EXHIBIT 10(dd)
AGREEMENT
between
THE RESEARCH FOUNDATION OF STATE
UNIVERSITY OF NEW YORK
and
ENZO BIOCHEM, INC
INDEX
Article Title Page
------- ----- ----
1. DEFINITIONS
2. GRANT
3. SUPPLEMENTAL INFORMATION
4. ROYALTY; FEES
5. REPORTS AND PAYMENTS
6. PATENTS
7. PATENTS INDEMNITY
8. PATENT ENFORCEMENT
9. TECHNICAL DEVELOPMENT
10. CONFIDENTIALITY
11. WARRANTY
12. TERM, RIGHT & OBLIGATIONS ON
TERMINATION
13. NOTICES AND REPORTS
14. MISCELLANEOUS
15 GOVERNING LAW
SCHEDULE A
ANNEX A
Stoneybrook gene function
SIM Rev. 050587A
page 1
AGREEMENT
THIS AGREEMENT, effective this 15 day of May, 1987, by and between the Research
Foundation of State University of New York, a corporation of the State of New
York, having a place of business at Xxxxx Xxxxxxxxxx Xxxxx, Xxxxxx, Xxx Xxxx
00000-0000 (hereinafter referred to as "FOUNDATION") and Enzo Biochem Inc., a
corporation of the State of New York, having a place of business at 000 Xxxxxx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 (hereinafter referred to as "ENZO")
WITNESSETH
WHEREAS, the manipulation of gene function by inhibitory nucleic acid in
prokaryotic cells and in eukaryotic cells has recently been shown to be possible
utilizing interfering nucleic acid sequences within such cells;
WHEREAS, the FOUNDATION has done certain work in this technical area;
WHEREAS, the FOUNDATION has filed applications for patent in the United States
and in certain countries foreign to the United States on the results of certain
work on interfering nucleic acid sequences done in the laboratory of Xx.
Xxxxxxxx Xxxxxx;
WHEREAS, ENZO is involved in developing gene therapy technology, including
various methods of manipulation of gen function;
WHEREAS, ENZO desires to establish an effort to do continuing research in gene
therapy technology and to staff this effort with a minimum of five (5)
professionals; and
WHEREAS, ENZO desires to obtain a license under FOUNDATION's PATENTS and
TECHNICAL INFORMATION (as hereinafter defined) and FOUNDATION is willing to
grant such a license
NOW THEREFORE, the parties hereto, intending to be legally bound, hereby agree
as follows.
1
Stoneybrook gene function
SIM Rev. 050587A
page 2
ARTICLE 1 DEFINITIONS
1.1 "PATENTS" means patents and applications for patent covering TECHNICAL
INFORMATION including the patents and applications for paten set forth in
Schedule A, together with any patents 1) issuing on or as a result of any
continuation, continuation-in-part, or division thereof or 2) issuing as a
result of any other patent application which may be substituted therefor or 3)
which are reissues and/or extensions of any such patents or patent applications.
It also includes any patents which have issued or which may in the future issue
anywhere in the world to the extent that such patents contain claims equivalent
to those contained in the patents or application for patents set forth in
Schedule A.
1.2 "LICENSED PROCESS" means a process which relates to the regulation,
stimulation or inhibition of the function of a gene.
1.3 GENETIC MATERIAL(S) means nucleic acid material(s) including but not limited
to plasmids and vectors (including virus vectors) or nucleic acid constructs or
transcripts therefrom which
1) are oligonucleotides or polynucleotides that act to regulate, stimulate
or inhibit the functioning of a gene; or
2) produce an oligonucleotide or polynucleotide capable of acting to
regulate stimulate, or inhibit the functioning of a gene,
1.4 "PRODUCT(S)" means formulation(s) which contain GENETIC MATERIALS
1.5 "TECHNICAL INFORMATION" means all information, including information
contained in pending application for patent, 1) developed in the laboratory of
Xx. Xxxxxxxx Xxxxxx, 2) which the FOUNDATION has the right to license as of the
effective date of this Agreement and 3) which relates to the manipulation of
gene function, to the practice of the LICENSED PROCESS, to the GENETIC
MATERIALS, or to the production and use of PRODUCTS.
1.6 "SUPPLEMENTAL INFORMATION" means information first developed or acquired by
FOUNDATION after the effective date of this Agreement and which is within the
scope of a) the claims of PATENTS or b) TECHNICAL INFORMATION.
2
Stoneybrook gene function
SIM Rev. 050587A
page 3
1.7 "CONFIDENTIAL INFORMATION" means TECHNICAL INFORMATION and SUPPLEMENTAL
INFORMATION relating to the LICENSED PROCESS, GENETIC MATERIALS or PRODUCTS
disclosed in writing marked confidential by FOUNDATION to ENZO pursuant to this
Agreement; provided, however, that there is excluded any part of such
information which
a) was known to ENZO prior to disclosure thereof by of for FOUNDATION; or
b) is or becomes generally publicly available through no fault of ENZO;
or
c) is furnished to ENZO by a third party no under the secrecy obligation
to FOUNDATION.
1.8 "NET SALES VALUE" means, with regard to PRODUCTS sold or otherwise disposed
of, the greater of a) the actual sum of money do or b) the sum of money which
would be due in an arm's length transaction with a non-affiliated third party
calculated in accordance with ENZO's normal pricing policy for PRODUCTS sold at
time of invoicing, less the following:
(i) Transportation charges or allowances, if any, paid, or allowed;
(ii) Trade discounts and quality discounts allowed, if any;
(iii) Cash discounts allowed, if any;
(iv) Any taxes or duties imposed on sales of PRODUCTS and payable directly
by ENZO;
(v) Allowance of credits to customers on account of rejection or return of
PRODUCTS or retroactive price reduction.
PRODUCTS shall be considered sold when billed out, or if not billed out, when
delivered to a purchaser or to a carrier for delivery to a purchaser.
3
Stoneybrook gene function
SIM Rev. 050587A
page 4
ARTICLE 2. GRANT
2.1 FOUNDATION grants to ENZO a world-wide exclusive license, with right to
sublicense, under PATENTS and TECHNICAL INFORMATION, to utilize the LICENSED
PROCESS, to make use and sell PRODUCTS and to make, use and sell GENETIC
MATERIALS.
2.2 FOUNDATION grants and agrees to xxxxx XXXX a world wide exclusive license
with right to sublicense, under SUPPLEMENTAL INFORMATION and any patents issuing
thereon, to utilize the LICENSED PROCESS, to make, use and sell PRODUCTS and to
make, use and sell GENETIC MATERIALS.
ARTICLE 3. SUPPLEMENTAL INFORMATION; DISCLOSURE
3.1 During the term of this agreement, Foundation shall notify ENZO of all
SUPPLEMENTAL INFORMATION developed or acquired by it with right of disclosure.
3.2 Notification of each item of SUPPLEMENTAL INFORMATION shall be made by
FOUNDATION with reasonable promptness after the development or acquisition of
such SUPPLEMENTAL INFORMATION and shall include a disclosure of such
SUPPLEMENTAL INFORMATION in written or other tangible form, in sufficient detail
to enable ENZO to utilize the SUPPLEMENTAL INFORMATION in its own facilities.
ARTICLE 4. ROYALTY FEES
4.1 ENZO shall pay a royalty to FOUNDATION on all commercial sales of PRODUCTS,
commencing with the first commercial sale of PRODUCTS.
4.2 With respect to each country of the world, ENZO shall pay a royalty of *
percent of NET SALES VALUE of each PRODUCT sold in that country during the
period 1) PATENTS are being prosecuted or are in existence in that country and
2) such PRODUCT is covered by a claim of PATENTS existing in that country.
4.3 ENZO shall pay to FOUNDATION a royalty of * percent of the royalties
actually received by ENZO from a sublicensee where such royalty is attributable
to the NET SALES VALUE of each PRODUCT sold in a country during
* The information omitted is confidential and has been filed separately with
the Commission pursuant to Rule 24b-2.
4
Stoneybrook gene function
SIM Rev. 050587A
page 5
the period 1) PATENTS are being prosecuted or are in existence in that country
and 2) such PRODUCT is covered by a claim of PATENTS existing in that country.
4.4 ENZO shall pay to FOUNDATION an amount equal to * percent of any initial
fees actually received by ENZO from a sublicensee where such fees are
attributable to the grant of sublicense under PATENTS or TECHNICAL INFORMATION.
ARTICLE 5. REPORTS AND PAYMENTS
5.1 ENZO shall, commencing with the quarter during which the first commercial
sale of PRODUCT is made, report to FOUNDATION in writing within thirty (30) days
after each December 31, March 31, June 30, and September 30 during the term of
and within thirty (30) days after termination of this Agreement stating the
royalty then due and the basis for the calculation of such royalty; and the
appropriate payments accruing pursuant to ARTICLE 4 shall accompany such
reports.
5.2 All payments made pursuant to Article 4 shall be payable at Albany, New York
in United States currency. Where payment is received by ENZO in a currency other
than United States currency, the United States currency payments made hereunder
shall be determined on the basis of the official rate of exchange quoted in New
York, New York on the date payment is made to FOUNDATION or on the last day on
which the payment to FOUNDATION is due, whichever is earlier.
5.3 ENZO shall keep records of its sale of PRODUCTS and of payments form
sublicensees and shall allow inspection of such records by a certified public
account selected by FOUNDATION and to whom ENZO has not reasonable objection
during reasonable hours and upon reasonable prior notice during the term of the
Agreement and for ninety (90) days thereafter.
5.4 ENZO shall report to FOUNDATION in writing within (30) days after each
December 31, and June 30 during the term of this Agreement setting forth the
status of ENZO's technical development efforts as set forth in Annex A.
* The information omitted is confidential and has been filed separately with
the Commission pursuant to Rule 24b-2.
5
Stoneybrook gene function
SIM Rev. 050587A
page 6
ARTICLE 6. PATENTS
6.1 The FOUNDATION, with the agreement of ENZO, shall select and outside patent
attorney to handle patent prosecution matters relating to the filing,
prosecution and maintenance of PATENTS and for the filing, prosecution and
maintenance of patents on SUPPLEMENTAL INFORMATION.
6.2 Both parties shall have the right to review and comment upon patent
prosecution matters.
6.3 ENZO shall have the right to determine if it desires to have applications
for patent filed in the USA or in various countries foreign to the United
States. If ENZO does not desire to have applications for patent filed in the USA
or in certain countries foreign to the United States or if ENZO desires to
terminate prosecution maintenance of any PATENT or any patent or application for
patent covering SUPPLEMENTAL INFORMATION, FOUNDATION shall have the right to
prosecute or maintain such patent or application for patent and shall be
responsible for all costs and expenses associated with the prosecution or
maintenance of such patent or application for patent and such patent or
application for patent shall no longer be considered to be within the scope of
PATENTS.
6.4 With the exception provided in paragraph 6.3, Enzo shall pay all costs and
expenses relating to the prosecution or maintenance of patents for patents
covering SUPPLEMENTAL INFORMATION and shall reimburse FOUNDATION for such costs
and expenses in and amount not to exceed $55,000 as expended by FOUNDATION prior
to the effective date of the Agreement.
ARTICLE 7. PATENT INDEMNITY
7.1 FOUNDATION represents and warrants that, to the best of it's knowledge, the
information furnished or to be furnished to ENZO under this Agreement is free
from infringement of any third party patent.
7.2 Each party hereto shall promptly notify the other party of any third party
patent of which it becomes aware where such third party patent may be infringed
by the practice of the LICENSED PROCESS or the use or sale of GENETIC MATERIALS
or PRODUCTS.
6
Stoneybrook gene function
SIM Rev. 050587A
page 7
7.3 FOUNDATION shall indemnify ENZO against all costs and expenses of defending
itself against any suit claiming infringement of a third party patent due to
ENZO's use of TECHNICAL INFORMATION, against any damages awarded in such suit or
for any payment made by ENZO to obtain the right of use of the patent that would
be otherwise infringed.
7.4 At such time as FOUNDATION becomes aware of a third party patent within the
scope of paragraph 7.2, FOUNDATION shall, in appropriate manner, set aside
payments received from ENZO pursuant to this agreement and based on sales of
PRODUCT in the country where the infringement is allege to have occurred, until
the matter is resolved and such payments shall be used, if necessary to fund
FOUNDATION'S liability pursuant to paragraph 7.3
7.5 FOUNDATION's liability pursuant to paragraph 7.3 is limited to 1)the amount
of payments set aside pursuant to paragraph 7.4 and 2) other future payments to
be made by ENZO pursuant to this Agreement and based on sales of PRODUCTS in the
country where the infringement is alleged to have occurred.
ARTICLE 8. PATENT ENFORCEMENT
8.1 Each party shall notify the other party of any possible third party
infringement of one or more claims of PATENTS or of patents covering
SUPPLEMENTAL INFORMATION.
8.2 FOUNDATION and ENZO shall discuss any allege third party infringement issue
and FOUNDATION may at its sole option, take steps to xxxxx any infringement of
the claims of PATENTS or of patents covering SUPPLEMENTAL INFORMATION.
8.3 ENZO's licenses hereunder shall become paid up and royalty free during the
period the alleged infringement continues unless 1) FOUNDATION cause abatement
of the infringement within ninety (90) days after the infringement comes to its
attention or 2) FOUNDATION files suit against the alleged infringer within one
hundred and eighty (180) days after the infringement comes to its attention and
diligently prosecutes such suit or 3) FOUNDATION, within one hundred and eighty
(180) days after the infringement comes to its attention, obtains the opinion of
7
Stoneybrook gene function
SIM Rev. 050587A
page 8
counsel acceptable to ENZO (which acceptance shall not be unreasonably withheld)
that the third party is not infringing PATENTS.
8.4 In addition to the paid-up and royalty free licenses under paragraph 8.3, if
FOUNDATION does not cause abatement of the infringement within ninety (90) days
after the infringement comes to its attention or if FOUNDATION does not file
suit against the alleged infringer within one hundred and eighty (180) days
after the infringement comes to its attention or if FOUNDATION does not
diligently prosecute such suit, then ENZO shall have the right to negotiate with
and file suit against the alleged infringer and FOUNDATION shall do all things
reasonable and necessary to facilitate such acts by ENZO.
8.5 If ENZO, in accordance with paragraph 8.4, negotiates and/or files suit
against the alleged infringer, ENZO shall deduct all costs and expenses incurred
by it in such negotiations or suit from any amount owed hereunder to FOUNDATION
to a maximum of 50% in any given calendar year. Any amounts received from the
infringer for past infringement shall be retained by ENZO and any amounts
received form the infringer for future use of PATENTS will be paid
proportionately to FOUNDATION pursuant to ARTICLE 4.
ARTICLE 9. TECHNICAL DEVELOPMENT
ENZO agrees to establish technical effort, as set forth in Annex A to this
Agreement, to work on the development of gene therapy technology.
ARTICLE 10. CONFIDENTIALITY
ENZO shall maintain the confidentiality of CONFIDENTIAL INFORMATION
ARTICLE 11. WARRANTY
FOUNDATION warrants that it has full right and title to PATENTS and TECHNICAL
INFORMATION, that it has not entered into any agreements with a third party
which are inconsistent with the rights granted to ENZO hereunder and that it has
the right to enter into this Agreement.
8
Stoneybrook gene function
SIM Rev. 050587A
page 9
ARTICLE 12. TERM, RIGHTS & OBLIGATIONS ON TERMINATION
12.1 This agreement shall be effective as of the date first above written and
shall extend thereafter until the last to occur of
a) termination of active prosecution of an application for patent
included within PATENTS or
b) the expiration of the last to expire of PATENTS.
12.2 Upon termination of this Agreement as above provided, and subject to ENZO's
payment to FOUNDATION of all fees and royalties due hereunder, ENZO shall have a
perpetual, paid-up, exclusive license, with right to sublicense, under TECHNICAL
INFORMATION, PATENTS, SUPPLEMENTAL INFORMATION and patents covering SUPPLEMENTAL
INFORMATION.
12.3 ENZO may at any time terminate this agreement by giving FOUNDATION thirty
(30) days written.
12.4 Upon default of any material provision herein by either party, including
payment of applicable royalties the injured party may give to the defaulting
party written notice of intent to terminate this Agreement, specifying the
allege default and if, within sixty (60) days after the giving of such notice
the default is not cured, then the injured party may terminate this Agreement
forthwith by written notice to such effect to the defaulting party.
12.5 If ENZO shall become bankrupt or insolvent and/or the business of ENZO
shall be placed in the hands of a receiver, assignee or trustee for the benefit
of creditors, whether by the voluntary act of ENZO or otherwise, FOUNDATION may
terminate this Agreement by giving notice to ENZO of such termination and
specifying the effective date thereof, which shall be at least sixty (60) days
after the date the notice is mailed by the FOUNDATION. If within such sixty (60)
day period, the receiver , assignee or trustee for the benefit of creditors does
not agree in writing to be bound by the obligations assumed under this
agreement, then the rights, privileges and license granted hereunder shall
thereupon immediately terminate and neither party shall have any further rights,
duties or obligations hereunder except as may have then accrued under this
Agreement.
12.6 Upon termination of this Agreement for any reason ENZO and any of its
sublicensees may, after the effective date of such termination, sell all
PRODUCTS
9
Stoneybrook gene function
SIM Rev. 050587A
page 10
and GENETIC MATERIALS then in existence, and complete PRODUCT and GENETIC
MATERIALS in the process of manufacture at the time of such termination and sell
the same, provided that ENZO pays to FOUNDATION the royalties due thereon and
provides the reports required by ARTICLE 5.
ARTICLE 13. NOTICES AND REPORTS
Any written notice which and party hereto is required or permitted to
give to the other party may be made (and shall be deemed to have duly been
served) by personal delivery or by telex or postal service (registered air mail,
return receipt requested) at the telex number or the address set forth below or
at such other address as shall have been previously designated by written notice
to the other party.
FOR ENZO: ENZO BIOCHEM, INC
Corporate Counsel
000 Xxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telex: ENZO Bio 424633
FOR FOUNDATION: RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK
Technology Transfer Office
X.X. Xxx 0
Xxxxxx, Xxx Xxxx 00000
The date of receipt for personal delivery, ten (10) days from the date of
mailing for postal service,or the date of transmission for telex shall be deemed
the date of any such notice or report.
ARTICLE 14. MISCELLANEOUS RIGHTS AND OBLIGATIONS.
14.1 Entire Agreement. This Agreement represents the full and complete
understanding between the parties, and there are not understandings,
representations or warranties of any kind between the parties except as
expressly set forth in this Agreement.
10
Stoneybrook gene function
SIM Rev. 050587A
page 11
14.2 Amendments. This Agreement shall not be amended except by an instrument in
writing signed by the parties and stating the parties' intent by such instrument
to amend this Agreement.
14.3 Non-Waiver. The failure by either party to exercise, or delay in
exercising, or any partial exercise by such party of any rights, power or
privilege available to such party hereunder shall not operate as a waiver
thereof, or preclude any other or further exercise thereof, or the exercise by
such party of any other right, power or privilege.
14.4 Force Majeure. The failure in performance of any obligation assumed
hereunder by either party shall not be deemed a breach of this Agreement is such
failure arises from any cause beyond the control of such party.
14.5 Condition. The performance of each party's obligations under this Agreement
shall be conditioned on the other party's performance of its obligations under
this Agreement.
14.6 Severability. If any provision of this Agreement, or the application
thereof to either party hereto, is held illegal, unenforceable or otherwise
invalid by government promulgations or court decree, such holding shall not
affect the other provisions or applications of this Agreement which can be given
effect without the invalid provision; provided that the parties shall promptly
negotiate in good faith as to adjustments in this Agreement as may be necessary
to make it fair and equitable to both parties.
14.7 Succession and Assignment. This Agreement shall inure to the benefit of and
shall be binding upon the successors and assigns of the respective parties
hereto provided, however, that this Agreement shall not be assigned by either
party, other than to an affiliate or subsidiary of such party, without the prior
written consent of the other
14.8 Product Liability. Enzo agrees to indemnify, defend and hold harmless
FOUNDATION from any loss, claim, damage or other liability arising out of a
claim of personal injury or property damage caused by the use of GENETIC
MATERIALS or PRODUCTS.
11
Stoneybrook gene function
SIM Rev. 050587A
page 12
ARTICLE 15. GOVERNING LAW
This Agreement is governed by the laws of the State of New York.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
representative have caused this Agreement to be executed as of the day first
above written.
ENZO BIOCHEM, INC.
By: X. Xxxxxxx
--------------------------------
Title: President
--------------------------------
RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK
By: Xxxxxxx XX Xxxxxxx 5/14/87
--------------------------------
Title: Director of Technology Transfer
--------------------------------
12
Stoneybrook gene function
SIM Rev. 050587A
page 13
SCHEDULE A
1. USSN 585,282 filed March 1, 1984
(CIP of USSN 543,528 filed Oct. 30, 1983)
ANNEX A
TECHNICAL DEVELOPMENT EFFORTS
As set forth in ARTICLE 9, ENZO agrees to establish a technical group in its own
facilities to work on the development of gene therapy technology. This group
will be established as soon as reasonably possible within the twelve (12) month
period after the effective date of the ENZO-FOUNDATION Agreement.
A separate laboratory shall be established by ENZO for this work. This
laboratory shall be staffed by one (1) Ph.D. level senior scientist and four (4)
support personnel. ENZO will support this effort for a period of not less than
two (2) years.
13