Licence Agreement - Cambridge University Technical Services Ltd. and TolerRx Inc.
LICENCE AGREEMENT
THIS AGREEMENT dated December 8, 2000 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
(2) TOLERRX (the "Licensee") a company incorporated in the State of Delaware
whose registered office is at 675 Mass Ave., Cambridge, MA 02139, USA.
RECITALS:
A. The University of Cambridge ("UC") has conducted research into anti-CD4
and anti-CD8 antibodies, through its Department of Pathology under the
Supervision of Professor H Waldmann, which has generated the Patents, the
YNB Patent, the YNB Antibodies and the Antibodies.
B. UC wishes to exploit the Patents, the YNB Patent, the YNB Antibodies and
the Antibodies.
C. The Licensee wishes to acquire rights under the Patents and YNB Patent
and to use the Antibodies and YNB 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 a calendar year.
ANTIBODIES Any and all of the monoclonal antibodies described in
Schedule 1, fragments of such antibodies, the clones
for producing such antibodies and the genetic material
encoding such antibodies,
1
<Page>
including but not limited to all derivatives,
modifications, progeny or part thereof.
COMMENCEMENT DATE December 8, 2000
FIELD The prevention and treatment of human diseases and
disorders and the diagnoses and monitoring of or
susceptibility to human diseases, including, but not
limited to, those characterised by autoimmune,
immune-mediated, and/or immunological component(s) and
monitoring, therapeutic induction, and therapeutic
maintenance of immunological tolerance.
LICENSED PRODUCTS Any and all products that (a) are within any Valid
Claim of the Patents and/or (b) incorporate any of the
Antibodies and/or (c) are within any Valid Claim of the
YNB Antibody Claims and/or (d) incorporate the YNB
Antibody.
NET SALES VALUE The invoiced price of Licensed Products sold by the
Licensee or its Affiliates or its Sub-Licensee(s) 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.
OPTION FEE The sum of $[*******] paid by the Licensee under the
terms of the Heads of Agreement and Option to Negotiate
a License Agreement of 27 September 2000 between CUTS
and the Licensee.
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 1, 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 YNB Patent or to Antibodies
or to YNB Antibody.
TERRITORY World-wide.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
2
<Page>
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.
YNB ANTIBODIES The monoclonal antibodies described in Schedule 2,
fragments of such antibodies, the clones for producing
such antibodies and the genetic material encoding such
antibodies, including but not limited to all
derivatives, modifications, progeny or part thereof.
YNB ANTIBODY CLAIMS Any and all claims of the YNB Patent which are directed
solely to (i) an antibody capable of binding to human
CD4 antigen, or (ii) a pharmaceutical composition
comprising such antibody.
For the avoidance of doubt, any and all claims of the
YNB Patent which are directed to a process for the
preparation of an antibody chain are not included.
YNB PATENT The patents and patent applications referred to in
Schedule 2, 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.
2. GRANT OF RIGHTS
2.1 LICENCES. CUTS hereby grants to the Licensee, subject to the provisions
of this Agreement:
(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, which licence shall take effect upon CUTS obtaining a
written assignment of the Antibodies from the inventors to CUTS.
CUTS shall use reasonable commercial efforts to obtain such
assignment; and
(c) a non-exclusive licence in the Field: i) to the YNB Antibodies,
and ii) under the YNB Antibody Claims, to develop, manufacture,
have manufactured, use, offer to sell, import and sell Licensed
Products that incorporate YNB Antibodies but only in the Field in
the Territory, which licences shall take effect upon CUTS
obtaining a written assignment of the YNB Antibodies from the
inventors to CUTS. CUTS shall use reasonable commercial efforts to
obtain such assignment. Such licence shall also be subject to any
licence granted by CUTS to a third party with whom CUTS is
currently negotiating a licence that may include rights to such
YNB Antibodies and/or YNB Antibody Claims and/or YNB Patent. 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 Patent Licensee shall have the
3
<Page>
right to sub-licence the non-exclusive licence granted under this
clause 2.1(c) with prior written permission of CUTS, and such
permission not to be unreasonably withheld.
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 and that it shall use all reasonable efforts to procure that UC
shall not use Antibodies in humans, without prior consent from the
Licensee. For the avoidance of doubt, CUTS and UC also reserve the right
to use the YNB Antibodies and the YNB Patent in the Field for the
purposes of academic research and teaching and to publish the general
scientific findings from research related to the YNB Patent and YNB
Antibodies.
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.
4
<Page>
Without prejudice to the generality of the foregoing CUTS reserves all
rights under the Patents, YNB Patent, YNB Antibodies 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 and that it shall use all 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 it shall use all reasonable efforts to
procure 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 publication of the genetic sequence of the Antibodies
without prior reasonable consent from CUTS and/or UC, and
(c) prohibit use of the Antibodies in the Field for the benefit of any
for-profit organisation.
2.11 CUTS agrees that it shall and that it shall use reasonable efforts to
procure that UC shall 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:
5
<Page>
(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. On the later of 30 (thirty) days of the Commencement
Date or the date on which CUTS provides to Licensee a written assignment
of the Antibodies from the inventors thereof to CUTS, the Licensee shall
pay to CUTS the non-refundable, non-deductible sum of $[*******]. On the
later of 30 (thirty) days of the Commencement Date or the date on which
CUTS provides to Licensee a written assignment of the Antibodies from the
inventors thereof to CUTS, the Licensee shall also pay to CUTS the sum of
all patent costs incurred by CUTS from 1 January 2000 to the Commencement
Date to maintain, renew, prosecute and/or register ownership of the
Patents, less the Option Fee.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
6
<Page>
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:
a) $[*******] within 30 (thirty) days of initiation of Phase
II clinical trials for each Licensed Product; and
(b) $[*******] within 30 (thirty) days of initiation of Phase
III clinical trials for each Licensed Product.
(c) 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.
4.3 ROYALTIES. 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 or its Sub-Licensees 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 $[*******].
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, all royalties paid under the Third Party Licence(s) shall be
treated as a deductible item when calculating Net Sales Value, provided
that the amount of royalty payable by the Licensee to CUTS in any period
shall not be reduced by more than [*******] of the amount which would
have been payable in the absence of this Clause 4.4.
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;
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
7
<Page>
(b) shall be paid in pounds sterling by telegraphic transfer
to the account of C.U.T.S. 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,
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
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
8
<Page>
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 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
9
<Page>
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 OBTAIN AND MAINTAIN THE YNB PATENT
6.2.1 CUTS shall file, prosecute and maintain the YNB Patent, so as to
secure the broadest patent protection reasonably available,
through patent counsel selected by CUTS. CUTS shall consult with
Licensee and keep Licensee advised with respect thereto.
6.2.2 For the period of time Licensee remains the sole licensee of the
YNB Patent, Licensee will pay all fees, costs, and expenses
reasonably incurred from the Commencement Date in the prosecution
and maintenance of the YNB Patent. For the avoidance of doubt,
Licensee will not be liable for any costs incurred in relation to
prosecuting and/or obtaining allowance of and/or defending claims
other than YNB Antibody Claims.
6.2.3 In any country in which CUTS desires patent protection under the
YNB Patent but in which Licensee does not desire to pay the
expenses thereof under Clause 6.2.2, the Licensee shall give three
(3) months prior written notice to CUTS and on the
10
<Page>
expiry of such notice period the licence granted hereunder will
for such country be revoked.
6.2.4 In the event that the YNB Patent is licensed to other parties
patent costs pursuant to Clause 6.2.2 will be shared on a pro-rata
basis according to the number of licences granted.
6.2.5 For the avoidance of doubt, Licensee shall not be responsible for
any costs or expenses associated with the opposition in the
European Patent Office with respect to the YNB Patent.
6.3 INFRINGEMENT OF THE PATENTS
6.3.1 Each Party shall inform the other Party promptly if it becomes aware of
any infringement or potential infringement of any of the Patents and/or
YNB Patent in the Field, and the Parties shall consult with each other to
decide the best way to respond to such infringement.
6.3.2 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.
6.3.3 The Licensee shall be entitled to retain any monetary recovery from
settlement with third parties after reimbursement of CUTS expenses
pursuant to Clause 6.3.2, 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 and/or YNB Patent within
the Field.
6.3.4 In any infringement suit either Party may institute to enforce the rights
in Patents and/or YNB Patent 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.
6.4 INFRINGEMENT OF THIRD PARTY RIGHTS
6.4.1 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 the YNB
11
<Page>
Patent or use of any Antibodies or use of any YNB Antibodies, that Party
shall promptly provide full details to the other Party, and the Parties
shall discuss the best way to respond.
6.4.2 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 or
YNB 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:-
(a) subject to Clause 7.3, it is the absolute and unencumbered
owner of the Patents and YNB Patent and has caused and will cause
its directors and employees and UC to execute such assignments of
the Patents and YNB Patent 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 YNB Patent or YNB Antibodies or any
improvements thereto; or
(ii) assign, mortgage, charge or otherwise transfer any of
the Patents or Antibodies or YNB Patent or YNB 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 YNB
Patent or YNB Antibodies or Antibodies; or
(b) that any of the Patents or YNB Patent are 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 or YNB
Patent or YNB Antibodies, the manufacture, sale or use of the
Licensed Products or the exercise
12
<Page>
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 YNB Patent; or
(f) as imposing any liability on CUTS in the event that any
third party supplies Licensed Products to customers located in the
Territory.
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 YNB Patent or YNB 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 or a breach of a warranty made by
CUTS.
(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 or YNB Patent 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;
13
<Page>
and on such date in such country the licences granted under sub-clause
2.1(a) and 2.1(c) 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 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 and/or YNB Patent and/or YNB 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 or YNB Patent, in so far and
for as long as any of the Patents or YNB Patent remains in force
or the Antibodies or YNB 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 or YNB Patent;
14
<Page>
(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 and/or a CD4 and/or CD8 antibody, 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
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, nor any of the YNB Patent or rights under the YNB Patent, nor
any of the YNB Antibodies or rights to the YNB 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, the YNB Patent, the
YNB Antibodies 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
15
<Page>
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;
(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) 617 354 8300.
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 posting (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. Notwithstanding the provisions of 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
16
<Page>
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 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.
17
<Page>
AGREED by the parties through their authorized signatories:-
For and on behalf of For and on behalf of
CAMBRIDGE UNIVERSITY TECHNICAL TOLERRX
SERVICES LIMITED
/s/ R.C. Jennings /s/ D.J. Ringler
------------------------------------- --------------------------------------
signed signed
R.C. JENNINGS D.J. Ringler
------------------------------------- --------------------------------------
print name print name
DIRECTOR C.E.O.
------------------------------------- --------------------------------------
title title
8 December 2000 Dec 8, 2000
------------------------------------- --------------------------------------
date date
18
<Page>
AGREEMENT
THIS AGREEMENT dated July 23, 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 1TS, England ("CUTS"); and
(2) TOLERRX (the "Licensee") a company incorporated in the State of Delaware
whose registered office is at 675 Mass Avenue, Cambridge, MA 02139, USA.
WHEREAS CUTS and Licensee have entered into License Agreement dated
December 8, 2000 (the "License Agreement"); and
WHEREAS the parties desire to amend the License Agreement.
IT IS AGREED as follows:
1. DEFINITIONS:
1.01 All initially capitalized word and phrases shall be defined as
defined in the License Agreement, except as amended herein.
2. AMENDMENTS:
2.01 Schedule 1 of the License Agreement is hereby amended to include
the following:
4. TRX1 Antibody and Uses Therefor which is the subject
matter of British patent application no. 0114517.6 and all patent
applications and granted patents taking priority from such British
application and all re-issues, re-evaluations and continuations in
part therefrom.
3. EFFECT
Except as amended herein, the License Agreement shall be unaffected by
this Agreement.
<Page>
AGREED by the parties through their authorized signatories:
For and on behalf of For an on behalf of
CAMBRIDGE UNIVERSITY TECHNICAL TOLERRX
SERVICES LIMITED
/s/ R.C. Jennings /s/ D.J. Ringler
------------------------------------- --------------------------------------
Signed Signed
R.C. JENNINGS D.J. Ringler
------------------------------------- --------------------------------------
Print Name Print Name
DIRECTOR CEO
------------------------------------- --------------------------------------
Title Title
23.7.01 18 July, 2001
------------------------------------- --------------------------------------
Date Date
<Page>
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 December, 8
2000 that, among other things, is directed to certain CD4 and CD8 antibodies
(the "Licence Agreement");
WHEREAS the CUTS and Licensee desired to amend the Licence Agreement, INTER
ALIA, to include a non-exclusive licence to the YNB Patent (as defined below);
and
WHEREAS on the date hereof, CUTS shall assign the YNB Patent 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 Patent (with the right
to sub-license to the Licensee).
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. For the avoidance of doubt, the term "Parties" in this Amendment
shall have the meaning given in the Licence Agreement and shall not include BTG
unless otherwise stated.
2. The following is added to the Licence Agreement as clause 2.1 (d):
(d) "TO THE EXTENT NOT LICENSED UNDER CLAUSE 2.1 (c) A NON-EXCLUSIVE
LICENCE IN THE FIELD: UNDER THE YNB PATENT, TO DEVELOP, MANUFACTURE,
HAVE MANUFACTURED, USE, OFFER TO SELL, IMPORT AND SELL LICENSED
PRODUCTS THAT INCORPORATE ANTIBODIES AND/OR LICENSED PRODUCTS THAT
INCORPORATE YNB ANTIBODIES, BUT ONLY IN THE FIELD IN THE TERRITORY.
LICENSEE SHALL HAVE THE RIGHT TO SUB-LICENSE THE NON-EXCLUSIVE
LICENCE GRANTED UNDER THIS CLAUSE 2.1(d): (i) IN RESPECT OF LICENSED
PRODUCTS INCORPORATING ANTIBODIES, SUBJECT TO CLAUSE 2.5; AND (ii)
IN RESPECT OF LICENSED PRODUCTS INCORPORATING YNB ANTIBODIES, ON THE
BASIS SET OUT IN CLAUSE 2.1(c). FOR THE AVOIDANCE OF DOUBT, NO
RIGHTS ARE GRANTED UNDER THIS AGREEMENT TO USE THE PROCESS FOR THE
PREPARATION OF AN ANTIBODY UNDER THE YNB PATENT (THE "YNB PROCESS
CLAIMS") OTHER THAN IN RELATION TO LICENSED PRODUCTS INCORPORATING
ANTIBODIES AND/OR YNB ANTIBODIES."
3. The description of the "YNB Patent" (but not the "YNB Antibodies") set
out in Schedule 2 of the Licence Agreement shall be replaced with the schedule
attached hereto.
<Page>
4. The following sentence shall be added to Clause 6.2.1:
"6.2.1 CUTS SHALL HAVE THE RIGHT TO PERFORM ITS OBLIGATIONS UNDER THIS
CLAUSE 6.2.1 THROUGH BTG."
5. At the beginning of Clause 6.3.2, add the following:
"IN RELATION TO ONLY THE YNB ANTIBODY CLAIMS AND THE PATENTS".
6. The following shall be added at the end of Clause 6.3.2:
"BTG (AND NOT THE OTHER PARTIES) SHALL BE ENTITLED TO TAKE SUCH ACTION AS
IT SHALL SEE FIT IN RESPECT OF INFRINGEMENT OR POTENTIAL INFRINGEMENT OF
THE YNB PROCESS CLAIMS".
7. The following clause shall be added after Clause 6.3.4:
"6.3.5 WITH RESPECT TO YNB PATENT ONLY, FOR THE PURPOSES OF CLAUSES
6.3.1, 6.3.2, 6.3.3 AND 6.3.4, PARTY SHALL INCLUDE CUTS, BTG AND
LICENSEE."
8. After Clause 6.4.1 add the following sentence:
"WITH RESPECT TO YNB PATENT ONLY, BTG SHALL BE A PARTY UNDER THIS CLAUSE
6.4.1."
9. Clause 7.4 shall be renumbered as clause 7.5 and the following shall be
added to that clause:
"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 AND/OR YNB ANTIBODIES."
10. 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 AND YNB ANTIBODIES ONLY"
11. Licensee agrees (for the purposes of clause 9.3.1 of the Licence
Agreement) that CUTS may assign the YNB Patents to BTG pursuant to the BTG
Agreements, that is subject to the sublicense granted by CUTS to Licensee under
the YNB Patent and provided that CUTS obtains a license under the YNB Patent of
a scope necessary to grant the rights and licenses that are granted by CUTS to
Licensee under the YNB Patent in accordance with the License Agreement and this
Amendment Agreement.
2
<Page>
12. 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.
3
<Page>
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
------------------------------------- --------------------------------------
In order to induce Licensee and CUTS to enter into this Amendment
Agreement and to induce CUTS to assign the YNB Patent to BTG and to induce
Licensee to agree to such assignment, BTG agrees that the license to CUTS from
BTG under the YNB Patent to the extent that the YNB Patent is licensed to
Licensee under the License Agreement and the Amendment Agreement shall continue
so long as the YNB Patents are sublicensed to Licensee under those agreements
and shall, if necessary, survive any earlier termination of the BTG agreements
and BTG hereby accepts its rights and obligations as set forth in this Amendment
Agreement.
BRITISH TECHNOLOGY GROUP
INTER-CORPORATE LICENSING LIMITED
By: /s/ [ILLEGIBLE]
-------------------------------------
5
<Page>
#142536 v9 - Amendment Agreement
AMENDMENT AGREEMENT
THIS AMENDMENT AGREEMENT dated December 19, 2002 is between:
CAMBRIDGE UNIVERSITY TECHNICAL SERVICE LIMITED, an English Company,
Register Number 1069886, whose registered office is at The Old Schools,
Cambridge CB2 ITS, England ("CUTS"); and
TOLERRX, INC., a company incorporated in the State of Delaware whose
registered office at 300 Technology Square, Cambridge, MA 02139, USA ("the
Licensee").
WHEREAS, CUTS and Licensee entered into a License Agreement dated
December 8, 2000, including an amendment dated July 23 2001, that, among other
things, is directed to certain CD4 and CD8 antibodies ("the License Agreement");
and
WHEREAS, the Licensee is seeking to enter into a sublicensing agreement
with Genentech, Inc. ("Genentech") in order to progress the development of
certain CD4 antibodies; and
WHEREAS, the terms of the License Agreement dated December 8, 2000 made
such sublicensing agreement commercially non-viable; and
WHEREAS, CUTS and Licensee desire to amend the License Agreement.
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. Save as provided below, all defined terms of the License Agreement shall
have the same meaning in this Amendment.
2. In clause 4.2, reletter existing subclause (c) as subclause -(d)--and add
the following as subclause (c) which shall apply only to Licensed Product sold
under a sublicense granted to Genentech.
--(c) [*******] on first regulatory approval of Licensed Product under a
sublicense granted to Genentech that permits sale thereof in the United States
and/or the European Union and/or Japan.--
3. Add clauses 4.11, 4.12 and 4.13 which shall be applicable as referred to
below with respect to Licensed Product sold under a sublicense granted to
Genentech pursuant to an agreement between Genentech and Licensee (the
"Genentech Agreement").
--4.11 In lieu of royalties under Section 4.3, the Licensee shall
pay to CUTS a royalty as a percentage of net sales as calculated under
the Genentech Agreement, including net sales in the United States as to
which TolerRx is entitled to receive royalties or profits or losses under
such U.S. Profit/Loss Sharing Option whether or not Licensee properly
exercises and participates in the US Profit/Loss Sharing Option (as
defined in the Genentech Agreement) ("Genentech Sales") of all Licensed
Products or any part thereof sold under a sublicense granted to Genentech
under the Genentech Agreement, on a country-by-country basis and Licensed
Product-by Licensed Product basis, as follows:
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
<Page>
(a) As to Licensed Product that infringes a Valid Claim (as
defined in the Genentech Agreement) of the Patents or a Valid Claim (as
defined in the Genentech Agreement) of the YNB Patents:
(i) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that is less than or equal to
$[*******] and
(ii) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that is greater than $[*******]
and less than or equal to $[*******] and
(iii) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that exceeds $[*******] and less
than or equal to $[*******] and
(iv) [*******] of the portion of Genentech Sales of such
Licensed Product that exceeds $[*******]
(b) As to Licensed Product that does not infringe a Valid Claim
(as defined in the Genentech Agreement) of the Patents and does not
infringe a Valid Claim (as defined in the Genentech Agreement) of the
YNB Patents:
(i) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that is less than or equal to
$[*******] and
(ii) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that is greater than $[*******]
and less than or equal to $[*******]
(iii) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that exceeds $[*******] and less
than or equal to $[*******] and
(iv) [*******] of the portion of Genentech Sales of such
Licensed Product in a calendar year that exceeds $[*******]
4.12 In the event that Licensee's royalty payment from Genentech is
reduced for a country as a result of another CD4 antibody product being
marketed by a third party in that country, then any such reduction in the
payment from Genentech shall be creditable against any royalty to be paid
by Licensee under clause 4.11 of this
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
2
<Page>
Agreement but in no event shall any royalty payment under clause 4.11 be
reduced by more than [*******] as a result of this clause.
4.13 In lieu of clause 4.4, in the event that Licensee owes a
royalty in a country for Licensed Product under a license agreement with
a third party(ies) ("Third Party License(s)") or Licensee's payment from
Genentech for a country is reduced because Genentech owes a royalty to a
third party with respect to Licensed Product in that country, then any
such royalty due under such a Third Party License(s) or any such
reduction in the payment from Genentech shall be creditable against any
royalty to be paid by Licensee under clause 4.11 of this Agreement but in
no event shall any royalty payment under clause 4.11 be reduced by more
than [*******] if this clauses applies and clause 4.12 does not apply, or
by more than [*******] if this clause and clause 4.12 both apply. It is
expressly understood that for the purpose of this clause 4.13, a Third
Party License does not include the License between Isis Innovation
Limited and the Chancellor Masters and Scholars of the University of
Oxford with Licensee dated December 5, 2000 and/or the License between
Mochida and Licensee dated September 20, 2001.
4.14 The royalties in clauses 4.11, 4.12 and 4.13 herein shall be
calculated on a country-by-country and Licensed Product-by-Licensed
Product basis. A royalty due for Genentech Sales of a Licensed Product in
a country under 4.11 may be reduced by [*******] if clause 4.12 applies
and by a further [*******] if clause 4.13 applies in addition to clause
4.12. For example purposes only: in a country where there is a valid
claim as defined in the clause 4.11, another CD4 antibody product is
marketed, but no royalties are owed to third parties the [*******]
royalty would be reduced to [*******]. In a country where there is a
valid claim as defined in clause 4.11, no other CD4 antibody product is
marketed, but royalties are owed to third parties the [*******] royalty
would be also reduced to [*******]. In a country where there is a valid
claim as defined in clause 4.11, another CD4 antibody product is marketed
and royalties are owed to third parties the [*******] royalty would be
reduced by [*******] under clause 4.12 and by another [*******] under
clause 4.13 whereby the cumulative reduction would be [*******] i.e.
[*******] x [*******] x [*******].
4. With respect to Clauses 2.5, 2.8, 3.3, 4.9.3, and 8.2.3 of the License
Agreement, CUTS waives any and all rights thereunder with respect to
sublicenses granted under the Genentech Agreement. For the avoidance of
doubt, clause 8.2.3 shall remain applicable to Licensee.
5. Upon the written request of Licensor, Licensee agrees to exercise the
audit rights of Licensee under the Genentech Agreement.
6. Licensee will provide to Licensor a true copy of the Genentech Agreement
within thirty (30) days of signing thereof by all parties thereto.
7. For the avoidance of doubt, in the event of conflict between clauses 7.3
and 7.4 of the License Agreement, clause 7.3 shall prevail.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
3
<Page>
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
Name: DR. R.C. JENNINGS Name: Douglas J. Ringler
Title: DIRECTOR Title: President and CEO
Date: 19 Dec. '02 Date: December 19, 2002
4