relation to the remaining countries in the Territory.
14.6 ML shall be entitled upon giving not less than 3 months' written
notice to terminate this Agreement.
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14.7 In the event that after 30th September 1996 there is not at any
time in existence a Programme which ML, a Member of ML's Group
or ML's sublicensees is actively pursuing then the parties shall
meet to discuss and agree the Start Date for the next Programme
within 3 months of that point in time. In the event that:
(a) the parties do not agree the date of the next Start Date
in writing within the said period of 3 months; or
(b) the relevant Programme does not in fact commence on or
before the date being the agreed Start Date;
then in the case of (a) above Proteus shall have the right to
terminate this Agreement forthwith on written notice 12 months
after the date there ceased to be an actively pursued Programme
provided that a further Start Date does not arise during the
said period of 12 months and in the case of (b) above Proteus
shall have the right to terminate this Agreement forthwith on
written notice after the date of the said agreed Start Date.
This clause 14.7 shall cease to be of any further effect once
Registration for any Product has been obtained in any country in
the Territory.
14.8 The rights given by this Section 14 to terminate this Agreement
for any breach shall not prejudice any other right or remedy of
either party in respect of the breach concerned or any other
breach.
15. EFFECT OF TERMINATION
15.1 Upon the termination of this Agreement for any reason:
(a) ML shall, on condition that it continues to pay
royalties in accordance with Sections 9 and 10, be
entitled for a period not exceeding 12 months to:
(i) manufacture any of the Products to the extent
necessary to satisfy orders accepted before
termination; and
(ii) sell, use or otherwise dispose of any unsold or
unused stocks of the Products;
(b) subject to clause 15.1(a) above, ML and/or Members of
its Group shall cease to exploit, use or develop the
Technology in any way, either directly or indirectly, in
so far and for as long as any of the Technology or part
thereof remains subject to the duties of confidentiality
under this Agreement;
(c) subject to clause 15.1(a) above, ML shall consent to the
cancellation of any license granted to it, or of any
registration of it in any register, in relation to any
of the Patents;
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(d) subject as provided in this clause 15.1 and the
remainder of Section 15, and except in respect of any
accrued rights, neither party shall be under any further
obligations to the other under this Agreement.
15.2 Forthwith upon the termination of this Agreement for any reason
(except where ML terminates for breach by Proteus in accordance
with clause 14.2) ML will and/or will procure that:
(a) all written, tangible or other records or storage
systems containing information all or part of which
relates to the Technology which remains subject to
duties of confidentiality under this Agreement are
either:
(i) delivered up to Proteus of a Member of Proteus'
Group; or
(ii) permanently erased or destroyed as appropriate;
and
(b) full disclosure is made to Proteus or a Member of
Proteus' Group, of:
(i) all results, data and details of studies
conducted in relation to the Technology and/or
under a Programme; and
(ii) all Improvements;
so that Proteus may assess the commercial worth of such
information and/or Improvements and discuss its commercial
exploitation with third parties provided that clause 15.2(b)
above shall not give Proteus any right or license to actually
exploit or use such information and/or Improvements for any
other purpose. ML shall ensure that the data files relating to
such information and/or Improvements are maintained for not less
than 6 months after the termination of this Agreement.
15.3 After the termination of this Agreement for any reason (except
where ML terminates for breach by Proteus in accordance with
clause 14.2) for a period of 6 months Proteus shall have the
exclusive right to negotiate for a license and/or assignment of
the information and/or Improvements referred to in clause
15.2(b) above. ML will and/or will procure that during such 6
month period such information and/or Improvements are not:
(a) disclosed, licensed, assigned, disposed of, dealt with
or otherwise exploited; or
(b) the subject of discussions or negotiations for any of
the matters referred to in clause 15.3(a) above;
unless Proteus confirms in writing to ML that Proteus does not
wish to take a license and /or assignment of such information
and/or Improvements.
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15.4 The provisions of Sections 11, 13 and 15 shall continue in force
in accordance with their terms, notwithstanding termination of
this Agreement for any reason.
16. SUPPLY OF CONJUGATE
16.1 ML will not (and will procure that ML's Group Members do not)
buy or obtain material of the same specification as the
Conjugate from any person other than Proteus or a Proteus' Group
Member.
16.2 ML will procure that each of ML's sub-licensees purchases their
supplies of material of the same specification as the Conjugate
only from ML, Proteus or a Proteus Group Member.
16.3 The parties agree that they will enter into a good faith
negotiations in relation to an agreement for the supply of
Conjugate to ML by Proteus the principal terms of which are
summarized in Schedule E.
17. NEW TECHNOLOGY
In the event that Proteus desires to out-license or otherwise dispose of
any new technology or invention then the parties agree that the new
technology or invention shall be offered to ML in accordance with the
mechanism set out in Schedule F.
18. NATURE OF AGREEMENT
18.1 Each party shall be entitled to perform any of the obligations
undertaken by it and to exercise any of the rights granted to it
under this Agreement through any other Member of its Group,
provided that any act or omission of any such other Member of
its Group shall, for all the purposes of this Agreement, to be
deemed to be the act or omission of that party.
18.2 Subject to clause 18.1 above, this Agreement is personal to ML,
which may not assign, mortgage charge (otherwise than by
floating charge) or (except as provided in this Agreement)
sub-license any of its rights or sub-contract or otherwise
delegate any of its obligations under this Agreement except with
the prior written consent of Proteus (such consent not to be
unreasonably withheld).
18.3 Nothing in this Agreement shall create, or be deemed to create,
a partnership, or the relationship of principal and agent,
between the parties.
18.4 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 authorized
representatives of the parties.
19. WARRANTIES AND LIMITATIONS
19.1 Each party warrants to the other that it has the authority to
enter into this Agreement.
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19.2 Proteus hereby warrants to NIL as at the date of this Agreement
to the best of its information, knowledge and belief that:
(a) the Patents include all patents or applications for a
patent made, owned by or registered in the name of
Proteus or to which Proteus is beneficially entitled
which may be material to the manufacture of Products
other than the Conjugate;
(b) the Know-how includes all know-how and confidential
information in the possession, custody or control of
Proteus which may be material to the manufacture of the
Products other than the Conjugate;
(c) the use and license for use by ML and any sub-licensee
of ML of the Patents and the Know-How shall not infringe
any intellectual property or other proprietary rights of
any third party nor give rise to the payment by ML or
any sub-licensee of ML of any royalty to any third party
(other than pursuant to this Agreement) or to any
liability to pay damages or compensation;
(d) the Know-How (including all documents recording or
embodying the Know-How) supplied to ML by Proteus is
true, accurate and up to date; and
(e) Proteus has not withheld or concealed any material fact,
(of which ML is not already aware) which would, judged
by objective industry standards, have resulted in ML
deciding not to enter into this Agreement if it had been
disclosed.
19.3 Proteus hereby warrants to ML as at the date of this Agreement
that:
(a) neither the execution of this Agreement nor the
performance by Proteus of its obligations nor the grant
herein of the rights to ML will cause it to be in breach
of any agreement or contract to which it is a party or
is subject;
(b) it is entitled to make each of the patent applications
listed in Schedule A;
(c) it does not have actual notice of any outstanding claim
or allegation by any third party to the effect that:
(i) the use or the disclosure of the Know-How
constitutes a breach of any duty of confidence
owed to the third party by Proteus;
(ii) the third party has any interest, whether legal
or equitable, in the Patents or any part
thereof; or
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(iii) Proteus has infringed the intellectual property
rights of that third party;
(d) the registered Patents are presently subsisting and the
particulars of each as well as the particulars of each
of the patent applications listed in Schedule A are true
and correct;
(e) Proteus has not granted any license or other right of
use to any person or undertaking in relation to the
matters licensed under this Agreement; and
(f) Proteus has not entered into any agreement or
arrangement involving the sale, mortgage, pledge,
charge, granting of options or any other right, title or
interest over the matters licensed under this Agreement
other than rights contained in licenses granted outside
the field of Use.
19.4 Proteus will indemnify and at all times hereafter hold ML fully
and effectively indemnified against any losses, costs, actions,
claims, expenses, judgements or other liabilities arising out of
any breach by Proteus of any of the warranties contained in
Clauses 19.2 or 19.3.
19.5 In relation to any claim by either party under this Agreement,
including claims under any warranties or indemnities, that party
shall be under a duty to mitigate any loss that it or Members of
its Group may suffer.
19.6 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.
19.7 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 expressly
provided in this Agreement or required by law.
19.8 Proteus shall not be liable to ML by reason of any
representation of the breach of any implied condition, warranty
or other term or any duty at common law or under any statute, or
under any express term of this Agreement, for any loss, damages,
costs, expenses or other claim for compensation whatsoever,
whether occasioned by the negligence of Proteus, its servants or
agents or otherwise, which arises out of or in connection with
this Agreement, or which in any way relates to the Technology,
or the manufacture, use or sale of any other dealing in any of
the Products by or for ML or any other Member of its Group or
any of its sub-licensees, to the extent that the claim is for:
(a) loss of profits, contracts, goodwill, anticipated
savings or for wasted expenditure (except in so far as
details of such matters have been expressly notified to
Proteus in advance of the occurrence of the event
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giving rise to the loss, damages, costs, expenses of other claim
for compensation as aforesaid); or
(b) any indirect, special or consequential loss or damages.
19.9 ML 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 ML
or any other Member of its Group or any of its sub-licensees of
the Technology or any defect in or otherwise in connection with
the manufacture, use, sale of or any other dealing in any of the
Products by or for ML or any other Member of its Group or any of
its sublicensees save to the extent that such loss, damages,
costs or expenses arise out of a breach by Proteus of clauses
19.2 or 19.3.
19.10 Each party shall not be liable to the other party (or any Member
of its Group) for any damage or loss to the extent that the
other party (or any Member of its Group) is compensated under
any policy of insurance.
20. APPLICABLE LAW AND JURISDICTION
20.1 Except as provided in clause 20.2 below, English law shall apply
to the whole of this Agreement, and each party agrees to submit
to the non-exclusive jurisdiction of the English courts.
20.2 Any question arising out of this Agreement as to the
construction or effect of any of the Patents shall be decided in
accordance with the laws of the country in which the Patent in
question has been granted or filed.
21. NOTICES AND SERVICE
21.1 Any notice or other information required or authorized by this
Agreement to be given by either party to the other shall be
given by:
(a) delivering it by hand; or
(b) sending it by pre-paid registered post; or
(c) sending it by telex, facsimile transmission or similar
means of communication;
to the other party at its registered or principal office, or any
other address which is notified in writing from time to time by
the other party.
21.2 Any notice or other information sent by post in the manner
provided by clause 22.1(b) which is not returned to the sender
or undelivered shall be deemed to have been given on the seventh
day after the envelope containing it was so posted; and proof
that the envelope containing any such notice or other
information was properly addressed, pre-paid, registered and
posted, and that it
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has not been so returned to the sender, shall be sufficient
evidence that the notice or other information has been duly
given.
21.3 Any notice or other information sent by telex, facsimile
transmission or similar means of communication shall be deemed
to have been duly given on the date of transmission, provided
that a confirming copy of it is sent as provided in clause
21.1(b) to the other party within 24 hours after transmission.
22. MISCELLANEOUS
22.1 Each party shall from time to time do all such acts and execute
all such documents as may be reasonably necessary in order to
give effect to the provisions of this Agreement.
22.2 Neither party shall make any press or other public announcement
concerning any aspect of this Agreement without first obtaining
the agreement of the other party to the text of that
announcement except in so far as it may be required to be made
by law or the rules of any Stock Exchange.
22.3 The Agreement may be executed in more than one counterpart and
shall come into force once each party has executed each a
counterpart in identical form and exchanged it with the other
party.
22.4 No failure or delay by either party in exercising any of its
rights under this Agreement shall be deemed to be a waiver of
that right, and no waiver by either party of a breach of any
provisions of this Agreement shall be deemed to be a waiver of
any subsequent breach of the same or any other provision.
22.5 If any provision of this Agreement is held by any court or other
competent authority to be invalid or unenforceable in whole or
in part, the other provisions of this Agreement and the
remainder of the affected provision shall continue to be valid.
22.6 If any restriction in this Agreement is held by any court or
other competent authority to be invalid or unenforceable then
the party against whom such restriction was intended to apply
agrees to be bound by a restriction the same as the terms of the
most onerous restriction which the court or other competent
authority would have allowed in place of the affected
restriction.
22.7 Without prejudice to the generality of clause 22.5, nothing in
this Agreement shall be read or construed as imposing on ML any
restriction which would be void under Section 44(l) of the
Patents Xxx 0000. To the extent that any provision herein could
be so read or construed then it shall:
(a) where possible, be read and construed so as not to
render it void under Section 441 of the Patents Xxx
0000; or
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(b) if not so possible, then it shall be deemed to be
deleted from this Agreement ab initio.
23. NOTIFICATION
Notwithstanding any other provision of this Agreement (or any other
agreement which, together with this Agreement, may form part of an
agreement for the purposes of the Restrictive Trade Practices Act 1976
(together the "RTPA Agreement") the parties hereto agree that they will
not give effect, and will procure that none of their Group Members shall
give effect, to any restriction or restrictions contained in the RTPA
Agreement which cause the RTPA Agreement to be registerable under the
Restrictive Trade Practices Act 1976 until one day after particulars of
the RTPA Agreement shall have been furnished to the Director General of
Fair Trading.
In witness whereof this Agreement has been executed the day and year first
before written.
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SCHEDULE A
THE PATENTS
MAMMALIAN LHRH ANALOGUES
APPLICANT Proteus Molecular Design Limited
INVENTORS Xxxxxxxxx, Xxxxxx X.; Xxxxxx Xxxxx;
Xxxxxxxx, Xxxxxxxxxxx X.
AGENT Xxxxx X. Xxxx & Co.;
Xxxxxxxx Xxxxx, 00-00 Xxxxxxxx,
Xxxxxx, XX0X 0XX
PRIORITY UK Patent Application No. 8713240
filed 5th June 1987
UK Patent Application No. 8723072
filed 1st October 0000
XXXXXX Patent Application No. 563,089 filed
31st March 0000
XXXXXX XXXXXX Patent Application No. 07/177,730
filed 5 April 1988
Case refiled on 2nd July 1992 as
File Wrapper Continuation
Patent Application No. 07/908,659
Divisional Patent Application No.
484839 filed 7th June 1995
EUROPE Patent Application No. 87308721.7
filed 1st October 1987.
Publication Xx. 0 000 000
XXX XXXXXXX Patent Application No. 222031 filed
2nd October 1987.
Accepted July 0000
XXXXXX XXXXXXX Patent Application No. 8723072 filed
1st October 1987.
Patent No. 2196969
granted 21st November 0000
XXXXXXXXX Patent Application No. 79453/87 filed
2nd October 1987.
Patent No. 610526
granted 19th September 1991
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SCHEDULE B
KNOW-HOW
PRECLINICAL RESEARCH AND DEVELOPEMENT.
PHARMACOLOGY
Results of extensive pharmacodynamic evaluation demonstrating proof of
concept in vivo for the immunotherapeutic construct selected for human
health development.
SAFETY EVALUATION
Results of acute and subacute (less than or equal to 6 weeks) studies in
two species, conducted to GLP, demonstrating the expected
pharmacologically mediated effects on gonadal and associated organs
(e.g. seminal vesicles; uterus) and the absence of non-mechanistic
toxicity.
CHEMISTRY AND PHARMACY
Clinical trial supplies formulated and manufactured by a validated
process and demonstrated to have biological potency in an in vivo batch
release study.
CLINICAL DEVELOPMENT
CTX APPLICATION
Documentation from above programme prepared in CTX format scheduled for
submission in 3/4th week April 1996.
CLINICAL TRIAL ORGANIZATION
Protocol and associated documentation for initial proof of concept study
in prostate cancer patients. Principal investigator identified.
FORMULATION
The process of Formulation of the Conjugate to facilitate the
manufacture of Products.
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SCHEDULE-C
Argentina
Australia
Brazil
Canada
China
Czech Republic
Hungary
India
Indonesia
Israel
Malaysia
Mexico
New Zealand
Norway
Poland
South Africa
South Korea
Switzerland
Turkey
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SCHEDULE D
ROYALTIES FOR SALES OF PRODUCTS BY ML
1. The calculation of royalties to be paid by ML to Proteus under
sub-clause 9.1(a) of this Agreement shall be carried out in the manner
and sequence of steps as follows:
(i) The total world wide Net Sales Value in each Quarter shall be
divided into four categories namely:
(a) ***
(B) ***
(C) ***
(D) ***
(ii) Next the values for each of "Y1", "Y2" and "Y3" are adjusted to
reflect the reduction in royalty which is to paid by ML in the
different circumstances referred to in paragraph 1 (i) above to
give the Adjusted Net Sales Value ("ANSV") in accordance with the
following formula:
***
(iii) Next the royalty rate of *** is applied to the adjusted Net Sales
Value to give the Total Royalty ("TR") payable as follows:
***
and the value "TR" equals the total amount of royalties payable
to Proteus by ML for that Quarter.
(iv) Net Sales Value falling within the value "Y4" are subject to a
royalty of 0% and therefore do not feature in the calculation of
royalties payable to Proteus by ML.
2. The royalty calculation set out in paragraph 1 above shall be
performed at the end of each
Quarter.
3. In the event that the Patents in any particular country are not granted
or held or declared invalid by a court of competent jurisdiction from
which no appeal is or can be made then the Net Sales Value arising in
that country shall cease to be part of the value Y1 from the date of
such holding or declaration and shall instead become part of the value
Y2, Y3 or Y4 as appropriate.
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SCHEDULE E
SUPPLY AGREEMENT TERMS
1. Proteus shall either manufacture itself or sub contract the manufacture
of the Conjugate.
2. The manufacture of Conjugate shall be carried out in accordance with
regulatory requirements (including GMP) to allow ML to obtain
Registration for Products. Proteus shall provide upon request details of
the manufacturing process to any regulatory authority to Facilitate
Registration for any Product.
3. ML shall give such advance notice of its purchase requirements of the
Conjugate as shall be specified by Proteus to allow Proteus sufficient
lead time to produce the required volume of Conjugate.
4. Minimum purchase requirements of Conjugate will be set. These will not
be higher than a level allowing Proteus to manufacture Conjugate on a
economically viable commercial scale given the cost of production
balanced against volume produced.
5. Conjugate will be supplied by Proteus with appropriate certificates of
analysis signed for release by a qualified person.
6. Proteus shall maintain the information forming the Closed Drug Master
File in a secure manner at its offices. The "Closed Drug Master File"
shall mean the file to be maintained by Proteus detailing the
methodologies and processes and the supporting technical data, drawings
and specifications for the manufacture of the Conjugate which are owned
by Proteus and are required by relevant regulatory authorities for the
purposes of Registration.
7. In the event that:
(a) Proteus is unable to procure the supply of Conjugate; and
(b) the non-supply of Conjugate has a material adverse effect on the
commercial value of the Products marketed in the Territory
(which it is not possible to mitigate so that the effect is not
material);
then:
(c) all right, title and interest in the Closed Drug Master File
shall pass to ML and Proteus shall deliver up the same within 7
days thereof; and
(d) ML shall be entitled to a license of the Patents in respect of
the matters reserved in clause 3.1(a) and in particular a
license to permit the manufacture by ML of Conjugate under the
Patents.
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8. To ensure continuity of Conjugate supply to ML Proteus shall endeavour
to procure not less than 2 sources of supply of Conjugate.
9. ML agrees to buy Conjugate exclusively from Proteus. Proteus shall
charge a commercial price for the Conjugate provided that if:
(a) ML has documentary evidence of at least 2 bona fide third party
offers to supply Conjugate to ML on the same terms which Proteus
is prepared to supply Conjugate to ML except as to price, and
(b) such third party bona fide offers are in respect of Conjugate of
the same quality and quantity of Conjugate as that which Proteus
was prepared to supply to ML; and
(c) ML shall notify Proteus of the terms and price contained in such
offers;
then Proteus shall have a period of 90 days from such notification under
(c) above in which to provide a written offer to match or better the
average price of the third party offers. If Proteus does match or better
the average price for Conjugate specified in the third party offers then
ML shall be bound to purchase Conjugate from Proteus in accordance with
the terms of Proteus' written offer at Proteus' revised price. If
Proteus does not match of better such average price for the Conjugate
within the period of 90 days referred to then ML shall be free to
purchase Conjugate from any of the third parties who made such bona fide
offers.
10. ML will be entitled to terminate the Supply Agreement if it has a bona
fide scientific reason for not continuing with the production of
Products.
11. Either party will have the right to terminate in the event of breach or
an event of insolvency in relation to the other party.
12. Other normal commercial terms, conditions, warranties, indemnities and
force majeure to be included.
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SCHEDULE F
FUTURE TECHNOLOGY
1. In the event that Proteus shall have any new or existing technology
which Proteus wishes to license, sell or otherwise dispose of to a third
party (other than any such technology in respect of which it has at the
date of this Agreement already agreed terms for commercialization with a
third party) then it shall notify ML of its desire to license the new
technology and give brief non confidential details of the new
technology.
2. ML shall notify Proteus in writing within 14 days of receipt of such
details if it wishes to enter into negotiations for a license of the new
technology.
3. In the event that Proteus does not receive written notification of ML's
wish to discuss the taking of a license for the new technology within
the 14 days referred to in paragraph 2 above then Proteus shall be free
to license or deal in the new technology without restriction.
4. In the event that Proteus does receive written notification of ML's wish
to discuss the taking of a license for the new technology within the 14
days referred to in paragraph 2 above then upon a confidentiality
agreement being signed to Proteus satisfaction Proteus shall forthwith
disclose to ML further details and information on the new technology and
the parties shall enter into good faith discussions regarding the grant
of a license.
5. If the negotiations and license of the new technology has not been
concluded within 60 days after receipt by Proteus of the written
notification from ML in accordance with paragraph 2 despite the good
faith negotiations of the parties then Proteus shall be free to enter
into negotiations with third parties for the licensing of that new
technology. If and when heads of terms are agreed with a third party
Proteus shall notify ML of that fact. ML shall then have the right to
make one revised written offer for taking a license of the new
technology within 7 days.
6. If ML's revised offer does not match the third party's terms in Proteus'
commercial judgement (and such decision shall be Proteus' absolute
discretion) then the parties shall meet within 14 days of the rejection
of MIL's revised offer to discuss the offer. In the event that after
such discussions Proteus still does not accept ML's offer or the written
offer is not received within the said 7 days then Proteus shall be under
no further obligation to ML in respect of that new technology.
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SCHEDULE G
1. In the event that the parties are unable to agree whether a particular
third party product is a Competing Product for the purposes of this
Agreement then the matter shall be referred to a single arbitrator (who
shall be a Patent Agent with not less than 10 years experience in the
field of pharmaceutical patents) to be appointed by agreement between
the parties or, failing agreement by the parties within 30 days,
appointed by the President of the Chartered Institute of Patent Agents
upon the application of either party.
2. Each party shall make written submissions to the arbitrator. Copies of
each party's written submissions shall be provided to the other party.
Each party shall be entitled to provide to the arbitrator a written
response to the other party's written submissions. The arbitrator shall
also hear oral submissions from each party at a meeting with both
parties present. Each parties' initial oral submissions shall last no
longer than 1 hour. Each party shall have a right of reply to other's
party's oral submissions lasting no longer than 30 minutes. The
timetable for written and oral submissions shall be as set by the
arbitrator. The arbitrator shall act as an expert and his decision shall
be final and binding on both parties. The costs of the arbitrator shall
be shared equally between the parties.
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Signed by
for and on behalf of
PROTEUS MOLECULAR DESIGN LIMITED
Signed by
for and on behalf of
ML LABORATORIES PLC
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