EXHIBIT 10.16
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
DATED 18 JULY 2003
CANCER RESEARCH TECHNOLOGY LIMITED
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ALNYLAM PHARMACEUTICALS, INC
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LICENCE AGREEMENT
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CONFIDENTIAL
CANCER RESEARCH TECHNOLOGY LIMITED
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THIS LICENCE AGREEMENT is made as of the 18th day of July 2003
BETWEEN:
(1) CANCER RESEARCH TECHNOLOGY LIMITED a company registered in England
(registered number 1626049) whose registered office is at ▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ ("CRT"); and
(2) ALNYLAM PHARMACEUTICALS INC a Delaware company whose principal place of
business is at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ of
America ("Alnylam")
WHEREAS:
(A) Researchers at the University of Cambridge (some of whom were formerly
in receipt of funding provided by the Lister Institute of Preventive
Medicine) have developed techniques for performing RNA interference
("RNAi") in mammalian cells and embryos which are the subject of an
international patent application entitled "inhibiting gene expression
with dsRNA". The research was supported by funding provided by The
Cancer Research Campaign ("CRC") and Cancer Research UK. The
researchers and the University have assigned their right, title and
interest in the foregoing patent application to Cancer Research
Ventures Limited ("CRV") a wholly owned subsidiary of CRT, and CRV have
assigned their right, title and interest to CRT.
(B) CRT is the wholly owned subsidiary of Cancer Research UK and is
responsible for the management and exploitation of the results derived
from research funded by CRC and Cancer Research UK. Cancer Research UK
(registered number 4325234) and registered charity (number 1089464) was
formed as the successor charity to the Imperial Cancer Research Fund
and CRC following the merger of their operations with effect from 4
February 2002.
(C) Alnylam have requested a licence under the technology described in the
CRT Patent Rights (as defined below) permitting them to develop
therapeutics and CRT has agreed to grant a licence to Alnylam on the
following terms and conditions.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS AND INTERPRETATION
1.1 In this Licence Agreement and in the Schedules to this Licence
Agreement the following words and phrases shall have the following
meanings unless the context requires otherwise:
"Affiliate" means any company, partnership or
other entity which directly or
indirectly Controls, is Controlled
by, or is under common Control
with, any Party including as a
subsidiary or holding company of
any Party.
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"Blocking IP" any and all Patent Rights (other
than that licensed under this
Licence Agreement) which, if claims
covering subject matter of such
Patent Rights issue, would render
the use, development, manufacture,
sale, or other disposal of a
Licensed Product unlawful in the
absence of a licence to such Patent
Rights from a Third Party.
"Business Day" means a day other than a Saturday,
Sunday, bank or other public
holiday in England or the United
States of America.
"Cancer Research UK-Funded means any academic researcher in
Researcher" receipt of Cancer Research UK
funding, whether an employee of
Cancer Research UK or a university
employee.
"Clinical Trial" means a clinical trial conducted in
accordance with recognised
protocols approved by a Competent
Authority including CTX clinical
trials or their equivalents
anywhere in the World.
"Commencement Date" means the date first above written.
"Competent Authority" means any local or national agency,
authority, department,
inspectorate, minister, ministry
official or public or statutory
person (whether autonomous or not)
of, or of any government of, any
country having jurisdiction over
this Licence Agreement or over any
of the Parties or over the
development or marketing of
medicinal products including, but
not limited to, the European
Commission and the European Court
of Justice.
"Control" means the ownership of at least 50%
of the issued share capital or the
legal power to direct or cause the
direction of the general management
and policies of the Party in
question.
"CRT Patent Rights" means the patent applications
referred to in Schedule 1 and all
Patent Rights deriving priority
from them and all Patent Rights
deriving priority from such Patent
Rights.
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"Field" means the development of RNAi
therapeutic products for the
treatment of human disease
(including by means of gene
therapy).
"Force Majeure" means in relation to a Party or its
Affiliate any event or
circumstances which is beyond the
reasonable control of that Party or
its Affiliate which event that
Party or its Affiliate could not
reasonably be expected to have
taken into account at the
Commencement Date and which results
in or causes the failure of that
Party or its Affiliate to perform
any or all of its obligations under
this Licence Agreement including
act of God, lightening, fire,
storm, flood, earthquake,
accumulation of snow or ice, lack
of water arising from weather or
environmental problems, strike,
lockout or other industrial
disturbance, war, terrorist act,
blockade, revolution, riot
insurrection, civil commotion,
public demonstration, sabotage, act
of vandalism, prevention from or
hindrance in obtaining in any way
materials, energy or other
supplies, explosion, fault or
failure of plant or machinery,
governmental restraint, act of
legislature and directive or
requirement of a Competent
Authority governing any Party or
its Affiliate provided that lack of
funds shall not be interpreted as a
cause beyond the reasonable control
of that Party or its Affiliate.
"Health Registration Approval" means, with respect to a country in
the Territory, approval by the
health or other Competent Authority
necessary to manufacture and market
a Licensed Product in the country.
"Issued Valid Claim" means a claim of an issued and
unexpired and unabandoned patent
included within the CRT Patent
Rights, which claim has not been
held permanently revoked,
unenforceable or invalid by a
decision of a court or other
governmental agency of competent
jurisdiction, unappealable or
unappealed within the time allowed
for appeal, or which has not been
admitted to be invalid or
unenforceable through reissue or
disclaimer or otherwise.
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"Licence Agreement" means this agreement and any and
all schedules, appendices and other
addenda to it as may be varied from
time to time in accordance with the
provisions of this agreement.
"Licensed Products" means product or products which, or
the process of production of which,
or the use of which falls within
the scope of a Valid Claim of the
CRT Patent Rights and Licensed
Product shall be construed as any
one of them.
"Milestone Patent Grant" means the first grant in the United
States or by the European Patent
Office of a claim comprised within
the CRT Patent Rights, which claim
is substantially similar to and of
equivalent breadth to claim 16 as
originally filed in the PCT
application number [**].
"Net Sales" means the invoiced amount billed
for sales of Royalty Licensed
Products to a Third Party (the
"Customer") by Alnylam or its
Affiliates or by Sub-licensees less
the following items to the extent
they are paid or incurred or
allowed:
a) quantity, trade and/or
cash discounts or rebates
actually granted or
accrued;
b) amounts repaid or credited
and allowances including
cash, credit or free goods
allowances, given by
reason of billing errors
and rebates actually
allowed or paid or
accrued;
c) amounts refunded or
credited for Licensed
Products which were
rejected or damaged or
recalled;
d) taxes, tariffs, customs
duties and surcharges and
other governmental charges
incurred in connection
with the sale, exportation
or importation of Licensed
Products; and
e) outbound transportation
costs prepaid or allowed
and costs of insurance in
transit.
Where Royalty Licensed Products are
not sold separately, but are sold
together with other therapeutic
agents and such combination has
received regulatory approval,
hereinafter such combinations
referred to as a "Combination
Product" and the Royalty Licensed
Product and each such other product
being referred to as a "Component
Product", the Net Sales price to be
used for the purpose of calculating
royalties payable in respect of
Combination Products shall be
determined by multiplying the Net
Sales price of the Combination
Product by the percentage value of
the Royalty Licensed
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Product comprising a Component
Product contained in the
Combination Product and subtracting
the items listed in subsections a)
through e) above, using the
following formula:
A/B = C
C*B = D
"A" equals the selling price of the
Royalty Licensed Product; "B"
equals the selling price of the
Combination Product; "C" represents
the fraction of the selling price
of the Combination Product
attributable to the Royalty
Licensed Product; "D" is the Net
Sales price attributable to the
Royalty Licensed Product to be used
for the purpose of calculating
royalties
If the selling price of a Component
Product is not known the fraction
attributable to the Royalty
Licensed Product shall be
calculated by subtracting the price
sold singly of the other Component
Product from the selling price of
the Combination Product.
If the selling price of each
Component Product is unknown the
Parties agree to negotiate in good
faith to agree on a reasonable
value.
For the sake of consistency the
selling price attributable to the
Royalty Licensed Product shall be
the same whether it is sold singly
or as part of a Combination
Product, providing that the grade,
amount, potency and purity of the
Royalty Licensed Product is the
same when sold singly or in
combination
The transfer of Royalty Licensed
Products by Alnylam or one of its
Affiliates to another Affiliate or
to a Sub-licensee shall not be
considered a sale. In such cases,
Net Sales shall be determined based
on the invoiced sale price levied
by the Affiliate or Sub-licensee on
the Customer, less the
aforementioned deductions to the
extent they are allowed, paid or
accrued.
"Non-cash Consideration" means any form of consideration
which is not directly calculable in
monetary terms, including, shares,
goods and cross-licences entered
into by Alnylam.
"Non-Platform Sub-licence" means a Sub-licence other than a
Platform Sub-
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licence.
"Non-Platform Sub-licence Income" means all upfront cash payments
excluding equity and research and
development payments, that accrue
to Alnylam or its Affiliate as of
the commencement date of the
Non-Platform Sub-licence (whether
due on the commencement date of the
Non-Platform Sub-licence or
thereafter) under a Sub-licence
other than a Platform Sub-licence.
"Parties" means CRT and Alnylam and "Party"
shall be construed as either one of
them.
"Patent Rights" means any patent applications,
patents, author certificates,
inventor certificates, utility
models (including all divisions,
renewals, continuations,
continuations-in-part, extensions,
reissues, substitutions,
confirmations, registrations,
revalidations and additions of or
to them, as well as any SPC, or any
like form of protection) and any
foreign counterparts thereto and
patents issuing therefrom.
"Pivotal Phase II Study" means a phase II Clinical Trial
upon the basis of which an
application for Health Registration
Approval is made.
"Platform Sub-licence" means a bare Sub-licence under the
CRT Patent Rights only and which
grants no rights inter alia: (i) to
Licensed Products developed by
Alnylam or its Affiliate; or (ii)
to develop Licensed Products in
collaboration with Alnylam or its
Affiliate.
Platform Sub-licence Income means any and all gross
consideration (including upfront,
periodic, and milestone payments
and Non-cash Consideration) other
than royalty payments on Net Sales
that accrue to Alnylam or its
Affiliates under a Platform
Sub-licence.
"Quarter" means a period of three (3)
consecutive calendar months
commencing on 1 January, 1 April, 1
July or 1 October in any year.
"Royalty Licensed Product" means a Licensed Product which, or
the process of production of which,
or the use of which falls within
the scope of an Issued Valid Claim.
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"SPC" means a right based on a patent
pursuant to which the holder of the
SPC is entitled to exclude third
parties from using, making, having
made, selling or otherwise
disposing or offering to dispose
of, importing or keeping the
product to which the SPC relates,
such as Supplementary Protection
Certificates in Europe, and any
similar right anywhere in the
world.
"Sub-licence" means a sub-licence in the Field
granted by Alnylam or its Affiliate
(in accordance with Clause 2.4).
"Sub-licensee" means any person granted a
Sub-licence by Alnylam or its
Affiliate.
"Territory" means the world.
"Third Party" means any entity or person other
than the Parties or an Affiliate of
a Party.
"Valid Claim" means either:-
a) a claim of an issued and
unexpired and unabandoned
patent included within the
CRT Patent Rights, which
claim has not been held
permanently revoked,
unenforceable or invalid
by a decision of a court
or other governmental
agency of competent
jurisdiction, unappealable
or unappealed within the
time allowed for appeal,
or which has not been
admitted to be invalid or
unenforceable through
reissue or disclaimer or
otherwise; or
b) a claim of a pending
patent application
included within the CRT
Patent Rights which claim
was filed in good faith
and has not been abandoned
or finally disallowed
without the possibility of
appeal or refiling of the
application.
"Year" means the one (1) year periods
commencing on 31 March annually,
and "Yearly" shall be construed
accordingly.
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1.2 In this Licence Agreement:
1.2.1 unless the context otherwise requires, all references to a
particular clause or schedule shall be a reference to that
clause or schedule in or to this Licence Agreement as it may
be amended from time to time pursuant to this Licence
Agreement;
1.2.2 the headings are inserted for convenience only and shall be
ignored in construing this Licence Agreement;
1.2.3 unless the contrary intention appears, words importing the
masculine gender shall include the feminine and vice versa and
words in the singular include the plural and vice versa;
1.2.4 unless the contrary intention appears, words denoting persons
shall include any individual, partnership, company,
corporation, joint venture, trust association, organisation or
other entity, in each case whether or not having separate
legal personality;
1.2.5 the words "include", "included" or "including" are to be
construed without limitation to the generality of the
preceding words; and
1.2.6 reference to any statute or regulation includes any
modification or re-enactment of that statute or regulation.
2. GRANT OF LICENCE
2.1 CRT hereby grants to Alnylam, and its Affiliate(s) who have confirmed
to Alnylam their agreement in writing to be bound (to CRT) by the terms
of this Licence Agreement which specifically apply to Affiliates, with
a copy to be sent to CRT, a licence in the Field throughout the
Territory under the CRT Patent Rights to research, develop, have
developed, use, keep, make, have made, import, have imported, sell,
have sold and otherwise dispose or offer to dispose of Licensed
Products. Such Affiliates shall be listed on Schedule 2 to this Licence
Agreement which shall be updated periodically by Alnylam and sent to
CRT. For the sake of clarity, save to the extent necessary for the
development and/or sale of Licensed Products in the Field neither
Alnylam or any Affiliate is granted the right to make use of the CRT
Patent Rights to research, develop, use, keep, make, have made, sell
and otherwise dispose or offer to dispose of products:
a) for any diagnostic application;
b) as research tools or reagents;
c) for target validation; or
d) small molecule drug discovery
including the provision of services in relation thereto to Affiliates
or Third Parties.
2.2 Subject to Clause 2.3, the licence granted in Clause 2.1 shall, in
relation to a particular country in the Territory, be exclusive within
the Field for the term of the relevant Patent Rights included within
the CRT Patent Rights.
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2.3 It is acknowledged and agreed that CRT and Cancer Research UK shall
have the right to use, and CRT shall have the right to consent to the
use by academic research institutions (including for the sake of
clarity those in receipt of Cancer Research UK funding) of, the CRT
Patent Rights in the Field for internal, or in collaboration with
another academic research institution, non-commercial, non-commercially
sponsored research. For the sake of clarity, Cancer Research UK-funded
Researchers shall be permitted under the CRT Patent Rights to conduct
clinical trials of potential dsRNA therapeutic agents as part of their
Cancer Research UK-funded academic research.
2.4 Alnylam and its Affiliates shall be entitled to sublicence the rights
granted in this Licence Agreement. Any Sub-licence which is granted in
breach of this Clause 2.4 shall be void. Alnylam or its Affiliate shall
(subject to Alnylam's and its Affiliate's right to redact confidential
information not related to CRT's rights hereunder) provide to CRT in
confidence a copy of each and every Platform Sub-licence entered into.
Any Sub-licence entered into by Alnylam or an Affiliate shall;
a) be limited to the Field and shall contain restrictions in
equivalent terms to those set out in Clause 2.1.
b) provide that the Sub-licence shall terminate automatically on
the expiry or termination for whatever reason of this Licence
Agreement. In the event of termination of this Agreement
pursuant to Clause 10, CRT shall enter into a direct licensing
arrangement with any Sub-licensee on terms substantially
similar to those contained herein save that any licence
granted by CRT to any Sub-licensee shall be consistent with
the terms of the Sub-licence granted by Alnylam (or its
Affiliate as the case may be) in relation to field, territory,
exclusivity, rights to sub-license and payment provisions.
However, in the event of termination of this Agreement by
Alnylam pursuant to Clause 10.2 the provisions of the
foregoing sentence shall apply save that the granting of such
licence by CRT shall be subject to CRT's consent. Nothing in
this Clause 2.4 shall confer upon CRT any obligation to enter
into a direct licensing arrangement with the Sub-licensee
where the Sub-licensee is in default of its obligations under
the Sub-licence. CRT shall not be expected to take any
responsibility for any disputes between Alnylam (or its
Affiliate as the case may be) and its Sub-licensees relating
to the terms of the Sub-licence(s) and notwithstanding the
foregoing provisions of this Clause 2.4, CRT shall not be
obliged to enter into a direct licence with a Sub-licensee in
circumstances in which the Sub-licensee reserves any right to
maintain a claim against CRT where such claim was previously
maintained against Alnylam (or its Affiliate as the case may
be).
c) provide that the Third Party with whom the Sub-licence has
been entered into shall undertake to CRT directly to allow CRT
the same access to the books and records as it has to
Alnylam's books and records under this Licence Agreement; and
d) contain restrictions on assignment in equivalent terms to
those set out in Clause 15 and require that any further
sublicensing be subject to the terms of this Clause 2.4.
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Alnylam shall only grant a Platform Sub-licence as a separate licence
(or sub-licence) for separate consideration identified in the Platform
Sub-licence and shall not include a Platform Sub-licence as part of any
other licence (or sub-licence).
2.5 CRT hereby grants an option to Alnylam and its Affiliates exercisable
during the term of this Licence Agreement to enter into non-exclusive,
non-sublicensable and non-assignable licences under the CRT Patent
Rights in the fields of either or both of:
a) [**]; and
b) [**]
on terms to be agreed in good faith between CRT and Alnylam, the
payment terms in respect of each licence which shall be no more than:
a) annual payments of [**] pounds sterling ((pound)[**]); or
b) any (lesser) sum that may be agreed between CRT and a Third
Party licensee after the Commencement Date in the same field
(other than a licence pursuant to which, or under the terms of
a related agreement, significant resources are provided by the
Third Party in respect of a collaboration in the field).
3. CONSIDERATION
3.1 In consideration of the rights granted under this Licence Agreement,
Alnylam shall pay the following sums to CRT:
3.1.1 subject to Clause 3.5, [**] United States dollars (US$[**]) on
the Commencement Date; and
3.1.2 until the expiry of the last to expire of the CRT Patent
Rights on each and every anniversary of the Commencement Date,
an annual fee of [**] United States dollars (US$[**]); and
3.1.3 a one-time payment of [**] United States dollars (US$[**]) on
Milestone Patent Grant; and
3.1.4 the following milestone fees in respect of the first Licensed
Product in the Field to achieve the milestone (upon
achievement of the milestone by Alnylam, or its Affiliate, or
a Non-Platform Sub-licensee);
(a) [**] United States dollars (US$[**]) on the
commencement of the first phase I Clinical Trial
conducted anywhere in the Territory; and
(b) [**] United States dollars (US$[**] on the
commencement of the first phase II Clinical Trial or
Privotal Phase II Study conducted anywhere in the
Territory.
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3.1.5 any and all reasonable patent filing, maintenance and
prosecution costs incurred after the Commencement Date by CRT
or its agents subject to Clause 7, within 30 (thirty) days of
the date of an invoice from CRT.
3.2 As further consideration of the rights granted under this
Licence Agreement, Alnylam (or its Affiliate as the case may
be) shall pay the following sums to CRT:
3.2.1 royalties of [**] percent ([**]%) of Net Sales of
Royalty Licensed Products in the Field; and
3.2.2 [**] percent ([**]%) of Platform Sub-licence Income
provided that to the extent Platform Sub-licence
Income includes;
(a) milestone payment(s) for patent issuance,
the milestone payment made by Alnylam in
Clause 3.1.3 shall be fully creditable
against that part of Platform Sub-licence
Income expressly payable for patent issuance
and Alnylam or its Affiliate shall not pay
[**]% of Platform Sub-licence Income payable
for patent issuance until the milestone
payment made by Alnylam in Clause 3.1.3 has
been fully credited against such Platform
Sub-licence Income; and/or
(b) Non-cash Consideration, Alnylam or its
Affiliate shall following consultation with
CRT have the option of apportioning such
Non-cash Consideration (including by
transfer of [**] percent ([**]%) of
Alnylam's or its Affiliate's shareholding
where Non-Cash Consideration is comprised of
shares), if possible, or valuing the
Non-cash Consideration at its fair market
value, when received and paying [**] percent
([**]%) of the cash equivalent to CRT; and
3.2.3 in respect of each Non-Platform Sub-licence, and
solely to the extent that Alnylam or its Affiliate
receives Non-Platform Sub-licence Income arising
therefrom, [**] percent ([**]%) of Non-Platform
Sub-licence Income under such Non-Platform
Sub-licence; and
3.3 Provided always that the royalty payable to CRT shall not in any event
be reduced below [**] percent ([**]%), if at any time prior to or
during the period for the payment of royalties under this Licence
Agreement in relation to any particular territory, Alnylam (or its
Affiliate as the case may be) or a Sub-licensee elects in its
reasonable opinion to take a licence from a Third Party to any Blocking
IP to develop, make, sell or otherwise dispose of Licensed Products,
the royalties set forth in Clause 3.2.1 applicable to such Licensed
Product shall be reduced by [**]% of the amount paid to such Third
Party to access said Blocking IP.
3.4 Provided always that Non-Platform Sub-licence Income shall not in any
event be reduced below [**] percent ([**]%), the percent payment of
Non-Platform Sub-licence Income set forth in Clause 3.2.3 shall be
reduced if at any time prior to or
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during the period for the payment thereof under this Licence Agreement
in relation to any particular territory, in order to grant the rights
under the Sub-licence Alnylam (or its Affiliate as the case may be)
elects to take a licence from a Third Party under Patent Rights which
Alnylam (or its Affiliate as the case may be) reasonably believes to be
Blocking IP and thereafter the percent of Non-Platform Sub-licence
Income payable shall be determined by applying the formula [**]N [**]
where N is the number of Third Party licensors of Blocking IP.
3.5 CRT agrees that in respect of the sum payable under Clause 3.1.1 credit
shall be given to Alnylam for the sum of [**] dollars (US$[**])
received by CRT under the terms of a letter of exclusivity dated 4 June
2003 entered into between the Parties, and provided that Alnylam has
confirmed that CRT is entitled to retain the said sum, Alnylam shall
only be obliged to pay [**] dollars (US$[**]) pursuant to Clause 3.1.1.
4. PAYMENT
4.1 All payments due to CRT under this Licence Agreement shall (subject to
written advice from CRT amending the account details) be made in United
States dollars or pounds sterling by telegraphic transfer to the
accounts below:
Payee: Cancer Research Technology Limited
Lloyds TSB, Pall Mall St James's Branch
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US$ account
Sort Code: 30-00-08
Account Code: [**]
Account Name: Cancer Research Technology Ltd
Sterling account
Sort Code: 30-00-08
Account Code: [**]
Account Name: Cancer Research Technology Ltd
For the attention of the Financial Controller (or such other nominee of
CRT as CRT may direct from time to time).
4.2 Alnylam (or its Affiliate as the case may be) shall make the payments
to CRT:
4.2.1 in the case of the royalties payable pursuant to Clause 3.2.1,
within 30 (thirty) days of the end of the Quarter in which the
sales of the relevant Licensed Products took place;
4.2.2 in the case of Platform Sub-licence Income and Non-Platform
Sub-licence Income payable pursuant to Clauses 3.2.2 and 3.2.3
within the later of 30 (thirty) days of the date of receipt of
the payment from the Sub-licensee (in respect of any up-front
payments) or the end of the Quarter in which the Sub-licence
Income has been received by Alnylam;
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4.2.3 in the case of the payments due under Clauses 3.1.1 through
3.1.3, within thirty (30) days of the date of an invoice from
CRT; and
4.2.4 in the case of the payments due under Clause 3.1.4, within
thirty (30) days of the achievement of the relevant milestone.
4.3 Where sums are received by Alnylam (or its Affiliate as the case may
be) in a currency other than United States dollars or pounds sterling,
conversion of such currencies to United States dollars will be
performed at the closing mid-point rate published in the Financial
Times in London on the last Business Day of the Quarter in which the
sum is to be paid. For the sake of clarity Alnylam (or its Affiliate as
the case may be) shall be under no obligation to convert payments
received into United States Dollars.
4.4 Where CRT does not receive payment of any sums due to it within thirty
(30) days of the dates set out in Clauses 3.1 or 4.2 as the case may be
(the "Due Date"), interest shall accrue on the sum due and owing to CRT
at the rate equivalent to an annual rate of four percent (4%) over the
then current US dollar base rate of Lloyds Bank plc, calculated on a
daily basis, without prejudice to CRT's right to receive payment on the
Due Date.
4.5 All payments to CRT shall be made free and clear of, and without
deduction or deferment in respect of, any claims, set-off and taxes
imposed or levied by any competent authority including any withholding
taxes. In the event that Alnylam (or its Affiliate as the case may be)
is obliged to deduct any withholding or other taxes it shall pay to CRT
an amount as shall result in the net amount being received by CRT being
equal to the amount which would have been received by CRT had no
deduction or withholding been made. If CRT is able to recover or
set-off any such deduction or withholding it shall refund such amount
to Alnylam (or its Affiliate as the case may be) as shall result in net
amount being retained by CRT being equal to the amount which would have
been received by CRT had no deduction or withholding been made. CRT
shall to any extent reasonably practicable co-operate with Alnylam in
seeking to effect a recovery from the relevant taxation authority of
any withholding taxes actually deducted and in the event that CRT makes
a recovery shall pay to Alnylam (or its Affiliate as the case may be)
any sums recovered.
5. BOOKS AND RECORDS
5.1 Following the earlier of the first commercial sale of a Licensed
Product in the Field by Alnylam or its Affiliate or the grant of a
Sub-licence, Alnylam (or its Affiliate as the case may be) shall
prepare an annual statement which shall show on a country by country
basis for the previous calendar year all monies due to CRT under this
Licence Agreement. That statement shall include the number of units of
each Royalty Licensed Product sold in each country in which sales
occurred, and shall be submitted to CRT within sixty (60) Business Days
of 31st March of each year. If CRT gives notice to Alnylam within
twenty (20) Business Days of the receipt of any such statement that it
does not accept the same, that statement shall be certified by an
independent accountant appointed by agreement between Alnylam and CRT
or, in default of agreement within ten (10) Business Days, appointed at
the request of either
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CRT or Alnylam by the President for the time being of the Institute of
Chartered Accountants of England and Wales in London. Alnylam (or its
Affiliate as the case may be) shall make available to the independent
accountant all books and records required for the purpose of that
certification under terms of confidentiality equivalent to those
contained in this Agreement and the statements so certified shall, in
the absence of manifest error, be final and binding between the
Parties. The cost of the certification shall be the responsibility of
Alnylam if the statement is shown to have underestimated the monies
payable to CRT by more than five percent (5%) and the responsibility of
CRT otherwise. Any outstanding payments due to CRT which are identified
as a result of carrying out the investigation shall be paid to CRT
immediately. There shall be no more than one certification by an
independent accountant in relation to any one annual statement.
5.2 Alnylam shall, and shall require that its Affiliates and Sub-licensees
shall, keep true and accurate records and books of account containing
all data necessary for the calculation of the amounts payable by it to
CRT pursuant to this Licence Agreement. Such records and books of
account shall be kept for five (5) years following the end of the
calendar year to which they relate and shall, upon reasonable notice
having been given by CRT, be open at all reasonable times on Business
Days for inspection under the terms of confidentiality contained in
this Licence Agreement, by an independent firm of accountants appointed
by agreement between the Parties or, failing such agreement within ten
(10) Business Days, appointed at the request of either CRT or Alnylam
by the President for the time being of the Institute of Chartered
Accountants of England and Wales in London. The cost of any such
examination shall be borne by CRT, such examination to take place not
later than five (5) years following the expiration of the period to
which it relates and there shall be no more than one examination per
year.
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6. PERFORMANCE AND CLINICAL DEVELOPMENT
6.1 Alnylam shall use reasonable efforts to develop, make, market, sell and
otherwise dispose of Licensed Products in all therapeutic areas within
the Field and market each Licensed Product in the Field throughout the
United States, Europe and Japan. This obligation may be satisfied by
the efforts of Alnylam's Affiliate(s) or Sub-licensee(s).
6.2 CRT shall provide notice to Alnylam of its knowledge of a willing
potential sub-licensee. Without prejudice to Clause 6.1, in the event
that Alnylam (itself or through Affiliates or Sub-licensees) declines
to develop, make, market, sell or otherwise dispose of Licensed
Products in any therapeutic area or any indication within the cancer
therapeutic area within the Field or any territory within the Territory
in the Field, Alnylam shall (save as hereinafter provided) upon direct
approach made by, or receipt of notice from CRT of a, willing potential
sublicensee in respect of a Licensed Product that has demonstrated
clinical efficacy be obliged to enter into negotiations in good faith
with such Third Party to enter into a Sub-licence in relation to such
therapeutic area, indication, or territory. The preceding provisions of
this Clause 6.2 shall not apply in respect of any therapeutic area,
indication, or territory in respect of which Alnylam provides to CRT's
reasonable satisfaction evidence that the conclusion of a Sub-licence
would:
6.2.1 be contrary to sound and reasonable business practice
applicable to pharmaceutical development; or
6.2.2 not materially increase the availability of therapeutic
products covered by the CRT Patent Rights.
6.3 If CRT believes that Alnylam has failed to meet the diligence
requirements set forth in Clause 6, it shall serve notice on Alnylam of
such failure and Alnylam shall have a [**] period from the date of
receipt of such notice to reestablish diligence towards its objectives,
and if Alnylam reestablishes diligence towards its objectives during
this [**] period, any prior lack of diligence will be deemed cured.
Notwithstanding anything in this agreement to the contrary, in the
event that Alnylam fails to reestablish diligence to the standard
provided in Clause 6 within the said [**] period, this shall not be
cause for CRT's termination of this Licence Agreement, rather, CRT's
remedy shall be limited to, at CRT's discretion, termination of
Alnylam's licence under the CRT Patent Rights in the particular
territory or therapeutic area or, with respect to Clause 6.2,
indication within the cancer therapeutic area for which Alnylam has
failed to meet the diligence requirements. For the sake of clarity
should Alnylam's licence be terminated in respect of a therapeutic area
or territory pursuant to this Clause 6.3 CRT shall be free to offer
such therapeutic area or territory to a potential licensee.
As part of its annual statement deliverable to CRT pursuant to Clause
6.4, Alnylam shall include a detailed description of therapeutic areas
and territories under development and an overview of Alnylam's
development plans for the forthcoming year (itself or through
Affiliates or Sub-licensees).
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6.4 Alnylam shall, within thirty days of the end of each Year provide CRT
with a written report of the steps taken by Alnylam, its Affiliates and
any Sub-licensees to comply with the performance obligations of Clauses
6.1 and 6.2.
6.5 In the event that Alnylam (or its Affiliate as the case may be) intends
to undertake a Phase I Clinical Trial of any Licensed Product in the UK
Alnylam shall, at its option (a) notify CRT providing particulars in
reasonable detail of the proposed investigation; and (b) allow Cancer
Research UK the opportunity of conducting or procuring the conduct of
the investigation on behalf of Alnylam or participate in such an
investigation, subject to the agreement of terms acceptable to Alnylam,
CRT and Cancer Research UK.
7. MANAGEMENT OF PATENT RIGHTS
7.1 CRT shall or shall procure in consultation with and (save to the extent
provided in Clause 7.2) at the reasonable expense of Alnylam the
filing, prosecution, and maintenance of any patents and patent
applications comprised within the CRT Patent Rights. CRT shall use
reasonable efforts to ensure that Alnylam is provided with copies of
all material correspondence with patent agents in sufficient time for
Alnylam to comment thereon. Alnylam's comments shall be incorporated to
the extent reasonably practicable. Alnylam shall (save to the extent
provided in Clause 7.2) bear the full expense and shall reimburse in
full and hold CRT harmless in respect of any and all reasonable fees,
charges, costs, levies or expenses incurred by CRT or its agents after
the Commencement Date in relation to such applications. Nothing in this
Licence Agreement shall oblige CRT or Alnylam to bring, defend or
contest any enforcement, interference, opposition or infringement
proceedings in respect of any of the CRT Patent Rights.
7.2 Save as hereinafter provided in this Clause 7.2, the reasonable costs
of opposition and interference proceedings in relation to the CRT
Patent Rights (together "Challenges") shall be borne equally by the
Parties. In the event that the total aggregate costs of Challenges in
any year exceed [**] United States dollars (US$[**]), CRT shall be free
to make no further contribution to the costs of Challenges and all
further costs incurred during that year ("Further Challenge Costs")
and, at Alnylam's option, the future control of such Challenge(s) shall
be borne by Alnylam solely. CRT shall give credit for [**] percent
([**]%) of Further Challenge Costs actually paid by Alnylam against
sums due from Alnylam to CRT pursuant to Clause 3 from that time
forward. In the event that one or more of the CRT Patent Rights are the
subject of a declaration of interference by the U.S. Patent and
Trademark Office as interfering with claims in a patent or patent
application which is owned by or licensed by Alnylam or its Affiliate,
CRT and Alnylam shall negotiate in good faith to reasonably agree on a
mechanism outside the U.S. Patent and Trademark Office which simplifies
the issues involved in determining priority and which awards priority
to the appropriate party to the interference.
In any country where Alnylam elects not to have a patent application
included in CRT Patent Rights filed or to pay expenses associated with
filing, prosecuting, interference or equivalent proceedings, or
maintaining a patent application or patent included in CRT Patent
Rights, CRT may file, prosecute, continue with interference or
equivalent proceedings, and/or maintain such patent application or
patent at its own expense and
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for its own exclusive benefit and Alnylam (and its Affiliates)
thereafter shall not be licensed under such patent or patent
application. For the sake of clarity, should Alnylam elect not to
continue with interference or equivalent proceedings and CRT elect to
continue with such proceedings, Alnylam (and its Affiliates) shall
cease to be licensed for the patent subject to interference for that
territory.
7.3 If either Party receives any notice, claim or proceedings from any
Third Party alleging infringement of that Third Party's intellectual
property by reason of Alnylam's activities in relation to this Licence
Agreement or the use and exploitation of the CRT Patent Rights by
Alnylam or its Sub-licensee(s) or its Affiliates, the Party receiving
that notice shall forthwith notify the other Party of the notice, claim
or proceeding.
7.4 Alnylam shall, at its option and at its own cost, defend and enforce or
shall procure the defence or enforcement of the rights under the CRT
Patent Rights. CRT shall, at Alnylam' reasonable cost, render such
reasonable assistance as Alnylam reasonably requests. If necessary, CRT
shall grant to Alnylam the right to conduct such an action in its name.
Any damages or financial settlement monies received by Alnylam pursuant
to such proceedings shall, after deduction of all of the costs incurred
by Alnylam in such proceedings, be treated as Net Sales.
7.5 Without prejudice to CRT's other rights arising from such failure, if
Alnylam opts not to defend or enforce the relevant CRT Patent Rights
and if CRT desires to enforce or defend such rights, CRT shall notify
Alnylam and Alnylam shall, at CRT's request, grant to CRT any and all
rights that would be necessary for CRT to undertake the enforcement or
defence. If Alnylam is unable to grant such rights then it shall, at
CRT's request, grant to CRT the right to conduct such an action in its
name. Alnylam shall provide, at CRT's request and CRT's reasonable
expense, such reasonable assistance as CRT may reasonably request in
any such proceedings. Any monies received by CRT pursuant to any
enforcement or defence of the CRT Patent Rights by them under this
Clause 7.5 shall be solely for the benefit of CRT.
8. WARRANTIES AND LIABILITY
8.1 Each Party represents and warrants to the other Party that it has legal
power, authority and right to enter into this Licence Agreement and to
perform its respective obligations hereunder.
8.2 CRT represents and warrants to Alnylam that it has had assigned to it
all Cambridge University's and the Lister Institute of Preventive
Medicine's rights under the CRT Patent Rights pursuant to the terms of
assignments, a copy of which will be provided to Alnylam upon request.
8.3 CRT represents and warrants to Alnylam that to the best of its
knowledge, upon reasonable inquiry, as at the Commencement Date the
inventors (as determined by the laws of England) of the patent
applications referred to in Schedule 1 are [**] and all of these
inventors have assigned their rights in the CRT Patent Rights to CRV
(to the extent that the same were not vested in Cambridge University or
the Lister Institute of Preventive Medicine and assigned to CRT in
accordance with Clause 8.2). CRV have in turn assigned their rights to
CRT. In the event of breach of this Clause 8.3,
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Alnylam's remedy for breach shall be limited to the rights conferred
upon Alnylam by Clause 8.9.
8.4 Other than expressly set out herein, no Party gives any representation
or warranty to any other Party that the performance of this Licence
Agreement will not result in the infringement of any rights, including
intellectual property rights, vested in a Third Party and it is agreed
and understood by the Parties that Alnylam is responsible for
undertaking each and every investigation necessary to satisfy itself
that the rights granted under this Licence Agreement can be properly
and lawfully exercised by Alnylam (and any Affiliate) without
infringing the rights of any Third Party, and save as expressly set out
in Clauses 8.1 and 8.2 no warranties of any kind are given by CRT in
relation to the intellectual property rights granted under this Licence
Agreement or owned or controlled by any Third Party which may affect
the exercise of such rights.
8.5 Nothing in this Licence Agreement shall be construed as a
representation made or warranty given by CRT in relation to the CRT
Patent Rights that:
8.5.1 any patent will issue based upon any pending patent
application;
8.5.2 any patent which issues will be valid; nor
8.5.3 the use of any CRT Patent Rights will not infringe the patent
or proprietary rights of any Third Party.
Furthermore, CRT makes no representation or warranty, express or
implied, with respect to merchantability or fitness of the CRT Patent
Rights for a particular purpose.
8.6 No Party shall be liable to the other Party, its Affiliates or
Sub-licensees in contract, tort, negligence, breach of statutory duty
or otherwise for any loss, damage, cost or expense of an indirect or
consequential nature (including any economic loss or other loss of
turnover, profits, business or goodwill) arising out of or in
connection with this Licence Agreement or the subject matter of this
Licence Agreement.
8.7 Alnylam and any Affiliate licenced under this Licence Agreement shall
respectively be responsible for and indemnify, defend and hold harmless
CRT, the University of Cambridge, the Lister Institute of Preventive
Medicine and their respective officers, servants and agents against any
and all liability, loss, damage, cost or expense (including reasonable
attorney's fees and court and other expenses of litigation) arising out
of or in connection with Third Party claims relating to the discovery,
research, development, manufacture, marketing, selling and disposal of
Licensed Products or candidate Licensed Products by Alnylam, its
Affiliates and their Sub-licensees except to the extent due to the
gross negligence or wilful misconduct of an indemnitee.
8.8 In the event that CRT intends to seek indemnification under Clause 8.7,
it shall promptly inform Alnylam (or its Affiliate as the case may be)
in writing of a claim after receiving notice of the claim and shall
permit Alnylam (or its Affiliate as the case may be) to direct and
control the defence of the claim and shall provide such reasonable
assistance as reasonably requested by Alnylam (or its Affiliate as the
case may be) (at Alnylam's (or its Affiliate's as the case may be)
cost) in the defence of
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the claim. Provided always that nothing in this Clause 8.8 shall permit
Alnylam (or its Affiliate as the case may be) to make any admission on
behalf of CRT, without the prior written consent of, CRT.
8.9 In the event that a Third Party has rights to the CRT Patent Rights,
CRT shall obtain, at its cost, such Third Party's rights in the CRT
Patent Rights to the extent necessary to preserve Alnylam's exclusive
licence granted under and on the terms of this Licence Agreement. If
CRT is not able to obtain such rights within one year of learning of
the existence of such Third Party's rights, Alnylam shall have the
option to 1) terminate this Licence Agreement; or 2) decrease all
financial obligations of Alnylam, its Sub-licensees and Affiliates by
50% in respect of all future revenues, credit 50% of past revenues
against future revenues owed to CRT under this Licence Agreement and,
at Alnylam's option, renegotiate the terms of this Licence Agreement
with CRT in order, to preserve the original intent of this Licence
Agreement. For the sake of clarity CRT shall not be obliged to repay
sums received previously.
9. CONFIDENTIALITY
9.1 Each Party undertakes and agrees not at any time for any reason
whatsoever to disclose or permit to be disclosed to any Third Party or
otherwise make use of or permit to be made use of (except as expressly
permitted by or in conjunction with a licence granted under this
Licence Agreement), any trade secrets or confidential information
relating to the other Party's technology or the business affairs or
finances of the other Party or of an Affiliate, Sub-licensee or of any
suppliers, agents, distributors or customers of the other Party (the
"Confidential Information") which come into its possession pursuant to
this Licence Agreement. Nothing in this Licence Agreement shall prevent
CRT from disclosing its own information relating to the CRT Patent
Rights for any purpose outside the Field.
9.2 The Parties shall ensure that only those of their and their Affiliates'
and Sub-licensee(s) officers, employees, agents and consultants who
have a need to know are given access to Confidential Information and
that those who are directly concerned with the carrying out of this
Licence Agreement and who have access to the Confidential Information
of the other Party are informed of its secret and confidential nature
and are bound by obligations of confidentiality and non-use comparable
to those obligations set forth in this Clause 9.
9.3 The obligations of confidence referred to in this Clause 9 shall not
extend to any Confidential Information which:
9.3.1 is at the time of disclosure, or thereafter becomes, available
to the public otherwise than by reason of a breach by the
recipient Party of the provisions of this Clause 9; or
9.3.2 is known to the recipient Party without obligations of
confidence to the disclosing Party prior to its receipt from
the disclosing Party, as can be shown by written record; or
9.3.3 is subsequently disclosed to the recipient Party by another
party owing no obligations of confidentiality to the
disclosing Party in respect thereof; or
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9.3.4 is required to be disclosed by any applicable law or any
Competent Authority to which a Party is from time to time
subject provided to any extent practicable that the disclosing
Party receives prior written notice of such disclosure and
that the receiving Party takes all reasonable and lawful
actions to obtain confidential treatment for such disclosure
and, if possible, to minimize the extent of such disclosure;
or
9.3.5 is independently developed by a servant, agent, consultant or
employee of the recipient Party having no access to the
Confidential Information disclosed by a Party, as demonstrated
by written records.
9.4 The obligations of each Party under this Clause 9 shall survive the
expiration or termination for whatever reason of this Licence Agreement
for a period of five (5) years.
10. TERM AND TERMINATION
10.1 This Licence Agreement shall become effective as of the Commencement
Date and expires when Alnylam's and its Affiliate's obligations to pay
sums according to Clause 3 finally expire.
10.2 In the event that Alnylam serves a written notice upon CRT confirming
Alnylam's intention to terminate this Licence Agreement, this Licence
Agreement shall terminate 90 (ninety) days after receipt by CRT of such
notice.
10.3 Either CRT on the one hand or Alnylam on the other hand ("the
Terminating Party") shall have the right to terminate this Licence
Agreement forthwith upon giving written notice of termination to
Alnylam on the one hand or CRT on the other hand as the case may be
("the Defaulting Party"), upon the occurrence of any of the following
events at any time during this Licence Agreement:
10.3.1 the Defaulting Party commits a material breach of this Licence
Agreement which in the case of a breach capable of remedy
shall not have been remedied within sixty (60) Business Days
of the receipt by it of a notice identifying the breach and
requiring its remedy;
10.3.2 the Defaulting Party for a period of longer than sixty (60)
Business Days becomes bankrupt or insolvent (including without
limitation being deemed to be unable to pay its debts);
10.3.3 proceedings are commenced in relation to the Defaulting Party
under any law, regulation or procedure relating to the
re-construction or re-adjustment of debts (including where a
petition is filed or proceeding commenced seeking any
reorganisation, arrangement, composition or re-adjustment
under any applicable bankruptcy, insolvency, moratorium,
reorganisation or other similar law affecting creditors'
rights or where the Defaulting Party consents to, or
acquiesces in, the filing of such a petition), which is not
dismissed within ninety (90) days;
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10.3.4 the Defaulting Party takes, any action, or any legal
proceedings are started or other steps taken by a Third Party,
which proceedings are not dismissed within ninety (90) days
with a view to:
(i) the winding up or dissolution of the Defaulting Party
(other than for the reconstruction of a solvent
company for any purpose, including the inclusion of
any part of the share capital of the Defaulting Party
on a recognised public Stock Exchange); or
(ii) the appointment of a liquidator, trustee, receiver,
administrative receiver, receiver and manager,
interim receiver custodian, sequestrator or similar
officer of the Defaulting Party against the
Defaulting Party or a substantial part of the assets
of the Defaulting Party,
or anything analogous to any of the foregoing occurs under the
laws of any country.
10.4 In the event of Alnylam's material breach of its obligations under
either or both of Clauses 6.1 and 6.2 CRT shall have the right in its
absolute discretion to selectively terminate the licence granted under
Clause 2 in respect of either or both of:
10.4.1 any therapeutic area or areas within the Field; and
10.4.2 any territory or territories within the Territory
in respect of which Alnylam is in material breach as set forth in
Clause 6.3. In the event of termination by CRT of any part of the
licence granted to Alnylam under Clause 2 pursuant to the exercise of
CRT of its rights under this Clause 10.4, the other terms of this
Licence Agreement (including any surviving licence under Clause 2)
shall remain in full force and effect.
10.5 CRT shall have the right to terminate this Licence Agreement forthwith
upon giving thirty (30) days written notice of termination to Alnylam
in the event that Alnylam or its Affiliate:
10.5.1 commences legal proceedings, with for the sake of clarity the
exception of interference proceedings declared by the USPTO or
any other patent office, contesting the validity of the CRT
Patent Rights ; or
10.5.2 commences itself, or provides any material assistance to a
Third Party in relation to, legal proceedings contesting the
ownership of the CRT Patent Rights.
For the sake of clarity and notwithstanding anything in this Licence
Agreement to the contrary, any actions taken concerning determination
of priority of invention under US patent law between a CRT Patent Right
and claims in a patent or patent application which is owned by or
licensed by Alnylam or its Affiliate, shall not be considered a contest
of validity or ownership under this Clause 10.5.
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11. CONSEQUENCES OF TERMINATION
11.1 Upon termination of this Licence Agreement:
11.1.1 the licence rights granted by CRT to Alnylam and its
Affiliates pursuant to Clause 2 shall terminate in its
entirety;
11.1.2 Alnylam and any Affiliates shall pay to CRT within sixty (60)
Business Days all sums due to CRT hereunder which have accrued
prior to the date of termination;
11.1.3 Save that each Party shall be entitled to retain a single copy
of any document for their records, Alnylam and CRT shall
return to each other any Confidential Information provided
under this Agreement.
11.2 Termination or expiry of this Licence Agreement for whatever reason
shall not affect the accrued rights of the Parties arising in any way
out of this Licence Agreement as at the date of termination or expiry
and in particular but without limitation the right to recover damages
and interest, and the provisions of Clauses 5, 8, 9 and 20 shall remain
in full force and effect.
12. WAIVER
12.1 Neither Party or its Affiliate shall be deemed to have waived any of
its rights or remedies conferred by this Licence Agreement unless the
waiver is made in writing and signed by a duly authorised
representative of that Party or its Affiliate. In particular, no delay
or failure of either Party or its Affiliate in exercising or enforcing
any of its rights or remedies conferred by this Licence Agreement shall
operate as a waiver of those rights or remedies or so as to preclude or
impair the exercise or enforcement of those rights or remedies nor
shall any partial exercise or enforcement of any right or remedy by
either Party or its Affiliate preclude or impair any other exercise or
enforcement of that right or remedy by that Party or its Affiliate.
13. ENTIRE AGREEMENT/VARIATIONS
13.1 This Licence Agreement constitutes the entire agreement and
understanding between the Parties and supersedes all prior oral or
written understandings, arrangements, representations or agreements
between them relating to the subject matter of this Licence Agreement.
No director, employee or agent of either Party is authorised to make
any representation or warranty to another Party not contained in this
Licence Agreement, and each Party acknowledges that it has not relied
on any such oral or written representations or warranties.
13.2 No variation, amendments, modification or supplement to this Licence
Agreement shall be valid unless made in writing in the English language
and signed by a duly authorised representative of each Party.
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14. NOTICES
14.1 Any notice to be given pursuant to this Licence Agreement shall be in
writing in the English language and shall be delivered by hand, sent by
reputable courier service, or sent by facsimile confirmed to the
address or facsimile number of the recipient set out below or such
other address or facsimile number as a Party may from time to time
designate by written notice to the other Party.
ADDRESS ▇▇ ▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇
▇▇▇▇ ▇▇▇
For the attention of the Chief Executive
Fax No. ▇▇ ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
For the attention of the Chief Executive.
ADDRESS OF ALNYLAM
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
For the attention of the Chief Executive
Fax No. ▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
14.2 Any notice given pursuant to this Clause 14 shall be deemed to have
been given upon receipt.
15. ASSIGNMENT
15.1 Subject to Clause 15.2, neither Party shall without the prior written
consent of the other Party, which shall not be unreasonably withheld,
assign the benefit and/or burden of this Licence Agreement nor
sub-contract any of its obligations hereunder unless otherwise
permitted by the terms hereof.
15.2 Either Party shall be entitled to assign the benefit and/or burden of
this Licence Agreement to any Affiliate or to its successor in
connection with any merger, consolidation or sale or other disposal of
all or substantially all of its assets and/or business to which this
Agreement relates.
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16. FORCE MAJEURE
16.1 If a Party or its Affiliate (the "Non-Performing Party") is unable to
carry out any of its obligations under this Licence Agreement due to
Force Majeure this Licence Agreement shall remain in effect but the
Non-Performing Party's relevant obligations under this Licence
Agreement and the relevant obligations of the other Party ("the
Innocent Party") under this Licence Agreement shall be suspended for a
period equal to the duration of the circumstance of Force Majeure
provided that:
16.1.1 the suspension of performance is of no greater scope than is
required by the Force Majeure;
16.1.2 the Non-Performing Party gives the Innocent Party prompt
notice describing the circumstance of Force Majeure, including
the nature of the occurrence and its expected duration, and
continues to furnish regular reports during the period of
Force Majeure;
16.1.3 the Non-Performing Party uses all reasonable efforts to remedy
its inability to perform and to mitigate the effects of the
circumstance of Force Majeure; and
16.1.4 as soon as practicable after the event which constitutes Force
Majeure, the Non-Performing Party shall discuss with the
Innocent Party how best to continue its operations as far as
possible in accordance with this Licence Agreement.
16.2 If an event of Force Majeure should persist for more than 12 (twelve)
months in any territory or therapeutic area, and a Third Party has the
ability and desire to perform Alnylam's or its Affiliate's obligations
under this Licence Agreement in such territory or therapeutic area, and
Alnylam or its Affiliate does not enter into good faith negotiations
with such Third Party during such twelve month period to conclude a
Sub-licence in such territory or therapeutic area during Alnylam's or
its Affiliate's period of disability and does not conclude a
Sub-licence within 18 (eighteen) months of the commencement of the
event of Force Majeure, then CRT shall have the right to terminate this
Licence Agreement for such therapeutic area or territory as the case
may be upon thirty (30) days written notice to Alnylam. The ability and
desire of a Third Party to enter into a Sub-licence and perform
Alnylam's or its Affiliate's obligations under this Licence Agreement
in such territory or therapeutic area shall be demonstrated by CRT
introducing a potential Sub-licensee who has confirmed in writing the
terms upon which they agree to be bound. If Alnylam or its Affiliate is
unable to conclude a Sub-licence with such Third Party, but such Third
Party agrees nonetheless with CRT on the terms of an agreement to
perform Alnylam's or its Affiliate's obligations in such territory or
therapeutic area, then Alnylam or its Affiliate shall be given the
opportunity to grant a Subl-icence to such Third Party on the same
terms as those agreed between CRT and such Third Party and uponentering
a Sub-licence with such Third Party, Alnylam's and its Affiliate's
rights and obligations under this Licence Agreement in such territory
or therapeutic area will be reinstated.
SECTION CONFIDENTIAL
- 25 -
17. SEVERANCE OF TERMS
17.1 If the whole or any part of this Licence Agreement is or becomes or is
declared illegal, invalid or unenforceable in any jurisdiction for any
reason (including both by reason of the provisions of any legislation
and also by reason of any court or Competent Authority which either has
jurisdiction over this Licence Agreement or has jurisdiction over
either or both of the Parties):
17.1.1 in the case of the illegality, invalidity or un-enforceability
of the whole of this Licence Agreement it shall terminate only
in relation to the jurisdiction in question; or
17.1.2 in the case of the illegality, invalidity or un-enforceability
of part of this Licence Agreement, that part shall be severed
from this Licence Agreement in the jurisdiction in question
and that illegality, invalidity or un-enforceability shall not
in any way whatsoever prejudice or affect the remaining parts
of this Licence Agreement which shall continue in full force
and effect.
17.2 If in the reasonable opinion of either Party any severance under this
Clause 17 materially affects the commercial basis of this Licence
Agreement, the Parties shall negotiate, in good faith, to modify the
Licence Agreement to eliminate the material effect and to preserve (to
the extent possible) the original intent. If the parties fail to reach
a modified agreement within thirty (30) days after the severance under
this Clause 17, then the dispute shall be resolved in accordance with
the procedures set forth in Clause 20.
18. THIS LICENCE AGREEMENT NOT TO CONSTITUTE A PARTNERSHIP
18.1 None of the provisions of this Licence Agreement shall be deemed to
constitute a partnership between the Parties and no Party shall have
any authority to bind any other Party in any way except as provided in
this Licence Agreement.
19. PUBLIC STATEMENTS
19.1 Except as provided in Clause 19.2, neither Party shall, without the
prior written consent of the other Parties, which shall not be
unreasonably withheld:
19.1.1 use in advertising, publicly or otherwise, any trade-name,
personal name, trademark, trade device, service ▇▇▇▇, symbol,
or any abbreviation, contraction or simulation thereof, owned
by another Party (including for the sake of clarity in
relation to CRT, Cancer Research UK); or
19.1.2 represent, either directly or indirectly, that any product or
service of another Party is a product or service of the
representing Party or that it is made in accordance with or
utilises the information or documents of another Party.
19.2 The restrictions in Clause 19.1 shall not apply to the following:
19.2.1 a press release, in a form agreed to in writing by the
Parties, publicly announcing this Licence Agreement; or
SECTION CONFIDENTIAL
- 26 -
19.2.2 use as required by any applicable law or governmental
regulation; or
19.2.3 a statement that Alnylam or its Affiliate is licensed by CRT
under one or more of the patents and/or patent applications
comprising the CRT Patent Rights; or
19.2.4 re-use of any previously agreed to public statement.
20. GOVERNING LAW AND JURISDICTION
20.1 Save to the extent provided in Clause 20.2, the Parties shall attempt
to settle any dispute or claim arising out of or relating to this
Agreement by good faith negotiations. If the Parties fail to agree on a
reasonable settlement within sixty (60) days after the affected Party
informed the other Party in writing of such dispute or claim, either
Party may initiate arbitration under the procedural Rules of the
American Arbitration Association upon written notice to the other Party
within thirty (30) days after such failure. The arbitration tribunal
shall be appointed as follows: each Party shall select, within thirty
(30) days after notice to initiate arbitration, an independent and
experienced Third Party as its arbitrator. The two arbitrators selected
by the parties shall mutually select an independent and experienced
Third Party as a third arbitrator. The venue for the arbitration
procedure shall be in London, England and the validity, construction
and performance of this Licence Agreement shall be governed by the laws
of England. The award of the arbitration tribunal shall be final and
binding for the parties. Notwithstanding the foregoing, each Party may
apply for interlocutory relief in court.
20.2 In the event of a dispute between the Parties as to whether:
20.2.1 the Milestone Patent Grant has been achieved; or
20.2.1 Alnylam's belief that any Patent Rights are Blocking IP is
reasonable,
the dispute shall be referred to an independent expert in the field of
patents (acting as an expert and not as an arbitrator) appointed by
agreement between the Parties and in the absence of such agreement
within thirty (30) Business Days, then at the request of either Party
by the President for the time being of the Chartered Institute of
Patent Agents. The cost of the expert shall be borne equally by the
Parties.
SECTION CONFIDENTIAL
- 27 -
SCHEDULE 1
CRT Patent Rights
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
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[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
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[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
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[**] [**] [**] [**] [**] Pending
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[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
[**] [**]
------------------------------------------------------------------------
[**] [**] [**] [**] [**] Pending
------------------------------------------------------------------------
SECTION CONFIDENTIAL
- 28 -
SCHEDULE 2
LICENSED AFFILIATES
(details to be provided by Alnylam pursuant to Clause 2.1).
SECTION CONFIDENTIAL
- 29 -
IN WITNESS whereof this Licence Agreement has been executed by duly authorised
officers of the Parties on the date first above written.
Signed by: /s/▇▇▇▇▇▇ ▇. ▇▇▇▇▇
---------------------------
Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: Chief Executive
For and on behalf of
CANCER RESEARCH TECHNOLOGY LIMITED
Signed by: /s/▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
---------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Title: CEO
For and on behalf of
ALNYLAM PHARMACEUTICALS INC
SECTION CONFIDENTIAL
ALNYLAM
PHARMA
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ - ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
TELEPHONE - ▇▇▇-▇▇▇-▇▇▇▇
FAX-617-252-0011
5 August 2003
▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Chief Executive Officer
Ribopharma ▇▇
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
RE: CANCER RESEARCH TECHNOLOGY LIMITED AND ALNYLAM PHARMACEUTICALS, INC.
LICENSE AGREEMENT DATED 18 JULY 2003
Dear ▇▇▇▇▇▇:
By signing this letter Riopharma AG hereby agrees to be bound to Cancer
Research Technology Ltd. By the terms of the above referenced License Agreement
that specifically apply to Affiliates.
Sincerely,
/s/▇▇▇▇ ▇. ▇▇▇▇▇▇
▇▇▇▇ ▇. ▇▇▇▇▇▇
Vice President Strategy, Chief Financial Officer
Acknowledge and Agreed,
/s/▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ August 11, 2003
------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
ALNYLAM
PHARMA
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ - ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
TELEPHONE - ▇▇▇-▇▇▇-▇▇▇▇
FAX-617-252-0011
August 27, ▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
Chief Executive
Cancer Research Technology Ltd.
▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇
RE: AMENDED SCHEDULE 2 TO THE LICENSE AGREEMENT BETWEEN CANCER RESEARCH
TECHNOLOGY LIMITED AND ALNYLAM PHARMACEUTICALS, INC. DATED 18 JULY 2003
Dear ▇▇. ▇▇▇▇▇
Enclosed please find an Amended Schedule 2 to be attached to our mutual License
Agreement. The amendment adds Ribopharma AG as a licensed Affiliate, now that
our merger has been completed. Pursuant to Clause 2, I have enclosed a copy of a
letter in which Ribopharma AG agrees to be bound as an Affiliate (to CRT) by the
terms of the License Agreement.
Please sign all copies of this letter acknowledging the above and return two
letters to me.
Sincerely,
/s/▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇ Acknowledged and agreed,
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, Ph.D.
President and Chief Executive Officer
Tel: ▇▇▇-▇▇▇-▇▇▇▇ /s/▇▇▇▇▇▇ ▇. ▇▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇ ------------------
▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇
cc: J.Solbe 29/8/03
▇.▇▇▇▇▇▇▇▇ Date
Enclosures (3)