LICENSE AGREEMENT
WHEREAS, on April 20, 1990 The Ohio State University, an instrumentality of
the State of Ohio, and The Ohio State University Research Foundation, a
non-profit corporation of Ohio having a principal place of business at 0000
Xxxxx Xxxx, Xxxxxxxx, Xxxx 00000-0000 (herein after collectively "OSU") and
Clinetics Corporation, a corporation of California entered into a License
Agreement; and
WHEREAS, on Xxxxxxxx 0, 0000, XXX and Clinetics Corporation amended the
License Agreement of April 20, 1990 whereby the said License Agreement was
assigned to ImmunoTherapy Corporation (hereinafter "ITC") by Clinetics
Corporation subject to its guarantee by a letter agreement dated October 21,
1993 of the performance by ITC; and
WHEREAS, on August 15, 1994, OSU, Clinetics Corporation, ITC and the World
Health Organization amended the License Agreement to replace Section 5, of
the said License Agreement to more fully describe the third party benefits;
and
WHEREAS, by a letter dated September 8, 0000, XXX notified ITC that ITC had
breached the said Agreement as specified in five numbered sentences and, that
unless the breaches were cured, OSU would terminate the said Agreement on
November 10, 1995; and
WHEREAS, as the parties have agreed to cancel the said Agreement and to enter
into this new License Agreement, which incorporates the unaltered Section 5
in its entirety to protect the third party beneficiary rights;
NOW, THEREFORE, in consideration of the mutual covenants and agreements
herein contained, the parties intending to be legally bound do hereby agree
as follows:
This License Agreement (hereinafter "License") is entered into between
The Ohio State University, an instrumentality of the State of Ohio, and The
Ohio State University Research Foundation, a non-profit corporation of Ohio
having a principal place of business at 0000 Xxxxx Xxxx, Xxxxxxxx, Xxxx
00000-0000 (hereafter collectively "OSU") and Immunotherapy Corporation
(hereinafter "ITC",) a corporation of California having a principal place of
business at 00000 Xxxxxxxx Xxxxxx, Xxxxxx, XX 00000. The World Health
Organization ("WHO") is a third party beneficiary of this agreement, as
provided herein.
1.0 The following definitions shall, unless the context clearly
indicates some other meaning, apply throughout this License and any
appendices, schedules and amendments thereto:
1.1 "Subject Product" is any composition covered by a claim of a
Licensed Patent and capable of inducing or enhancing the potential for immune
response to human chorionic gonadotropin.
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1.2 "Subject Vaccine" is a Subject Product that is fully formulated so as
to be practically effective and safe for administration to subjects.
1.3 "Subject Service" is a method or process covered by a claim of a
Licensed Patent and employed in the development, testing, manufacture or use
of a Subject Product.
1.4 "Licensed Patents" are the patents and patent applications listed in
Appendix A and, all other patents and patent applications for past and future
inventions of Xx. Xxxxxxx and coworkers under his direction first reduced to
practice before the expiration or earlier termination of this License,
insofar as such patent or application is owned or controlled by OSU during
the term of the License, unless rejected by ITC as Licensed Patents by
written notice to OSU within 30 days after receiving notice from OSU of any
such other patent or patent application or of OSU's intention to prepare and
file such application. Specifically excluded are certain Canadian patents
owned personally by Xx. Xxxxxx X. Xxxxxxx. Except as may be otherwise
provided herein, while any application included within the definition of
Licensed Patents is pending, it will be treated under this License as if it
were an issued patent in the jurisdiction(s) for which it is pending.
1.5 "Licensed Product", "Licensed Vaccine" and "Licensed Service" are
Subject Product, Subject Vaccine and Subject Service, respectively, insofar
as covered by the within License.
1.6 "Licensed Know How" is the technical data, specifications,
processes, manufacturing methods and techniques, and clinical data owned or
controlled by OSU during the term of the License which relate to or are
reasonably usable in the development, manufacture use or sale of a Subject
Product, a Subject Vaccine, or a Subject Service.
1.7 "Developing Countries" are all countries except those listed as
developed market economy countries in Appendix B.
1.8 "Net Sales" shall mean ITC's gross xxxxxxxx for Licensed Products,
Licensed Vaccine and Licensed Services produced hereunder less the sum of the
following:
(a) discounts allowed in amounts customary in the trade:
(b) sales tax, tariff duties and/or use taxes directly imposed and with
reference to particular sales;
(c) outbound transportation prepaid or allowed;
(d) amounts allowed or credited on returns;
(e) sales for research, development and product testing; and
(f) any transaction under the commitment to WHO pursuant to section 5
below.
No deductions shall be made for commissions paid to individual whether
they be with independent sales agencies or regularly employed by ITC and on
its payroll, or for cost of collections. Licensed Products, Licensed Vaccine
and Licensed Services shall be considered "sold" when billed out or invoiced.
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1.9 "Field of Use" shall be the use of Subject Products for the
treatment, detection, diagnosis and/or prevention of cancer only.
2. OSU hereby grants to ITC a license ("License") with the right to
sublicense others, under Licensed Patents and Licensed Know How to develop,
test, manufacture, export, import, sell and use Subject Products and Subject
Services in the Field of Use, which license, except insofar as otherwise
provided herein, --
(i) is, with respect to each Licensed Patent, for the full term
thereof remaining at the effective date of this Agreement or at such later
time as it becomes a Licensed Patent hereunder;
(ii) is exclusive within its scope, but does not preclude OSU from
licensing Licensed Patents and Licensed Know How to others for other
purposes, from practicing Licensed Patents or Licensed Know How for any
research or educational purpose, and is subject to rights of WHO to a
non-exclusive royalty-free license in the public sector under Licensed
Patents and Licensed Know How with the right to sub-license non-profit
organizations and governments in Developing Countries to make, use and sell
License Products, Licensed Vaccine and Licensed Services in only public
sector of Developing Countries:
(iii) includes the right of ITC to sublicense others, provided that
ITC remains responsible for all payments, representations, and
undertakings and promises made herein or hereunder by ITC to or for the
benefit of OSU or WHO; and
(iv) includes access by ITC to all Licensed Know How, data and
other information developed by Xx. Xxxxxxx and coworkers under his general
direction during the term of this license through their activities at or
on behalf of OSU and relating to the development, testing, manufacture or
use of Licensed Product, together with the right of ITC to use such
Licensed Know How, data and other information in developing, testing,
manufacturing and using Licensed Product for the ultimate purpose of
preventing or treating cancer, subject to any rights of others in such
data and other information and to obligations of confidentiality where
appropriate.
3. ITC will pay OSU royalties of five percent (5%) of Net Sales by ITC
in the U.S. of Licensed Product or Licensed Service. However, no royalty will
be due hereunder in respect of any transaction or activity unless such
transaction or activity would, in the absence of the within License,
constitute an infringement of a claim of a Licensed Patent, where neither
such claim nor Licensed Patent has (i) expired, (ii) been abandoned,
canceled, disclaimed or dedicated with prejudice, or (iii) been finally and
unappealable declared unpatentable, invalid or unenforceable. Any royalties
accruing hereunder solely by virtue of one or more applications pending that
are included within the definition of Licensed Patents shall be deposited in
escrow for the benefit of OSU, and will be paid to OSU upon notice to ITC
that a patent has issued on such an application.
3.1 ITC will pay OSU a royalty of two percent (2%) of Net Sales in the
U.S. of any Licensed Product and Licensed Service on which ITC paid a royalty
during the life of the
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Licensed Patents in the U. S., said royalty being for use of the Licensed Know
How and to commence only upon expiration of the last Licensed Patent in the
U. S. and to run for ten (10) years from such expiration date.
3.2 ITC will pay OSU a royalty of two percent (2%) of Net Sales by ITC
in the countries which are members of the European Economic Community (EEC)
on December 31, 1995 of any Licensed Product or Licensed Service on which
Licensed Product or Licensed Service ITC paid a royalty on sales in the U. S.
during the life of the Licensed Patents in the U. S., said obligation to
begin on the effective date of this License and run for thirty (30) years,
said royalty to be for both the Licensed Know How and for any Licensed Patent
which has or will issue in the EEC.
3.3 ITC will pay OSU twenty five percent (25%) of any royalties
received by ITC from sublicenses of the Licensed Patents and /or Licensed
Know How in the U. S., EEC or Korea.
3.4 If, beginning with the calendar quarter January 1, 1996, royalties
payable by ITC to OSU, including any royalties accrued for such quarter
under the provisions of section 3.0 above but now escrowed, do not exceed the
following amounts:
1st - 4th quarters $ 7,500 per quarter;
5th - 8th quarters $10,000 per quarter; and
Thereafter $12,500 for each quarter.
ITC shall pay OSU the difference.
3.5 All royalties and other payments due to OSU under this License will
be paid by ITC to OSU within 60 days after the close of each calendar quarter
with respect to such sales in that quarter. Such royalties will be due with
respect to each sale of any particular unit of Licensed Product, or of
Licensed Service in respect of such unit, in any form, through the first
sale of such unit, or of Licensed Service resulting in the production or use
of such unit, in the form of a Licensed Vaccine, to a buyer not affiliated
with either ITC or the seller in such transaction, provided that any
royalties paid to OSU with respect to prior sales of such unit, or of
Licensed Service in respect of such unit, in any form, will be offsettable
against royalties that would otherwise be payable to OSU hereunder with
respect to later sales of the same unit, or of Licensed Service in respect of
such same unit, in any form, and further provided that the maximum cumulative
royalty due and payable to OSU hereunder with respect to any such unit, in
all forms, shall not exceed five percent (5%) of the amount of said first
sale of such unit, or of Licensed Service involving such unit, in the form of
a Licensed Vaccine, to an unaffiliated buyer.
3.6 ITC will submit to OSU a concise written statement setting forth
the determination of the amount of royalties payable to accompany any payment
rendered but in any event not later than 60 days after the end of each
calendar quarter in which any royalties have accrued hereunder. ITC will
prepare records reasonably adequate to accurately determine the amount of
royalties payable to OSU hereunder, make such records available for
reasonable inspection and analysis by OSU, and retain such records for at
least 3 years after the end of any period in which royalties may have accrued
or until any questions with regard to such records raised
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within such 3 year period has been finally resolved, and will cause or
require others whose records are required for this purpose to do all of the
same. If it is finally determined that ITC is at any time in arrears for more
than 30 days on payment(s) totaling at least $25,000.00 owing to OSU under
this License, then, in addition to any other remedy available to Foundation,
ITC will reimburse OSU for OSU's actual and reasonable expenses in
determining and collecting such payment(s).
4.0 ITC shall initiate five (5) clinical studies of a Licensed Vaccine,
including obtaining the approval of the US FDA or such other regulatory body
having equivalent jurisdiction for such studies, for the treatment of a
cancerous condition. The first such study, involving a minimum of twenty-four
(24) patients completing the protocol, shall be in metastatic colorectal
cancer patients at the Medical College of Pennsylvania as set forth in a
letter dated October 27, 1995 from Xxxxxxx X. Xxxxxx to Xxxxxxx Xxxxxxx, and
described in Appendix C, or such other clinical site and or sites selected by
ITC to conduct an equivalent trial in colorectal cancer. This study shall be
initiated by March 31, 1996, and completed by March 31, 1998. The second such
study, involving a minimum of forty-three (43) patients completing the
protocol, shall be in pancreatic cancer patients under the direction of Xx.
Xxxxxx Xxxxxxx, or such other clinical investigators selected by ITC to
conduct an equivalent trial or trials in pancreatic cancer. A description of
this study is attached hereto as Appendix D. This study shall be initiated
May 1, 1996, and completed by May 1, 1998. ITC will initiate the third
clinical trial on or before 3/1/97. ITC will initiate the fourth clinical
trial on or before 1/1/98. ITC will initiate the fifth clinical trial on or
before 3/1/99. These milestones (planned dates) for initiating the above
mentioned clinical trials are established to exemplify and manifest the
mutual understanding and commitment of ITC and OSU to gaining product
approval for use of subject Licensed Vaccine to treat and/or prevent a
cancerous condition in a reasonable time period. It is understood and
accepted that the projected clinical trial starting dates and completion
dates as outlined in this section and sections 4.1 and 4.2 below have been
established to provide reasonable allowances for delays. Initiating and
actively pursuing the clinical trials mentioned in sections 4.0, 4.1 and 4.2
is a requirement of this agreement. It is further understood that delays
and/or modifications to the above projected clinical trial schedule may be
required for certain technical reasons, including, but not limited to,
obtaining necessary regulatory/human review committee approvals, patient
accrual, manufacturing and/or allocation of non-financial resources, all of
which may cause a delay or modification to the above projected clinical trial
schedule. In such event, ITC will promptly notify OSU of such change,
modification and/or delay. It is understood that total patient accrual in the
clinical trials mentioned in sections 4.0, 4.1 and 4.2 is subject to the
subject Vaccine meeting certain clinical trial milestones which support
continuation of patient accrual for a specified clinical trial. It is further
understood that unless the performance of subject Vaccine meets and or
exceeds minimum standards of efficacy as established in the clinical trial
protocol, ITC will not be required to complete total patient accrual in any
said clinical trial. Lack of performance for non-technical reasons in
starting the above mentioned clinical trials will be considered a material
breach of this agreement.
4.1 Following completion of the colorectal Phase I/II clinical trial
being conducted at the Medical College of Pennsylvania, ITC shall initiate at
least one additional clinical trial of a Licensed Vaccine, for the treatment
of colorectal cancer on or before 1/1/99. It is anticipated that such
additional clinical study will lead to US FDA approval for the sale of
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said Licensed Vaccine. ITC will not be obligated to conduct additional
clinical trials in colorectal cancer unless data from the present Phase I/II
colorectal study supports additional studies in colorectal cancer.
4.2 ITC shall expand the scope of its OSU pancreatic clinical trial to
include at least one additional clinical site on or before 1/1/98. ITC will
not be obligated to add an additional clinical site for the treatment of
pancreatic cancer unless data from the present pancreatic study by Xx.
Xxxxxxx supports additional studies in pancreatic cancer.
4.3 Within sixty (60) days of obtaining regulatory approval from the
U. S. FDA for commercial sale of a Licensed Product to treat a cancerous
condition, ITC shall pay OSU $500,000, which amount shall not be creditable
against minimum royalties or earned royalties. No such extra payment shall be
due for any subsequent government approval to sell a Licensed Product or a
Licensed Service anywhere in the world for the treatment and/or prevention of
a cancerous condition.
4.4 ITC shall provide Xxxxxx X. Xxxxxxx a gift of $150,000 to conduct
research, the details of such research to be at the sole discretion of Xxxxxx
X. Xxxxxxx. The money shall be paid by ITC or by one or more third parties on
behalf of ITC in three (3) equal installments of $50,000 each beginning in
1996, on June 1 or the first business day thereafter. The research program
shall begin on June 3, 1996, and shall terminated on June 1, 1999, unless
extended by agreement of the parties. In the event Xx. Xxxxxxx is unable or
unwilling to continue work under the grant at any time prior to June 1, 1999,
this program shall be canceled, and ITC shall have no obligation to make any
future payments coming due after such cancellation.
4.5 ITC will keep OSU apprised of the progress and status of those
activities set forth in paragraph 4.0 at least quarterly, under obligation of
confidentiality where appropriate. ITC will give OSU opportunity to make
recommendations with respect to clinical studies (including product
formulation) and will consider in good faith any such recommendations that
OSU may make.
5.0 Subject to the terms and conditions of this License, ITC will
undertake, at the instance of WHO and on reasonable terms favorable to the
recipients, to supply Licensed Vaccine and other Licensed Product, for
distribution under the auspices of governmental and/or non-profit entities for
the ultimate purpose of preventing and/or treating cancer in humans in
Developing Countries. ITC's obligations to WHO shall be limited to the supply
of Licensed Vaccine and Licensed Product in Developing Countries for which
the governmental authorities, or in which the aforesaid non-profit entities,
wish to have such Licensed Vaccine and/or Licensed Product distributed. The
foregoing shall not, however, be construed as an obligation on the part of
ITC to register the Licensed Vaccine and Licensed Product in such Developing
Countries. In Developing Countries where the Licensed Vaccine and/or other
Licensed Product is not registered, it shall be the responsibility of the
aforesaid governmental or non-profit entities to ensure such registration
prior to the distribution of the Licensed Vaccine and/or other Licensed
Product in such Developing Countries. ITC shall, however, provide the said
governmental and non-profit entities with its full cooperation to permit such
registration.
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5.1 The supply referred to in section 5.0 above shall be at
manufacturing cost, including full allocation of overhead based on ITC's
overall production of the Licensed Vaccine or other Licensed Product, plus
the cost of liability insurance for the public sector of the Developing
Country, plus a xxxx-up of twenty five percent (25%). No more than twenty
percent (20%) of ITC's gross capacity (as of the time for delivery) shall be
required to be devoted to such supply. In no event will this Section 5 impose
requirements on ITC's licensees. All supplies contemplated by section 5.0
above shall be subject to non-cancelable written orders for Licensed Vaccine
or other Licensed Product at least six months in advance of delivery and with
commercially acceptable credit risk for such supply.
5.2 ITC will also share information with, and accept recommendations
from, WHO on the same basis as OSU under section 4.5 above, insofar as
relevant to WHO's interest in making Licensed Vaccine and/or Licensed Product
practically available for distribution in Developing Countries.
5.3 ITC's obligation to supply the Licensed Vaccine and other Licensed
Product in accordance with the provisions of this License shall be subject to
ITC having obtained all such governmental approvals and authorizations
including U.S. FDA approvals as may be required in the United States of
America to allow such production and supply. ITC shall use its best
reasonable efforts to obtain such approvals and authorizations as soon as
reasonably possible.
5.4 ITC's supply obligations shall not apply to any governmental or
non-profit entity through which ITC can show that Licensed Vaccine and/or
Licensed Product has become available for use in the private sector or for
use outside the field, in non-negligible quantities.
5.5 In the event ITC breaches any of its obligations under this Section
5, and, after receipt of a written notification to that effect from OSU,
fails to cure such breach within ninety (90) days, then ITC shall pay OSU an
additional one percent (1%) royalty on Net Sales which shall be remitted to
WHO or this License will be terminated.
5.6 ITC and OSU acknowledge that this Section 5 creates rights which are
important to the mission of WHO; however, OSU as a direct party to this
License retains the right to notify and enforce third party rights including
the right to terminate this agreement for non-performance by ITC as indicated
in Section 5.5.
5.7 ITC's supply obligations hereunder shall have an initial duration of
the earlier of (l) 10 (ten) years commencing on receipt of the first firm
orders for such supply or (2) termination of the License.
5.8 For the purpose of this License "distribution in the Public Sector"
shall mean any distribution constituting distribution on a social marketing
basis under the auspices of governmental or non-profit entities for the
ultimate purpose of preventing or treating cancer in humans in Developing
Countries.
7
6.0 This License shall become effective as of the date specified herein,
or if no such date is specified then as of the date upon which execution of
the License by ITC and OSU and of the Acknowledgment by OSU is completed.
6.1 Unless earlier terminated by a party in accordance with applicable
law or the provisions hereof, this License shall remain in effect until ten
(10) years after every patent licensed hereunder has expired and every patent
application licensed hereunder has been finally granted, refused or
abandoned, or until thirty (30) years from the effective date of this
License, whichever occurs last, provided that any specific obligations of
payment or other performance that have matured prior to termination shall
survive. Furthermore, in case of termination all information and data
relevant to obtaining or maintaining requisite regulatory approval(s) for
investigating, making and/or marketing Licensed Product obtained by or
subject to the control of ITC shall be made available for such use by OSU and
WHO, or their respective designees.
6.2 ITC may terminate the License upon written notice to OSU, provided
that such notice is given at least six months in advance of its effective
date if manufacture of Licensed Product for distribution and not solely for
research or trials has not begun as of the date of notice and at least one
year in advance of its effective date if manufacture for distribution has
begun as of the date of notice, unless OSU consents to shorter notice.
6.3 OSU may terminated this License for breach by ITC of a material term
or condition thereof by giving written notice to ITC of the breach(es) relied
upon and specifying the effective date, not less than 60 days after such
notice, when the termination shall be effective, but if within 60 days of
such notice ITC either
(i) cures such breach(es) and gives written notice to OSU of such
cure or
(ii) provides a written explanation, acknowledged by OSU to be
acceptable, of why such breach(es) has(have) not in fact occurred,
then such termination shall not take effect. Unavailability of funds will not
be deemed to excuse delay or default of performance by ITC, except that a
reasonable delay will be excused insofar as the need for funds was not
reasonably foreseeable. ITC's insolvency, bankruptcy or assignment for the
protection of creditors shall be deemed a material breach by ITC.
6.4 No waiver of any breach(es) shall constitute or imply waiver of any
other breaches(es)
6.5 Any termination of this License shall not relieve either party of
obligations, nor deprive either party of rights, that
(i) are provided for hereunder in the event of such termination,
(ii) relate to confidentiality of information or
8
(iii) relate to tender or receipt, respectively, of accrued reports,
royalties or expenses, including royalties escrowed pursuant to section 3.1
above insofar as the condition for their payment to OSU is subsequently
satisfied.
7. Neither OSU nor WHO makes any representations or warranties as to
the safety, efficacy, acceptability, or suitability for any use of any
Licensed Product or Licensed Service, or as to the accuracy or reliability of
any information provided by or for any term in connection with this License,
or as to the enforceability of any patent or other proprietary rights
granted, or as to the applicability of any other patent rights to the
products or activities contemplated herein, and in particular OSU AND WHO
DISCLAIM ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OF ANY PRODUCT, SERVICE OR INFORMATION PROVIDED BY OR UNDER THE AUTHORITY OF
EITHER OF THEM UNDER OR IN CONNECTION WITH THIS LICENSE.
8. OSU will neither abandon, cancel, disclaim (other than a terminal
disclaimer necessary to secure allowance) nor dedicate, nor fail to prosecute
or maintain, any Licensed Patent, unless ITC is first given reasonable notice
and ITC fails to give timely request and authorization to OSU in writing or
by phone call confirmed by fax to continue prosecution and/or maintenance.
ITC will reimburse OSU the full amount of the actual and reasonable expenses
thereafter incurred for such continued prosecution and/or maintenance, net of
any reimbursement to or recovery by OSU of such expenses from any third
party. OSU will give ITC prompt notice of any such reimbursement or recovery
from a third party and will credit ITC's account accordingly. ITC will
reimburse for one-half (1/2) of OSU's actual and reasonable expenses of
obtaining and maintaining Licensed Patents, incurred with respect to Licensed
Patents listed in Appendix A after the effective date of this License or with
respect to any other Licensed Patent after the date of notice to ITC of such
other Licensed Patent under section 1.4 above. Such reimbursements may be
offset against up to one-fourth of the excess of earned royalties over the
amounts of the minimum royalties specified in section 3.5 hereof, and may be
carried forward against future royalties until fully offset. Any amount due
and payable to OSU by ITC as reimbursement of such expenses, after applicable
offsets and credits, shall be paid to OSU within thirty days after receipt by
ITC of invoice therefor.
9. ITC and OSU will each promptly inform the other of any information
of which they become aware relating to possible infringement of any Licensed
Patent in the field(s) of ITC's exclusive rights under the within License.
Following consultation between them, either ITC or OSU may seek to xxxxx such
infringement by negotiation or by instituting suit, provided that:
(i) ITC will not, without the prior express written consent of
OSU, make any admission of invalidity, unenforceability or
unpatentability of, or of fraud or inequitable conduct on the part of
OSU, WHO or any employee, agent or representative of any of them in
connection with, any Licensed Patent or any claim(s) thereof, and will
take reasonable precautions against providing grounds for declaratory
judgement action by any third party against OSU and/or WHO;
9
(ii) if ITC or OSU unilaterally institutes such suit it will,
except as otherwise provided herein or agreed at the time, bear the
actual and reasonable expenses of such suit and will keep the other
party apprised of the progress thereof, and the other party will provide
reasonable cooperation of such suit, including permitting its joinder as
a necessary or indispensable party in such suit;
(iii) if ITC and OSU jointly institute such suit they will bear the
actual and reasonable expenses of such suit equally and will confer and
cooperate with each other in the prosecution and/or settlement thereof;
and
(iv) out of any recovery, whether by negotiation, preceding suit,
settlement or judgement, OSU and ITC will each first be reimbursed pro
rata for their respective actual and reasonable expenses, with any
balance divided equally between them.
10. In determining the amount of any sale, royalty, expense,
reimbursement, offset or the like under this License, the fair value of any
payment, thing, right or forbearance, constituting or in lieu of all or part
thereof shall be included in such amount.
11. In the event that either party is delayed or prevented from
performing any of the respective obligations under this License by reason of
acts of God, governmental requirements, fire, floods, strikes or because of
any other cause beyond the reasonable control of the party, then the time
period for performance of such obligations shall be extended for the period
of such delay.
12. Any notice, report or payment under this Agreement shall, if to
ITC, be sent to:
Immunotherapy Corporation
Attn. President
00000 Xxxxxxxx Xxxxxx,
Xxxxxx, Xx 00000
and, if to OSU, be sent to:
The Ohio State University Research Foundation
Office of Technology Transfer
0000 Xxxxx Xxxx
Xxxxxxxx, Xxxx 00000-0000
or to such other address for either party as that party may from time to time
give notice of to the other.
13. ITC will not use the name of OSU without the express prior written
consent of OSU, or of WHO without the express prior written consent of WHO,
in any commercial promotion or advertising relating to the subject matter of
this License.
14. This License will be construed under the laws of the State of Ohio.
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15. OSU will encourage any other licensees under the Licensed Patents to
make any improvements developed by them that may be applicable to the subject
of this License available to ITC on reasonable terms. Correspondingly ITC
will give good faith consideration to making any improvements developed by it
that may be applicable to the subject of any other licenses available to the
licenses on reasonable terms.
16. All Appendices to this Agreement must be initialed and dated by the
signatories.
AGREED TO AND ACCEPTED
The Ohio State University
By /s/ Xxxxx X. Xxxxxxxx Date 8 Mar 96
---------------------------- ------------------
Print Name/Title V.P. Bus. & Admin.
---------------------
The Ohio State University Research Foundation
By /s/ Xxxx X. La Fyatif Date 3/12/96
---------------------------- ------------------
Print Name/Title Dir. Tech. Transfer
---------------------
ImmunoTherapy Corporation
By /s/ Xxxxxxx X. Xxxxxxxx Date 2/23/96
---------------------------- ------------------
Print Name/Title
Xxxxxxx X. Xxxxxxxx
Chief Executive Officer
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APPENDIX A
Patent Applications and Patents Covered by this Agreement.
U.S. PATENTS AND PENDING APPLICATIONS
UNIVERSITY RESEARCH FOUNDATION
OUR FILE NO.
------------
2-056 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 804,642 Filed : 12-4-85
Patent No.: 4,713,366 Issued: 12-15-87
Status : Maintenance fee due 6-15-99;
Expires 12-15-2004
2-056-3 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 086,401 Filed : 8-17-87
Patent No.: 4,855,285 Issued: 8-8-89
Status : Maintenance fee due 2-8-97;
Expires 8-8-2006
2-056-3-3-1 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 07/958,601 Filed : 10-6-92
Patent No.: Issued:
Status : Pending;
2-056-3'US VACCINES AND ANTIGENIC CONJUGATES
Appl. No. : 08/406,916 Filed : 3-27-95
Patent No.: Issued:
Status : Pending
2-056-DIV 1 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/471,002 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-056-DIV 2 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/465,694 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-506-DIV 3 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/467,997 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
12
APPENDIX A (CONT.)
U.S. PATENT AND PENDING APPLICATIONS CONT'D
UNIVERSITY RESEARCH FOUNDATION
OUR FILE NO.
------------
2-056-DIV 4 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/470,744 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-056-DIV 5 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/466,473 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-056-CONT 6 ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 08/467,569 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
13
APPENDIX A (CONT.)
U.S. PATENTS AND PENDING APPLICATIONS CONT'D
OHIO STATE UNIVERSITY
OUR FILE NO.
------------
2-011-3(4)-2-3(1)- ANTIGENIC MODIFICATION OF POLYPEPTIDES
2 III
Serial No.: 73,769 Filed : 7-15-87
Patent No.: 4,762,913 Issued: 6-9-88
Status : Maintenance fee due 2-9-96;
Expires 8-9-2005
2-011-3(4)-2-3(4)- ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 073,748 Filed : 7-15-87
Patent No.: 5,006,334 Issued: 4-9-91
Status : Maintenance fee due 10-9-98;
Expires 4-9-2008
2-011-3(4)-2-3(4)- METHOD OF TREATMENT USING ANTIGENICALLY MODIFIED
-2-1 POLYPEPTIDES
Serial No.: 935,331 Filed : 8-26-92
Patent No.: Issued:
Status : Pending (on appeal);
2-011 DIV 1 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
Serial No.: 08/466,445 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-011 DIV 2 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
Serial No.: 08/469,689 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
2-011 DIV 3 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
Serial No.: 08/468,716 Filed : 6-6-95
Patent No.: Issued:
Status : Pending
14
APPENDIX A (CONT.)
U.S. PATENTS AND PENDING APPLICATIONS
OHIO STATE UNIVERSITY
OUR FILE NO.
------------
2-011-3(4) ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 936,876 Filed : 8-25-78
Patent No.: 4,201,770 Issued: 5-6-80
Status : No further action is necessary;
Expires 5-6-97
2-011-3-3-3-3 ANTIGENIC MODIFICATION OF POLYPEPTIDES
-2
Serial No.: 112,628 Filed : 1-16-80
Patent No.: 4,302,386 Issued: 11-24-81
Status : No further action is necessary;
Expires 11-24-98
2-011-3-3-3-3 ANTIGENIC MODIFICATION OF POLYPEPTIDES
-2-3
Serial No.: 323,690 Filed : 11-20-81
Patent No.: 4,384,995 Issued: 5-24-83
Status : No further action is necessary;
Expires 5-24-2000
2-011-3-3-3-3 ANTIGENIC MODIFICATION OF POLYPEPTIDES
-2-3-3
Serial No.: 472,190 Filed : 3-4-83
Patent No.: 4,526,716 Issued: 7-2-85
Status : Maintenance fee due 1-2-97;
Expires 7-2-2002
2-011-3(4)-2-3(3) ANTIGENIC MODIFICATION OF POLYPEPTIDES
Serial No.: 667,863 Filed : 11-2-84
Patent No.: 4,691,006 Issued: 9-1-87
Status : Maintenance fee due 3-1-99;
Expires 9-1-2004
2-011-3(4)-2-3(3)- ANTIGENIC MODIFICATION OF POLYPEPTIDES
2 I
Serial No.: 73,570 Filed : 7-15-87
Patent No.: 4,767,842 Issued: 8-30-88
Status : Maintenance fee due 2-28-96;
Expires 8-30-2005
15
APPENDIX A (CONT.)
U.S. PATENTS AND PENDING APPLICATION CONT'D
OHIO STATE UNIVERSITY
OUR FILE NO.
------------
2-011 DIV 4 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
SERIAL NO.: 08/465,870 FILED : 6-6-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-011 DIV 5 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
SERIAL NO.: 08/471,422 FILED : 6-6-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-011 DIV 6 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
SERIAL NO.: 08/465,777 FILED : 6-6-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-011 DIV 7 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
SERIAL NO.: 08/469,043 FILED : 6-6-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-011 DIV 8 METHOD OF TREATMENT OF ANTIGENICALLY MODIFIED
POLYPEPTIDES
SERIAL NO.: 08/466,660 FILED : 6-6-95
PATENT NO.: ISSUED :
STATUS : PENDING
16
APPENDIX A (CONT.)
FOREIGN PATENTS
UNIVERSITY RESEARCH FOUNDATION
OUR FILE NO.
------------
2-056-3(3)AU VACCINES AND ANTIGENIC CONJUGATES
APPL. NO. : 28063/92 FILED : 3-21-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-056-3(3)CA VACCINES AND ANTIGENIC CONJUGATES
APPL. NO. : 2145391 FILED : 3-23-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-506-3(3)EP VACCINES AND ANTIGENIC CONJUGATES
APPL. NO. : 92921753 FILED : 3-20-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-056-3(3)JP VACCINES AND ANTIGENIC CONJUGATES
APPL. NO. : 508977/94 FILED : 3-30-95
PATENT NO.: ISSUED :
STATUS : PENDING
2-056-3(3)KO VACCINES AND ANTIGENIC CONJUGATES
APPL. NO. : 1993-700712 FILED : 3-9-93
PATENT NO.: ISSUED :
STATUS : AWAITING COMMUNICATION FROM THE KOREA
PATENT OFFICE.
17
APPENDIX A (CONT.)
FOREIGN PATENTS
OHIO STATE UNIVERSITY
OUR FILE NO.
------------
2-011-3-3 CA ANTIGENIC MODIFICATION OF POLYPEPTIDES
CANADA
SERIAL NO.: 199003 FILED : 5-6-74
PATENT NO.: 1,057,742 ISSUED : 7-3-79
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 7-3-96
2-011-3-3-3 HK ANTIGENIC MODIFICATION OF POLYPEPTIDES
HONG KONG
APPL. NO. : 1 567 764 FILED : 10-12-76
PATENT NO.: 108/1983 ISSUED : 3-24-83
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
2-011-3-3-3 MA ANTIGENIC MODIFICATION OF POLYPEPTIDES
MALAYSIA
APPL. NO : 1,567,764 FILED : 12-20-82
PATENT NO.: 808/1985 ISSUED : 7-30-85
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
2-011-3-3-3 SI ANTIGENIC MODIFICATION OF POLYPEPTIDES
SINGAPORE
APPL. NO. : 1,567,764 FILED : 12-23-82
PATENT NO.: 635/82 ISSUED : 6-9-83
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
2-011-3-3-3 SL ANTIGENIC MODIFICATION OF POLYPEPTIDES
SIERRA LEONE
APPL. NO. : 1,567,764 FILED : 10-12-76
PATENT NO.: 113 ISSUED : 1-5-83
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
2-011-3-3-3 SR ANTIGENIC MODIFICATION OF POLYPEPTIDES
SARAWAK
APPL. NO. : 1,567,764 FILED : 10-12-76
PATENT NO.: C1838 ISSUED : 1-10-83
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
18
APPENDIX A (CONT.)
FOREIGN PATENTS CONT'D
OHIO STATE UNIVERSITY
OUR FILE NO.
------------
2-011-3-3-3 TT ANTIGENIC MODIFICATION OF POLYPEPTIDES
TRINIDAD & TOBAGO
APPL. NO. : 1,567,764 FILED : 12-17-82
PATENT NO.: 92 OF 1982 ISSUED : 12-17-82
STATUS : NO FURTHER ACTION IS NECESSARY;
EXPIRES 10-12-96
2-011(83) AU ANTIGENIC MODIFICATION OF POLYPEPTIDES
AUSTRALIA
APPL. NO. : 17040/83 FILED : 5-18-83
PATENT NO.: 570004 ISSUED : 9-2-88
STATUS : ANNUITY DUE 5-18-95;
EXPIRES 5-18-99
2-011(83) EPC ANTIGENIC MODIFICATION OF POLYPEPTIDES
EUR. XXX. CONV.
APPL. NO. : 83302888.9 FILED : 5-26-83
PATENT NO.: 117 934 ISSUED : 7-20-88
STATUS : NO FURTHER ACTION IS NECESSARY
2-011(83) GB- ANTIGENIC MODIFICATION OF POLYPEPTIDES
2 I
APPL. NO. : 8619232 FILED : 3-18-83
PATENT NO.: 2 178 041 ISSUED : 1-6-88
STATUS : ANNUITY DUE 3-18-96;
EXPIRES 3-18-2002
2-011(83) GB- ANTIGENIC MODIFICATION OF POLYPEPTIDES
2 II
APPL. NO. : 8619233 FILED : 3-18-83
PATENT NO.: 2 178 042 ISSUED : 1-6-88
STATUS : ANNUITY DUE 3-18-965;
EXPIRES 3-18-2002
2-011(83) GR ANTIGENIC MODIFICATION OF POLYPEPTIDES
GREECE
APPL. NO. : 71441 FILED : 5-24-83
PATENT NO.: 79126 ISSUED : 10-2-84
STATUS : ANNUITY DUE 5-24-96;
EXPIRES 5-24-98
2-011(83) IS ANTIGENIC MODIFICATION OF POLYPEPTIDES
ISRAEL
APPL. NO. : 68749 FILED : 5-20-83
PATENT NO.: 68749 ISSUED : 11-1-88
STATUS : ANNUITY DUE 5-19-97;
EXPIRES 5-20-2003
19
APPENDIX B
DEVELOPING COUNTRIES
1. All countries in Africa, Asia and Oceania except Australia, Israel,
Japan, New Zealand and South Africa.
2. All countries in the Americas except Argentina, Canada and the United
States.
APPENDIX C
COLORECTAL CANCER TREATMENT CLINICAL TRIAL
A condition of this License Agreement is the requirement of ITC to
pursue diligently the evaluation and testing of the Licensed Product. One
major obligaiton in such testing is the commitment to initiate two clinical
trials in 1996, one of which shall be for colorectal cancer. The timing and
scope of the COLORECTAL TREATMENT TRIAL is outlined below:
1. An hCG vaccine shall be tested in 24 subjects diagnosed with colorectal
cancer. All subjects will have measurable disease.
2. Any subjects dropping out of the study after enrollment for medical,
personal or any other reason shall be replaced with other subjects until a
minimum of 24 patients have received all treatments specified in the FDA
approved protocol.
3. This trial shall be initiated on or before March 31, 1996 and shall be
completed by March 31, 1998. Completion shall mean the complete assessment of
24 or more patients including all clinical and laboratory evaluations
described in the FDA approved protocol.
4. Any protocol changes in the number of subjects, timing of treatment or
expansion of the number of trial subjects shall be made for medical or
technical reasons, only. Any such changes shall be reported to the foundation
by ITC.
21
APPENDIX D
PANCREATIC CANCER TREATMENT CLINICAL TRIAL
A condition of this License Agreement is the requirement of ITC to pursue
diligently the evaluation and testing of the Licensed Product. One major
obligation in such testing is the commitment to initiate two clinical trials
in 1996, one of which shall be for pancreatic cancer. The timing and scope of
the PANCREATIC TREATMENT TRIAL is outlined below:
1. An hCG vaccine shall be tested in patients with metastatic pancreatic
cancer. The primary objectives will be to: (1) determine if at least 50
percent of patients survive six months or more, (2) determine the objective
response rate and the duration of response and, 3) evaluate the effects of
treatment on the quality of life using the EORTC criteria.
2. Initially, 15 subjects will be treated at 0, 4 and 12 weeks with the
Product and those demonstrating stable disease or tumor recession shall be
given an additional booster injection st 6 months from the first treatment.
3. If 8 or more subjects of the first 15 are alive at six months from their
first treatment, the study will be expanded to include 43 patients.
4. Upon interim analysis of study findings after 43 subjects have been
treated, the study may be expanded to include a total of 60 patients. Such
expansion will be based upon clinical and ethical considerations of the
likelihood of benefit to the patients with this disease.
5. This study shall commence on or before May 1, 1996 and shall have
assessed effects in at least 15 subjects with 12 months after this date. If
the study is expanded to 43 patients, the interim analyses will be completed
on or before April 30, 1998.
6. Any protocol changes in the number of subjects, timing of treatment or
expansion of the number of trial subjects shall be made for medical or
technical reasons, only. Any such changes shall be reported to the foundation
by ITC.
22
