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EXHIBIT 10.43
DATED APRIL 30, 1999
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ROSLIN INSTITUTE (EDINBURGH)
GERON CORPORATION
- AND -
ROSLIN BIO-MED LIMITED
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LICENCE AGREEMENT
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Dundas & Xxxxxx
000 Xxxx Xxxxxx Xxxxxx
XXXXXXX X0 0XX
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LICENCE AGREEMENT made the 30th day of April, 1999
BETWEEN
ROSLIN INSTITUTE (EDINBURGH) a company registered in Scotland with registered
number 157100 and having its registered office at Xxxxxx, Xxxxxxxxx, Xxxxxxxxxx,
XX00 0XX ("the Licensor");
GERON CORPORATION, a Delaware corporation having a principal place of business
at 000 Xxxxxxxxxxxx Xxxxx, Xxxxx Xxxx, Xxxxxxxxxx 00000 ("Geron");
and
ROSLIN BIO-MED LIMITED a company registered in Scotland with registered number
179263 and having its registered office at Xxxxxx Xxxxxxxxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxx XX00 0XX ("RBM")
WHEREAS
(A) The Licensor is, together with the Minister of Agriculture, Fisheries
and Food, acting through the Ministry of Agriculture, Fisheries and Food
("MAFF") and the Biotechnology and Biological Sciences Research Council
("BBSRC"), the joint-owner of patent applications and the Licensor and
BBSRC are the joint owners of certain valuable know-how relating to both
nuclear transfer technology and the cloning and genetic modification of
animals;
(B) by an agreement dated 26 March and 7 April 1998, MAFF and BBSRC
irrevocably consented for all purposes (except in relation to the
Cloning of Humans) to the Licensor negotiating and granting licenses
under the said patent applications on such terms and conditions as the
Licensor shall in its entire discretion decide in respect of all
applications of the inventions which fall within the claims of the said
patent applications relating to end products for human healthcare and by
a letter dated 3 April 1998, BBSRC consented to the Licensor granting
rights in the know-how to RBM;
(C) by an agreement dated 7th April 1998 (the "Original Licence") the
Licensor granted to RBM a license of the said patent applications,
know-how and certain other intellectual property rights in respect of
the field of use defined in the Original Licence;
(D) Geron proposes to acquire the entire issued share capital of RBM and to
fund the Licensor to carry out research;
(E) to further the objectives of the Licensor in a manner consistent with
its status as a research and educational institute and its recognition
as a Scottish charity (No. SCO23592) the Licensor has agreed to grant a
new licence to Geron with agreed changes to and a wider field of use
than that contained in the Original Licence;
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(F) therefore it has been agreed, subject to the satisfaction or waiver of
certain conditions precedent, that as from the Commencement Date the
Original Licence will be terminated and a licence of the said patent
applications, know-how and other intellectual property rights be granted
to Geron on the terms and conditions set out in this Agreement; and
(G) by letters dated 29 April 1999 MAFF has consented to the Institute
granting a licence of the said patent applications, and BBSRC has
consented to the Institute granting a licence of the said patent
applications know-how and other intellectual property rights to Geron on
the terms and conditions set out in this Agreement.
NOW IT IS HEREBY AGREED as follows :
1 DEFINITIONS
1.1 In this Agreement, unless the context otherwise requires, the following
defined terms shall have the meanings set out opposite them below:-
"Associate" shall mean in relation to any company, any
subsidiary or holding company of that company or
any subsidiary of any such holding company and for
this purpose "subsidiary" and "holding company"
shall have the meanings specified in Section 736
of the Companies Xxx 0000;
"Cloning of Humans" shall mean the uterine implantation and
development of a reconstructed embryo with
identical nuclear genetic information to another
living or deceased human being;
"Commencement Date" shall mean the last date of execution of this
Agreement;
"Co-ownership Agreement" the Agreement dated 26 March 1998 between the
Licensor, BBSRC and MAFF;
"Disclosure Letter" shall mean the Warrantors' Disclosure
Letter of even date herewith referred to in the
agreement of even date herewith between Geron and,
inter alia, the Licensor for the sale and purchase
of the whole issued share capital of RBM,
"EEA" shall mean the European Economic Area as
constituted from time to time;
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"Fields of Use" shall mean, subject to Clause 4, all applications
of the Intellectual Property Rights, with the
exception of the production of and the
facilitation of the commercial manufacture of
products for pharmaceutical or Nutraceutical use
by modification of the composition of the milk of
ruminant livestock and rabbits;
"First Sale Date" shall mean the date on which Geron or a
Sub-Licensee first puts a Product or Process on
the market in the EEA;
"Geron Improvements" shall mean Improvements made or acquired by Geron
or its Associates;
"Improvements" shall mean all improvements or modifications or
adaptations to or any new application of the
Intellectual Property Rights or any part thereof
in the Fields of Use which may be made or acquired
by any party during the continuance of this
Agreement, but excluding any improvements,
modifications, adaptations or new applications of
the Intellectual Property Rights developed in the
performance of the Research;
"Intellectual Property shall mean the Patent Rights, the Know-How, any
Rights" Licensor Improvements and any copyright, design
rights or any other intellectual property rights
of a similar nature relating to the Technology
owned or co-owned by or under the control of the
Licensor;
"Know-How" shall mean all ideas, concepts, inventions,
unpatented drawings, designs, models,
specifications, data, formulae, processes and
procedures, techniques and any other technical
information or documentation (including computer
stored information and documentation) owned or
co-owned by or under the control of the Licensor
and relating to the Technology which is secret,
substantial and identified ;
"Licensor Improvements" shall mean Improvements made or acquired by the
Licensor ;
"Net Sales Price" shall mean, in relation to Sales:-
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(a) where the Royalty Products are Sold or
supplied on arms length terms, the price charged
in the relevant invoice less any value added tax
or other sales taxes and other government imposed
duties, trade or cash discounts, insurance and
packing and freight costs (to the extent
identified in the relevant invoice), rebates and
allowances for promotions and returns; and
(b) where the Royalty Products are Sold or
supplied otherwise than on arm's length terms but
are subsequently sold or supplied on arm's length
terms, the price charged under the first such
arm's length sale calculated in accordance with
paragraph (a) above less any value added tax or
other sales taxes, trade or cash discounts,
insurance and packing and freight costs (if
separately charged) and allowances for returns;
"Nutraceuticals" shall mean an active ingredient of a food which is
formulated to be consumed or administered
enterally under the supervision of a physician and
which is intended for the specific dietary
management of a disease or condition for which
distinctive nutritional requirements based on
recognised scientific principles are established
by medical evaluation and/or any milk product
intended for infant nutrition;
"Patent" shall mean any and all patents throughout the
world including any re-issues, extensions,
substitutions, continuations, divisions,
continuations in part applications and
supplementary protection certificates and all
other rights of a like nature;
"Patent Methods" means any process or method the use or practice of
which would constitute an infringement of a Valid
Claim in a particular territory but for any
licence granted under this Agreement;
"Patent Rights" shall mean the patent applications details of
which are set out in the Schedule and all
corresponding national and regional patent
applications, all
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patents which may be granted pursuant to such
patent applications, any Supplementary Protection
Certificates or other means by which any of the
aforesaid patent applications and patents or the
effects of such patent applications and patents
are extended, and all continuations, divisionals,
re-issues and re-examinations of any of the
foregoing;
"PPL License shall mean the licence agreement between PPL
Therapeutics (Scotland) Limited and the Institute
and the terms and conditions of the Department of
Trade & Industry Link project entitled "Link
Engineering Programs - Strategies for the Gene
Targeting in Livestock" dated 17, 22 and 23 June
1998;
"Process" shall mean any process which is obtained or
derived directly or indirectly from or utilising
the Intellectual Property Rights ;
"Products" shall mean any product or technology which is
obtained or derived directly or indirectly from or
utilising the Intellectual Property Rights;
"Research" shall mean the programme of research to be carried
out by the Licensor in terms of the Research
Agreement;
"Research Agreement" shall mean the Research and Licence Agreement of
even date herewith to be entered into between
Geron, the Licensor and RBM;
"Royalty Products" shall mean any product, process, kit, composition
of matter, material, or service to the extent that
the manufacture, use, sale, offer for sale, or
importation of any such product, process, kit,
composition of matter, material, or service would
constitute an infringement of a Valid Claim in a
particular territory but for the licence herein
granted by the Institute to Geron in respect of
patents which constitute Licensor Improvements.
"Quarter" shall mean the period from the Commencement Date
until 30 June 1999 (inclusive), the period of
three (3) months beginning on 1 July 1999 and each
successive period of three (3) months during the
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continuation of this Agreement, and "Quarterly"
shall be construed accordingly;
"SAC Collaboration" shall mean the academic collaboration between the
Licensor and the Scottish Agricultural College
(Aberdeen) in relation to the causes of the birth
of unusually large offspring after nuclear
transfer;
"Sale" shall mean any sale, hire, lease or other disposal
on a commercial basis of any Royalty Product by
Geron any of its Associates or any sub-licensees
and "Sold" shall be construed accordingly;
"Sub-Licensee" shall mean a sub-licensee of the Intellectual
Property Rights from Geron in accordance with
Clause 3.6;
"Technology" shall mean cell based systems for the cloning of
human and animal cells and non-human animals;
"Territory" shall mean the world;
"Valid Claim" shall mean
(a) any claim of any issued and unexpired Patent
which is a Licensor Improvement; and
(b) any claim contained within any application for
a Patent referred to in sub-para (a) which, if
granted, would constitute a Valid Claim;
and which claim has not been finally rejected or
declared invalid by a patent office or by a court
of competent jurisdiction;
"VAT" shall mean Value Added Tax; and
"Year" shall mean each period of twelve months
commencing on the Commencement Date and on each
anniversary hereof.
1.2 In this Agreement:
1.2.1 references to the singular include the plural and vice versa;
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1.2.2 references to Clauses and the Schedule are to clauses of and the
schedule to this Agreement;
1.2.3 headings to Clauses and the Schedule are inserted for
convenience only and shall not affect the construction or
interpretation of this Agreement; and
1.2.4 references to statutory provisions shall be construed as
including references to:-
(a) any statutory modification, consolidation or
re-enactment (after the date of execution of this
Agreement) of such statutory provisions for the time
being in force; and
(b) all statutory instruments or orders made pursuant to
such statutory provisions.
2 CONDITIONS PRECEDENT
2.1 This Agreement is entered into conditional upon and subject to:-
2.1.1 the completion of the acquisition by Geron of the entire issued
share capital of RBM; and
2.1.2 the execution of the Research Agreement by the Licensor, Geron
and RBM,
in each case on or before 4th May 1999 or such later date as the parties
may agree.
2.2 None of the parties shall be entitled to waive in whole or in part
compliance with the conditions contained in Clause 2.1 without the
written consent of the other parties.
3 GRANT OF LICENSE
3.1 The Licensor hereby grants to Geron an exclusive licence to use the
Intellectual Property Rights in the Fields of Use anywhere in the
Territory:
3.1.1 to develop any Products, any Process and the Technology;
3.1.2 to manufacture, have manufactured, use, market, sell, lend, let
out, hire or lease, or otherwise dispose of Products;
3.1.3 to exploit any Process; and
3.1.4 to grant sub-licences of the Intellectual Property Rights in the
Fields of Use,
subject to and on the terms and conditions contained in this Agreement.
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3.2. Subject to its obligations to keep the Know-How confidential, the
Licensor shall be entitled to use the Intellectual Property Rights and,
subject as hereinafter provided, any Geron Improvements for its own
academic research and teaching purposes and for non commercial
collaboration with other academic parties, charitable, research and
other not for profit organisations. To the extent necessary to enable
such non-commercial collaborations to proceed, the Licensor shall be
entitled to request Geron to grant Sub-licenses of the Intellectual
Property Rights and licences of Geron Improvements (but with no right to
grant further sub-licences) to such other academic parties, charitable,
research and other not for profit organisations for the sole purpose of
such non-commercial collaboration and Geron shall grant such
Sub-licenses and licenses unless it has reasonable objection thereto.
For the avoidance of doubt, any such grant by Geron may be subject to
the proposed collaborating party agreeing terms with Geron as to the
ownership and/or rights of exploitation of the results of such
collaboration and the terms under which any confidential materials may
be transferred to such collaborating party.
3.3 Except to the extent expressly permitted by or under this Agreement and
subject to any mandatory provisions under any applicable legal system
which expressly or by implication apply notwithstanding the terms of
this Agreement, the Licensor will not use for commercial purposes and
will not licence any third party to use the Intellectual Property Rights
in the Fields of Use in the Territory. The Licensor's obligations under
this Clause 3.3 shall remain in force for the duration of this
Agreement. Without prejudice to the foregoing, in respect of any country
or territory in the EEA, such obligations will remain in force in
respect of that country or territory for the longer of:
* 3.3.1 the period in which the Patent Rights [*]; or
* 3.3.2 the period from the Commencement Date until the date [*] from
the First Sale Date or the [*] through no fault of either party,
whichever is earlier.
3.4 The Licensor and Geron will execute, at their joint expense, such
short-form licence agreements as may be required by the relevant patent
registries and do such other acts and things as may be reasonably
necessary for the purpose of registering the licences granted in terms
of this Agreement in the Territory.
3.5 Geron shall from time to time keep the Licensor advised as to the
progress of any applications for regulatory approvals in the Territory
with respect to any Process and /or any Products. All such
communications shall be considered confidential and shall be treated in
accordance with Clause 8.
3.6 Geron shall be entitled to grant sub-licences of its rights under the
Agreement and to sub-contract manufacture of Products to appropriate
third parties, provided that the
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* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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sub-contract agreement contains undertakings by the sub-contractor to
observe all applicable provisions of
* this Agreement and that the sub-contract [*], and the sub-licence
agreement contains undertakings by the Sub-Licensees to perform
provisions substantially similar to those contained in this Agreement
with regard to fields of use, confidentiality and termination (including
in particular a prohibition on Cloning of Humans) and prohibits
assignation, although in the case of Sub-Licensees further sub-licensing
to any extent may be permitted.
3.7 Following termination of this Agreement, any sub-licence that has been
granted by Geron
* shall, except as provided in Clause 3.8, continue to operate provided
that [*]
3.8 Geron shall, prior to or within 30 days of the grant of any sub-licence,
notify the Licensor of the identity of the Sub-Licensee and the fields
of use for which the sub-licence has been granted. The Licensor acting
reasonably and with good reason may object in writing to the relevant
Sub-Licensee within 30 days of receipt of Geron's notification under
this Clause specifying the reason for the Licensor's objection. Where
* the Licensor acting reasonably has notified Geron of its objection to
any Sub-Licensee under this Clause, the sub-licence agreement which
Geron has entered into with that Sub-Licensee shall, upon termination of
this Agreement, [*]
3.9 Geron shall at all times indemnify and keep indemnified the Licensor
against all losses, costs, claims, damages or expenses incurred by the
Licensor or for which the Licensor may become liable as a result of any
breach by any Sub-Licensee or sub-contractor of the terms of any
sub-licence agreement or sub-contract agreement, as if the breach had
been a breach by Geron.
4 Use of the Intellectual Property Rights for Human Applications
4.1 Subject to Clause 6.3, Geron shall be entitled to use the Intellectual
Property Rights to produce
* [*] without requiring any further consent or permission from the
Licensor.
4.2 Notwithstanding the terms of Clause 3, Geron shall not use the
Intellectual Property Rights to carry out experiments or otherwise
engage in research in the field of the Cloning of Humans, and Geron
shall not and shall use its reasonable endeavours (including ensuring
that all sub-licence agreements contain appropriate restrictions and
taking all reasonable steps to enforce such restrictions, including
termination of the sub-licence agreement) to procure that its
Sub-Licensees shall not use the Intellectual Property Rights for the
purpose of the Cloning of Humans.
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* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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4.3 Geron shall not use the Intellectual Property Rights to carry out
experiments or otherwise engage in research in any territory which are
illegal within that territory as at the date on which the experiments
are carried out or the research is conducted.
5 TECHNICAL ASSISTANCE
Throughout the term of this Agreement, the Licensor shall deliver to
Geron the Know-How in written form in sufficient detail to enable Geron
to use and exploit to the fullest extent the Intellectual Property
Rights in the Fields of Use.
6 PERFORMANCE
6.1 Geron undertakes at all times when this Agreement is in force to use all
reasonable endeavours to exploit the Intellectual Property Rights in the
Fields of Use for commercial gain in the Territory.
6.2 All Products supplied by Geron pursuant to Sub-Clause 3.1.2 shall, where
reasonably practicable, be marked clearly with the relevant patent
numbers of the Licensor and a statement that the Products are
manufactured and supplied by Geron under licence from the Licensor.
6.3 Geron will ensure that it conforms with all legislation, rules,
regulations and statutory requirements, including but without limitation
obtaining necessary consents from the relevant authorities, existing in
any country within the Territory from time to time in relation to the
use and exploitation of the Intellectual Property Rights in that
country.
7 IMPROVEMENTS
7.1 If during the term of this Agreement the Licensor or Geron develops an
Improvement then it shall forthwith notify the other in writing of the
Improvement and shall disclose all necessary information to permit the
use of the Improvement by the other party upon the terms of this
Agreement, except neither Geron nor the Licensor shall be obliged to
disclose any Improvement to the other to the extent that or for so long
as the party disclosing is precluded from doing so by law or any
obligation owed to a third party.
7.2 Any Improvements developed by the Licensor shall be the absolute
property of the Licensor and any Improvements developed by Geron shall
be the absolute property of Geron.
7.3 Where any party has developed or acquired an Improvement it shall have
sole discretion as to whether and in what manner to apply for patent
protection.
7.4 If during the term of this Agreement the Licensor shall make any
discoveries or inventions which have application in the Fields of Use
not falling within the definition of "Improvement" pursuant to this
Agreement or which is not an intellectual property
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right and arising in the performance of Research Geron shall to the
extent that the Licensor is not prohibited by law or any obligation to
any other person have a right of first refusal with respect to such
discovery or invention. The Licensor shall use its reasonable endeavours
to present any such discovery or invention to Geron promptly and Geron
shall have 60 days from such notification within which to make the
Licensor an offer to obtain a licence of any such discovery or
invention. The Licensor agrees that it shall consider all such offers in
good faith and shall revert to Geron within 60 days of receipt of the
offer with its acceptance or refusal. If the Licensor refuses any such
offer from Geron, it shall be free to grant any rights to such discovery
or invention to any third party on terms no less favourable to the
Licensor as those offered by Geron.
8 CONFIDENTIALITY
8.1 Both during the term of this Agreement and following its expiry or
termination each party shall keep the Know-How and any confidential
know-know disclosed to it under Clause 7 confidential and use the
Know-How and confidential know-how only for the purpose of this
Agreement and not at any time for any reason whatsoever (save as
permitted by this Agreement) to disclose or permit to be disclosed the
same to any third party other than any Sub-Licensees (to any level of
sub-licensing) or to any persons who the party considers need to know
the same in connection with its use of the rights granted to it under
this Agreement, but then only if such persons have been informed of the
secret and confidential nature of the same and have agreed to be bound
by an obligation of confidentiality in terms no less onerous than the
obligations of confidentiality to which the parties have agreed in this
Clause.
8.2 Each party undertakes and agrees not to disclose or permit to be
disclosed to any third party or make use of or permit to be made use of
for any purpose other than as permitted by this Agreement any trade
secrets or any confidential information relating to the other parties'
business, affairs or finances which comes into their possession. In the
case of the Licensor this obligation shall cover the identity of any
Sub-Licensee and any information relevant to such Sub-Licensee disclosed
by the Licensor under Clause 3.
8.3 The obligations referred to in Clauses 8.1 and 8.2 shall not extend to
any information which:
8.3.1 is generally available to the public otherwise than by reason of
breach by the recipient of the provisions of this Clause 8;
8.3.2 is known to the recipient party and is at its free disposal
prior to its receipt under this Agreement provided that such
prior knowledge can be demonstrated by written evidence;
8.3.3 is subsequently disclosed to the recipient party without
obligations of confidence by a third party owing no such
obligations in respect thereof;
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8.3.4 is required to be disclosed to any governmental or other
authority or other regulatory body including, without
limitation, MAFF, BBSRC or as may be required under the National
Audit Xxx 0000 or otherwise legally required to be disclosed
PROVIDED THAT in all cases the party required to make the
disclosure shall take all reasonable steps to ensure that the
disclosure is the minimum necessary to comply with its legal
requirements and in the case of any disclosure pursuant to any
Court order to seek from the Court an appropriate order
safeguarding the confidentiality of the material disclosed;
8.3.5 is independently developed by the recipient party without
reference to the information disclosed to it under this
Agreement,
PROVIDED THAT in using such information the recipient party shall not
take any action which would prevent protection of an invention or any
intellectual property right contained in such information.
9. Royalties
9.1 Geron shall pay to the Institute royalties in respect of all Sales of
Royalty Products during each Quarter at the rate of [*] per cent of the
* aggregate Net Sales Prices of the Royalty Products Sold during that
Quarter.
9.2 Any royalties payable by Geron in respect of Royalty Products Sold
during any Quarter shall be paid within sixty (60) days following the
end of that Quarter in accordance with the procedures set out in Clauses
9.5 to 9.7 and shall be accompanied by a written statement showing:-
9.2.1 the total number of Royalty Products Sold during the relevant
Quarter;
9.2.2 the Net Sales Price in respect of each Royalty Product Sold
during the relevant Quarter; and
9.2.3 the total amount of the royalties payable with all necessary
particulars of how the royalties have been calculated.
9.3 If any judgment that one or more Patent claims which constitute a
Licensor Improvement are not Valid Claims is subsequently reversed on
appeal then the Patent claims in question shall be deemed to have been
Valid Claims for the whole of the period ("the relevant period") from
the date of first judgment until the date of the Appeal (the "Appeal
Judgment"). Within sixty (60) days of the date of the Appeal Judgment
Geron shall provide to the Institute a statement containing a
recalculation of the Royalties arising during the relevant period taking
into account that the aforesaid Patent claims were Valid Claims and
shall at the same time pay to the Institute any
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* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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shortfall between the Royalties previously paid in respect of the
relevant period and the Royalties which are shown by such recalculation
to have been due.
9.4 For the avoidance of doubt Geron shall only be obliged to pay royalties
in respect of Sales of Royalty Products. All the other licenses and
privileges granted to Geron hereunder shall be royalty free and Geron
shall not be obliged to make any payment to the Institute in respect of
Geron's exercise of such licenses and privileges.
9.5 All sums payable to the Institute under this Agreement:-
9.5.1 are stated exclusive of value added tax or any other tax which
may at any time during the period of this Agreement replace
value added tax, which (if payable) shall be paid in addition by
Geron at the appropriate rate subject to receipt of a suitable
invoice; and
9.5.2 shall be paid in Pounds Sterling by bank transfer to the
Institute's bank account
* [No: [*]] at Bank of Scotland, The Mound, Edinburgh (Sort Code
No [*]) or such other bank account as may be designated in
writing by the Institute.
9.6 Without prejudice to any other rights accruing to the Institute, if any
sums payable by Geron to the Institute pursuant to this Agreement remain
unpaid on the due date for payment,
* interest at the rate of [*] above the base rate from time to time of the
Bank of Scotland shall be payable on such sums from the due date for
payment until the date of actual payment in full, PROVIDED THAT no
interest shall be payable by Geron where the failure to make payment by
the due date is due to any default or failure on the part of the
Institute.
9.7 All sums payable under this Agreement shall be made in full without
deduction of taxes, charges and other duties (including any withholding
or other income taxes) that may be imposed except where Geron is
required by law to make such deduction or withholding, in which event
Geron shall:-
9.5.1 ensure that the deduction or withholding does not exceed the
minimum amount legally required;
9.5.2 pay to the applicable taxation or other authorities within the
period for payment permitted by law the full amount of the
deduction or withholding;
9.5.3 furnish to the Institute, within the period for payment
permitted by law, either (a) an official receipt of the
applicable taxation or other authorities for all amounts
deducted or withheld as aforesaid or (b) if such receipts are
not issued by the taxation or other authorities concerned on
payment to them of amounts so
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* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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deducted or withheld, a certificate of deduction or equivalent
evidence of the relevant deduction or withholding; and
9.5.4 co-operate in all respects necessary to permit the Institute to
take advantage of such double taxation agreements as may be
available.
10 Proper Accounts
10.1 Geron shall maintain (and retain for not less than six (6) years) true
and accurate accounts and records of all Sales which shall show in
sufficient detail all facts necessary for the accurate calculation of
the royalty payments payable by Geron pursuant to this Agreement.
10.2 Geron shall permit the Institute and its accountants not more than once
in any Year on reasonable prior notice to inspect the accounts and
records referred to in Clause 10.1 for the purpose of verifying that all
royalties due to the Institute pursuant to this Agreement have been
properly calculated. The Institute shall, and shall procure that its
accountants shall, treat information arising from such inspection as
strictly confidential.
10.3 If it is established that the amount of royalties paid in respect of any
Quarter is 5% or more less than the amount of the royalties which were
properly payable under Clause 9 in respect of that Quarter Geron, shall,
within seven (7) days of the date on which it is so established, pay the
shortfall to the Institute together with any interest due thereon and
the reasonable costs and expenses incurred by the Institute in making
the inspection and audit pursuant to which the underpayment is
discovered. Any overpayment of royalties Quarters shall be credited
against royalties owed to the Institute for the following Quarter or
shall be repaid by the Institute to Geron within fourteen (14) days of
the Institute's receipt of a notice from Geron requiring repayment.
10.4 The provisions of this Clause 10 shall remain in full force and effect
following the expiry or termination of this Agreement for any reason
whatsoever until the settlement of all subsisting claims of the
Institute under this Agreement.
11 PATENT MAINTENANCE, WARRANTIES AND INFRINGEMENT
11.1 Geron shall diligently prepare, file, prosecute and maintain all patents
and patent applications comprising the Patent Rights using patent
counsel of its choice. Geron shall have sole discretion in relation to
the patenting strategy to be adopted in relation to any patentable
inventions, patent applications and/or patents comprised within the
Patent Rights provided that Geron shall consult with the Licensor in
relation to the patenting strategy and shall take reasonable account of
any comments received from the Licensor in relation to and prior to
implementation of such patenting strategy. Geron will promptly provide
copies of all relevant documentation to the Licensor so that, insofar as
reasonably practicable, the Licensor may be currently informed of the
continuing
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prosecution and maintenance of the Patent Rights and may comment upon
such documentation sufficiently in advance of any initial deadline for
filing a response thereto.
11.2 Geron will use all reasonable efforts to amend any patent applications
to include reasonable and appropriate claims requested by the Licensor
to protect patent products contemplated to be sold, or patent methods
contemplated to be practiced, in connection with the production of and
the facilitation of the commercial manufacture of products for
pharmaceutical or Nutraceutical use by modification of the composition
of the milk of ruminant livestock and rabbits.
*11.3 The Licensor shall bear [*] and Geron shall bear [*] of all costs
actually incurred by the Licensor and/or Geron on or after the
Commencement Date relating to the preparation and maintenance of the
Patent Rights ("Patent Costs"). Patent Costs shall include inter alia
filing costs such as government fees as required, extension fees where
appropriate, translation charges relating to claims and/or the entire
patent applications or patent applications in non-English speaking
territories as the case may be, filing costs in relation to any
divisional, continuation or continuation-in-part patent application or
patent applications which may arise in the course of prosecution of any
patent application and expenses related thereto, reasonable professional
charges of patent agent or patent attorney or patent counsel engaged by
Geron, reasonable expenses relating to the travel or accommodation of
the patent agent or patent attorney or patent counsel incurred in
connection with actions required relating to the patent application(s)
and/or granted patent(s) which may arise and all costs relating to
interferences, oppositions and the defence of any invalidity claims
pursuant to clause 11.4 which may arise in the course of the viable life
of any of the Patent Rights. Patent costs shall not include any internal
costs of the parties and the expense of any management time.
11.4 If at any time any claim is made by a third party that any of the Patent
Rights is invalid, then each party shall promptly notify the other
parties of such claim. Geron shall be entitled to conduct the defence of
any such claim provided that Geron shall at all times keep the Licensor
informed as to the progress of such defence, and shall insofar as it is
practicable to do so, take into account any comments received from the
Licensor prior to taking any steps in the conduct of such defence. The
Licensor hereby agrees to do any deeds, execute any agreements and
render any assistance as Geron shall reasonably require for the purpose
of conducting the defence of any third party claim (including
authorising any attorneys appointed by Geron to conduct the defence in
the name of the Licensor) providing that Geron shall indemnify the
* Licensor against [*] of its reasonable costs and expenses actually
incurred in doing any such deeds, executing any agreements or rendering
any assistance pursuant to this Clause. If within a period of 90 days
from the date upon which notice of any third party
--------
* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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claim is received Geron has not initiated defence of the claim the
Licensor shall be entitled to do so in its own name and at its own
expense and Geron hereby agrees to do any deeds, execute any agreements
and render any assistance as the Licensor shall reasonably require for
the purpose of conducting the defence of any third party claims provided
that the Licensor shall indemnify Geron against its reasonable costs and
expenses actually incurred in doing any deeds, executing any agreements
or rendering any assistance pursuant to this Clause . Subject to the
foregoing provisions of this Clause the Licensor shall not take any part
in the defence of any claims and shall not settle or compromise any
claims in any way without the prior written consent of Geron.
11.5 Notwithstanding any other provisions of this Agreement, Geron may, upon
90 days written notice to the Licensor terminate its obligations with
respect to prosecution and maintenance of any of the patents and patent
applications comprising the Patent Rights and payment of the Patent
Costs incurred after the effective date of such notice with respect to
any particular patent application or patent in any or all countries or
territories. The Licensor may continue prosecution and/or maintenance of
such patent application or patent at its sole discretion and expense,
and Geron shall have no further right or licences thereunder in this
Agreement or otherwise.
11.6 The Licensor warrants to Geron that :
11.6.1 as at the Commencement Date it, MAFF and BBSRC are be the
co-owners of the Patent Rights but that as between and among
them the Licensor has and shall at all times have full and sole
authority to make any decisions and take any necessary steps to
protect and enforce the Patent Rights.
11.6.2 it has the authority to enter into this Agreement and to grant
the rights granted under this Agreement;
11.6.3 save for the rights granted to PPL Therapeutics (Scotland)
Limited under the PPL Licence and the rights arising under the
SAC collaborations it has not granted and will not during the
term of this Agreement grant to any third party any rights which
are inconsistent with the rights granted under this Agreement;
11.6.4. it has not granted and will during the term of this Agreement
not grant to any third party to whom it licenses the Patent
Rights outside the Fields of Use any greater right in relation
to patent prosecution or patent maintenance then are granted to
Geron pursuant to the Agreement;
11.6.5 as at the Commencement Date the Intellectual Property Rights
constitute all the intellectual property rights owned by or
under the control of the Licensor required to exploit the
Intellectual Property Rights in the Fields of Use;
11.6.6 as at the Commencement Date it has not received notice of any
third party rights which would prevent the exercise by Geron of
any of the rights granted under this Agreement; and
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11.6.7 as at the Commencement Date , it has not disclosed the Know-How
to any third party except as expressly permitted by the terms of
this Agreement.
The warranties under Clauses 11.6.5, 11.6.6 and 11.6.7 are subject to
the information disclosed in the Disclosure Letter.
11.7 Each party shall forthwith notify the other parties of any infringement
or suspected infringement of any Intellectual Property Rights by any
person, which comes to that party's attention. Unless otherwise agreed
Geron shall have 90 days in which to commence at its own expense
proceedings for the purposes of protecting such Intellectual Property
Rights in the Fields of Use. The Licensor hereby authorises Geron to
institute proceedings in the joint names of Geron and the Licensor in
respect of any such infringement or suspected infringement of the
Intellectual Property Rights in the Fields of Use. The Licensor hereby
agrees to do any deeds, execute any agreements and render any assistance
as Geron shall reasonably require for the purposes of any such
infringement action (including authorising any attorneys appointed by
Geron to conduct the action in the name of the Licensor) provided that
Geron shall indemnify the Licensor and keep it identified against its
reasonable costs and expenses actually incurred in doing any deeds,
executing any agreements or rendering any assistance pursuant to this
Clause. Geron shall have full conduct of any such proceedings and the
right to give instructions to the appointed attorneys as to how such
proceedings are to be conducted but shall at all times keep the Licensor
informed as to the conduct of the proceedings and shall take account of
all reasonable comments of the Licensor in relation to the proceedings.
Subject thereto and to the provisions of Clause 11.8, the Licensor shall
not take any part in the proceedings and shall not settle or compromise
such proceedings in any way without the prior written consent of Geron.
11.8 If within the period of 90 days specified in Clause 11.7 Geron has not
initiated any action in respect of the infringement of the Intellectual
Property Rights then the Licensor shall be entitled to do so in its own
name and at its own expense and Geron hereby agrees to do any deeds,
execute any agreements and render any assistance as the Licensor shall
reasonably require for the purposes of any such infringement action
provided that the Licensor shall indemnify Geron against its reasonable
costs and expenses actually incurred in doing any deeds, executing any
agreements or rendering any assistance pursuant to this Clause.
11.9 Subject to reimbursing in full all costs and expenses incurred by the
parties in bringing any infringement actions pursuant to Clauses 11.7
and 11.8 any damages or costs awarded or any sums which are agreed to be
paid in settlement of any such action will belong solely to the party
bringing the infringement action.
11.10 Geron shall at all times indemnify and keep indemnified the Licensor,
against all costs, claims, damages or expenses incurred by the Licensor
or for which the Licensor may become liable with respect to any product
liability claim relating to any Process or Products produced or supplied
or put into use by Geron (or any Sub-Licensee or any sub-contractor
appointed by Geron) pursuant to this Agreement, provided that the
Licensor shall give, at Geron's expense, such assistance as Geron may
reasonably require
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in order to defend any such claim, shall not without the prior written
consent of Geron take any steps to defend, settle or compromise any such
claim, and shall not without such consent make any admission with
respect to such claim. Such indemnity will not apply where the costs,
claims, damages or expenses arise as a result of negligence or wilful
deceit by the Licensor, its agents or employees.
11.11 At all times during which any Products are being produced, supplied or
put to use by Geron or any of the Associates or any sub-licensee, Geron
shall in order to meet its obligations to the Institute under Clause
11.10, either self insure or obtain and maintain reasonable insurance in
each case commensurate with good industry practice. In the event that
Geron obtains insurance it shall on request by the Institute, and
(subject to Clause 8) supply the Institute with a copy of the insurance
policy.
12 ASSIGNATION
12.1 Subject to Clause 3.6 none of the parties may assign, transfer,
sub-contract or otherwise dispose of the benefit or burden of this
Agreement to a third party without the prior written consent of the
other parties, such consent not to be unreasonably withheld or delayed
save that:
12.1.1 the Licensor may assign the benefit or burden to a publicly
funded research body (including a trust, foundation or similar
body) which assumes all rights and obligations of the Licensor
under this Agreement; and
12.1.2 Geron may assign the benefit and burdens of this Agreement in
connection with the sale of all or substantially all of the
assets of Geron whether by way of sale, merger or other
corporate reorganisation; and
12.1.3 Geron may assign the benefit and burden of this Agreement to any
Associate of Geron;
PROVIDED THAT in the case of an assignation pursuant to Sub-Clauses 12.1.2 or
12.1.3 if the Licensor is able to reasonably demonstrate that the proposed
assignee is incapable of fulfilling Geron's obligations under this Agreement
then Geron will remain liable to the Licensor to procure the performance of such
obligations notwithstanding that it may have assigned this Agreement.
13 TERM AND TERMINATION
13.1 Subject to any mandatory provisions under any applicable legal system
which expressly or by implication apply notwithstanding the terms of
this Agreement, this Agreement shall start on the Commencement Date and
shall continue in force, on a country by country or territory by
territory basis, as appropriate, until the later of:
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* 13.1.1 [*] or
* 13.1.2 [*] from the Commencement Date or (in relation to countries
within the EEA) [*] from the First Sale Date, whichever is the earlier
* This Agreement shall expire [*]
13.2 This Agreement may be terminated by the Licensor forthwith by notice in
writing in the event of a breach by Geron of its obligations under
Clauses 4.2 (Cloning of Humans) or 4.3 (Illegal Uses).
13.3 If Geron challenges the validity or contests the Licensor's ownership of
any of the Patent Rights or if Geron claims that any or all of the
Patent Rights is not a "necessary patent" within the meaning of
Commission Regulation EEC No. 240/96 or contests the secrecy or
substantial nature of the Know-How, the Licensor shall be entitled to
terminate this Agreement forthwith by giving written notice to Geron.
13.4 Geron may at any time terminate this Agreement by giving not less than
90 days' written notice of termination to the Licensor.
13.5 The Licensor and RBM hereby agree that the Original Licence shall
terminate with effect from the Commencement Date. The termination of the
Original Licence is without prejudice to any accrued rights and
obligations of the Licensor and RBM as at the date of termination
thereof. The provisions of Clauses 8 and 9 of the Original Licence shall
remain in full force and effect as regards the Licensor's and RBM's
rights and obligations under those clauses in respect of the period
prior to the termination of the Original Licence.
14 CONSEQUENCES OF TERMINATION
14.1 Upon termination of this Agreement pursuant to Clauses 13.2, 13.3 or
13.4;
14.1.1 Geron shall be entitled to sell any stock of the Products
manufactured prior to the date of termination, but shall not be
entitled to manufacture any further Products or further exploit
any Process;
14.1.2 Each party shall remain due to pay to the other any sums which
have accrued, or which subsequently accrue, due hereunder and
shall not be entitled to reimbursement of any such sums paid or
any proportions thereof;
14.1.3 each party shall return to the other parties any property of the
other parties in its possession or under its control;
--------
* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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14.1.4 each party shall return to the other parties any Know-How or
other technical documentation or information provided to it by
the other parties in the course of this Agreement;
14.1.5 Geron shall co-operate with the Licensor in the cancellation of
all or any confirmatory licences registered pursuant to Clause
3.4 of this Agreement, and shall execute any and all such
documents and do acts and things as may be reasonably required
in such connection;
* 14.1.6 any sub-contracts entered into by Geron under Clause 3.6
shall [*]; and
14.1.7 any sub-licenses granted by Geron in accordance with Clause 3.6
shall be dealt with in accordance with Clauses 3.7 and 3.8.
14.2 Upon termination or expiry of this Agreement all rights and licenses
granted in favour of the Licensor or Geron under this Agreement shall
cease except and to the extent expressly provided otherwise under the
terms of this Agreement.
14.3 Clauses 1, 3.7, 3.9, 8, 9.2, 9.6, 10.1, 11.2, 11.10, 11.11, 13.5, 14,
16, 19, 22 and 23 shall survive the termination or expiry of this
Agreement.
14.4 Termination of this Agreement shall not affect any rights or obligations
of any of the parties either party which have accrued prior to the date
of termination and all provisions which are expressed to or by
implication survive the termination of this Agreement shall remain in
full force and effect.
14.5 For the avoidance of doubt if this Agreement terminates by reason of the
expiry of the Patent Rights, the Licensor acknowledges that Geron shall
be entitled to use the Technology thereafter without reference to the
Licensor.
15 WAIVER
15.1 The failure of a party to exercise or enforce any right conferred upon
it by this Agreement shall not be deemed to be a waiver of any such
right or operate so as to bar the exercise or enforcement of such right
at any time or times thereafter. No waiver or discharge shall be valid
unless in writing and signed by the relevant party against whom such
waiver or discharge is sought to be enforced.
16 NOTICES
16.1 Notice under this Agreement shall be given by delivery by hand, or by
recorded delivery mail, posted prepaid and addressed as follows:
--------
* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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22
In the case of Licensor:
Roslin Institute (Edinburgh)
Roslin
Edinburgh
Midlothian EH25 9P5
For the attention of: (Company Secretary)
In the case of Geron:
Geron Corporation
000 Xxxxxxxxxxxx Xxxxx
Xxxxx Xxxx
Xxxxxxxxxx 00000
For the attention of:VP Corporate Development
In the case of RBM:
Roslin Bio-Med Limited
x/x Xxxx Xxxxxxxxx (Xxxxxxxxx)
Ruby
Edinburgh
Midlothian EH25 9P5
For the attention of: Managing Director
If a party changes its address for notification purposes, then it shall
give the other parties prior written notice of the new address and the
date on which it shall become effective.
Notices served by mail shall be deemed to be delivered 72 hours after
the date of posting.
17 ENTIRE AGREEMENT
17.1 With effect from the Commencement Date this Agreement constitutes the
entire Agreement between the parties relating to the subject matter
hereof and supersedes all prior agreements in connection with that
subject matter. No amendment or alteration or addition variations or
waiver of or to the terms of this Agreement shall be valid unless in
writing and signed by each of the parties.
18 FORCE MAJEURE
18.1 In the event that either Geron or the Licensor is delayed or prevented
from the performance of its obligations under this Agreement by any
cause beyond its reasonable control it shall immediately inform the
other. The party whose performance is delayed or prevented shall be
released from its obligations under this Agreement for so long as
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such circumstances prevail, provided that it shall use its reasonable
endeavours to avoid or remove the cause of delay or non-performance.
19 PUBLICITY
19.1 None of the parties shall use the name of the other parties (and
Geron and RBM shall not use the name "Dolly" or the name of any member
of staff employed by or at the Licensor) in any publicity advertising or
news release without the prior written consent of the other parties,
such consent not to be unreasonably withheld.
19.2 None of the parties may issue a press release in relation to this
Agreement unless its wording has been agreed by the other parties, such
agreement not to be unreasonably withheld.
20 NO AGENCY
20.1 Nothing in this Agreement shall be deemed to constitute a partnership
between the parties nor shall any party have any authority to bind or
commit the other or have authority to act as the agent of the other or
in any others capacity other than expressly authorised in this
Agreement.
21 FURTHER ASSURANCE
21.1 Each party agrees that it will do all such further acts and undertake as
such further deeds as may be necessary in order to give full effect to
the transaction herein set out and to fully vest in Geron the rights and
licences granted hereunder.
21.2 The Licensor agrees that it will at the request and cost (as to out of
pocket expenses only) of Geron exercise its rights under the
Co-ownership agreement and seek to procure the reasonable co-operation
of MAFF and BBSRC to give full effect to the provisions of this
agreement.
22 COMPLIANCE WITH LAWS
22.1 In their performance of their respective obligations pursuant to this
Agreement, the parties shall comply in all respects with the
requirements of Scottish law.
23 GOVERNING LAW
23.1 This Agreement shall be governed by and construed in accordance with the
law of Scotland and each party hereby irrevocably submits to the
non-exclusive jurisdiction of the Scottish courts.
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IN WITNESS WHEREOF these presents consisting of this and the preceding 20 pages
together with the Schedule annexed hereto are executed as follows:
Subscribed for and on behalf of )
ROSLIN INSTITUTE (EDINBURGH) )
at__________________________________________)
on the______day of________1999______________)
by_____________________its Director_________) _________________________
Director
before the following witness:-
Name _______________________________________
Address_____________________________________
____________________________________________
____________________________________________
Witness_____________________________________
Occupation__________________________________
Subscribed for and on behalf of )
GERON CORPORATION )
at__________________________________________)
on the______day of________1999______________)
by_____________________its Director_________) _________________________
Vice President
before the following witness:-
Name _______________________________________
Address_____________________________________
____________________________________________
____________________________________________
Witness_____________________________________
Occupation__________________________________
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Subscribed for and on behalf of )
the said ROSLIN BIO-MED LIMITED )
at__________________________________________)
on the______day of________1999______________)
by__________________________________________
one of its Directors________________________) _________________________
Director
before the following witness:-
Name _______________________________________
Address_____________________________________
____________________________________________
____________________________________________
Witness_____________________________________
Occupation__________________________________
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SCHEDULE
This is the Schedule referred to in the foregoing Licence Agreement
between (1) Roslin Institute (Edinburgh) (2) Geron Corporation and (3)
Roslin Bio-Med Limited.
* [*]
--------
* Material has been omitted pursuant to a request for confidential treatment.
Such material has been filed separately with the Securities and Exchange
Commission.
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