1
EXHIBIT 10.5
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
AMENDED AND RESTATED
--------------------
EXCLUSIVE LICENSE AGREEMENT CRF D-416 AND D-520
-----------------------------------------------
D-913, D-1069, D-1239, D-1258, D-1403, D-1426
---------------------------------------------
THIS AGREEMENT, executed as of August 12, 1996, amends, restates and
supersedes the Exclusive License Agreement CRF D-416 and D-520, D-913,
D-1069, D-1239, D-1258, D-1403, D-1426 dated April 5, 1994 (the "Original
Agreement") by and between the CORNELL RESEARCH FOUNDATION, INC., having
offices at Cornell Business & Technology Park, 00 Xxxxxxxxx Xxxxx, Xxxxx
000, Xxxxxx, Xxx Xxxx 00000, hereinafter referred to as "FOUNDATION" and
TRANSCEND THERAPEUTICS, INC., having offices at 000 Xxxxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000, hereinafter referred to as "LICENSEE." This
Agreement (i) shall be retroactively effective as of April 6, 1994, (ii) is
executed for administrative convenience to avoid the requirement of certain
exhibits attached to the Original Agreement, and (iii) is subject to
agreements executed by FOUNDATION and LICENSEE subsequent to April 6, 1994,
including but not limited to the Letter Agreement dated October 5, 1995
between FOUNDATION and LICENSEE.
W I T N E S S E T H T H A T:
- - - - - - - - - - - - - -
WHEREAS, United States Patent No. 4,710,489, entitled "Glutathione
Delivery System," was issued on December 1, 1987;
2
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
WHEREAS, United States Patent No. 4,784,685, entitled "Glutathione
Delivery System," was issued on November 15, 1988;
WHEREAS, United States Patent No. 4,879,370, entitled "Glutathione
Delivery System," was issued on November 7, 1989;
WHEREAS, a United States patent application entitled
*********************************************, as filed in the U.S. Patent
and Trademark Office on ****************;
WHEREAS, a United States patent application entitled
*************************************, was filed in the U.S. Patent and
Trademark Office on **************;
WHEREAS, Japanese Patent No. 1,592,957 was issued on July 11, 1989;
WHEREAS, the above group of patents and patent applications is
hereinafter referred to as the "Glutathione Technology" and includes all
the patents and patent applications presently owned by FOUNDATION that are
necessary to practice the inventions that comprise Glutathione Technology
as well as all patents and patent applications that name Xxxxx Xxxxxxx as
an inventor and relate to Glutathione Technology;
WHEREAS, United States Patent No. 4,335,210, entitled "Method of
Producing L-Cysteine," was issued on July 15, 1992;
WHEREAS, United States Patent No. 4,434,158 entitled "Cysteine
Delivery System," was issued on February 28, 1984;
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
WHEREAS, United States Patent No. 4,647,571, entitled "Cysteine
Delivery Composition," was issued on March 3, 1987;
WHEREAS, United States Patent No. 4,665,082 entitled "Cysteine
Delivery System," was issued on May 12, 1987;
WHEREAS, United States Patent No. 4,438,124 entitled "Cysteine
Delivery System," was issued in March 20, 1984;
WHEREAS, counterpart European Patent No. 0057942 and Canadian Patent
1,167,766, have issued;
WHEREAS, the immediately-above group of patents is hereinafter
referred to as the "Procysteine Technology" and includes all the patents
and patent applications presently owned by FOUNDATION that are necessary to
practice the inventions that comprise Procysteine Technology as well as all
patents and patent applications that name Xxxxx Xxxxxxx as an inventor an
relate to Procysteine Technology;
WHEREAS, a United States patent application entitled
***************************************************************, was filed
in the U.S. Patent and Trademark Office on ************;
WHEREAS, a United States patent application entitled ******
******************************************************* **********, was
filed in the U.S. Patent and Trademark Office on *************;
WHEREAS, a United States patent application entitled
*************************************************, was filed in the U.S.
Patent and Trademark Office on *************;
-3-
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
WHEREAS, a patent application is presently being prepared related to
*************************************************************************
********************************************;
WHEREAS, a PCT application equivalent to U.S. Serial No. 07/862,525,
was filed on July 9, 1993;
WHEREAS, the immediately-above group of patent applications is
hereinafter referred to as the "Gene Technology";
WHEREAS, the invention or inventions disclosed and claimed in the
above-listed patents and patent applications are assigned to FOUNDATION and
FOUNDATION is a wholly owned subsidiary corporation of Cornell University
having as one of its principal purposes the holding of ownership interests
of patents issued on inventions made by Cornell University's staff and the
administration of licenses in pursuance thereof in a manner consistent with
the patent policy of Cornell University;
WHEREAS, FOUNDATION represents that it is assignee of the above-listed
patents and patent applications and any patents issuing thereon, and has
the right to grant exclusive worldwide licenses under said patents, it
being pointed out however with respect to U.S. Serial No. SN 07/862,525,
FOUNDATION is the joint assignee thereof with Fox Chase Cancer Center
(hereinafter "Fox");
WHEREAS, FOUNDATION represents that it can grant licenses under U.S.
Serial No. 07/862,525 to LICENSEE without LICENSEE incurring any
obligations or liability to Fox;
-4-
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WHEREAS, the work leading to the inventions disclosed and claimed in
above-identified patents and patent applications was supported in part by
an agency of the U.S. Government, FOUNDATION is obligated to comply with
the U.S. Office of Management and Budget Circular No. A-124;
WHEREAS, FOUNDATION is not aware of any patent or patent application
that it owns, controls, or is licensed under with the right to sublicense
that is necessary to manufacture, sell, or use any product that falls
within the scope of any of the patents or patent applications that comprise
Glutathione Technology or Procysteine Technology;
WHEREAS, LICENSEE is desirous of securing an exclusive worldwide
license under the discoveries and inventions embodied in said patents and
patent applications and patents issuing therein to make, use and sell
products;
WHEREAS, FOUNDATION is willing to grant an exclusive worldwide license
in said patents and patent applications and any patents issuing thereon to
LICENSEE upon the terms and conditions hereinafter set forth;
WHEREAS, LICENSEE holds the complete LICENSEE'S interest in two prior
license agreements entitled respectively "Exclusive License Agreement
D-416" and "Exclusive License Agreement D-520" both effective July 1, 1989
(hereinafter collectively referred to as "The Prior Agreements"), with the
LICENSEE on their face being
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Xxxxxx International, Inc., and whereas, LICENSEE and FOUNDATION both
intend that this agreement will supersede and replace The Prior Agreements;
NOW, THEREFORE, in consideration of the covenants and obligations
hereinafter set forth, the parties hereto hereby agree as follows:
I
DEFINITIONS
-----------
The following definitions will apply throughout this
agreement:
1. IMPROVEMENTS shall mean any patents or patent applications, other
than Licensed Patents or Licensed Patent Applications (as defined
below), relating to any Licensed Product or Procysteine
Technology, Glutathione Technology, or Gene Technology that is
developed during the term of this Agreement, and owned by the
FOUNDATION, which is not committed to a third party by law or
prior research agreement.
2. LICENSED PATENT APPLICATIONS shall mean U.S. Patent applications
S/N's *********************************************************
***** as well as the patent application to be filed on ********
*********************** and any continuation, continuation-
in-part, or
-6-
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divisional applications thereof, as well as foreign counterparts
thereof, if any.
3. LICENSED KNOW HOW shall mean any proprietary right other than a
patent or patent application owned by, controlled by, or licensed
to FOUNDATION with right to sublicense that relates to
Procysteine Technology, Glutathione Technology, or Gene
Technology.
4. LICENSED PATENTS shall mean U.S. Patents 4,710,489; 4,784,685;
4,879,370; 4,335,210; 4,434,158; 4,438,124; 4,647,571 and
4,665,082 and European Patent No. 0057942, Canadian Patent No.
1,167,766, and Japanese Patent No. 1,592,957 and any patents
issuing on a Licensed Patent Application and all reissues
thereof, as well as foreign counterparts to a Licensed Patent or
Licensed Patent Application.
5. LICENSED PRODUCTS shall mean a product that would infringe a
valid Licensed Patent in the country it is manufactured, used, or
sold but for the licenses granted herein.
6. LICENSE YEAR shall mean each twelve (12) month period beginning
on the effective date of this Agreement first written above and
thereafter on the anniversary date thereof.
-7-
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
7. LICENSEE shall mean the above named company and any of its
affiliates in which it owns or controls at least 50 percent of
the voting stock or in the case of a partnership or other entity
50% of the interests in profits or capital of the entity.
8. NET SALES PRICE shall mean the gross amount of money billed by
LICENSEE to its customers on sale or use of Licensed Products
subsequent to the effective date of this Agreement,
**************************************************************
**************************************************************
**************************************************************
**************************************************************
**************************************************************
**************************************************************
9. REDUCTION TO PRACTICE shall mean that the applicable invention is
in such a form as to render it capable of practical and
successful use. For a method of treatment or pharmaceutical
invention, this requires the demonstration of in vivo efficacy.
II
GRANT
-----
Subject only to the rights of and obligations to the U.S. Government
as set forth in OMB Circular Xx. X-000 xxx 00 XXX Xxxx
-0-
0
XXXXXXXXXXXX MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
401, and existing in Law, and except for application Serial No. **********,
the FOUNDATION hereby grants to the LICENSEE for the term set forth below
and under the royalty basis set forth herein, an exclusive worldwide
license to the Licensed Patents and Licensed Applications including the
right to make, have made, use and/or sell Licensed Products. With respect
to application Serial No. **********, the FOUNDATION hereby grants to the
LICENSEE for the term set forth below and under the royalty basis set forth
herein, a non-exclusive worldwide license to that application and any
patent issuing therefrom including the right to make, have made, use and/or
sell Licensed Products. The period of the license in each country shall be
coextensive with the enforceable life of the patent in that country.
Additionally, FOUNDATION grants to LICENSEE a royalty free non-exclusive
license to Licensed Know How.
III
EQUITY AS CONSIDERATION FOR THE EXECUTION OF THIS AGREEMENT
-----------------------------------------------------------
Provided that FOUNDATION'S equity position is approved in writing by
the Executive Committee of FOUNDATION'S Board of Directors and that the
interaction with LICENSEE of all Cornell University Employees, if any, who
have an interest in LICENSEE, is approved in writing by the Xxxx of the
Cornell University Medical College, FOUNDATION at its option will receive
from LICENSEE, as consideration for entering into this Agreement an equity
position
-9-
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in LICENSEE that is 175,127 shares of the common stock of LICENSEE.
At FOUNDATION'S sole option, should said approval of the Xxxx and
Board not be obtained in writing six months from the effective date of this
Agreement, FOUNDATION and LICENSEE will negotiate in good faith to
determine a monetary equivalent of equity position referred to above, which
equivalent shall be granted by LICENSEE to FOUNDATION.
In addition, LICENSEE will provide, over a three (3) year period from
the Effective Date of this Agreement, $400,000.00 in cumulative funding for
Dr. Xxxx Xxxxxxxx and/or Xx. Xxxxx Xxxxxxx laboratories for research in the
areas of the subject matter of Licensed patents and Licensed Patent
Applications pursuant to the Research Agreement attached hereto as Exhibit
A. In exchange for supporting such research, LICENSEE shall receive an
exclusive worldwide license to any patentable invention that results from
the research and is conceived or reduced to practice during the term of the
Research Agreement or one (1) year thereafter for the royalty rate set
forth herein. Any patent application filed on such patentable invention
shall become a Licensed Patent Application under this Agreement.
Additionally, LICENSEE shall receive a royalty free exclusive right to any
unpatentable inventions that result from the research and are conceived or
Reduced to Practice during the term of the Research Agreement or one (1)
year thereafter.
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IV
PAYMENT OF EXISTING PATENTS AND APPLICATIONS RENEWAL FEES AND CONTINUING
PROSECUTION COSTS
------------------------------------------------------------------------
Where a Licensed Patent Application is pending in the United States or
a foreign country, LICENSEE agrees to pay all reasonable prosecution costs
for such Licensed Patent Application incurred after the date of this
Agreement and all maintenance fees that become due on Licensed Patents
after the date of this Agreement; provided, however, that LICENSEE shall
have the right to deduct the costs and fees that are paid by LICENSEE from
any royalty that may be due and owing the FOUNDATION. Additionally,
LICENSEE shall have the right to not pay or discontinue payment of said
prosecution costs and/or maintenance fees upon thirty (30) days written
notice to FOUNDATION, in which case said patent application or patent, as
the case may be shall no longer be deemed a Licensed Patent Application or
Licensed Patent and LICENSEE shall have no further license under such
Licensed Patent Application or Licensed Patent.
FOUNDATION agrees to promptly provide LICENSEE with copies of all
Office Actions received from the applicable Patent Office, as well as
proposed responses to same for LICENSEE'S comments, before the responses
are filed. FOUNDATION shall make reasonable efforts to consider LICENSEE'S
comments and revise the proposed response if appropriate.
-11-
12
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Prior to abandoning or failing to prosecute any Licensed Patent or
Licensed Patent Application, FOUNDATION shall advise LICENSEE and provide
LICENSEE with the option to assume financial responsibility for such
Licensed Patent or Licensed Patent Application. If LICENSEE agrees to
assume such financial responsibility, FOUNDATION agrees to transfer all
relevant files to LICENSEE and assign such Licensed Patent or Licensed
Patent Application to LICENSEE and LICENSEE shall therefore not be
obligated to pay royalties under such patent or patent application.
V
FUTURE FOREIGN PATENTS AND APPLICATIONS AND PAYMENT OF COSTS
------------------------------------------------------------
In the event that after the date of this Agreement an opportunity
arises to file counterpart patent applications to the United States
Licensed Patent Applications in any foreign country, FOUNDATION shall
notify LICENSEE in writing of said opportunity. Within sixty (60) days
after receipt of said notice, LICENSEE shall advise FOUNDATION in which
foreign countries LICENSEE intends to pay all expenses incurred in the
preparation, filing, prosecution, renewal and continuation of the Licensed
Patent Applications , including all taxes, official fees and attorney fees
("Foreign Licensed Patent Application Expenses"); however, LICENSEE shall
have the right to deduct ******************* of any
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
such Foreign Licensed Patent Application Expenses from any royalties that
may be due and owing FOUNDATION under this Agreement. In the event that
LICENSEE elects not to pay said Foreign Licensed Patent Application
Expenses in any foreign country, and FOUNDATION elects to pay said Foreign
Licensed Patent Application Expenses, then and in such foreign country,
LICENSEE'S right to the Foreign Licensed Patent or Licensed Patent
Application in that foreign country shall become a non-exclusive license.
Should LICENSEE agree to pay the Foreign Licensed Patent Application
Expenses, FOUNDATION will promptly provide LICENSEE with copies of all
communications from the relevant Patent Offices and proposed responses
thereto for LICENSEE'S comments prior to filing. FOUNDATION shall make
reasonable efforts to consider LICENSEE'S comments and revise the proposed
response if appropriate.
VI
ROYALTIES AND ADVANCE ROYALTIES TO BE PAID DURING THE LICENSE AGREEMENT
-----------------------------------------------------------------------
In consideration for the rights granted herein LICENSEE will pay to
the FOUNDATION in U.S. dollars a royalty on Net Sales Price of Licensed
Products sold by LICENSEE according to the following schedule:
************************************** in annual sales, and ***********
****************** on all annual sales ****************** annually. In
determining annual sales, net sales of Licensed
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Product in each Technology shall be separately considered and shall not be
combined for purposes of the royalty schedule.
LICENSEE'S obligation to pay royalty upon each such Licensed Product
in any country shall cease:
(i) if the applicable claims in the Licensed Patent in that country
are held invalid by an unappealed or unappealable decision of a
court of competent jurisdiction, in that country, or
(ii) upon expiration of the last said Licensed Patent in that country.
On July 1 of each License Year commencing on the effective date of
this Agreement, LICENSEE shall pay FOUNDATION *************************
*********** for each of the Glutathione Technology and the Procysteine
Technology (i.e., a combined total of ********** as an advance royalty
payment for that License Year and such moneys will be considered as a
credit for the royalties due on each respective Technology for that License
Year under this Agreement and the royalty reports should reflect the use of
such credit. Such provision is to be construed as an annual minimum royalty
payment requirement for each Technology and none of the advance royalty
payments are refundable or applicable to succeeding License Years. Payment
of actual royalties in excess of minimum royalties on one Technology does
not remove the obligation to pay minimum royalties on the second
Technology.
-14-
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No minimum royalty payment is due for Gene Technology.
FOUNDATION acknowledges the payment due on July 1993 under The Prior
Agreements has been paid and the next annual payment is due July 1, 1994.
VII
ACCOUNTING
----------
LICENSEE will deliver to the FOUNDATION within ninety (90) days after
the end of each License Year a report in writing setting forth sales of
Licensed Products by Technology (including a negative report if
appropriate) and will accompany such report with an appropriate payment of
royalty due for such period. LICENSEE will keep accurate records for at
least three (3) years, certified by it, showing the information by which
LICENSEE arrived at a royalty determination and will permit an auditor
appointed and paid for by the FOUNDATION and acceptable to LICENSEE to make
such inspection of said records as may be necessary to verify royalty
reports made by LICENSEE. However, if such inspection demonstrates that the
royalties paid were less than 90% of the royalties due, and LICENSEE'S Net
Sales of Licensed Product for the applicable year was $500,000.00 or more
than LICENSEE shall reimburse FOUNDATION the reasonable charges charged by
the auditor for such inspection.
-15-
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VIII
TERM
----
The aforesaid exclusive license under a Licensed Patent Application or
Licensed Patent shall last for a period of not to exceed the effective life
of the last to expire Licensed Patent. After the last to expire Licensed
patent, LICENSEE shall have a royalty free license to all Licensed Know
How.
IX
DUTY OF DILIGENCE
-----------------
LICENSEE shall exercise due diligence to effect the introduction of
Licensed Product(s) within each Technology group into the commercial market
as soon as practical. FOUNDATION acknowledges that the licensees of The
Prior Agreements have exercised due diligence under each of The Prior
Agreements. LICENSEE agrees to develop and exploit Licensed Product for the
duration of the term of this Agreement, or alternatively by the use of
sublicensing. LICENSEE further agrees to maintain quality control over
Licensed Products and generally attend to proper, safe, fair, lawful and
reasonable development and exploitation of the market for Licensed
Products. Sublicensees, if any will be held to the same standards as
LICENSEE.
At the end of each licensee year, LICENSEE will provide a report on
the progress toward commercialization made within each
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Technology group and a projection of efforts to be made in the coming year.
FOUNDATION'S determination of a lack of due diligence must be made in good
faith and the written notice must specifically state why FOUNDATION
believes LICENSEE has not exercised due diligence. LICENSEE shall have six
(6) months after written notice to exercise due diligence in the relevant
Technology. After the six (6) month period should the FOUNDATION in good
faith using reasonable standards determine that due diligence has not been
exercised by LICENSEE in the relevant technology, FOUNDATION can upon
written notice to LICENSEE convert LICENSEE'S exclusive license to the
Licensed Patents and Applications in the relevant Technology to a
non-exclusive license. Failure to exercise due diligence in one Technology
shall not adversely effect LICENSEE'S exclusive rights in another
Technology under this Agreement.
X
ENFORCEMENT
-----------
Upon learning of the infringement of a Licensed Patent by a third
party, FOUNDATION shall inform LICENSEE in writing of that fact and shall
supply LICENSEE with any evidence available pertaining to the infringement.
LICENSEE may at its own expense take whatever steps are necessary to stop
any infringement of a Licensed Patent and recover damages therefore, and
shall be
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
entitled to retain all damages so recovered except the royalty that would
otherwise be due FOUNDATION had the infringing sales been made by LICENSEE
under this Agreement. FOUNDATION agrees to cooperate at LICENSEE'S expense
to allow LICENSEE to prosecute such action. With respect to royalties
otherwise due and payable by it to FOUNDATION, LICENSEE shall have the
right to use such royalties to pay for or defray the costs of enforcing
said Licensed Patent against the infringement. In withholding royalties to
pay for the cost of enforcing said Licensed Patent, LICENSEE shall only be
entitled to withhold royalties due to FOUNDATION subsequent to the start of
the litigation. During proceedings relating to the enforcement of said
Licensed Patent, LICENSEE shall submit semiannual written reports
accompanying its royalty reports showing royalties accruing to FOUNDATION
and the expenses of enforcing the Licensed Patent against the infringement.
Upon termination of all proceedings involving such claims or allegations,
LICENSEE shall remit the balance, if any, of the royalties accrued but not
yet paid to FOUNDATION. If the withheld royalties have not equalled the
expenses of conducting the suit at the termination of all proceedings in
the suit, LICENSEE shall be entitled to continue withholding **** of the
royalties due until it has recovered all the expenses incurred in
conducting the suit.
If LICENSEE does not undertake within sixty (60) days of
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notice by FOUNDATION to enforce the Licensed Patent against the infringing
party, FOUNDATION shall have the right to take whatever action it deems
appropriate at FOUNDATION'S expense. FOUNDATION shall have the right to
retain all damages it recovers.
Where LICENSEE takes action to enforce the Licensed Patent, LICENSEE
shall hold FOUNDATION harmless from all claims, counterclaims and the like
rising from LICENSEE'S' action.
XI
ASSIGNMENT
----------
The rights and obligations of the LICENSEE are not assignable except
that said rights and obligations may be assigned to its successor to the
entire business to which this agreement pertains.
XII
TERMINATION
-----------
The FOUNDATION may terminate this License Agreement for failure of the
LICENSEE to make a royalty payment or to comply with [Section]XI or the hold
harmless provision on page 21 by giving notice of its intentions to do so six
(6) months before termination. If LICENSEE shall, within the six-month notice
period correct the breach, the notice shall have no further effect and this
License Agreement shall continue.
LICENSEE may terminate this License Agreement by giving notice of its
intentions to do so six (6) months before termination.
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XIII
SUBLICENSING
------------
LICENSEE may sublicense third parties provided that FOUNDATION is
provided with a copy of all sublicense agreements.
With regard to Glutathione Technology and Procysteine Technology, all
such sublicense agreements must insure that FOUNDATION receives the royalty
on all Net Sales that would otherwise be due FOUNDATION under this
Agreement.
However, with respect to Gene Technology, LICENSEE shall pay
FOUNDATION, instead of the royalty set forth in Section VI, one-third of
all financial value received from the sublicensee in consideration for a
sublicense agreement related to Gene Technology be it cash or other things
of value.
XIV
FAVORED NATIONS
---------------
If, under Sections V or IX, LICENSEE'S rights to any Licensed Patent
Application or Licensed Patent become non-exclusive and the FOUNDATION
grants nonexclusive licenses to others under such Licensed Patent
Application or Licensed Patent, such licenses will not be granted at a
royalty rate which is more favorable than the rate herein granted to
LICENSEE unless such more favorable rates are extended to the LICENSEE.
This Favored Nations clause does not apply to License agreements which are
in settlement of patent litigation.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
XV
RIGHT OF FIRST NEGOTIATION
--------------------------
FOUNDATION grants LICENSEE, to the extent not granted under another
section or paragraph of this Agreement, a right of first negotiation with
respect to any Improvement. LICENSEE shall have an exclusive right to
negotiate an agreement with FOUNDATION for any such Improvement for a
******************************************************* to LICENSEE or
Reduction to Practice of the invention that comprises the Improvement,
whichever is later. FOUNDATION will negotiate in good faith such an
agreement with LICENSEE during this period.
XVI
OTHER
-----
LICENSEE agrees that it will not use the indicia or names FOUNDATION
or of Cornell University or any of their personnel in advertising,
promotion, or labeling of Licensed Products without prior written approval
of the FOUNDATION. Such approval shall not be unreasonably withheld by
FOUNDATION. It is understood, however, that LICENSEE shall be free to
disclose the terms and conditions of this Agreement to any third parties
including potential investors.
FOUNDATION makes no representations other than those
-21-
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specified in the WHEREAS clauses. FOUNDATION MAKES NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
FOUNDATION by this Agreement makes no representation as to the
patentability and/or breadth of the inventions and/or discoveries involved
in a Licensed Patent. FOUNDATION by this Agreement makes no representation
as to patents now held or which will be held by others in the field of the
Licensed Products for a particular purpose.
LICENSEE agrees to defend, indemnify and hold FOUNDATION harmless from
and against all liability, demands, damages, expenses or losses for death,
personal injury, illness or property damage arising (a) out of use by
LICENSEE or its sublicensees of inventions licensed or information
furnished under this Agreement, or (b) out of any use, sale or other
disposition by LICENSEE or its sublicensees of products made by use of such
inventions or information. As used in this clause, FOUNDATION includes its
Trustees, Officers, Agents and Employees, and those of Cornell University,
and "LICENSEE" includes its Affiliates, Subsidiaries, Contractors and
Sub-Contractors.
This Agreement shall be interpreted under the Laws of the State of New
York.
Reports, notices and other communications to the FOUNDATION shall be
addressed to:
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H. Xxxxxx Xxxxxxxxx, President
CORNELL RESEARCH FOUNDATION, INC.
Cornell Business & Technology Park
00 Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxx, XX 00000
and other notices and other communications to the LICENSEE to:
Xx. Xxxxxx X. Xxxxx, M.D., Ph.D.
TRANSCEND THERAPEUTICS, INC.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
IN WITNESS WHEREOF, the parties have caused this instrument to be
executed in duplicate as of the day and year first above written.
ATTEST: CORNELL RESEARCH FOUNDATION, INC.
/s/ X. X. Xxxxxxxxxx By: /s/ H. Xxxxxx Xxxxxxxxx
-------------------------- ------------------------------
H. Xxxxxx Xxxxxxxxx
Title: President
---------------------------
Date: August 12, 1996
---------------------------
ATTEST: TRANSCEND THERAPEUTICS, INC.
/s/ X. X. Xxxxxxxxxx By: /s/ Xxxxxx X. Xxxxx
--------------------------- ------------------------------
Title: President
---------------------------
Date: August 12, 1996
---------------------------
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Exhibit A
---------
RESEARCH AGREEMENT
------------------
AGREEMENT between
CORNELL UNIVERSITY, for its Medical College, hereinafter Called "the
Medical College," and FREE RADICAL SCIENCES, INC., an Illinois partnership,
having offices at 000 Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000,
hereinafter called "FRS".
The Medical College will undertake the following project:
1. Title (protocol number if applicable).
-------------------
2. The Scope of Work. The work to be performed is as described in the
attached scope of work labeled Attachment "A".
3. Principal Investigators. The project will be under the supervision
of:
Xxxx Xxxxxxxx, M.D., as Principal Investigator, and Xxxxx Xxxxxxx,
M.D., as Co-Principal Investigator.
4. Period. The period of performance will be from ______, 1994 to
________, 1997.
5. Payments. The total costs to FRS under the agreement will be four
hundred thousand dollars ($400,000.00). The payment schedule will
be as follows:
$134,000 paid on _________, 1994
$133,000 paid on _________, 1995
$133,000 paid on _________, 1996
6. Applicable Law. FRS and the Medical College agree to comply with all
applicable local, state, and Federal laws, regulations, and guidelines
with respect to the conduct of the study.
X-0
00
0. Inventions. All inventions, developments, findings and discoveries
conceived solely by the Investigators or other employees of the
Medical College relating to this Agreement ("Inventions") shall be the
property of, and title to reported Inventions will be held by, the
Cornell Research Foundation, Inc. (Foundation), the research and
technology transfer arm of Cornell University. It is hereby
acknowledged that FRS and the Foundation have entered into a License
Agreement to which this Research Agreement is attached as Exhibit R.
The Foundation hereby grants an exclusive license to any such
Inventions to FRS pursuant to the terms of the License Agreement
between Foundation and FRS. This grant shall apply to any invention
that is developed pursuant to this Research Agreement or with any
funding from this Research Agreement, whether such invention is
patentable or not, if such invention is conceived or reduced to
practice during the term of this Agreement or one (1) year thereafter.
8. Proprietary Data. The Medical College's acceptance and use of any
proprietary data which may be supplied by FRS in the course of this
research project shall be subject to the following:
(a) The date must be marked or designated in writing as proprietary
to FRS.
(b) The Medical College retains the right to refuse to accept any
such data which it does not consider to be essential to the
completion of the project or which it believes to be improperly
designated, or for any reason.
(c) Where the Medical College does accept such data as proprietary,
it agrees to exercise its best efforts not to publish or
otherwise reveal the data to others outside the Medical College
without the permission of FRS, unless the data has already been
published or disclosed publicly by third parties or is required
to be disclosed by order of a court of law.
9. Publications and Copyrights. The Medical College will be free to
publish papers dealing with results of research under this Research
Agreement, after giving a copy of the paper to FRS and allowing FRS to
object to the disclosure of proprietary information, which information
will not be disclosed for a period of ninety (90) days or until
appropriate patent applications are filed whichever is sooner. FRS
will be given full credit and acknowledgment for
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the support provided to the Medical College in any publication
resulting from this research. Original research data will belong to
the Medical College. Title to and the right to determine the
disposition of any copyrights, or copyrightable material, first
produced or composed in the performance of this research, shall remain
with the Medical College, provided that the Medical College shall
grant to FRS an irrevocable royalty free, non-exclusive right to
reproduce, translate, and use all such copyrighted material for its
own purposes.
10. Reports. A final report of the progress of the work shall be made to
FRS by the Principal Investigators within three months of completion.
The Principal Investigators shall provide FRS with written interim
reports at no more often than four-month intervals following
initiation of the study as mutually agreed upon by the Principal
Investigators and FRS.
11. Changes. FRS or the Medical College may, at any time, in writing to
each other, suggest and by mutual agreement make changes within the
general scope of the work, including but not limited to (a) revising
or adding to the work or deleting portions thereof, (b) revising the
period or schedule of performance, or (c) increasing or decreasing the
total cost. Upon receipt of such notice of change and their mutual
agreement thereto, the parties shall immediately use their best
efforts to take all necessary steps to comply therewith.
12. On-Site Visits. During normal business hours, FRS representative(s)
will be permitted on-site visits for the purposes of monitoring the
study and conferring with the Investigators. Additional monitoring
activities will include telephone and letter communication.
13. Use of Drugs and/or Chemicals. If drugs and/or chemicals are supplied
by FRS, and if requested by the Medical College, FRS agrees to accept
unused portions of drugs and/or chemicals supplied by FRS under this
agreement, including the containers in which the drugs and/or
chemicals are shipped, provided that said drugs and/or chemicals and
containers are properly labeled by the Medical College, upon the
return to FRS. Further, for each drug and/or chemical supplied under
this agreement, FRS agrees to furnish the Medical College with
sufficient information to permit reasonable interpretation of the
results obtained in the investigations described herein, and to
identify precautions needed to help protect the health and safety of
personnel using the drugs
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and/or chemicals. FRS agrees to indemnify the Medical College, its
officers, trustees, agents, and employees, and hold them harmless from
any and all injury, illness, death, property damage, claim, lawsuit,
judgment thereon, or cause of action which results either in whole or
in part from the use of the drugs and/or chemicals if such use was
pursuant to FRS's directions or reasonable under the circumstances.
14. Indemnification. FRS shall defend, indemnify and hold harmless the
Medical College, its officers, trustees, employees and agents from and
against all claims, liabilities, losses, damages, costs or expenses of
any kind (including attorneys' fees) which may arise as a result of
injuries caused solely by the negligence of FRS. The party to be
indemnified shall notify FRS within ten (10) days of receipt of such
claim and shall cooperation in the defense of the claim.
15. Notices. All communications, reports, and notices required or
permitted hereunder shall be deemed sufficiently given if in writing
and personally delivered or sent by registered mail, postage prepaid,
return receipt requested, addressed to the parties as follows or at
such other address as a party shall have given notice of pursuant
hereto:
If to the Medical College:
Associate Xxxx for Research and Sponsored Programs
Cornell University Medical College
0000 Xxxx Xxxxxx, Xxxx X-000
Xxx Xxxx, XX 00000
If to FRS:
Xxxx X. Xxxx, Ph.D.
FREE RADICAL SCIENCES, INC.
000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
16. Governing Law. This Agreement shall be governed by, and construed and
enforced in accordance with, the Laws of the State of New York.
17. General Provisions.
(a) This Agreement shall be binding upon, and inure to the benefit of
the parties and their successors and assigns.
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(b) All rights under this Agreement shall be assignable by a party
only with the written consent of the other, except that FRS may assign
this Agreement in whole or in part to any subsidiary or to any entity
that owns at least 50% of FRS's ownership interest.
The respective parties have executed this Agreement on the dates
indicated below:
CORNELL UNIVERSITY FOR ITS FREE RADICAL SCIENCES, INC.
MEDICAL COLLEGE
-------------------------- --------------------------
Medical College Official
-------------------------- --------------------------
Typed Name Typed Name
-------------------------- --------------------------
Title Title
------------------------- --------------------------
Date Date
CORNELL RESEARCH FOUNDATION, INC.
---------------------------
---------------------------
Typed Name
---------------------------
Title
---------------------------
Date
We agree to act as Principal
Investigator for the project
described above:
-------------------------- ---------------------------
Principal Investigator Co-Principal Investigator
Xxxx Xxxxxxxx, M.D. Xxxxx Xxxxxxx, M.D.
Chairman and Xxxxxx Xxxxxxx
Professor of Biochemistry
-------------------------- ---------------------------
Date Date
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