License Agreement - Isis Innovation Ltd., University of Oxford and TolerRx Inc.
DATED DECEMBER 5, 2000
(1) ISIS INNOVATION LIMITED
(2) THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF
OXFORD
(3) TOLERRX, INC
Licence of Certain Improvements
to anti-CD4 and anti-CD8 Antibodies
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[*******] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER
THE SECURITIES ACT OF 1933, AS AMENDED.
THIS AGREEMENT dated December 5, 2000 is made BETWEEN:
(1) ISIS INNOVATION LIMITED whose registered office is at University Offices,
Wellington Square, Oxford OX1 2JD, England ("the Licensor");
(2) THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD whose
administrative offices are at Wellington Square, Oxford OX1 2JD, England
("the University"); and
(3) TOLERRX, INC, a Delaware Corporation whose principal place of business is
at 675 Mass Ave., Cambridge, MA 02139 ("the Licensee"):-
1. 1. SUBJECT-MATTER
1.1 This Agreement relates to the intellectual property and know how
described in the Schedule.
1.2 For the purposes of this Agreement, the following definitions apply:
(a) "Affiliate" means with respect to a party, an entity that
controls, is controlled by or is under common control with a
party. As used herein, "control" means possession, of the power
to direct or cause the direction of the management and policies
whether through the ownership of voting securities, by contract
or otherwise.
(b) "Antibody(ies)" means, individually and collectively, any and
all antibodies (or portions thereof) encoded by genetic
material of a Cell Line.
(c) "Cell Line(s)" means, individually and collectively (i) the
cell lines and cell banks of the Schedule and genetic material
contained therein.
(d) "Know-How" means the know-how described in the Schedule.
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(e) "Licensed Patents" means any patent application or patent
anywhere in the world that is owned by the Licensor and that
claims Licensed Technology.
(f) "Licensed Product" means any product or composition that is or
includes one or more Antibodies.
(g) "Licensed Technology" means, individually and collectively,
Cell Lines, Antibodies and Know-How.
(h) "Net Sales" means the gross selling price of the Licensed
Product in the form in which it is sold or leased to a customer
after regulatory approval thereof by Licensee or its
sublicensee (as recorded in the standard customer pricing
records of the Licensee or the Licensee's sub-licensee if and
to the extent that such records are applicable to the Licensed
Product in question), after deducting:
(i) transportation charges or allowances, including freight
pickup allowances, and shipping packaging costs, if any; (ii)
trade, quantity or cash discounts, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account
of returns, any and all Federal, state or local government
rebates, whether in existence now, or enacted at any time
during the term of this Agreement, rejections, recalls or
destruction (voluntarily made or requested or made by an
appropriate government agency, sub-division or department) for
the Licensed Product; (iv) any tax, excise or other
governmental charge upon or measured by the production, sale,
transportation, delivery or use of the Licensed Product,
exclusive of income tax; (v) any government mandated surcharge,
levy, tax or
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assessment to fund a compensation program or reserve for
persons injured or alleged to be injured by the Licensed
Product; and (vi) a reasonable allowance for bad debt.
It is understood that a Licensed Product may be marketed in a
combination package containing other products or materials or in
combination with active ingredients that are not Antibodies. In such
a case "Net Sales", for the purpose of determining royalty payments
on the combination package, shall be calculated by multiplying the
Net Sales of that combination package by the fraction A/(A+B); where
A is the gross selling price, during the royalty-paying period in
question, of the Licensed Product marketed separately and B is the
aggregate of the gross selling prices, during the royalty-paying
period in question, of the other products or materials marketed
separately. In the event that no such separate sales or leases are
made of the Licensed Product or any of the other products or
materials in such combination package during the royalty-paying
period in question, "Net Sales," for the purpose of determining
royalty payments, shall be calculated by multiplying the Net Sales
of the combination package by the fraction C/(C+D); where C is the
standard fully-absorbed cost to the Licensee of the Licensed
Product, and D is the aggregate of the standard, fully-absorbed
costs to the Licensee of the other products or materials, such costs
being determined by using the Licensee's standard accounting
procedures, which shall be in accordance with generally accepted
practice.
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2. GRANT
2.1 (a) Subject to Section 2.1(b), Licensor reserves the right to grant to
the University of Oxford ("University") a licence for the University
and every employee, student, agent and appointee of the University
to use and publish (notwithstanding clause 2.3) the Licensed
Technology and any Licensor Improvement made under clause 2.8 for
academic and research purposes: and this will include the right for
the University to use the Licensed Technology as enabling technology
in other research projects (including projects which benefit from
third-party funding received from commercial entities).
(b) Notwithstanding anything herein to the contrary, Licensor and
University agree, (i) not to disclose or publish sequence
information with respect to Antibody and/or Cell Line to any person
or entity other than Licensee or as permitted by Section 2.5(b);
(ii) not to transfer Antibody or Cell Line to any person or entity
other than Licensee or students or employees of University, provided
that any student or employee agrees not to transfer Antibody or Cell
Line, or as permitted by Section 2.5(b).
2.2 (a) The Licensor grants to the Licensee:
(i) a licence to use the Cell Lines and the Licensed Patents to the
extent that the Licensed Patents relate to the Cell Lines worldwide; and
(ii) a licence in, to and under the Antibodies and the Licensed
Patents to the extent that the Licensed Patents relate to the Antibodies
worldwide to make, have made, use, sell, offer to sell, and import Licensed
Product (together, the "Licences"). Subject only to clause 2.1, the Licence
shall be exclusive.
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(b) Licensor agrees to provide Licensee with samples of the Cell Lines
and vectors of the Schedule and with the Know-How.
2.3 During the term of this Agreement, it is contemplated that each party will
disclose to the other proprietary and confidential technology, inventions,
technical information, biological materials and the like which are owned or
controlled by the party providing such information or which that party is
obligated to maintain in confidence and which is designated by the party
providing such information as confidential ("Confidential Information").
For this purpose, Confidential Information includes the Licensed Technology
to the extent that such Licensed Technology is not disclosed by any patents
or published patent applications. Subject to subclause 2.4 and 2.5, each
party agrees to retain the other party's Confidential Information in
confidence and not to disclose any such Confidential Information to a third
party without the prior written consent of the party providing such
information and to use the other party's Confidential Information only for
the purposes of this Agreement, which obligation shall terminate five (5)
years after the expiration or termination of this Agreement.
2.4 The obligations of confidentiality will not apply to Confidential
Information which:
(i) was known to the receiving party or generally known to the public
prior to its disclosure hereunder; or
(ii) subsequently becomes known to the public by some means other than a
breach of this Agreement;
(iii) is subsequently disclosed to the receiving party by a third party
having a lawful right to make such disclosure;
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(iv) is required by law or BONA FIDE legal process to be disclosed,
provided that the party required to make the disclosure takes all
reasonable steps to restrict and maintain confidentiality of such
disclosure and provides reasonable notice to the party providing the
Confidential Information; or
(v) is approved for release by the parties, or
(vi) is independently developed by the employees or agents of either
party without any knowledge of the Confidential Information provided
by the other party.
(vii) is disclosed to a government body, agency or authority as required
by applicable law, rule, or regulation or in order to obtain
regulatory approval for or authorization to market and sell Licensed
Product.
2.5 (a) Notwithstanding the foregoing, the parties shall have the right
to disclose Confidential Information to a third party who
undertakes an obligation of confidentiality and non-use with
respect to such information, at least as restrictive as
Licensee's obligation under subclause 2.4 and 2.5.
(b) Notwithstanding the foregoing, the University and every
employee, student, agent and appointee of the University shall
have the right to:
(i) disclose Confidential Information, to the extent that it
relates to the Licensed Technology, to other employees
and students of the University for academic and research
purposes only so long as such employees and students of
the University are subject to obligations of
confidentiality; and
(ii) transfer Antibody to any academic collaborator to use
solely for academic and research purposes (not including
commercially funded
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research purposes) for in vitro research provided that
the academic collaborator signs a material transfer
agreement in the form of the University material transfer
agreement attached as Exhibit A.
2.6 Each of University, Licensor and Licensee warrants and represents to the
other that it has the full right and authority to enter into this
Agreement, and that it is not aware of any impediment which would inhibit
its ability to perform the terms and conditions imposed on it by this
Agreement.
2.7 Licensor warrants and represents that except for rights of Cambridge
University (i) it owns all right, title and interest in and to Licensed
Technology, (ii) it has not licensed or assigned any right or interest in
or to Licensed Technology to any third party; (iii) it has the right to
grant the rights granted hereunder; (iv) that, so far as it is aware, after
a reasonable investigation, the granting of such rights does not require
the consent of a third party; and (v) that, so far as it is aware, after a
reasonable investigation, there are and will be no outstanding agreements,
assignments or encumbrances entered into or incurred by the Licensor
inconsistent with the provisions of this Agreement.
2.8 The Licensor will communicate to the Licensee any improvements which the
Licensor and the University makes to the Licensed Technology, to the extent
that the Licensor is aware of the improvements made by the University (the
"Licensor Improvements"). The Licensor and the Licensee may enter into
negotiations with respect to the Licensee licensing the Licensor
Improvements from the Licensor. Subject to clause 2.1, neither the Licensor
nor the University will grant rights to exploit or use the Licensor
Improvements, even if the Licensee does not enter into a licence in respect
of the
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Licensor Improvements, so long as the Licensor Improvements remain
confidential for the purposes of clause 2.3.
2.9 At the request of the Licensee in writing, the Licensor agrees to grant to
the Licensee a non-exclusive, [*******] licence to use any improvements
which:
(a) are made to the Licensed Technology by academic collaborators in
accordance with a material transfer agreement entered into under clause
2.5(b)(ii); and
(b) have been assigned by the University to the Licensor.
The Licensee may, at any time, subject to negotiating the terms of the
licence with the Licensor, request the Licensor to convert the
non-exclusive [*******] licence to an exclusive, [*******] licence.
3. UNDERTAKINGS BY AND RIGHTS OF THE LICENSEE
3.1 Except as provided in Section 9.6, the Licensee will not assign the
Licence. The Licensee may grant sub-licences, and may disclose to
sub-licensees such of the Licensed Technology as is necessary for the
exercise of the rights sub-licensed. Immediately following the grant of
each sub-licence, the Licensee will forward to the Licensor in writing a
note of the name and address of the sub-licensee, a description of the
technology sub-licensed and its intended applications, and confirmation of
the duration of the sub-licence. By controlling the wording of its
contracts with sub-licensees, the Licensee will ensure that the
sub-licensees are subject to the confidentiality obligations of this
Agreement in order to protect the intellectual property rights in the
Licensed Technology, and the interests of the Licensor therein; and that in
no circumstances do the terms of any sub-licence in force from time to time
conflict with the terms of this Agreement.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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3.2 The Licensee will be responsible for the design and construction of the
Licensed Products and the Licensor shall have no responsibility or
liability in that respect.
3.3 The Licensee will ensure that the Licensed Products and the packages
associated with them are marked suitably with any relevant patent or patent
application numbers of Licensed Patents to satisfy the laws of each of the
countries in which the Licensed Products are sold or supplied and in which
they are covered by the claims of any patent or patent application of
Licensed Patents, to the intent that the Licensor shall not suffer any loss
or loss of damages in an infringement action.
3.4 The Licensee agrees not to change its name to or trade under any name which
includes the word "Oxford".
3.5 (a) Taking into account the complexity, and stage of development of the
Licensed Technology, the Licensee shall select and use reasonable
commercial efforts under the circumstances to research, develop and then
commercialize the Licensed Technology. The efforts of a sublicensee of
Licensee or a person or entity performing work for Licensee under a
contract negotiated at arm's length shall be considered as efforts of
Licensee.
(b) In the event that Licensor reasonably believes that Licensee is not
making reasonable commercial efforts under the circumstances to research,
develop and then commercialize the Licensed Technology pursuant to
subclause 3.5(a), then Licensor shall provide written notice to Licensee
which specifies Licensor's basis for such belief and what additional
efforts Licensor believes should be made by Licensee. Upon receipt of such
written notice, Licensor and Licensee shall enter into good faith
negotiations in order to reach mutual agreement as to what efforts by
licensee shall
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satisfy the requirements of subclause 3.5(a), and if such mutual agreement
is not reached within thirty (30) days after receipt of such written
notice, then the parties agree to submit to arbitration pursuant to
subclause 9.8 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) Within sixty (60) days after the end of each calendar year, Licensee shall
provide Licensor with a report detailing progress made and steps taken
during the calendar year in:
(i) applying for and defending any patent, design, trade mark, copyright
and other registrations which may be available for the protection of
the Licensed Technology;
(ii) taking legal action against any misappropriation or infringement of
the Licensed Technology of which the Licensee becomes or is made
aware;
(iii) developing the Licensed Technology in order to facilitate its
commercial exploitation;
(iv) promoting and marketing Licensed Products.
3.6 In the event that the Licensed Technology includes potentially patentable
subject matter (an "Invention"), Licensee shall file, prosecute and
maintain patent applications and patents directed to Inventions in the name
of the Licensor through patent counsel selected by Licensee and approved by
the Licensor (which approval shall not be unreasonably withheld or delayed)
who shall consult with and keep Licensor 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 Licensed Patents
in
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the United States, European Patent Office and subsequent national filings
which derive from it, and Japan and any other foreign countries mutually
agreed by the Licensee and the Licensor. If, in good faith, the Licensor
believes a patent may be granted in a country but the Licensee is unwilling
to bear the cost and expense for filing, prosecuting and maintaining the
patent in that country, the Licensor may instruct the patent counsel
selected by the Licensee at its own cost to file, prosecute or maintain the
Licensed Patents in that country, and the country in question shall be
removed from the scope of this Agreement.
3.7 With respect to any Licensed Patents, each patent application, office
action, response to office action, request for terminal disclaimer, and
request for reissue or re-examination of any patent issuing from such
application shall be provided to Licensor. Licensor shall have the right to
take any action that in its judgement is necessary to preserve such
Licensed Patents.
3.8 Licensor and the University shall cooperate with Licensee with respect to
filing, prosecution and maintenance of Licensed Patents and shall use
reasonable endeavours to cause the inventors to cooperate.
3.9 (a) If any of the Licensed Technology or Licensed Patents under which
Licensee is licensed hereunder is infringed by a third party, Licensee
shall have the right and option but not the obligation to bring an action
for infringement, at its sole expense, against such third party in the name
of Licensor and/or in the name of Licensee, and to join Licensor as a party
plaintiff if required. Licensee shall promptly notify Licensor of any such
infringement and shall keep Licensor informed as to the prosecution of any
action for such infringement. No settlement, consent judgment or other
voluntary final disposition
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of the suit which adversely affects Licensed Technology or Licensed Patents
may be entered into without the consent of Licensor, which consent shall
not unreasonably be withheld.
(b) Any recovery of damages by Licensee for any such suit shall be applied
first in satisfaction of any unreimbursed expenses and legal fees of
Licensee relating to the suit and the remainder thereof shall be retained
by Licensee and treated as Net Sales subject to royalty under this
Agreement.
3.10 In the event that Licensee elects not to pursue an action for infringement,
upon written notice to Licensor by Licensee that an unlicensed third party
is an infringer of Licensed Technology or Licensed Patents, Licensor shall
have the right and option, but not the obligation at its cost and expense
to initiate infringement litigation and to retain any recovered damages.
3.11 In any infringement suit either party may institute to enforce the rights
in Licensed Technology or Licensed Patents pursuant to this Agreement, the
other party hereto shall, at the request 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. All reasonable out-of-pocket
costs incurred in connection with rendering cooperation requested hereunder
shall be paid by the party requesting cooperation.
3.12 The Licensee will communicate to the Licensor any improvements which the
Licensee makes to the Licensed Technology (the "Licensee's Improvements").
The Licensee and the Licensor may enter into negotiations with respect to
the Licensor licensing the
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Improvements from the Licensee, but Licensee shall not be under any
obligation to enter into such a license.
4. 4. PAYMENT
4.1 The Licensee agrees to pay to the Licensor the sum of [*******] US
dollars (US $[*******]) on the signature of this Agreement.
Thereafter, for so long as any Licensed Products are used or
marketed by the Licensee and its sub-licensees, the Licensee will
pay to the Licensor a royalty equal to [*******] of the Net Sales
of all such Licensed Products.
4.2 The Licensee will pay to the Licensor the following non-refundable
non-creditable milestone payments within sixty (60) days after the
occurrence of the specified events with the total milestones due
under this Section 4.2 being [*******]
EVENT AMOUNT
Initiation of Phase II trials for a Licensed [*******]
Product
Initiation of Phase III trials for a Licensed [*******]
Product
4.3 The Licensee shall provide the Licensor with a royalty report within
sixty (60) days after the close of each calendar quarter for each
Licensed Product marketed, and for each Licensed Product brought
into use by or within the groups of the Licensee and sub-licensees.
Each report shall state the Net Sales and provide a calculation of
the royalties due, and shall be accompanied by payment to the
Licensor of the royalties due.
4.4 In marketing the Licensed Products, the Licensee will not accept or
solicit any non-monetary consideration without the prior written
consent of the Licensor.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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The use by the Licensee of a commercially reasonable quantity of
Licensed Products for promotional sampling shall not violate this
prohibition.
4.5 In the case of a Licensed Product which is not marketed, but rather
manufactured by the Licensee or a sub-licensee for use by that
party, or within that party's group, the term "Net Sales" shall mean
[*******] of the gross selling price of the Licensed Product in the
form in which it is normally sold, as recorded in the standard
customer pricing records of the Licensee or the sub-licensee or
sub-sub-licensee if and to the extent that such records are
applicable to the Licensed Product in question, or as ascertained by
applying reasonable uplifts to the standard, fully-absorbed cost of
the Product to the Licensee, sub-licensee or sub-sub-licensee if and
to the extent that those records are not so applicable. For the
avoidance of doubt, this clause shall not apply to Licensed Product
used by the Licensee or within the Licensee's group solely for the
purposes of internal research or solely for the purposes of internal
quality control.
4.6 For the purpose of calculating running-earned royalties under this
clause, a Licensed Product shall be regarded as sold or leased by
the Licensee or a sub-licensee when invoiced, or if not invoiced,
when shipped or delivered by the Licensee or sub-licensee. If a
Licensed Product marketed by the Licensee or a sub-licensee is sold
to an Affiliate for re-sale, the royalty on each such Licensed
Product so re-sold shall be calculated on the highest of the prices
at which it is (i) marketed or sold to an Affiliate for re-sale or
(ii) re-sold; provided, however, that in no event shall royalty be
paid more than once on each Licensed Product.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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4.7 If the Licensee or a sub-licensee is obliged to pay royalties to
third parties (other than the Licensee's Affiliate, for the right to
make, use or sell a Licensed Product, then the Licensee shall be
entitled to deduct from the royalty payment due to the Licensor a
portion of the royalty payment actually made to such third party as
the Licensee has negotiated with the Licensor, but in any event, not
greater than [*******] of the royalty payment due to the Licensor.
4.8 For the avoidance of doubt, any payment made by a [*******] relevant
for the purposes of calculating Net Sales.
4.9 All payments provided for under this clause 4 shall be made to the
Licensor in US dollars without any deductions apart from any tax
which is required to be withheld under applicable local law. Any
exchange of currency made to calculate sales for the purpose of this
clause 4 shall be determined as at the last business day of each
quarter, using the average of the average daily buying and selling
rates quoted by Barclays Bank plc during that quarter. Where the
Licensee is required to withhold tax under applicable local law, the
Licensee shall deduct such tax, pay it to the relevant taxing
authority, and supply the Licensor with a Certificate of Tax
Deduction at the time of payment to the Licensor. The parties shall
co-operate under any applicable Double Taxation Treaty so that, if
possible, payments are made gross or, if payment gross is not
possible, the Licensor obtains appropriate relief under the Treaty.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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4.10 Where the Licensee is obliged to make a payment to the Licensor
under this Agreement which attracts value-added, sales, use, excise
or other similar taxes or duties, the Licensee shall be responsible
for paying such taxes and duties.
4.11 In the event that full payment of any amount due from the Licensee
to the Licensor under this Agreement is not made by any of the dates
stipulated, the Licensee shall be liable to pay interest on the
amount unpaid at the rate of two percent (2%) over the base rate for
the time being of Barclays Bank plc, from the date when payment was
due until the date of actual payment.
4.12 The Licensee and the Licensee's sub-licensees shall keep complete
and accurate accounts of all Licensed Products used and marketed;
and will permit the Licensor through an independent certified
accountant to audit such accounts on at least thirty (30) days'
written notice and no more than once each calendar year solely for
the purpose of determining the accuracy of the royalty reports and
payments. The Licensee's obligation and that of the Licensee's
sub-licensees concerning audit of their accounts shall terminate as
to any report three (3) years after the date of that report.
5. 5. DURATION AND TERMINATION
5.1 Subject to clause 5.2, this Agreement shall take effect on the date
of signature and (subject to the remaining sub-clauses of this
clause) shall continue in force until the expiration of the period
of ten (10) years from the date on which a Licensed Product is first
put on the market by the Licensee or one of its sub-licensees, after
which time Licensee shall have a fully paid-up license under Section
2.2 and no further royalties will be due.
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5.2 Insofar as the rights and obligations in this Agreement concern
territories in which the commercial practice of the Licensed
Technology is covered by a claim being prosecuted in a patent
application filed by the Licensee that is a Licensed Patent, or by a
valid claim of an unexpired patent which issues in response to such
an application, the royalty obligations shall extend for those
territories beyond the period defined in clause 5.1 if and for so
long as the commercial practice of the Licensed Technology is
covered in those territories.
5.3 If Licensee commits a material breach of clause 2.3, 3.1, 3.6 and 4
of this Agreement or fails to exert the efforts determined by the
parties or by arbitration under clause 3.5(b), and such breach or
failure is not remedied within the period allowed by notice given by
Licensor in writing calling on the Licensee to remedy such failure
(such period being not less than thirty (30) days), the Licensor may
by further written notice terminate this Agreement immediately.
5.4 The Licensee may terminate this Agreement at any time by serving not
less than three (3) months' written notice on the Licensor.
5.5 The Licensor shall have the right to terminate this Agreement by
serving written notice on the Licensee in the event that Licensee
files a voluntary petition in bankruptcy, is adjudicated a bankrupt,
makes a general assignment for the benefit of creditors, or fails to
discharge within 30 days an involuntary petition in bankruptcy filed
against it. Such notice may terminate this Agreement either
immediately or at the end of such period as the Licensor shall
select.
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5.6 Clauses 2.3, 2.4, 2.5, 4 (in relation to any payments which have
fallen due but not been made), 5.1, 5.2, 5.6, 5.8, 5.9 6, 7, 8, 9.4
and 9.8 shall survive the termination or expiration of this
Agreement, for whatever reason.
5.7 This Agreement may be terminated only as set forth in this clause 5.
5.8 Upon any termination of this Agreement, Licensee, at its option,
shall be entitled to finish any work-in-progress which is completed
within six (6) months of termination of this Agreement and to sell
any completed inventory of a Licensed Product covered by this
Agreement which remains on hand as of the date of the termination,
so long as Licensee pays to Licensor the royalties applicable to
said subsequent sales in accordance with the same terms and
conditions as set forth in this Agreement.
5.9 In the event that this Agreement and/or the rights and licenses
granted under this Agreement to Licensee are terminated, any
sublicense granted under this Agreement shall remain in full force
and effect as a direct license between Licensor and the sublicensee
under the terms and conditions of this Agreement, subject to the
sublicensee agreeing to be bound to Licensor under such terms and
conditions within thirty (30) days after Licensor provides written
notice to the sublicensee of the termination of Licensee's rights
and licenses under this Agreement. At the request of Licensee,
Licensor will acknowledge to a sublicensee, Licensor's obligations
to the sublicensee under this paragraph.
6. LIABILITY
6.1 (a) The Licensee agrees to indemnify the Licensor and the
University and hold the Licensor and the University harmless from
and against any and all claims,
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damages and liabilities asserted by third parties and arising
directly or indirectly from use of the Licensed Technology or the
sale of Licensed Products by the Licensee and its sub-licensees and
sub-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
and solely attributable to the intentional misconduct of the
Indemnitees.
(c) Licensee shall have the right to control the defense,
settlement or compromise of any such action and shall select counsel
for such defense.
(d) Licensor and the University shall notify Licensee promptly of
any claim or threatened claim under this subclause 6.1(a) and shall
fully cooperate with all reasonable requests of Licensee with
respect thereto.
6.2 The Licensor makes no representation or warranty that advice given
to the Licensee pursuant to this Agreement by any employee, student,
agent or appointee of the Licensor or of the University, or the use
of any works, designs or information which they, the Licensor or the
University provide in connection with this Agreement, will not
result in infringement of third-party rights.
6.3 The Licensee undertakes to make no claim against any employee,
student, agent or appointee of the Licensor or of the University
which seeks to enforce against any of them any liability whatsoever
in connection with this Agreement or its subject-matter. It is
understood that this Clause 6.3 does not prevent Licensee from
asserting a claim(s) against Licensor or University.
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6.4 The liability of any party for any breach of this Agreement, or
arising in any other way out of the subject-matter of this
Agreement, will not extend to loss of business or profit or to any
indirect or consequential damages or losses.
6.5 Except in the case of fraud or intentional misconduct or intentional
breach of this Agreement or a breach of a warranty where Licensor
had knowledge that the warranty was untrue or by the investigation
undertaken by the University the Licensor would have known that the
warranty was untrue, Licensor's maximum liability with respect to
payment of damages awarded to the Licensee by a court of law under
or otherwise in connection with this Agreement or its subject
matter, shall be the return of all royalty, milestone and up-front
payments paid by the Licensee under this Agreement, together with
interest on the balance of such moneys from time to time
outstanding, accruing from day to day at two percent over the
Barclays Bank plc base rate from time to time in force and
compounded annually as at 31 December and if the damages awarded
exceed such amount, such excess may be credited against future
royalties and milestones owed by Licensee under this Agreement, as
and when they become due.
6.6 The University's maximum liability with respect to payment of
damages awarded to the Licensee by a court of law under or otherwise
in connection with this Agreement or its subject matter, shall not
exceed the return of all royalty, milestone and up-front payments
paid by the Licensee to the Licensor under this Agreement less any
return of those royalties, milestones or up-front payments by the
Licensor to the Licensee under clause 6.5, together with interest on
the balance of such moneys from time to time outstanding, accruing
from day to day
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at two percent over the Barclays Bank plc base rate from time to
time in force and compounded annually as at 31 December and if the
damages awarded exceed such amount, such excess may be credited
against future royalties and milestones owed by Licensee under this
Agreement less any return of those royalties, milestone or up-front
payments by the Licensor to the Licensee under clause 6.5, as and
when they become due.
6.7 If any sub-clause of this clause 6 is held to be invalid or
unenforceable under any applicable statute or rule of law, then it
shall be deemed to be omitted, and if as a result any party becomes
liable for loss or damage which would otherwise have been excluded,
then such liability shall be subject to the remaining sub-clauses of
this clause 6.
7. FORCE MAJEURE
If the performance by either party of any of its obligations under this
Agreement (other than an obligation to make payment) shall be prevented by
circumstances beyond its reasonable control, then such party shall be
excused from performance of that obligation for the duration of the
relevant event.
8. NOTICES
The Licensor's representative for the purpose of receiving payments and
notices shall until further notice be:
The Managing Director
Isis Innovation Limited
Ewert House
Ewert Place
Summertown
Oxford OX2 7DD
England
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The Licensee's representative for the purpose of receiving notices shall
until further notice be:
TOLERRX, Inc.
675 Mass. Ave.
Cambridge, MA 02139
Attn: CEO
9. GENERAL
9.1 Clause headings are inserted in this Agreement for convenience only,
and they shall not be taken into account in the interpretation of
this Agreement.
9.2 Nothing in this Agreement shall create, imply or evidence any
partnership or joint venture between the Licensor and the Licensee
or the relationship between them of principal and agent.
9.3 This Agreement constitutes the entire agreement between the parties
with regard to the Licence. Specifically, but without limitation,
this Agreement does not impose or imply any obligation on the
Licensor or the University to conduct development work: any
arrangements for such work shall be the subject of a separate
agreement between the University and the Licensee. Any variation of
this Agreement shall be in writing and signed by authorised
signatories for both parties.
9.4 This Agreement shall be governed by English Law. Except as provided
in Section 9.8, Licensee submits to the non-exclusive jurisdiction
of the English courts with respect to any dispute which may arise
out of or in connection with this Agreement.
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9.5 If any one or more clauses or sub-clauses of this Agreement would
result in this Agreement being prohibited pursuant to any applicable
competition law, then it or they shall be deemed to be omitted. The
parties shall uphold the remainder of this Agreement, and shall
negotiate an amendment which, as far as legally feasible, maintains
the economic balance between the parties.
9.6 This Agreement shall not be assignable by either of the parties
without the prior written consent of the other party (which consent
shall not be unreasonably withheld), except that Licensee without
the consent of Licensor may assign this Agreement to an Affiliate or
to a successor in interest or to a transferee of all or
substantially all of the portion of the business to which this
Agreement relates.
9.7 Subject to the limitations on assignment herein, this Agreement
shall be binding upon and inure to the benefit of said successors in
interest and assigns of Licensee and Licensor. Any such successor or
assignee of a party's interest shall expressly assume in writing the
performance of all the terms and conditions of this Agreement to be
performed by said party.
9.8 Any dispute, controversy or claim arising under subclause 3.5(b) of
this Agreement will be submitted to mediation in accordance with the
WIPO Mediation Rules. The place of mediation will be London. The
language to be used in the mediation will be English. If, and to the
extent that, any such dispute, controversy or claim has not been
settled pursuant to the mediation within 60 days of the commencement
of the mediation, it will, upon the filing of a request for
arbitration by either party, be referred to and finally determined
by arbitration
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in accordance with the WIPO Arbitration Rules. The arbitral tribunal
will consist of a sole arbitrator. The place of arbitration will be
London.
9.9 The parties to this Agreement intend that by virtue of the Contracts
(Rights of Third Parties) Act 1999 the people referred to in clause
6.3 will be able to enforce the terms of clause 6.3 of this
Agreement as if the people referred to in clause 6.3 were a party to
it.
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AS WITNESS the hands of authorised signatories for the parties on the date first
mentioned above
SIGNED for and on behalf of
Name: D. J. Ringler
------------------------
Positions: President
-------------------
Signature: /s/ D. J. Ringler
-------------------
SIGNED for and on behalf of
ISIS INNOVATION LTD
Name: T. Cook
-----------------------
Position: Director
--------------------
Signature: /s/ T. Cook
-------------------
SIGNED for and on behalf of
THE CHANCELLOR
MASTER AND SCHOLARS OF THE
UNIVERSITY OF OXFORD:
Name: S.R. Clements
------------------------
Position: Director
--------------------
Signature: /s/ S.R. Clements
-------------------
Please note that these signatures are subject to the underlying documents having
been changed as we discussed and are conditional upon us receiving signed copies
of the original documents in agreed form.
<Page>
THIS AMENDMENT AGREEMENT, dated December 19, 2002 (the "Effective Date") is made
BETWEEN:
(1) ISIS INNOVATION LIMITED, a company registered in England (No.
02199542), whose registered office is at University Offices, Wellington
Square, Oxford OX1 2JD, England (the "Licensor"); and
(2) THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF
OXFORD whose administrative offices are at the University Offices,
Wellington Square, Oxford OX1 2JD, England ("the University"); and
(3) TOLERRX, INC., a Delaware corporation whose principal place of
business is at 300 Technology Square, Cambridge, MA 02139 (the
"Licensee").
WHEREAS, the parties have entered into a License Agreement dated December 5,
2000 that is directed to Anti-CD4 and Anti-CD8 Antibodies (the "License
Agreement"); and
WHEREAS, the parties wish to amend the License Agreement.
In consideration of the sum of $1 (United States) paid by each party hereto to
each of the other parties, IT IS AGREED as follows:
1. All defined terms of the License Agreement shall have the same meaning in
this Amendment Agreement.
2. Clause 3.1 of the License Agreement shall be replaced in its entirety with
the following:
3.1 The Licensee:
3.1.1 will not assign the License, except as provided in clause 9.6
of this Agreement.
3.1.2 may grant sub-licenses, and may disclose to sub-licensees
such of the Licensed Technology as is necessary for the exercise of the rights
sub-licensed.
3.1.3 will, immediately following the grant of each sub-license,
forward to the Licensor in writing a note of the name and address of the
sub-licensee, a description of the technology sub-licensed and its intended
applications, and confirmation of the duration of the sublicense.
3.1.4 will ensure that any and all sub-licensees are subject to
reasonable obligations of confidentiality sufficient to protect the intellectual
property rights in the Licensed Technology and the interests of the Licensor
therein
3.1.5, will, except in respect of the Genentech Agreement, take
reasonable steps to ensure that the terms of any sublicense in force from time
to time do not conflict with the terms of this Agreement.
3.1.6 will ensure that the terms of the Genentech Agreement do not
conflict with clauses 2.1 and 2.5(b) of this Agreement.
3.1.7 acknowledges that, notwithstanding the above clauses 3.1.5
and 3.1.6, clause 5.9 will remain in full force and effect, and Licensee's
obligations
<Page>
to Licensor and University under clause 4.4 and clause 6 will remain in full
force and effect.
3.1.8 agrees that nothing in any sub-license in force from time to
time absolves the Licensee of its obligations to pay royalties under this
Agreement, or its other obligations as set out in this Agreement.
3. Clause 3.3 of the License Agreement shall be replaced in its entirety with
the following:
3.3 The Licensee will take reasonable endeavours to ensure that the
Licensed Products and the packages associated with them are marked suitably
with any relevant patent or patent application numbers of Licensed Patents
to satisfy the laws of the countries in which the Licensed Products are
sold or supplied and in which they are covered by the claims of any patent
or patent application of Licensed Patents, to the intent that the Licensor
shall not suffer any loss or loss of damages in an infringement action. For
the avoidance of doubt, in respect of the Genentech Agreement, reasonable
endeavours shall be limited to requesting that Genentech mark Licensed
Products and the packages associated with them as described in this clause
3.3. The Parties Acknowledge that the Licensee has no power to force
Genentech to comply with such a request.
4. Clause 3.4 of the License Agreement shall be replaced in its entirety with
the following:
3.4 No right, express or implied is granted by this License for the
Licensee or any of its sublicensees to use in any manner the names "Oxford"
or "Isis" or any other trademark or trade name of the University or Isis
without the prior written consent of the University and/or Isis. The
Licensee agrees not to change it name to or trade under any name that
includes the word "Oxford".
5. Clause 4.1 of the License Agreement will be replaced in its entirety with
the following:
4.1(a) The Licensee agrees to pay to the Licensor the sum of [*******] the
receipt of which is acknowledged. For so long as any Licensed
Products are used or marketed by the Licensee and its sublicensees,
subject to clauses 4.1 (b) and (c), the Licensee will pay to the
Licensor a royalty equal to [*******] of the Net Sales of all such
Licensed Products.
4.1(b) In regard to royalty payments with respect to Licensed Product for
which royalties are due under clause 4.1(a) of this Agreement that
are sold pursuant to an agreement between Licensee and Genentech,
Inc. (the "Genentech Agreement") (which for the avoidance of doubt
includes any sublicense under the Genentech Agreement), such royalty
payments shall be (i) calculated based on net sales of Licensed
Product where net sales are determined as defined in the Genentech
Agreement (and not Net Sales as defined in the License Agreement),
both in the case where TolerRx is receiving royalty payments under
the Genentech Agreement and in the case where
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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TolerRx is receiving a share of Operating Profits and Losses under
the Genentech Agreement.
4.1(c) In the event that royalties based on Licensed Product pursuant to
the Genentech Agreement are reduced thereunder as a result of
commercialization of a product by a third party, then, with respect
to Licensed Products to which such reduction applies, the royalty
rate under clause 4.1(a) of the License Agreement [*******].
6. Clause 4.3 of the License Agreement shall be replaced in its entirety with
the following:
4.3.1 Except as provided in clause 4.3.2, the Licensor shall provide the
Licensor with a royalty report within sixty (60) days after the
close of each calendar quarter for each Licensed Product brought
into use by or within the groups of the Licensee and sub-licensees.
Each report shall state the Net Sales and provide a calculation of
the royalties due, and shall be accompanied by payment to the
Licensor of the royalties due.
4.3.2 In respect of royalty payments and royalty reports as to royalties
due under the Genentech Agreement, such sales and reports will be
due thirty (30) days after such payments and reports from Genentech
become due with respect to Genentech Sales.
7. Clause 4.12 of the License Agreement shall be replaced in its entirety with
the following:
4.12.1 Except as provided in clause 4.12.2, the Licensee and the Licensee's
sub-licensees shall keep complete and accurate accounts of all
Licensed Products used and marketed and will permit the Licensor
through an independent certified accountant to audit such accounts
on at least thirty days' written notice and no more than once each
calendar year solely for the purpose of determining the accuracy of
the royalty reports and payments. The Licensee's obligation and that
of the Licensee's sub-licensees concerning audit of their accounts
shall terminate as to any report three (3) years after the date of
that report
4.12.2 Where the Licensee enters into a sub-license with Genentech, the
Licensor expressly agrees to waive the audit-rights set out in
sub-clause 4.12.1 above in respect of Genentech and its
sub-licensees. However, upon the written request of the Licensor,
Licensee agrees to exercise the audit rights of the Licensee under
the Genentech Agreement. The Licensor retains the right to audit the
Licensee and to inspect any records of audits carried out by the
Licensee upon Genentech
8. The Licensee agrees to provide the Licensor with a true copy of the
Genentech Agreement within thirty (30) days of signing thereof by all parties
thereto.
* Confidential treatment requested:
material has been omitted and filed
separately with the Commission.
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9. The License Agreement is amended as provided herein with effect from the
date of this Amendment Agreement. All other terms and provisions of the License
Agreement shall be unaffected by this Amendment Agreement.
10. All references in the License Agreement to the "Agreement" shall be deemed
to include this Amendment Agreement.
11. This Amendment Agreement shall be governed by English Law. The Licensee
submits to the non-exclusive jurisdiction of the English courts with
respect to any dispute which may arise out of or in connection with this
Amendment Agreement.
AS WITNESS the hands of authorized signatories for the parties on the date
first mentioned above.
SIGNED for and on behalf of
ISIS INNOVATION LIMITED:
Name: Mr. T. Hockaday
Position: Executive Director
Isis Innovation Ltd
Signature: /s/ T. Hockaday
SIGNED for and on behalf of
THE CHANCELLOR, MASTERS
AND SCHOLARS OF THE
UNIVERSITY OF OXFORD:
Name: Dr. Richard Liwicki
Position: Associate Director
Research Services
University of Oxford
Signature: /s/ Richard Liwicki
SIGNED for and on behalf of
TOLERRX, INC.:
Name: Douglas J. Ringler
Position: President and Chief Executive Officer
Signature: /s/ Douglas J. Ringler
4