Licence Agreement - Cambridge University Technical Services Ltd. and TolerRx Inc.
CD2 ANTIBODY LICENCE AGREEMENT
THIS AGREEMENT dated 25 September 2001 is between:
1) CAMBRIDGE UNIVERSITY TECHNICAL SERVICES LIMITED an English Company,
Registered Number 1069886, whose registered office is at The Old Schools,
Cambridge CB2 ITS, England ("CUTS"); and
A. TOLERRX (the "Licensee") a company incorporated in the State of Delaware
whose registered office is at 675 Mass Avenue, Cambridge, MA 02139.
RECITALS:
A. The University of Cambridge ("UC") has conducted research into anti-CD2
antibodies, through its Department of Pathology under the Supervision of
Professor H Waldmann, which has generated the Patents and the Antibodies.
B. UC wishes to exploit the Patents and the Antibodies.
C. The Licensee wishes to acquire rights under the Patents and to use the
Antibodies for the development and commercialisation of Licensed Products
in the Field and in the Territory, in accordance with the provisions of
this Agreement.
D. UC is willing to grant the licence through its wholly owned subsidiary
CUTS subject to the terms and conditions of this Agreement.
IT IS AGREED as follows:
1. DEFINITIONS
In this Agreement, the following words shall have the following meanings:
AFFILIATE In relation to a Party, means any entity or person
which controls, is controlled by, or is under common
control with that Party. For the purposes of this
definition, "control" shall mean direct or indirect
beneficial ownership of 50% (or, outside a Party's home
territory, such lesser percentage as is the maximum,
permitted level of foreign investment) or more of the
share capital, stock or other participating interest
carrying the right to vote or to distribution of
profits of that entity or person, as the case may be.
ANNUAL NET SALES VALUE The total Net Sales Value achieved by the Licensee
during the calendar year.
ANTIBODIES Any and all of the monoclonal antibodies described in
Schedule I, fragments of such antibodies, the clones
for producing such antibodies (and progeny thereof) and
the genetic material encoding such antibodies.
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COMMENCEMENT DATE 25 September 2001
FIELD The prevention and treatment of human diseases and
disorders.
LICENSED PRODUCTS Any and all products that (a) are within any Valid
Claim of the Patents and/or (b) incorporate any of the
Antibodies, provided to Licensee by or on behalf of
CUTS.
NET SALES VALUE The invoiced price of Licensed Products sold by the
Licensee or its Affiliates or its Sub-Licensees to
independent third parties in arm's length transactions
exclusively for money or, where the sale is not at
arm's length, the price that would have been so
invoiced if it had been at arm's length, after
deduction of (i) normal trade discounts actually
granted and any credits actually given, and, (ii)
provided the amounts are separately charged on the
relevant invoice any costs of packaging, insurance,
carriage and freight, (iii) any value added tax or
other sales tax, and any import duties or similar
applicable government levies, and (iv) any and all US
Federal, estate or local government rebates, whether in
existence now, or enacted at any time during the term
of this Agreement, insofar as it applies to Licensed
Product, and (v) any invoiced price of Licensed
Products for which payment has not been received by the
Licensee due to bad debt.
PARTIES CUTS and the Licensee, and "Party" shall mean either of
them.
PATENTS Any and all of the patents and patent applications
referred to in Schedule I, including any continuations,
continuations in part, extensions, reissues,
reexaminations, divisions, and any patents,
supplementary protection certificates and similar
rights that are based on or derive priority from the
foregoing.
SUB-LICENSEE(S) Any person or entity to whom Licensee grants a
sublicense under Patents or to Antibodies.
TERRITORY World-wide.
VALID CLAIM A claim of a patent or patent application that has not
expired or been disclaimed or been held invalid or
unenforceable by a court of competent jurisdiction or
other government agency of competent jurisdiction in a
final and non-appealable judgement or decision.
2. GRANT OF RIGHTS
a) LICENCES. CUTS hereby grants to the Licensee, subject to the provisions
of this Agreement:
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(a) an exclusive licence in the Field under the Patents, with the right
to sub-licence, subject to Clause 2.5 below, to develop,
manufacture, have manufactured, use, offer to sell, import and sell
Licensed Products but only in the Field in the Territory; and
(b) an exclusive licence in the Field, with the right to sub-licence,
subject to Clause 2.5 below, to develop, manufacture, have
manufactured, use, offer to sell, import and sell Licensed Products
that incorporate Antibodies but only in the Field in the Territory.
2.2 CUTS will not manufacture or sell the Licensed Products in the Field
exclusively reserved to the Licensee, and will not grant a licence to
other parties to use the Patents or Antibodies to make and sell the
Licensed Products in the Field exclusively reserved to the Licensee.
2.3 For the avoidance of doubt, CUTS will have the right to grant licences to
use the Patents and Antibodies to other parties for commercial purposes
outside the Field.
2.4 FORMAL LICENCES. The Parties shall execute such formal licences as may be
necessary or appropriate for registration with Patent Offices and other
relevant authorities in particular territories. In the event of any
conflict in meaning between any such licence and the provisions of this
Agreement, the provisions of this Agreement shall prevail wherever
possible. Prior to the execution of the formal licence(s) (if any)
referred to in Clause 2.4, the Parties shall so far as possible have the
same rights and obligations towards one another as if such licence(s) had
been granted. The Parties shall use reasonable endeavours to ensure that,
to the extent permitted by relevant authorities, this Agreement shall not
form part of any public record.
2.5 SUB-LICENSING. The Licensee shall be entitled to grant sub-licences of
its rights under this Agreement to any person, provided that:
(a) the sub-licence shall include obligations on the Sub-Licensee which
are equivalent to the obligations on the Licensee under this
Agreement and the Sub-Licensee shall be made aware of the
obligations under this Agreement;
(b) within 30 days of the grant of any sub-licence the Licensee shall
provide to CUTS a true copy of it; and
(c) the Licensee shall be responsible for any breach of the sub-licence
by the Sub-Licensee that is also a breach of this Agreement, as if
the breach had been that of Licensee under this Agreement, and the
Licensee shall indemnify CUTS against any loss, damages, costs,
claims or expenses which are awarded against or suffered by CUTS as
a result of any such breach by the Sub-Licensee.
2.6 RESERVATION OF RIGHTS. Subject to clause 2.10, CUTS and UC specifically
reserve the non-exclusive right to use the Antibodies and the Patents in
the Field for the purposes of academic research and teaching and to
publish the general scientific findings from research related to the
Patents and/or the Antibodies, provided that no commercial entity has
rights to the results of such research in the Field. CUTS agrees that it
shall not use and that it shall use reasonable efforts to procure that UC
shall not use Antibodies in humans, without prior consent from the
Licensee.
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2.7 NO OTHER LICENCE. It is acknowledged and agreed that no licence is
granted by CUTS to the Licensee other than the licence(s) expressly
granted by the provisions of this Clause 2. Without prejudice to the
generality of the foregoing CUTS reserves all rights under the Patents
and Antibodies outside the Field.
2.8 QUALITY. The Licensee shall ensure that all of the Licensed Products
marketed by it and its Sub-Licensees are of satisfactory quality and
comply with all applicable laws and regulations in each part of the
Territory.
2.9 RESPONSIBILITY FOR DEVELOPMENT OF LICENSED PRODUCTS. The Licensee shall
be exclusively responsible for the technical and commercial development
and manufacture of Licensed Products and for incorporating any
modifications or developments thereto that may be necessary or desirable
and for all Licensed Products sold or supplied, and accordingly the
Licensee shall indemnify CUTS in the terms of Clause 7.3.
2.10 CUTS agrees that it shall not transfer Antibodies and that it shall exert
reasonable efforts to procure that UC shall not transfer Antibodies in
the possession of CUTS or UC to any for-profit organisation for use in
the Field. CUTS further agrees that the transfer of Antibodies to any
third party for use in the Field by CUTS and/or UC shall be subject to
the completion of a material transfer agreement between said third party
and UC and that the terms of such material transfer agreement shall:
(a) prohibit use of the Antibodies in humans, and
(b) prohibit use of the Antibodies in the Field for the benefit of any
for-profit organisation.
2.11 Licensor agrees to provide to Licensee within thirty (30) days after the
signing of this Agreement a sample of each material that is encompassed
by Antibodies and that is in the possession of CUTS and/or UC.
3. CONFIDENTIAL INFORMATION
3.1 CONFIDENTIALITY OBLIGATIONS. Each Party ("Receiving Party") undertakes:
(a) to maintain as secret and confidential all technical or
commercial information obtained directly or indirectly from the
other Party ("Disclosing Party") in the course of or in anticipation
of this Agreement and to respect the Disclosing Party's rights
therein.
(b) to use the same exclusively for the purposes of this
Agreement, and
(c) to disclose the same only to those of its employees,
contractors and Sub-Licensees pursuant to this Agreement (if any) to
whom and to the extent that such disclosure is reasonably necessary
for the purposes of this Agreement.
3.2 EXCEPTIONS TO OBLIGATIONS. The provisions of Clause 3.1 shall not apply
to information which the Receiving Party can demonstrate by reasonable,
written evidence:
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(a) was, prior to its receipt by the Receiving Party from the
Disclosing Party, in the possession of the Receiving Party and at
its free disposal; or
(b) is subsequently disclosed to the Receiving Party without any
obligations of confidence by a third party who has not derived it
directly or indirectly from the Disclosing Party; or
(c) is or becomes generally available to the public through no act
or default of the Receiving Party or its agents, employees,
Affiliates or Sub-Licensees; or
(d) the Receiving Party is required to disclose to the courts of
any competent jurisdiction, or to any government regulatory agency
or financial authority, provided that the Receiving Party shall (i)
inform the Disclosing Party as soon as is reasonably practicable,
and (ii) at the Disclosing Party's request seek to persuade the
court, agency or authority to have the information treated in a
confidential manner, where this is possible under the court, agency
or authority's procedures; or
(e) in the case of information disclosed by CUTS to the Licensee,
is disclosed to actual or potential customers for Licensed Products
in so far as such disclosure is reasonably necessary to promote the
sale or use of Licensed Products; or
(f) in the case of information disclosed by CUTS to Licensee,
Licensee shall have the right to disclose information of CUTS to a
third party in exercising the rights and licences granted to
Licensee under this Agreement, provided that such third party agrees
to be bound by confidentiality obligations at least as restrictive
as Clauses 3.1 and 3.2.
3.3 DISCLOSURE TO EMPLOYEES. The Receiving Party shall procure that all of
its employees, contractors and Sub-Licensees pursuant to this Agreement
(if any) who have access to any of the Disclosing Party's information to
which Clause 3.1 applies, shall be made aware of and subject to these
obligations and shall have entered into written undertakings of
confidentiality at least as restrictive as Clauses 3.1 and 3.2 and which
apply to the Disclosing Party's information.
3.4 The obligations of the Parties under this Clause 3 shall survive the
expiration or termination of this Agreement for whatever reason for a
period of 5 years.
4. PAYMENTS
4.1 INITIAL PAYMENT. Within 30 (thirty) days of the Commencement Date, the
Licensee shall pay to CUTS the non-refundable, non-deductible sum of
$[*******].
4.2 MILESTONE PAYMENTS. In addition to the payments made under Clause 4.1,
the Licensee shall pay CUTS the following sums ("Milestone Payments") for
each Licensed Product upon Licensee or its Sub-Licensee achieving the
following:
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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a) $[*******] upon initiation of a Phase I clinical trial or a first in
man study for each Licensed Product; and
b) $[*******] within 30 (thirty) days of initiation of Phase II
clinical trials for each Licensed Products; and
c) $[*******] within 30 (thirty) days of initiation of Phase III
clinical trials for each Licensed Product.
d) It is expressly understood that a Milestone Payment shall not be due
with respect to a Licensed Product for which such Milestone Payment
has already been paid that replaces a Licensed Product or for
clinical trials directed to new indications for the same Licensed
Product or for clinical trials for a Licensed Product in a new
dosage form, provided, however that within (30) thirty days of
regulatory approval in the United States or Europe of a Licensed
Product for a different additional indication after regulatory
approval of a first indication, Licensee shall pay CUTS $[*******]
4.3 ROYALTIES.
(a) The Licensee shall pay to CUTS a royalty as a percentage of the Net
Sales Value of all Licensed Products or any part thereof sold by Licensee
as follows:
(i) [*******] of the Net Sales Value when the Annual Net Sales
Value of Licensed Products is less than or equal to
$[*******] or
(ii) [*******] of the Net Sales Value when the Annual Net Sales
Value of Licensed Products is greater than $[*******] and
less than or equal to $[*******] or
(iii) [*******] of the Net Sales Value when the Annual Net Sales
Value of Licensed Products is greater than $[*******].
(b) Licensee shall pay to CUTS a royalty of [*******] of the running
royalties that Licensee receives from a Sub-Licensee based on Net Sales
Value of Licensed Product PROVIDED ALWAYS THAT such royalty paid to CUTS
under this Clause 4.3(b) shall not be less than [*******] of the Net
Sales Value of all Licensed Products or any part thereof sold by such
Sub-Licensee.
4.4 If, during the continuation of this Agreement, the Licensee considers it
necessary to obtain a licence from any third party ("Third Party
Licence(s)") in order to avoid infringing such third party's patent(s) in
the course of manufacture or sale of Licensed Products AND the total
royalty payable by the Licensee on the Licensed Products under this
Agreement and all Third Party Licence(s) exceeds [*******] of the Net
Sales Value, then all royalties paid under the Third Party Licence(s)
shall be treated as a deductible item against royalties under Clause 4.3
until the aggregate royalty is reduced to [*******] of the Net Sales
Value, provided that the amount of royalty payable by the Licensee to
CUTS in any period shall not be less than [*******] of the Net Sales
Value.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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4.5 PAYMENT TERMS. Royalties due under this Agreement shall be paid within 60
days of the end of each calendar year, in respect of sales of Licensed
Products made during such calendar year and within 60 days of the
termination of this Agreement.
4.6 All sums due under this Agreement:-
(a) are exclusive of Value Added Tax which where applicable will
be paid by the Licensee to CUTS in addition;
(b) shall be paid in pounds sterling by telegraphic transfer to
the account of Cambridge University Technical Services Ltd at
[*******] and in the case of sales made by Licensee or a
Sub-Licensee in a currency other than pounds sterling, the royalty
shall be calculated in the other currency and then converted into
equivalent pounds sterling at the buying rate of such other currency
as quoted by Barclays Bank plc in London as at the close of business
on the last business day of the quarterly period with respect to
which the payment is made;
(c) shall be made without deduction of income tax or other taxes
charges or duties that may be imposed on Licensee, except insofar as
the Licensee is required to deduct the same to comply with
applicable laws. The Parties shall cooperate and take all steps
reasonably and lawfully available to them, at the expense of CUTS,
to avoid deducting such taxes and to obtain double taxation relief.
If the Licensee is required to make any such deduction it shall
provide CUTS with such certificates or other documents as it can
reasonably obtain to enable CUTS to obtain appropriate relief from
double taxation of the payment in question; and
(d) shall be made by the due date, failing which CUTS may charge
interest on any outstanding amount on a daily basis at a rate
equivalent to 3% above the Barclays Bank plc base lending rate then
in force.
4.7 If at any time during the continuation of this Agreement the Licensee is
prohibited from making any of the payments required hereunder by a
governmental authority in any country then the Licensee will within the
prescribed period for making the said payments in the appropriate manner
use its best endeavours to secure from the proper authority in the
relevant country permission to make the said payments and will make them
within 7 days of receiving such permission. If such permission is not
received within 30 (thirty) days of the Licensee making a request for
such permission then, at the option of CUTS, the Licensee shall deposit
the royalty payments due in the currency of the relevant country either
in a bank account designated by CUTS within such country or such royalty
payments shall be made to an associated company of CUTS designated by
CUTS and having offices in the relevant country designated by CUTS.
4.8 ROYALTY STATEMENTS. The Licensee shall send to CUTS at the same time as
each royalty payment is made in accordance with Clause 4.5 a statement
setting out, in respect of each territory or region in which Licensed
Products are sold, the types of Licensed Product sold, the quantity of
each type sold, and the total Net Sales Value in respect of each type,
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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expressed both in local currency and pounds sterling and showing the
conversion rates used, during the period to which the royalty payment
relates.
4.9 RECORDS
4.9.1 The Licensee shall keep at its normal place of business detailed and up
to date records and accounts showing the quantity, description and Net
Sales Value of Licensed Product sold, and the amount of sublicensing
revenues received by it in respect of Licensed Products, on a country by
country basis, and being sufficient to ascertain the royalties due under
this Agreement.
4.9.2 The Licensee shall make such records and accounts available, on
reasonable notice, for inspection during business hours by an independent
chartered accountant nominated by CUTS for the purpose of verifying the
accuracy of any statement or report given by the Licensee to CUTS under
this Clause 4. The accountant shall be required to keep confidential all
information learnt during any such inspection, and to disclose to CUTS
only such details as may be necessary to report on the accuracy of the
Licensee's statement or report. CUTS shall be responsible for the
accountant's charges unless the accountant certifies that there is an
underpayment of more than 5 per cent in any royalty statement, in which
case the Licensee shall pay his charges in respect of that inspection.
4.9.3 The Licensee shall ensure that CUTS has the same rights as those set out
in this Clause 4.9 in respect of any Sub-Licensee of the Licensee.
4.10 Only one royalty shall be due for each unit of a Licensed Product. As a
result, a purchaser of a Licensed Product for which a royalty has been
paid shall have the right to use or resell such Licensed Product without
the payment of a further royalty under this Agreement.
5. COMMERCIALISATION
5.1 (a) Taking into account the complexity, and stage of development of the
Licensed Products, Licensee shall use reasonable commercial efforts
under the circumstances to research, develop and then commercialise
Licensed Product in the United States, European Union and in other
countries of the world in which Licensee can reasonably develop and
market Licensed Product. The efforts of a Sub-Licensee and/or an
Affiliate and/or a collaborator of Licensee shall be considered as
efforts of Licensee.
(b) In the event that CUTS reasonably believes that Licensee is not
making reasonable commercial efforts under the circumstances to
research, develop and then commercialise Licensed Products pursuant
to subclause 5.1(a), then CUTS shall provide written notice to
Licensee which specifies CUTS' basis for such belief. Upon receipt
of such written notice, CUTS and Licensee shall enter into good
faith negotiations in order to reach mutual agreement as to what
efforts by Licensee shall satisfy the requirements of Clause 5.1(a),
and if such mutual agreement is not reached within ninety (90) days
after receipt of such written notice, then the Parties agree to
submit to arbitration pursuant to Clause 9.14 to determine the
efforts which
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should be exerted by Licensee. Thereafter, Licensee shall exert the
efforts determined by the Parties or in such arbitration.
(c) If Licensee fails to meet the goals and objectives determined by the
Parties or in such arbitration and such failure results from
Licensee failing to reasonably attempt to meet such goals and
objectives, CUTS' sole and exclusive remedy is for the licences
granted hereunder to be terminated which shall take effect sixty
(60) days after written notice to Licensee unless prior to
expiration of such sixty (60) day period, Licensee provides CUTS
with reasonable assurances that such goals and objectives can be met
in a reasonable time thereafter.
5.2 Without prejudice to the generality of the Licensee's obligations under
Clause 5.1, the Licensee shall provide at least annually to CUTS an
updated, written report, showing all past, current and projected
activities taken or to be taken by the Licensee to bring Licensed
Products to market and after initiating sales in a country, the
activities taken to market Licensed Product in such country. CUTS'
receipt or approval of any such plan shall not be taken to waive or
qualify the Licensee's obligations under Clause 5.1.
6. INTELLECTUAL PROPERTY
6.1 OBTAIN AND MAINTAIN THE PATENTS.
(a) Licensee shall file, prosecute and maintain Patents, so as to secure
the broadest patent protection reasonably available, through patent
counsel selected by Licensee and reasonably acceptable to CUTS who
shall consult with CUTS and keep CUTS advised with respect thereto.
After the Effective Date of this Agreement, Licensee shall bear the
cost and expense for the filing, prosecution and maintenance of
Patents in the United States, European Patent Office, and Japan and
any other foreign countries designated by Licensee.
(b) With respect to any Patents, each patent application, office action,
response to office action, request for terminal disclaimer, and
request for reissue or reexamination of any patent issuing from such
application shall be provided to CUTS. CUTS shall have the right to
take any action that in its judgement is necessary to preserve such
Patents.
(c) CUTS shall and shall cause the inventors and UC to cooperate with
Licensee with respect to filing, prosecution and maintenance of
Patents.
(d) If the Licensee wishes to abandon any such application or not to
maintain any such Patent (or to cease funding such application or
Patent) it shall give 3 months' prior written notice to CUTS and on
the expiry of such notice period the Licensee shall cease to be
licensed under the patent application or Patent identified in the
notice and shall take all actions necessary to transfer the
prosecution and maintenance of such patent application or Patent to
CUTS.
6.2 INFRINGEMENT OF THE PATENTS
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6.2.1 Each Party shall inform the other Party promptly if it becomes aware of
any infringement or potential infringement of any of the Patents in the
Field, and the Parties shall consult with each other to decide the best
way to respond to such infringement.
6.2.2 If the Parties fail to agree on a joint program of action within thirty
(30) days, including how the costs of any such action are to be borne and
how any damages or other sums received from such action are to be
distributed, then the Licensee shall be entitled to take action against
the third party at its sole expense and it shall reimburse CUTS for any
reasonable expenses incurred in assisting it in such action. CUTS shall
agree to be joined in any suit to enforce such rights subject to being
indemnified and secured in a reasonable manner as to any costs, damages,
expenses or other liability awarded against CUTS in such suit and shall
have the right to be separately represented by its own counsel at its own
expense. If the alleged infringement is both within and outside the
Field, the Parties shall also co-operate with CUTS' other licensees (if
any) in relation to any such action.
6.2.3 The Licensee shall be entitled to retain any monetary recovery from
settlement with third parties after reimbursement of CUTS expenses
pursuant to Clause 6.2.2, provided that the Licensee shall pay CUTS a
royalty in accordance with Clause 4.3 on any monetary recovery as if such
monetary recovery was Net Sales Value, to the extent that such monetary
recovery by the Licensee exceeds its reasonable expenses in respect of
the protection and enforcement of the Patents within the Field.
6.2.4 In any infringement suit either Party may institute to enforce the rights
in Patents pursuant to this Agreement, the other Party hereto shall, at
the request and expense of the Party initiating such suit, cooperate in
all respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information,
samples, specimens, and the like. The Party requesting cooperation shall
reimburse the other Party for amounts paid to a third party by such other
Party pursuant to such cooperation.
6.3 INFRINGEMENT OF THIRD PARTY RIGHTS
6.3.1 If any warning letter or other notice of infringement is received by a
Party, or legal suit or other action is brought against a Party, alleging
infringement of third party rights in the manufacture, use or sale of any
Licensed Product or use of any Patents or use of any Antibodies, that
Party shall promptly provide full details to the other Party, and the
Parties shall discuss the best way to respond.
6.3.2 The Licensee shall have the right but not the obligation to defend such
suit and shall have the right to settle with such third party, provided
that if any action or proposed settlement involves the making of any
statement, express or implied, concerning the validity of any Patent, the
consent of CUTS must be obtained before taking such action or making such
settlement.
7. WARRANTIES AND LIABILITY
7.1 WARRANTIES BY CUTS. CUTS warrants, represents and undertakes as follows:-
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(a) subject to Clause 7.3, it is the absolute and unencumbered
owner of the Patents and has caused and will cause its directors and
employees and UC to execute such assignments of the Patents as may
be necessary to give title to the Patents to CUTS; and
(b) it has not done, and will not do nor agree to do during the
continuation of this Agreement, any of the following things if to do
so would be inconsistent with the exercise by the Licensee of the
rights granted to it under this Agreement, namely:
(i) grant or agree to grant any rights in the Patents or
Antibodies or any improvements thereto; or
(ii) assign, mortgage, charge or otherwise transfer any of
the Patents or Antibodies or (subject to Clause 9.3 below) any
of its rights or obligations under this Agreement.
7.2 NO OTHER WARRANTIES
7.2.1 Each of the Licensee and CUTS 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 from this Agreement to the fullest extent permitted by
law.
7.2.2 Without limiting the scope of Clause 7.2.1, CUTS does not give any
warranty, representation or undertaking:-
(a) as to the efficacy or usefulness of the Patents or Antibodies;
or
(b) that any of the Patents is or will be valid or subsisting or
(in the case of an application) will proceed to grant; or
(c) that the use of any of the Patents or Antibodies, the
manufacture, sale or use of the Licensed Products or the exercise of
any of the rights granted under this Agreement will not infringe any
other intellectual property or other rights of any other person; or
(d) that any information communicated by CUTS to the Licensee
under or in connection with this Agreement will produce Licensed
Products of satisfactory quality or fit for the purpose for which
the Licensee intended; or
(e) as imposing any obligation on CUTS to bring or prosecute
actions or proceedings against third parties for infringement or to
defend any action or proceedings for revocation of any of the
Patents; or
(f) as imposing any liability on CUTS in the event that any third
party supplies Licensed Products to customers located in the
Territory.
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7.3 INDEMNITY. (a) The Licensee shall indemnify CUTS against any loss,
damages, costs or expenses which are awarded against or incurred by CUTS
as a result of any third party claim or threatened claim concerning the
use by the Licensee or any of its Sub-Licensees of the Patents or
Antibodies or otherwise in connection with the manufacture, use or sale
of or any other dealing in any of the Licensed Products by Licensee or
its Affiliates or any of its Sub-Licensees.
(b) Licensee's indemnification under (a) shall not apply to any
liability, damage, loss or expense to the extent that it is directly
attributable to the negligent activities or intentional misconduct
of the Indemnitees.
(c) Licensee shall have the right to control the defence,
settlement or compromise of any such action and shall select counsel
for such defence.
7.4 LIABILITY. Notwithstanding any other provision of this Agreement, no
Party shall be liable to any other Party to this Agreement in contract,
tort, negligence, breach of statutory duty or otherwise for any loss,
damage, costs or expenses of any nature whatsoever incurred or suffered
by that other party or its Affiliates of an indirect or consequential
nature including without limitation any economic loss or other loss of
turnover, profits, business or goodwill.
8. DURATION AND TERMINATION
8.1 COMMENCEMENT AND TERMINATION BY EXPIRY. This Agreement, and the licences
granted hereunder, shall come into effect on the Commencement Date and,
unless terminated earlier in accordance with this Clause 8, shall
continue in force on a country by country basis until the later of:
(a) the date on which all the Patents in a country have expired or
been revoked or declared invalid or unenforceable without a
right of further appeal, or
(b) the tenth anniversary of the Commencement Date;
and on such date in such country the licence granted under sub-clause
2.1(a) shall terminate automatically by expiry and the licence granted
under sub-clause 2.1(b) shall become a fully paid-up, royalty-free
non-exclusive licence.
8.2 EARLY TERMINATION
8.2.1 The Licensee may terminate this Agreement at any time on 90 (ninety) days
notice in writing to CUTS.
8.2.2 Without prejudice to any other right or remedy, either Party may
terminate this Agreement at any time by notice in writing to the other
Party ("Other Party"), such notice to take effect as specified in the
notice:-
(a) if the Other Party is in material breach of a material obligation of
this Agreement and, in the case of a breach capable of remedy within
ninety (90) days, the breach is not remedied within ninety (90) days
of the Other Party receiving notice
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specifying the breach and requiring its remedy; or (b) if the Other
Party becomes insolvent, or if an order is made or a resolution is
passed for the winding up of the Other Party (other than voluntarily
for the purpose of solvent amalgamation or reconstruction), or if an
administrator, administrative receiver or receiver is appointed in
respect of the whole or any part of the Other Party's assets or
business, or if the Other Party makes any composition with its
creditors or takes or suffers any similar or analogous action in
consequence of debt.
8.2.3 CUTS may forthwith terminate this Agreement by giving written notice to
the Licensee if the Licensee or its Affiliate or Sub-Licensee commences
legal proceedings, or assists any third party to commence legal
proceedings, to challenge the validity or ownership of any of the Patents
and/or Antibodies.
8.3 CONSEQUENCES OF TERMINATION
8.3.1 Upon termination of this Agreement for any reason otherwise than in
accordance with Clause 8.1:
(a) the Licensee and its Sub-Licensees shall be entitled to sell,
use or otherwise dispose of (subject to payment of royalties under
Clause 4.3) any unsold or unused stocks of the Licensed Products for
a period of 6 months following the date of termination;
(b) subject to paragraph (a) above, the Licensee shall no longer
be licensed to use or otherwise exploit in any way, either directly
or indirectly, the Patents, in so far and for as long as any of the
Patents remains in force or the Antibodies;
(c) subject to paragraph(a) above, the Licensee shall consent to
the cancellation of any formal licence granted to it, or of any
registration of it in any register, in relation to any of the
Patents;
(d) subject as provided in this Clause 8.3.1 and 8.3.2, and except
in respect of any accrued rights, and except with respect to clauses
3.7.3, and 8.4 which shall survive termination of this Agreement,
neither party shall be under any further obligation to the other.
8.3.2 In the event that this Agreement is terminated and at the time of
termination Licensee and its Sub-Licensee(s) no longer intend to pursue
development of Licensed Products, if requested by CUTS, Licensee agrees
to negotiate in good faith with CUTS a royalty bearing licence on
reasonable commercial terms to technology owned by Licensee that is
useful for Licensed Product. In no event is Licensee obligated to grant
such a license and Licensee and/or CUTS shall have the right to terminate
such negotiations at any time by written note to the other party.
8.4 In the event that this Agreement and/or the rights and licences granted
under this Agreement to Licensee are terminated, any sublicense granted
under this Agreement shall remain in full force and effect as a direct
licence between CUTS and the Sub-Licensee under the terms and conditions
of this Agreement, subject to the Sub-Licensee agreeing to be bound to
CUTS under such terms and conditions within thirty (30) days after CUTS
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provides written notice to the Sub-Licensee of the termination of
Licensee's rights and licences under this Agreement. At the request of
Licensee, CUTS will acknowledge to a Sub-Licensee, CUTS' obligations to
the Sub-Licensee under this paragraph.
9. GENERAL
9.1 FORCE MAJEURE. Neither Party shall have any liability or be deemed to be
in breach of this Agreement for any delays or failures in performance of
this Agreement which result from circumstances beyond the reasonable
control of that Party, including without limitation labour disputes
involving that Party. The Party affected by such circumstances shall
promptly notify the other Party in writing when such circumstances cause
a delay or failure in performance and when they cease to do so.
9.2 AMENDMENT. This Agreement may only be amended in writing signed by duly
authorised representatives of CUTS and the Licensee.
9.3 ASSIGNMENT AND THIRD PARTY RIGHTS.
9.3.1 Subject to Clause 9.3.2 below and Licensee's right to grant sublicenses,
neither Party shall assign this Agreement, nor any of the Patents or
rights under the Patents, nor any of the Antibodies or rights to the
Antibodies, without the prior written consent of the other Party, which
shall not be withheld unreasonably.
9.3.2 Either Party may assign all its rights and obligations under this
Agreement together with its rights in the Patents and the Antibodies to
any company to which it transfers all or part of its assets or business
or to a successor-in-interest or to an Affiliate, PROVIDED that the
assignee undertakes to the other Party to be bound by and perform the
obligations of the assignor under this Agreement.
9.4 WAIVER. No failure or delay on the part of either Party to exercise any
right or remedy under this Agreement shall be construed or operate as a
waiver thereof, nor shall any single or partial exercise of any right or
remedy preclude the further exercise of such right or remedy.
9.5 INVALID CLAUSES. If any provision or part of this Agreement is held to be
invalid, amendments to this Agreement may be made by the addition or
deletion of wording as appropriate to remove the invalid part or
provision but otherwise retain the provision and the other provisions of
this Agreement to the maximum extent permissible under applicable law.
9.6 NO AGENCY. Neither Party shall act or describe itself as the agent of the
other, nor shall it make or represent that it has authority to make any
commitments on the other's behalf.
9.7 INTERPRETATION. In this Agreement:
(a) the headings are used for convenience only and shall not
affect its interpretation:
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(b) references to persons shall include incorporated and
unincorporated persons; references to the singular include the
plural and vice versa; and references to the masculine include the
feminine:
(c) references to Clauses and Schedules mean clauses of, and
schedules to, this Agreement; and
(d) references to the grant of "exclusive" rights shall mean that
the person granting the rights shall neither grant the same rights
(in the same Field and Territory) to any other person, nor exercise
those rights directly to the extent that and for as long as the
Licensed Products are within Valid Claims of unexpired Patents.
9.8 NOTICES
9.8.1 Any notice to be given under this Agreement shall be in writing and shall
be sent by first class mail or air mail, or by fax (confirmed by first
class mail or air mail) to the address of the relevant Party set out at
the head of this Agreement, or to the relevant fax number set out below,
or such other address or fax number as that Party may from time to time
notify to the other Party in accordance with this Clause 9.8. The fax
numbers of the Parties are as follows: CUTS +44 (0)1223 332797;
Licensee (001) 617 426 3071.
9.8.2 Notices sent as above shall be deemed to have been received three working
days after the day of posting (in the case of inland first class mail),
or seven working days after the date of position (in the case of air
mail), or on the next working day after transmission (in the case of fax
messages, but only if a transmission report is generated by the sender's
fax machine recording a message from the recipient's fax machine,
confirming that the fax was sent to the number indicated above and
confirming that all pages were successfully transmitted).
9.9 DISPUTES. Except as provided in Clause 5.1, any disputes incapable of
resolution shall be settled by mediation at the Centre for Dispute
Resolution (CEDR) or if ineffective then either by court proceedings if
considered expedient by the complainant or alternatively and if agreed at
the time by sole arbitrator to be appointed, and to proceed according to
the Rules of the International Chamber of Commerce(ICC) whose decision
will be final.
9.10 LAW AND JURISDICTION. The validity, construction and performance of this
Agreement shall be governed by English law and shall be subject to the
nonexclusive jurisdiction of the English courts to which the parties
hereby submit, except that a Party may seek an interim injunction in any
court of competent jurisdiction.
9.11 FURTHER ACTION. Each Party agrees to execute, acknowledge and deliver
such further instruments, and do all further similar acts, as may be
necessary or appropriate to carry out the purposes and intent of this
Agreement.
9.12 ANNOUNCEMENTS. Neither Party shall make any press or other public
announcement concerning any aspect of this Agreement, or make any use of
the name of the other Party in connection with or in consequence of this
Agreement, without the prior written consent of the other Party, which
consent shall not be withheld or delayed unreasonably. No
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consent shall be required where the disclosure is in conjunction with a
financing or offering of securities or where required by applicable law,
rule or regulation.
9.13 ENTIRE AGREEMENT. This Agreement, including its Schedules, sets out the
entire agreement between the Parties relating to its subject matter and
supersedes all prior oral or written agreements, arrangements or
understandings between them relating to such subject matter. The Parties
acknowledge that they are not relying on any representation, agreement,
term or condition which is not set out in this Agreement.
9.14 Any matter or disagreement under Clause 5.1(b) which this Agreement
specifies is to be resolved by arbitration shall be submitted to a
mutually selected single arbitrator to so decide any such matter or
disagreement. The arbitrator shall conduct the arbitration in accordance
with the Rules of the International Chamber of Commerce, unless the
Parties agree otherwise. If the Parties are unable to mutually select an
arbitrator, the arbitrator shall be selected in accordance with the
procedures of the International Chamber of Commerce. The decision
rendered by the arbitrator shall be final and binding. Any arbitration
pursuant to this section shall be held in London, England, or such other
place as may be mutually agreed upon in writing by the Parties.
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AGREED by the parties through their authorised signatories:-
For and on behalf of For and on behalf of
CAMBRIDGE UNIVERSITY TECHNICAL SERVICES TOLERRX
LIMITED
/s/ David Secher /s/ D. J. Ringler
---------------------------- ----------------------------
signed signed
DAVID SECHER D. J. Ringler
---------------------------- ----------------------------
print name print name
DIRECTOR CEO
---------------------------- ----------------------------
title title
21 SEPTEMBER 2001 25 September 2001
---------------------------- ----------------------------
date date
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AMENDMENT AGREEMENT
THIS AMENDMENT AGREEMENT dated December 31, 2001 is between:
1. CAMBRIDGE UNIVERSITY TECHNICAL SERVICES LIMITED, an English Company,
Register Number 1069886, whose registered office is at The Old Schools,
Cambridge CB2 TS, England ("CUTS"); and
2. TOLERRX, INC. a company incorporated in the State of Delaware whose register
office is at 675 Mass Ave., Cambridge, MA 02139, USA (the "Licensee").
WHEREAS CUTS and Licensee entered into a Licence Agreement dated September 25,
2001 that, among other things, is directed to certain CD2 antibodies (the
"Licence Agreement");
WHEREAS CUTS and Licensee desired to amend the Licence Agreement, INTER ALIA, to
include a non-exclusive licence to the YNB Patents (as defined below);
WHEREAS on the date hereof, CUTS shall assign the YNB Patents to BRITISH
TECHNOLOGY GROUP INTER-CORPORATE LICENSING LIMITED, an English Company,
Registered Number 2501784, whose registered office is at 10 Fleet Place,
Limeburner Lane, London EC4M 7SB ("BTG") by way of assignment and
commercialisation agreements (the "BTG Agreements"). Under the BTG Agreements,
BTG shall grant CUTS a non-exclusive licence to the YNB Patents (with the right
to sub-license to the Licensee); and
In consideration of the sum of L 1 paid by each party hereto to the other (the
receipt of which is hereby acknowledged) IT IS AGREED as follows:
1. All defined terms of the Licence Agreement shall have the same meaning in
this Amendment.
2. The following is added to the definitions of Clause 1 of the Licence
Agreement:
"YNB PATENTS: THOSE PATENTS AND PATENT APPLICATIONS IDENTIFIED IN SCHEDULE 2
TOGETHER WITH ALL CONTINUATIONS, CONTINUATIONS IN PART, RE-ISSUES,
EXTENSIONS, RE-EXAMINATIONS, DIVISIONS AND ANY PATENTS AND SUPPLEMENTARY
PROTECTION CERTIFICATES THAT ARE BASED ON OR DERIVE PRIORITY THEREFROM."
3. The patents and patent applications set out in the schedule hereto shall be
added to the Licence Agreement as Schedule 2.
4. The following is added to the Licence Agreement as Clause 2.1(c):
"(c) A NON-EXCLUSIVE LICENCE IN THE FIELD UNDER THE YNB PATENTS WITH RIGHT
TO SUB-LICENSE, SUBJECT TO CLAUSE 2.5 BELOW, TO DEVELOP, MANUFACTURE, HAVE
MANUFACTURED, USE, OFFER TO SELL, IMPORT AND SELL LICENSED PRODUCTS THAT
INCORPORATE ANTIBODIES BUT ONLY IN THE FIELD IN THE TERRITORY. FOR THE
AVOIDANCE OF DOUBT, NO RIGHTS ARE GRANTED UNDER THIS AGREEMENT TO USE THE
PROCESS FOR THE PREPARATION OF AN ANTIBODY CHAIN UNDER THE YNB PATENTS OTHER
THAN IN RELATION TO LICENSED PRODUCTS INCORPORATING ANTIBODIES."
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5. The following shall be added to the Licence Agreement:
"6.3.3 NOTWITHSTANDING 6.3.1, IF ANY WARNING LETTER OR OTHER NOTICE OF
INFRINGEMENT IS RECEIVED BY CUTS, LICENSEE OR BTG, OR LEGAL SUIT OR
OTHER ACTION IS BROUGHT AGAINST ANY OF THEM, ALLEGING INFRINGEMENT OF
THIRD PARTY RIGHTS IN THE MANUFACTURE, USE OR SALE OF ANY LICENSED
PRODUCTS BY USE OF ANY OF THE YNB PATENTS, THE RELEVANT ENTITY SHALL
PROMPTLY PROVIDE FULL DETAILS TO THE OTHERS.
6.3.4 NEITHER CUTS NOR LICENSEE SHALL TAKE ANY ACTION OR MAKE ANY
STATEMENT, EXPRESS OR IMPLIED, CONCERNING THE VALIDITY OF ANY OF THE
CLAIMS OF ANY OF THE YNB PATENTS, WITHOUT FIRST OBTAINING THE CONSENT
OF BTG WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD.
6.3.5 BTG AS THE OWNER OF THE YNB PATENTS (AND NOT CUTS NOR LICENSEE) SHALL
HAVE THE RIGHT TO ENFORCE AND DEFEND THE YNB PATENTS AS IT MAY SEE
FIT, SAVE THAT BTG SHALL CONSULT WITH CUTS AND KEEP CUTS ADVISED WITH
RESPECT THERETO. IT SHALL BE THE OBLIGATION OF CUTS (AND NOT BTG) TO
CONSULT WITH LICENSEE AND KEEP LICENSEE ADVISED IN RESPECT OF SUCH
ACTIONS."
6. Clause 7.4 shall be renumbered as clause 7.5 and the following shall be
added to that clause 7.5:
7.5 "BTG SHALL NOT HAVE ANY LIABILITY TO LICENSEE OR CUTS IN CONTRACT,
TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY LOSS,
DAMAGE, COSTS OR EXPENSES OF ANY NATURE WHATSOEVER INCURRED OR
SUFFERED BY CUTS, LICENSEE OR ITS AFFILIATES OR SUB-LICENSEES AS A
DIRECT OR INDIRECT RESULT OF THE USE OF THE YNB PATENTS".
7. The following shall be added as a new clause 7.4:
"7.4 LICENSEE SHALL INDEMNIFY BTG (AND ITS PARENT COMPANY, BTG PLC AND THE
OTHER DIRECT OR INDIRECT SUBSIDIARIES OF BTG PLC AND THEIR RESPECTIVE
DIRECTORS, OFFICERS AND EMPLOYEES) ON THE SAME BASIS AS THAT PROVIDED
TO CUTS UNDER CLAUSES 2.5(c) AND 7.3 BUT IN RESPECT OF THE YNB
PATENTS ONLY"
8. CUTS and BTG agree that the assignment of the YNB Patents to BTG shall be
subject to the sublicense granted to Licensee to the YNB Patents under this
Amendment Agreement, and that the license that CUTS obtains under the BTG
Agreements to the YNB Patents shall not be terminable prior to the termination
or expiry of the licence of the YNB Patents from CUTS to Licensee.
9. CUTS and Licensee agree that by virtue of the Contracts (Rights of Third
Parties) Act 1999 BTG (but no other person) not a party hereto shall have the
right to enforce Clauses 6.3.3, 6.3.4, 6.3.5, 7.4 and 7.5 of the Licence
Agreement (as amended by this Amendment Agreement) as if it was a party to it.
10. The Licence Agreement is amended as provided herein as of the date first
written above. All other terms and provisions of the Licence Agreement shall be
unaffected by this Amendment.
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In order to induce Licensee and CUTS to enter into this Amendment Agreement
and to induce CUTS to assign the YNB Patents to BTG, BTG agrees that the license
to CUTS under the YNB Patents shall continue so long as the YNB Patents are
sublicensed to Licensee under this Amendment and shall, if necessary, survive
any earlier termination of the BTG Agreements.
Agreed by the parties through their authorized signature.
CAMBRIDGE UNIVERSITY TOLERRX, INC.
TECHNICAL SERVICES LIMITED
By: /s/ R. C. Jennings By: /s/ D. J. Ringler
---------------------- ----------------------
BRITISH TECHNOLOGY GROUP
INTER-CORPORATE LICENSING LIMITED
By: /s/ [ILLEGIBLE]
----------------------
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