EXHIBIT 10.11
DATED 28 SEPTEMBER 2001
BTG INTERNATIONAL LIMITED
- and -
TOLERRX, INC
LICENCE AGREEMENT
INDEX
Clause Heading Page
------ ------- ----
1 Definitions 1
2 Payments 7
3 Commencement and duration 7
4 Licences and Patents 8
5 Exclusivity 10
6 Know-how 11
7 Royalties 12
8 Accounting for royalties 16
9 Currency and taxes 17
10 Verification 17
11 Suspension of royalties and Payments 17
12 Undertakings by the Licensees 18
13 Marking 19
14 Supplementary Protection 19
Certificates
15 Exclusion of liability: Indemnity
and Warranties 20
16 Termination 22
17 Rights on termination 23
18 Miscellaneous 25
19 Notices 25
20 Law and Jurisdiction 26
21 Force Majeure 26
First Schedule The Patents 27
Second Schedule The Cell Lines 30
Third Schedule The Genetic Material 31
Fourth Schedule Sub-Licence Terms 32
[*******] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER
THE SECURITIES ACT OF 1933, AS AMENDED.
THIS DEED is made the 28 day of September 2001 BETWEEN:
(1) BTG INTERNATIONAL LIMITED whose company registration number in England is
2664412 and whose registered office is at ▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇,
London, EC4M 7SB, England, United Kingdom ("BTG"); and
(2) TOLERRX, INC a company registered under the laws of Delaware and whose
principal office is at ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇, ▇▇▇ ("the Licensee").
WHEREAS:
A. BTG is the registered proprietor and/or is beneficially entitled to the
patents and patent applications specified in the First Schedule.
B. BTG owns or controls certain technical information and data, and the
copyright in such items, all relating to the inventions which are the subject of
the said patents and patent applications.
C. The Licensee has requested the grant of licences under such patents,
patent applications, information and data, and BTG is willing to grant such
licences on the terms set out below.
NOW in consideration of the mutual undertakings contained herein, IT IS HEREBY
AGREED as follows:
1. DEFINITIONS
1.1 IN this Agreement the following terms shall have the following meanings:
1.1.1 "Accounting Date" 31 March, 30 June, 30 September and 31
December in each year;
1.1.2 "Accounting Period" the period commencing on the Effective
Date and ending on the next Accounting
Date and each subsequent period ending
on the subsequent Accounting Date and in
the case of the final Accounting Period,
the lesser period ending on the date of
expiry or termination;
1.1.3 "the Biological
Material" (a) the Genetic Material and any
changes to the Genetic Material made by
Licensee; and
(b) any biological or chemical material
produced from any of the Cell Lines or
the Genetic Material; and
(c) the amino-acid sequences of the
antibody as set out in the claims of the
Patents;
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1.1.4 "the Cell Lines" the cell lines specified in the Second
Schedule;
1.1.5 "Chargeable
Transaction" the manufacture, use, sale or other
disposal of a Product by the Licensee or
Sub-licensee, provided always where such
sale or other disposal is made by the
Licensee or Sub-licensee to another
company within its Group for further
sale or disposal then the Chargeable
Transaction shall be the first sale or
other disposal outside that Group
provided further that neither use of
Product in research or clinical trials
nor distribution of samples as part of
Product promotion shall be deemed
Chargeable Transactions as long as no
consideration of any nature whatsoever
is received by the Licensee,
Sub-licensee or any Group Company in
relation thereto and provided always
that if on the sale or other disposal of
Product by or on behalf of the Licensee,
Sub-licensee or relevant Group company
(as the case may be) the Product is not
in Final Form then the Chargeable
Transaction shall be the first sale of
Product which is in Final Form;
1.1.6 "Connected Persons" means a person or entity that is under
the Control of or that Controls or is
under common Control with the Licensee
or a Sub-licensee (as the context may
require);
1.1.7 "Control" the direct or indirect ownership of more
than 50% of the securities having the
power to vote on or direct the affairs
of the relevant entity, or the right to
appoint the majority of the directors of
the board or the ability to direct the
management and policies, of the relevant
entity;
1.1.8 "Deductions" normal trade discounts, charge backs,
rebates and refunds and credits actually
given, amounts actually written off as
bad debts as evidenced in the Licensee's
(or if applicable Sub-licensee's)
audited accounts (provided that if such
deducted amounts are subsequently
received the Licensee shall account to
BTG for the relevant royalties) and,
where such items are specifically shown
in the invoice and are actually incurred
and paid by the
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Licensee or Sub-licensee, any
government-mandated charges, surcharges,
levy or assessments, sales, import or
Value Added Taxes and the costs of
delivery and transit insurance, but not
commissions or cash discounts;
1.1.9 "Development Plan" a development and marketing plan for
Products verified by the President and
Chief Executive Officer of the Licensee
as a true record of the Licensee's plans
to develop, obtain necessary regulatory
approvals, manufacture and commercially
exploit and market Products in each of
the regions of United States of America,
Europe and Japan including, where
appropriate, relevant milestones;
1.1.10 "Dollars" US dollars;
1.1.11 "the Effective Date" the date of this Agreement;
1.1.12 "Europe" those countries which are from time to
time members of the European Community
or the European Free Trade Association;
1.1.13 "Final Form" fully formulated, in final form packaged
for ultimate consumer use and suitable
for purchase by a purchaser or
distributor who is not undertaking
substantial product support and
marketing (e.g., a drug wholesaler, a
pharmacist or group of pharmacists, a
chain of drug retailers or a hospital or
central purchasing department for a
group of hospitals);
1.1.14 "the Genetic Material" the plasmids specified in the Third
schedule;
1.1.15 "Group" the Licensee or a Sub-licensee (as
appropriate in the context) and, as from
time to time, any Connected Person of
the Licensee or Sub-licensee (as
applicable);
1.1.16 "the Inventors" ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇; ▇▇▇▇ ▇▇▇▇▇▇;
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇; ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇;
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇▇▇▇ ▇▇▇▇▇▇
Routledge;
1.1.17 "Know-how" all confidential and proprietary
technical information, data, knowledge,
inventions, techniques, processes,
systems, formulae, records and other
materials and information supplied to
the Licensee hereunder and which relate
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to the Biological Material and the Cell
Lines (including that already provided
by or on behalf of the BTG prior to the
Effective Date or by the Inventors to
the extent that ownership of such
information has been assigned by the
Inventors to BTG);
1.1.18 "Launch Date" the first arm's length sale of Product
by the Licensee or any Sub-licensee in
any country following the grant of
Regulatory Approval for such country;
1.1.19 "the Licences" the licences granted or to be granted
under this Agreement;
1.1.20 "Licensee Technology" all inventions, patents, patent
applications, information, data and
materials (other than Stealth
Technology) owned by Licensee at the
time of termination of this Agreement
and to which the Licensee has the right
to grant a license and that results from
research and/or development of Product
and that may be used for developing,
making, producing or otherwise
commercialising Product;
1.1.21 "Net Selling Price" the price of Products the subject of a
Chargeable Transaction calculated as
follows:
1.1.21.1 in the case of an arm's
length sale or other
disposal, the gross price as
charged or invoiced (before
taxes and discounts), less
any Deductions; or
1.1.21.2 in the case of use of a
Product in a country, or of a
sale of Product in a country
in combination with a product
that is not a Product or in
combination with a service,
and if in either case there
is no price set forth for the
Product for such use or in
such combination, then the
price shall be the price of
Product in such country when
sold alone and if there is no
such sale, then the parties
shall reach agreement on a
price for the Product used in
such a process or as part of
such
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a combination, and in the
absence of such agreement,
the price will be determined
by an independent auditor
(acting as an expert and not
an arbitrator) and appointed
by agreement by the parties
(or in the absence of such
agreement by the President
for the time being of The Bio
Industry Association in the
United Kingdom) with the
decision of such auditor
being final and binding on
the parties;
1.1.22 "the Patents" the patents and applications for patents
specified in the First Schedule and any
patent which may be granted pursuant to
any of such applications; and
1.1.22.2 any patents and applications
corresponding to such patents
and applications which may be
granted to or made by BTG in
other countries; and
1.1.22.3 any re-issues or extensions
of such patents and any
Supplementary Protection
Certificates in respect of
such patents and any division
and continuations of such
applications;
1.1.23 "Phase II Clinical
Trial" an investigation or series of
investigations to assess the efficacy
and safety of a medical product in
patients as approved by the appropriate
Regulatory Authority, excluding
specifically the first study or studies
(whether approved by a Regulatory
Authority or not) whose principal
objective is to evaluate safety across a
range or doses in a small number of
subjects (Phase I);
1.1.24 "Phase III Clinical
Trial" an investigation or a series of
investigations to assess the efficacy
and safety of a medicinal product on a
significantly large group of patients
with the objective of obtaining
Regulatory Approval and as approved by
the appropriate Regulatory Authority;
5
1.1.25 "Product" a product: (i) that but for this license
in the country where made, used, or sold
or otherwise disposed of infringes a
claim that is in force, at the time, of
a Patent as to which Licensee has a
license under this Agreement; or (ii) is
produced from or by use of the Cell
Lines, Biological Material or any
fragment thereof as to which Licensee
has a license under this Agreement;
1.1.26 "Product Licence" any licence issued by a Regulatory
Authority whereby the manufacture, use,
or sale or other disposal of Products is
authorised;
1.1.27 "Regulatory Approval" the approval of the relevant Regulatory
Authority for products to be placed on a
market;
1.1.28 "Regulatory Authority" the body having responsibility for the
regulation of medicinal products in a
particular market;
1.1.29 "Relevant Company" the Licensee; each Sub-licensee; each
Connected Person of the Licensee and
each Sub-licensee; each member of each
Group and each company acting on behalf
of any of the above;
1.1.30 "Stealth Patent" means a patent application(s) and/or
patent(s) that claims an antibody and/or
use thereof that has a reduced
immunological immune response other than
by producing a chimeric or humanized
antibody;
1.1.31 "Stealth Technology" Stealth Patent together with all
biological and other materials, cell
lines, confidential information and data
in written or other permanent form in
the Licensee's possession or control
related to the inventions the subject of
such patents or patent applications;
1.1.32 "Sub-licence" a written sub-licence or sub-sub-licence
of any of the Licenses or any written
agreement or written commitment for the
grant of a sub-licence or
sub-sub-licence of any of the Licenses;
1.1.33 "Sub-licensee" the recipient of a Sub-licence or a
sub-sub-licence;
1.1.34 "Sub-licence Terms" the terms contained in the Fourth
Schedule;
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1.1.35 "Supplementary
Protection Certificates" supplementary protection certificates
granted pursuant to Certificates"
Council Regulation (EEC) ▇▇. ▇▇▇▇/▇▇
("▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇") and any like
rights granted by any government,
authority or agency; and
1.1.36 "Territory" the World.
2. PAYMENTS
2.1 THE Licensee shall pay to BTG:
2.1.1 within seven (7) days of the Effective Date the sum of
[*******]; and
2.1.2 before 30 March, 2002, the sum of [*******]; and
2.1.3 upon commencement by a Relevant Company of the first Phase III
Clinical Trials of a Product in any country, the sum of
[*******]; and
2.1.4 upon receipt by a Relevant Company of the first Regulatory
Approval of a Product in any country, the sum of [*******].
2.1.5 the royalties specified in Clause 7; and
2.1.6 the share of the down payments specified in Clause 7.6.
2.2 All sums referred to in this Agreement are not refundable. Subject to
clause 7, the obligation on the Licensee to make the payments set out in clauses
2.1.3 and 2.1.4 shall be in addition to the obligation on the Licensee to pay to
BTG a share of the down payments specified in Clause 7.6.
2.3 WHEN making any payment under this Agreement the Licensee shall also pay
any Value Added Tax payable. Where the Licensee has to pay Value Added Tax, BTG
shall provide the Licensee with a Value Added Tax invoice in respect of the
relevant payment.
3. COMMENCEMENT AND DURATION
3.1 THIS Agreement shall come into force on the Effective Date.
3.2 SUBJECT to Clauses 16 and 17:
3.2.1 the Licences under the Patents shall continue in force in each
country until all of the Patents of that country have expired;
3.2.2 the Licences in respect of the know-how and/or the
Biological Material and/or the Cell Lines shall continue in
force in each country until the date on which the know-how and
the Biological Material and the Cell Lines have entered the
public domain in the relevant country otherwise than through
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
7
breach or default by or through the Licensee or any Sub-licensee
or any person receiving the same from them;
3.2.3 the Agreement shall continue in force until all of the royalty
obligations have expired after which the Licensee shall have a
fully paid up, non-cancellable licence which is equivalent in
scope to that held by the Licensee immediately before the expiry
of the said royalty obligations.
3.3 THE Licensee shall be responsible for obtaining any requisite
registration or governmental approval of this Agreement and of acts to be
carried out pursuant to or in connection with this Agreement (including in
particular that of transferring the know-how and/or Biological Material and/or
the Cell Lines (or part thereof) from the UK to the USA) and the Licensee shall
expeditiously take all necessary steps to obtain the same.
4. LICENCES AND PATENTS
4.1 BTG grants to the Licensee on and from the Effective Date:
4.1.1 Subject to Clause 5, exclusive licenses under the Patents to
make, and have made Products and to use, sell, offer for sale,
import and otherwise dispose of Products so made for therapeutic
or preventive use in human healthcare; and
4.1.2 non-exclusive licenses for the purposes set out in Clause 4.1.1
above to use:
4.1.2.1 the Biological Material and the Cell Lines; and
4.1.2.2. the Know-how; and
4.1.2.3 the copyright in the know-how;
such licences are without geographical restriction and, subject to the
fact that the Patents only relate to some countries, are worldwide, and
are sub-licensable.
4.2 BTG shall not use and shall not grant rights to or disclose the Know-how
and/or the Biological Material and/or the Cell Lines to any third party during
the period from the Effective Date to the date falling ten years after the date
when a Product is first put on the market within Europe by the Licensee, any
Sub-licensee or any other licensee of BTG as to which BTG has the right, if any,
to grant a license under this Agreement. If the Licensee loses exclusivity for
the Licences under the Patents pursuant to clauses 5.1 or 5.4 then the
restriction on BTG under this clause shall also terminate as regards the
relevant territory.
4.3 The restriction referred to in clause 4.2 and the exclusivity of the
licences under the Patents shall be qualified by and subject to the right of the
Inventors to carry out non-commercial work in relation to the Cell Lines and the
Biological Materials (including but not limited to by way of collaborations with
third party academic institutions); in the event that such research produces a
cell line which produces antibodies with the same specificity as those claimed
in the Patents and such cell line and the intellectual property rights related
thereto are assigned to BTG then BTG shall notify the Licensee of such
assignment and (on written request by the Licensee) such cell line and
intellectual property rights shall be licensed
8
to the Licensee hereunder (and form part of the Patents, Know-how, Cell Lines or
the Biological Material as appropriate).
4.4 WITHOUT prejudice to Clause 3.2, the Licences are granted for the
purpose only of making, having made, using, selling, offering for sale,
importing and otherwise disposing of Products during the life of this Agreement.
The Licenses shall not be used for any other purpose unless and until the
Know-how and the Biological Material and the Cell Lines have come into the
public domain otherwise than through breach or default of the Licensee or the
copyright in the Know-how has expired.
4.5 BTG shall, at the request and expense of the Licensee, execute any
further formal document which may be necessary to give effect to this Agreement
in any part of the Territory. Until such licence shall be granted formally, this
Agreement shall take effect as a licence.
4.6 At the cost and expense of BTG, BTG shall use its reasonable endeavours
to file, prosecute and maintain such of the Patents as it considers, in its sole
discretion, appropriate for the purposes of commercialising Products. If BTG
desires to allow any of the Patents to lapse, become abandoned or disclaimed, it
shall first notify the Licensee of that fact in advance. The Licensee shall have
the right, exerciseable by submission of written notice to BTG within 30 days of
receipt by the Licensee of BTG's notice and subject to the following payment
obligation, to require that BTG continues to file, prosecute and maintain all or
any of the Patents for the remaining duration of this Agreement. The Licensee
shall indemnify BTG against all out of pocket costs and expenses incurred in
undertaking such actions. For the avoidance of doubt, the Licensee shall not be
required to pay BTG royalties in respect of Products manufactured or sold in the
country the subject of the Patents set out in the notice from BTG of intention
to lapse, abandon or disclaim.
4.7 In respect of any country in which the Licenses to the Patents hereunder
remain exclusive, if any of the Patents is infringed by a third party, Licensee
shall have the right and option but not the obligation to bring an action for
infringement, at its sole expense, against such third party in the name of BTG
and/or in the name of Licensee, and to join BTG as a party plaintiff if
required, provided that the Licensee shall indemnify BTG in respect of any
liabilities, costs or expenses that BTG may incur as a result of the same other
than those that arise out of any misconduct by BTG. The Licensee shall be
obliged to satisfy such indemnity irrespective of whether any damages or other
sums are received in respect of the suit. Licensee shall promptly notify BTG of
any such infringement and shall consult with, and give good faith reasonable
consideration to BTG's requirements BTG in relation to the prosecution of any
action for such infringement. Any recovery of damages by Licensee for any such
suit shall be applied first in satisfaction of any unreimbursed expenses and
legal fees of Licensee relating to the suit. If requested by BTG, the Licensee
shall provide BTG with evidence of the Licensee having incurred such deducted
costs and expenses. The balance remaining from any such recovery shall be
considered as Net Selling Price of Product subject to royalties under Clause
7.1. In the event that Licensee is unwilling, within a reasonably timely fashion
to pursue an action for infringement, upon written notice to BTG by Licensee
that an unlicensed third party is an infringer of a Patent, BTG shall have the
right and option, but not the obligation, at BTG's cost and expense, to initiate
infringement litigation and to retain any recovered damages.
9
In any infringement suit, subject to this clause 4.7, if either party
institutes to enforce Patents pursuant to this Agreement, the other party hereto
shall, at the request of the party initiating such suit, cooperate in all
reasonable respects and, to the extent possible, on receipt of reasonable
notice, have its employees testify when requested and, so far as it is free to
do so, make available relevant records, papers, information, samples, specimens,
and the like.
5. EXCLUSIVITY
5.1 BTG may at any time terminate the exclusivity of the Licences by giving
sixty (60) days written notice to the Licensee if the grant and continuation of
an exclusive Licence in the Territory would be contrary or a violation of
applicable anti-trust or competition law PROVIDED THAT if the ground for
termination referred to herein only relates to a particular country in the
Territory, then BTG's right under this Clause 5.1 shall be restricted to that
country.
5.2 IT is hereby declared that BTG has agreed to grant exclusivity in
respect of the Licences under the Patents on the basis that the parties consider
that this Agreement is concerned with the introduction and protection of a new
technology, and by reason of the scale of research that needs to be undertaken
and of the risk that is involved in manufacturing and marketing a product which
is unfamiliar to users at the Effective Date.
5.3 IF the Commission of the European Communities withdraws the benefit of
its Regulation 240/96, or that Regulation expires and is not replaced by another
Regulation of similar or equivalent effect, the Licences shall forthwith become
non-exclusive in Europe, except for such measure of exclusivity as the parties
may then agree to be appropriate, taking into account the provisions of Article
81(3) of the Treaty of Rome.
5.4 Subject to receipt of notification pursuant to clause 7.13, BTG may at
any time terminate the exclusivity of the Licences in any country by giving the
Licensee five days (5) written notice to that effect. Such Licenses shall
include the right to Sub-licence and shall be non-exclusive but otherwise on the
terms hereof.
5.5 In the event that the Licenses become non-exclusive in whole or in part
pursuant to Clause 5.1 and/or 5.3, then BTG will not grant any licenses with
respect to the Patents and/or Biological Material and/or Cell Lines and/or the
Know-how and/or the copyright in the Know-how except and only to the extent that
is required by any applicable law, rule, or regulation.
5.6 In the event that the exclusivity of the License is terminated under
Section 5.1 or 5.3 then following the date of the first commercial sale in any
country (by a third party licensee of the Patents other than by or on behalf of
the Licensee or any Sub-licensee) of a Product in Final Form following the
granting of a Product Licence in that country, the royalty rate solely in
respect of the manufacture or sale of Products in that country shall be reduced
to [*************] but in no event shall Licensee be paying a royalty greater
than any third party granted a license under Patents.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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6. KNOW-HOW
6.1 THE Licensee shall arrange and pay the costs of and be responsible for,
copying, shipment to the Licensee and storage of the Know-how and/or the
Biological Material and/or the Cell Lines and such shipment and storage shall be
at the Licensee's risk.
6.2 Subject to Clause 6.3, the Licensee shall, by using at least the same
degree of care which it uses with respect to its own information and material of
a similar nature, keep the Know-how, disclosed in writing by BTG and designated
in writing by BTG as confidential, and/or the Biological Material and/or the
Cell Lines confidential to the Licensee, and to such of its officers and
employees and (subject to clause 6.3 and solely in respect of the know-how but
not Biological Materials or Cell Lines) its consultants and advisors, as are, in
each case, bound by obligations of confidence and need to be informed for the
purposes of this Agreement, and shall ensure that the know-how and/or the
Biological Material and/or the Cell Lines are not disclosed to others orally or
in writing or by any act of transfer, save to the extent that the know-how
and/or the Biological Material and the Cell Lines:
6.2.1 as evidenced by the Licensee's written, records, were lawfully
known to or lawfully possessed by the Licensee prior to its
communication or transfer by or through BTG and were not
communicated to or supplied to the Licensee subject to any
restrictions on disclosure or use PROVIDED THAT this exemption
shall not be applicable in respect of any know-how and/or
Biological Material and/or Cell Lines communicated or disclosed
(directly or indirectly) by any or all of the Inventors to the
Licensee; or
6.2.2 is necessarily disclosed by the sale of Products embodying any
of the know-how; or
6.2.3 is or becomes in the public domain, otherwise than by any
default of the Licensee, or persons acquiring the same from the
Licensee; or
6.2.4 as evidenced by the Licensee's written records, becomes known to
or in the possession of the Licensee by the action of a third
party not in breach of any obligation of confidence PROVIDED
THAT this exemption shall not be applicable in respect of any
know-how and/or Biological Material and/or Cell Lines
communicated or supplied (directly or indirectly) by any or all
of the Inventors to the Licensee.
Without limiting the effect of this clause, a combination of
parts of the know-how shall not be deemed to be in the public
domain by reason only that each separate part is in the public
domain.
IT is acknowledged by the Parties that, from time to time, the Inventors
may act as consultants to the Company and to such extent, the Company
may disclose Biological Materials and/or Cell Lines and/or know-how to
the relevant Inventors, provided that they are bound by obligations of
confidence no less onerous than those contained in clause 6.2 above in
respect of the same.
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6.3 Licensee shall have the right to disclose and permit a third party to
use the Know-how and/or the Biological Material and/or the Cell Lines in
pursuing and/or exercising the rights granted to Licensee under the Agreement
provided that such third party agrees to confidentiality obligations no less
onerous than those of Clause 6.2 and where necessary subject to the terms of a
Sub-licence.
6.4 During the term of this Agreement, it is contemplated that Licensee will
disclose to BTG written confidential information that is owned or controlled by
Licensee or that Licensee is obligated to maintain in confidence ("Confidential
Information"). BTG agrees to retain Licensee's Confidential Information
disclosed to it in writing and marked as confidential in confidence and not to
disclose any such Confidential Information to a third party without the prior
written consent of Licensee and to use the confidential Information only for the
purposes of this Agreement. The obligations of confidentiality of this clause
6.4 will not apply to Confidential Information that:
(i) was known or generally known to the public prior to
its disclosure hereunder; or
(ii) subsequently becomes known to the public by some
means other than a breach of this Agreement;
(iii) is subsequently disclosed to the receiving party by a
third party without a breach of an obligation of
confidentiality to Licensee; or
(iv) is independently developed by the employees or agents
of BTG without any knowledge of the Confidential Information
provided Licensee; or
(v) is already lawfully known to or lawfully possessed by
BTG prior to its communication by the Licensee and was not
supplied to BTG subject to any restrictions on disclosure or
use; or
(vi) is required to be disclosed pursuant to any law,
order of a court of competent jurisdiction or rules of any
competent regulator.
6.5 The obligations of non-use and confidentiality of this Article 6 shall
terminate five (5) years after termination of this Agreement.
7. ROYALTIES
7.1 SUBJECT to Clauses 4.6, 7.2, 7.3 and 7.13 below, the Licensee shall pay
to BTG in respect of Products that are Products as a result of Clause 1.1.25(i)
and are the subject of Chargeable Transactions and as provided in Clause 17.2 on
such Products held on termination, a royalty at the rate of [*******] on the Net
Selling Price.
7.2 IF, in respect of any Chargeable Transaction all of the following apply:
7.2.1 the Licensee is also paying patent royalties to a third
party/third parties; and
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
12
7.2.2 that the third party/parties (as the case may be) is not/are not
a Connected Person(s) of the Licensee; and
7.2.3 such patent royalties are paid under an arm's length BONA FIDE
licence; and
7.2.4 those patent royalties are for rights to patents which are
deemed by the Licensee (acting reasonably) to be required for
the commercialisation, manufacture or sale of the Products in
question;
7.2.5 the sum of such patent royalties with all of the characteristics
set out in 7.2.1 to 7.2.4 above and the royalties payable to BTG
under Clause 7.1 above would in total ("the Total Royalty")
amount to more than [*******] on the Net Selling Price for that
Chargeable Transaction ("the Cut-off Royalty"),
then the royalty to be paid to BTG on that Chargeable Transaction shall
be reduced by one half of the amount that the Total Royalty exceeds the
Cut-off Royalty provided that in no event shall the royalty payable to
BTG be reduced under this Clause 7.2 below [*******] on the Net Selling
Price for the relevant Chargeable Transaction. (By way of illustration
if the Total Royalties equal [*******] then the royalty payable to BTG
would be [*******].
If requested by BTG the Licensee shall promptly provide to BTG: (i) a
copy of the relevant
licence agreements supporting its requirement to
pay royalties to third parties; and (ii) evidence that the conditions
set out in clauses 7.2.1, 7.2.2, 7.2.3 and 7.2.4 have been fulfilled.
FOR the avoidance of doubt, the right of set-off of Third Party
Royalties under this clause 7.2 shall only apply to royalties payable
under clause 7.1 and not to any other amount payable under this
Agreement (including but not limited to the payments under clause 2 or
the minimum payments to BTG pursuant to clause 7.3).
7.3 IF the aggregate royalty payments due to be paid by the Licensee
hereunder to BTG in respect of any of the following calendar years are less than
the minimum sums set out below for that year, then the Licensee shall pay BTG
the amount by which the actual royalties payable fall short of the relevant
minimum sum as follows:
Period Minimum Sum
--------------------------------------------------------------
The 12 month period starting on [*******]
January 1st in the next calendar year
immediately following the Launch Date
("Year 1").
--------------------------------------------------------------
The 12 month period immediately [*******]
following the end of Year 1 ("Year 2")
--------------------------------------------------------------
The 12 month period immediately [*******]
following the end of Year 2 ("Year 2")
7.4 ROYALTY shall only be payable once in respect of the same Product.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
13
7.5 THE Licensee shall at the request of BTG provide half-yearly forecasts
of the amount of royalties likely to be payable under this Agreement.
7.6 Subject to Clause 7.8, in respect of each lump sum payment (as opposed
to royalties paid as a consequence of actual sales of Products) and non-cash
consideration received by the Licensee (or by any Connected Person of the
Licensee) from a third party for rights granted under a Sub-licence, or for
distribution rights in respect of the Products including, without limitation,
any payments for an option to a Sub-licence, or upon the exercise of any such
options, signature fees, milestone payments and any other lump sum payments
under licences; the Licensee shall in accordance with clause 7.7 pay to BTG the
following percentage of such sums:
7.6.1 [*******] of such payments if at the time of grant of the
Sub-licence the Licensee has not granted such licensee a license in
respect of Stealth Patent; and
7.6.2 [*******] of such payments if, at the time of grant of the
Sub-licence, the Licensee has granted a license in respect of Stealth
Patent and such grant is prior to commencement of a Phase II Clinical
Trial of a Product; and
7.6.3 [*******] of such payments for a Sub-license entered into after
commencement of a Phase II Clinical Trial of a Product that the
manufacture, use or sale thereof at the time of grant, would infringe a
claim of a patent or patent application that is a Stealth Patent.
Notwithstanding the preceding sentence with respect to any such payments
received with respect to a milestone for a Product that the manufacture,
use or sale of which does not, at the time of payment, infringe a claim
of a patent application or patent that is a Stealth Patent, Licensee
shall pay BTG [*******] of any such milestone payment.
For the purposes of this clause 7.6, the following shall be excluded: (a)
royalties; and (b) amounts received in respect of the research and/or
development of the Product, provided that such sums are actually expended by or
on behalf of the Licensee on such research and/or development within twenty-four
(24) months of receipt. In order to exclude any payment in accordance with (a)
or (b) above, if requested by BTG; the Licensee shall provide evidence to BTG's
reasonable satisfaction that the payments fall in either category. For the
purposes of this Clause 7.6 monies paid for securities of Licensee shall be
excluded to the extent that such payment does not exceed the fair market value
of the securities. IN addition if Licensee receives non-cash consideration under
a Sub-license the fair market value of the non-cash consideration shall be
subject to the payment provisions of this Clause 7.6.1.
7.7 THE Licensee shall, within thirty (30) days of receipt by the Licensee
(or by any Connected Person of the Licensee or Sub-licensee) of each of each
lump sum payment and non cash consideration notify BTG of and provide full
details of each such lump sum payment and non-cash consideration. At the same
time as it gives BTG such notification the Licensee shall pay BTG the sum or
sums due.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
14
7.8 WITH regard to payments received for equity or non-cash consideration
the Licensee shall make its own valuation but BTG may challenge such valuation
in writing. On receipt of either type of challenge the Licensee shall promptly
obtain an independent auditor's certificate specifying the valuation made by the
auditor. Both parties shall abide by the auditor's certificate and shall rectify
any overpayment or underpayment (as the case may be).
7.9 Where Sub-licences are granted by the Licensee prior to the initiation
of the first Phase III Clinical Trial of Products and the Licensee receives a
lump sum payment in respect of such initiation of the first phase III Clinical
Trial of Products, then the Licensee may offset against its obligation to make
payment to BTG under clause 7.6 above, up to [*******]. No provision of this
clause 7 shall reduce the amount of the payment required to be made by the
Licensee to BTG under clause 2.1.3.
7.10 Where Sub-licences are granted by the Licensee prior to the receipt of
the first Regulatory Approval of a Product in any country and the Licensee
receives a lump sum payment in respect of such first Regulatory Approval, then
the Licensee may offset against its obligation to make payment to BTG under
clause 7.6 above, up to [*******]. No provision of this clause 7 shall reduce
the amount of the payment required to be made by the Licensee to BTG under
clause 2.1.4.
7.11 If the Licensee licenses Stealth Technology and/or Licensee Technology
to a Sub-licensee with the intention or result that such Sub-licensee develops,
makes, has made, sells, has sold or otherwise disposes of Products which
incorporate the Stealth Technology and/or Licensee Technology and/or Results,
then all lump sum payments received from such Sub-licensee for Stealth
Technology and/or Licensee Technology for use with respect to Product (whether
recorded as relating to the Sub-licence or the licence to Stealth Technology
and/or Licensee Technology) shall be considered payments to which the revenue
sharing obligations of clause 7.6 apply.
7.12 The Licensee hereby represents and warrants that, with respect to a
chemical substance that binds to CD3 antigen, as at the Effective Date and
subject to the terms of this Agreement, it presently only intends to develop
(itself or via a Relevant Company) a chemical substance which is an antibody (or
a derivative or conjugate thereof) against human CD3 antigen that is claimed in
a Patent.
7.13 On initiation of the first clinical trial by a Relevant Company in
respect of each antibody (or a derivative or conjugate thereof) against human
CD3 antigen, the Licensee shall, within seven (7) days of such event, provide
BTG with written confirmation of whether Licensee believes that the antibody in
question at the time:
(a) infringes a claim of any of the Patent; and/or
(b) is produced from the Biological or the Cell Lines.
In the event that such confirmation indicates that any one or more of the
conditions set out in paragraphs (a) or (b) above are not satisfied, the
Licensee shall provide evidence to BTG to verify that fact.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
15
7.13.1 If the antibody (or a derivative or conjugate thereof)
in question satisfies condition (b) but not (a) above, then:
(i) BTG shall have the right to terminate the exclusivity
of the Licenses which shall continue as non-exclusive
Licenses as set out in clause 5.4 with Licensee having
the right to grant sublicenses thereunder; and
(ii) the royalty rate for such Products (but not other
Products) shall, in respect of the relevant countries
be reduced to [*******] with such royalty only being
payable in each country for ten (10) years from the
date of the first commercial sale of the Product in
that country following the granting of a license
issued by a Regulatory Authority for the manufacture,
use, sale or other disposal of such Products in that
country.
8. ACCOUNTING FOR ROYALTIES
8.1 THE Licensee shall:
8.1.1 keep true and detailed accounts and records of all royalties and
other sums due under this Agreement;
8.1.2 within thirty days after each Accounting Date deliver to BTG a
statement of all royalties and other sums due for the Accounting
Period ended on that Accounting Date showing separately the
Chargeable Transactions in each country, and (where relevant),
the rate of exchange used or, if it be the case, a statement
that no royalties are due;
8.1.3 send with the above statement the amount shown to be due;
8.1.4 immediately and without demand send to BTG the difference
between an amount already paid and the correct amount shown to
be due and payable as a result of verification under Clause 10.
8.2 IN each year the Licensee shall within thirty days (30) after approval
of the Licensees annual report and accounts at the Licensee's shareholders
meeting, deliver to BTG a copy of such annual report and accounts for each such
year.
8.3 ON termination or expiry, the final statement shall be delivered within
thirty days of termination or expiry and shall include details of royalties on
all Products being manufactured and all Products manufactured but not yet
disposed of.
8.4 IF the Licensee defaults in payment of the royalties and other sums due
within the period stated above, the amount due shall bear compound interest,
accruing from day to day, at the rate per annum of Four per cent (4%) above the
Base Rate for the time being of the National Westminster Bank p.l.c.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
16
9. CURRENCY AND TAXES
9.1 ALL payments shall be made in sterling to [*******] or as otherwise
directed by BTG. Any necessary currency conversion shall be at the rate at which
English bank transfers are made on the last business day of the period to which
the relevant sales and royalty statement relates.
9.2 PAYMENTS shall be made without deduction, other than such amount as the
Licensee is required to deduct or withhold by law. In regard to any such
deduction, the Licensee shall use all reasonable endeavours to assist BTG to
claim recovery or exemption under any double taxation or similar agreement.
Evidence as to the payment of such tax or sum withheld shall, on request, be
given by the Licensee to BTG.
10. VERIFICATION
10.1 THE Licensee shall permit any authorised representative appointed by
BTG, upon reasonable notice, access to the premises of the Licensee and access
to the accounts, records and relevant documentation of the Licensee and shall
provide such information and explanations as the representative shall require to
verify the statements and to satisfy BTG that the provisions of this Agreement
are being complied with. The representative shall also be permitted to take
copies and extracts. If the verification discloses an underpayment to BTG of
more than 5% of the amount due the Licensee shall promptly on demand reimburse
BTG the fees and costs of the representative, and the reasonable costs incurred
by BTG in respect of the verification. The Licensee shall also provide to such
representative, if so requested, reasonable assistance and information to
establish that the relevant transactions are at arm's length.
10.2 BTG and its authorised representatives shall keep confidential any
information which it may acquire in the exercise of its rights under this Clause
10 with the exception of information which was already known to it, or which BTG
is required to disclose by law or the requirements of any regulator, or which is
or becomes in the public domain otherwise than by any default of BTG.
11. SUSPENSION OF ROYALTIES AND PAYMENTS
If any of the following events shall occur in respect of the Patents:
11.1 any patent application is finally refused so that the grant of a patent
thereon is unobtainable; or
11.2 any patent application is abandoned or withdrawn; or
11.3 any patent lapses; or
11.4 any patent is declared invalid or unenforceable by a court or tribunal
of competent jurisdiction;
then the royalties payable solely in respect of such patent application or
patent shall cease after the date of the relevant event, but BTG shall be
entitled to all sums which shall have then already fallen due, and whether paid
or unpaid at such date. If such patent application is reinstated or such patent
is restored or is subsequently established as being valid and enforceable,
royalties shall again become payable, together with all
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
17
royalties which would have been payable if the relevant event had not occurred.
11.5 In the event that BTG is in material breach of any of the warranties
under clause 15.6 or is in material breach of any of BTG's obligations under
this Agreement, upon written notice from Licensee to BTG specifying the breach,
unless such breach is cured within sixty (60) days after such notice, Licensee
may discontinue all payments under this Agreement without being in breach of
this Agreement until BTG cures the breach set forth in such notice, save that
once BTG has cured the applicable breach such amounts shall again become payable
as if the relevant breach had not occurred.
12. UNDERTAKINGS BY THE LICENSEE
THE Licensee:
12.1 shall not at any time make any use of the Know-how and/or the Biological
Material and/or the Cell Lines other than for the purposes of the Licences;
12.2 shall have full control, authority and responsibility for development,
registration and commercialisation of Products.
12.3 shall deliver the Development Plan to BTG within three (3) months of the
Effective Date and on each anniversary of the Effective Date deliver to BTG an
updated Development Plan (which shall provide for no less timely development and
commercialisation of Products in the Territory than as set out in the initial
Development Plan). BTG and the Licensee shall seek to agree the initial
Development Plan by good faith discussions within the period of 30 days from the
date of receipt of the Development Plan by BTG. In addition, the Licensee shall
further deliver to BTG at intervals of six (6) months short written reports of
the evaluation, development, regulatory and commercialisation work, manufacture,
use and sales carried out by and for the Licensee in relation to Products during
the preceding six month period. Such reports shall also contain details of all
studies and estimated time scales for the initiation and completion of the
various regulatory stages and the development of and commercial prospects for
Products. The Licensee shall arrange for its staff to answer any reasonable
questions that BTG may raise with such question and answer sessions to be either
on the telephone or at a meeting (as reasonably requested by BTG).
12.4 undertakes to BTG that when selling Product as part of a package with
other products the Licensee shall ensure that it does not favour the other
products, or discriminate against the Product, in terms of pricing, discounts,
or in any other way which would adversely affect the royalties due to BTG under
this Agreement;
12.5 shall use reasonable commercial efforts to develop Products in
accordance with the Development Plan (with the efforts of Sub-licensees, members
of the Licensee's Group and collaborators being considered as efforts of the
Licensee in this regard);
12.6 shall use all reasonable commercial endeavours to market and sell and to
continue to market and sell Products in the Territory following receipt of a
Product Licence;
18
12.7 on obtaining each Regulatory Approval and/or Product Licence, or the
like in relation to Products, promptly deliver to BTG a copy of the same; and
12.8 shall give BTG written notice with seven (7) days of the Launch Date for
each country.
13. MARKING
THE Licensee shall legibly ▇▇▇▇ the Products or, if not practicable, then any
associated packaging or literature, with the relevant patent or application
number.
14. SUPPLEMENTARY PROTECTION CERTIFICATES
14.1 IN the event that BTG wishes to make any application for a Supplementary
Protection Certificate or Certificates in respect of Products the Licensee shall
promptly take all necessary steps to facilitate such application.
14.2 IN particular, but without limitation, the Licensee shall:
14.2.1 promptly notify BTG of the number and date of the first
and any subsequent authorisation to place Products on the market
in any country in which BTG may be able to apply for any
extension of the Patents or Supplementary Protection
Certificate;
14.2.2 promptly and free of charge provide to BTG:
14.2.2.1 a copy of every authorisation fulfilling the
requirements of Article 8.1(b) of the SPC Regulation
(and of any additional applicable requirements imposed
by relevant national law) in respect of all Products;
14.2.2.2 additional information fulfilling the
requirements of Article 8.1(c) of SPC Regulation and a
copy of the notice publishing the authorisation in the
appropriate official publication (and information and
documents fulfilling any additional requirements
imposed by relevant national law);
14.2.3 permit use of documents and information provided pursuant
to this clause for the purpose of such application for a
19
Supplementary Protection Certificate or Certificates.
14.3 BTG shall be entitled to disclose any Regulatory Approval or Product
Licence or any part thereof to any relevant authorities for the purposes of
obtaining a Supplementary Protection Certificate in respect of the Products or
any extension of the Patents.
14.4 BTG shall notify the Licensee of the grant of every Supplementary
Protection Certificate in respect of Products.
14.5 BTG shall not be obliged to apply for grant of any Supplementary
Protection Certificates.
14.6 FOR the avoidance of doubt the Licensee shall not be entitled to make an
application for or participate in negotiations for grant of any Supplementary
Protection Certificate.
15. EXCLUSION OF LIABILITY; INDEMNITY AND WARRANTIES
15.1 SAVE as expressly stated herein, no representation condition or warranty
whatsoever is made or given by or on behalf of BTG. All conditions and
warranties, arising by operation of law or otherwise:
15.1.1 to the effect that any of the Patents or the Know-how or the
copyright therein are valid or enforceable, or
15.1.2 to the effect that any of the acts hereby licensed or agreed to
be licensed by BTG will not infringe the rights of third
parties; or
15.1.3 in relation to the provision or use of the Know-how or its
fitness for purpose, accuracy or completeness; or
15.1.4 in relation to the provision, storage or use of the Biological
Material and/or the Cell Lines or its fitness for purpose or
completeness;
are hereby expressly excluded. For the avoidance of doubt in relation to
15.1.1, 15.1.2 and 15.1.4 above, the Licensee hereby acknowledges that
it may require licences from third parties to utilise the Biological
Material and/or the Cell Lines.
15.2 BTG shall be under no liability whatsoever to the Licensee (whether in
negligence or otherwise, in contract or in tort) for any expense, loss, death,
damage or injury of any kind (including any loss of profit or consequential
damage) sustained by the Licensee or any third party which arises directly or
indirectly from any cause or circumstance referred to in sub-clause 15.3 below.
15.3 THE Licensee acknowledges that it bears all risks and liabilities
associated with its own activities under this Agreement. Subject to Clause 15.5
the Licensee shall indemnify BTG against all claims and actions by and all
damages awarded to any third party against BTG (and any related costs and
expenses) which arise directly or indirectly from:
20
15.3.1 the evaluation, development, manufacture, use, storage,
transportation, sale or disposal of Products by the Licensee or
any Sub-licensee or any persons on their behalf; or
15.3.2 the use of the Patents or copyright in the Know-how by the
Licensee or any Sub-licensee or any persons on their behalf; or
15.3.3 the provision to, evaluation by or use of the Know-how by the
Licensee or any Sub-licensee or any persons on their behalf; or
15.3.4 the provision, storage, transportation, evaluation or use of the
Biological Material and/or the Cell Lines by the Licensee or any
Sub-licensee or any persons on their behalf; or
15.3.5 the use by the Licensee or any Sub-licensee or any persons on
their behalf any technical or other advice given by BTG or any
of its officers, employees or agents to the Licensee or from any
reliance by the Licensee or any third party thereon.
15.4 UPON the initiation of clinical trials to be conducted by the Licensee
hereunder and for six (6) years after termination of this Agreement the Licensee
shall, at its own cost effect and maintain in force with reputable insurers,
adequate insurance in respect of the development, storage, manufacture, use and
supply of Products and/or the Biological Material and/or the Cell Lines and
shall provide evidence of such insurance to BTG on request. Any consequent
policy shall name BTG as additional insured; waive any right of subrogation of
the insurers against BTG; be primary and without right of contribution from
other insurance which may be available to BTG. In the event that a court
determines that the Licensee has failed to meet its obligations to obtain or
maintain adequate insurance, BTG may terminate this Agreement provided however
that this Agreement may not be terminated on this ground unless the Licensee has
been given at least ninety (90) days to cure such failure and has failed to do
so.
15.5 Licensee shall have the right to control the defense compromise or
settlement of any action or claim to be indemnified under Clause 15.3 and BTG
shall use all reasonable endeavours to cooperate with Licensee and Licensee's
counsel in the defense of any such claim or action. Licensee shall have the
right to select counsel. BTG shall not settle or compromise any claim, action or
damages without the written consent of Licensee and the indemnification shall
not apply to any claim, action or damages that is settled or compromised without
such consent. BTG shall promptly notify Licensee of any claim or action that is
to be indemnified and the failure to do so shall relieve Licensee of its
indemnification and defense obligations. The indemnification shall not apply to
any claim or action that arises from the intentional conduct or wrong doing (or
intentional failure to act when required to do so) of BTG.
15.6 BTG warrants and represents that, as at the date hereof: (i) it owns all
right, title and interest in and to the Patents, Biological Material (other than
in respect of any changes to the Genetic Material made by the Licensee) and Cell
Lines licensed under the Agreement to the extent
21
necessary to grant the rights granted to the Licensee hereunder; (ii) except as
set forth in Clause 4.3 no other person or entity has any rights or license or
interest in or to the Patent, Biological Material (subject to the above
exclusion) or Cell Lines; (iii) it has the right to grant the rights and
licenses granted hereunder and that this Agreement validly grants to Licensee
the rights and licenses granted hereunder; (iv) that, except as specifically
permitted herein, BTG will not grant any rights or licenses to any third party
in or to the Patents, Biological Material (as described above) or Cell Lines;
and (iv) except for the patents, as far as it is aware, BTG does not own or
control any patent or patent application that would necessarily be infringed by
manufacture, use or sale of all and any Products.
16. TERMINATION
16.1 THE Licensee may, at any time, terminate this Agreement or any of the
Licences, with or without breach of this Agreement by BTG, by giving not less
than three (3) months notice to that effect. In such notice the Licensee must
specify whether it is terminating on account of breach by BTG, and, if it is,
must give details of that breach.
16.2 Subject to Clause 16.4, BTG may terminate this Agreement, or any of the
Licences or any exclusive rights, upon the happening of any of the following
events:
16.2.1 if any royalties or other sums payable remain unpaid after the
due date; or
16.2.2 if the Licensee is in material breach of any of the terms or
obligations of this Agreement, other than a payment obligation;
and other than an obligation under Section 12.5, with the
provisions of Section 16.3.1. governing any such termination.
16.2.3 if in the United Kingdom the Licensee has a Receiver or an
Administrative Receiver or Administrator appointed of the whole,
or any part, of its undertaking or assets, or in any other
country has an officer appointed to perform a function analogous
to that of a Receiver, Administrative Receiver or Administrator;
or if an order is made, or a resolution passed, for winding-up
or administering the Licensee, (unless such order or resolution
is part of a scheme of solvent reconstruction of the Licensee
which has previously been approved by BTG which approval shall
not be unreasonably withheld);
16.2.4 if the Licensee directly or indirectly opposes or assists any
third party to oppose the grant of any of the Patents or
disputes or directly or indirectly assists any third party to
dispute the validity of any of the Patents or the
confidentiality of the Know-how, except in an action or suit
brought by BTG against Licensee.
16.3
16.3.1 BTG shall have the right to terminate this Agreement if the Licensee:
22
(i) at any time the Licensee ceases active development and/or
commercialisation of Products by reference to the latest 6 month report
produced by the Licensee under clause 12.3 (with the efforts of
Sub-licensees, members of the Licensee's Group and collaborators being
considered as efforts of the Licensee in this regard);
(ii) subject to clause 16.3.3, fails to initiate the clinical trials
of Products (which for the purposes of this clause 16.3 shall include
clinical trials undertaken or sponsored by the Licensee or any
Sub-licensee) by January 1, 2004; or
(iii) subject to clause 16.3.2, is twelve months or more behind
schedule on achievement of any milestone as per the Development Plan
then BTG may, as its sole and exclusive remedy for such delay, serve on
the Licensee a notice of termination of this Agreement and that notice
shall have effect six months after the date of service unless within
that period, the Licensee shall have achieved the relevant Development
plan milestone.
16.3.2 BTG shall not have the right of termination under clause 16.3.1 (iii),
if the Licensee is using all reasonable endeavors in the circumstances to
develop and to progress towards the marketing of Products in a timely manner and
is prevented from meeting a milestone in the Development Plan due to technical,
safety or efficacy problems outside its reasonable control (including any
significant problems arising under any clinical trials relating to Product). In
event of such delays, the Licensee shall promptly give notice in writing to BTG
of the relevant delay and give evidence to BTG relating thereto. The Licensee
shall deliver to BTG within 2 months of the date of such notice, a revised
Development Plan to take into account such matters and BTG's right of
termination under clause 16.3.1(iii) shall apply equally to such revised
Development Plan.
16.3.3 BTG shall only have the right to terminate this Agreement under
clause 16.3.1(ii), if (a) BTG has provided written notice that it will
terminate this Agreement under that clause and (b) within thirty (30) days
after receipt of such written notice Licensee has not paid BTG fifty thousand
dollars ($50,000). If fifty thousand dollars is paid to BTG under this
section 16.3.3 such amount shall be fully creditable against any future
payments to be made by Licensee under clauses 2 or 7 of this Agreement.
16.4 With respect to clause 16.2, BTG shall serve on the Licensee a written
notice of termination of the Agreement or any of the Licences or any exclusive
rights that specifies the breach and that notice shall have automatic effect
sixty (60) days after the date of service, unless within that period the
Licensee shall have remedied the breach.
16.5 This Agreement and the rights and licenses granted hereunder may be
terminated or modified only as expressly set forth in a provision of this
Agreement.
17. RIGHTS ON TERMINATION
17.1 TERMINATION (or expiry) of this Agreement, or of any of the Licenses,
shall be without prejudice to any rights of either party against the other which
may have accrued up to the date of termination.
23
17.2 ON termination of this Agreement for whatever cause the Licensee shall
pay to BTG royalty in respect of all Products being manufactured at the date of
termination and all Products manufactured and not yet sold. The Licensee shall
then be free to sell or dispose of Products on which royalty has been paid.
17.3 TERMINATION of this Agreement for any reason shall not bring to an end:
17.3.1 the provisions of clause 4.4;
17.3.2 the confidentiality obligations of Clause 6.2 until the Know-how
and the Biological Material and the Cell Lines shall have come
into the public domain otherwise than through the breach or
default of the Licensee;
17.3.3 the obligations of the Licensee in respect of the accounting
for, payment of and verification of payments and royalties under
Clauses 2, 7, 8, 9, 10, 17.2, 17.4 and 17.5;
17.3.4 the obligations contained in Clause 13 in relation to any
Products falling within Clause 17.2;
17.3.5 the obligations contained in Clause 15;
17.4 ON early termination the Licensee shall/shall procure transfer to BTG or
destruction (at BTG's option, and in the former case at BTG's expense) of the
Know-how and all copies and/or the Biological Material and/or the Cell Lines
(other than those that include stealth Technology).
17.5 On early termination of this Agreement or the Licenses (except where the
termination is for breach by BTG) the Licensee shall within sixty (60) days of
BTG's request grant to BTG a non-exclusive license with respect to Licensee
Technology to make, use, sell have made, offer for sale, and import Product on
commercially reasonable terms, including the right to grant sublicenses. If the
parties fail to reach agreement with respect to the terms, either party shall
have the right to submit the terms upon which agreement has not been reached to
binding arbitration to a single arbitrator to be agreed between the parties (or
in default nominated by the President for the time being of The Bio Industry
Association in the United Kingdom). Such reference shall be in London, and shall
be deemed to be an arbitration agreement within the meaning of the Arbitration
Acts 1996 or any re-enactment or modification thereof for the time being in
force.
17.6 With respect to Stealth Technology, upon written request of BTG within
sixty (60) days after termination of this Agreement (except where termination is
for breach by BTG), Licensee shall negotiate with BTG with respect to granting a
license to BTG with respect to Stealth Technology in connection with Product to
the extent that Licensee has the ability to do so. Licensee is under no
obligation to enter into such a license and has no liability to BTG for failure
to grant such a license. The granting of the license and/or the terms on which
such a license will be granted is within the sole discretion of Licensee.
17.7 Subject to the following sentence, on termination of this Agreement, BTG
shall, if requested to do so by the Licensee or a Sub-licensee, enter into a
licence agreement on the terms of this Agreement with the relevant
24
Sub-licensees. It is acknowledged that BTG shall not be obliged to enter into a
licence with any Sub-licensee who is in breach of its Sub-licence.
At the request of Licensee, BTG shall acknowledge to a sub-licensee in writing
BTG's obligations under this clause 17.7.
18. MISCELLANEOUS
18.1 THE Licensee shall not assign, charge or otherwise dispose of any of its
rights or obligations under this Agreement, or any of the Licences except that
the Licensee may by submission of written notice to BTG, require this Agreement
to be transferred by way of novation, to a wholly owned Subsidiary or an
acquiror in the case of a merger,- or consolidation or in the case of an
acquisition or transfer of all or substantially all of the Licensee's assets to
which this Agreement relates as long as, at the date of the novation the
Licensee's rights under this Agreement do not represent all, or substantially
all of the Licensee's assets. The Licensee shall reimburse BTG its reasonable
legal costs in respect of any such novation. For the avoidance of doubt, it is
declared that in any such assignment the assignor must transfer all of the
Know-how and Biological Materials to the beneficiary of the novation. Clause 6.2
shall continue to bind the Licensee in the event of such novation.
18.2 The Licensee may grant Sub-Licences (including the right to
sub-sub-license) by written agreement but only on the Sub-Licence Terms.
18.3 THE failure by either party to exercise or enforce any rights under this
Agreement shall not be deemed to be a waiver of any such rights, nor shall any
single or partial exercise of any right, power, or privilege, or further
exercise thereof, operate so as to bar the exercise or enforcement thereof at
any later time.
18.4 THE waiver by either party of any breach of any of the terms of this
Agreement by the other shall not be deemed to be a waiver of any other breach of
the Agreement.
18.5 IF any part or provision of this Agreement is prohibited, or rendered
void or unenforceable, by any legislation, the validity or enforceability of the
Agreement as a whole or of any other part of this Agreement shall not be
affected.
18.6 THE rights and remedies provided in this Agreement are cumulative and
not exclusive of any rights or remedies provided by law or in equity.
18.7 THE Licensee shall not originate any publicity, news release, or other
public announcement, written or oral, whether to the public press, to
shareholders or otherwise, relating to this agreement, to any amendment hereto
or to performance hereunder or to the existence of an arrangement between the
parties without the prior written approval of BTG (such approval not to be
unreasonably withheld or delayed). However this restriction shall not apply to
disclosures required by law or necessary to comply with the rules of any
securities market or applicable regulatory authority.
19. NOTICES
19.1 ANY notice authorised or required to be given by either party under this
Agreement to the other party, shall be in writing, and shall be deemed
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The COMMON SEAL of BTG
INTERNATIONAL LIMITED was
affixed to this Deed in the
presence of:
[SEAL] /s/ [ILLEGIBLE]
Director/Authorised Signatory
/s/ [ILLEGIBLE]
Authorised Signatory
The COMMON SEAL of TOLERRX, INC
was affixed to this Deed in the
presence of:
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
Director
/s/ ▇▇▇▇▇ ▇▇▇▇
Secretary