THIS INFORMATION MARKED BY * AND [ ] HAS BEEN OMITTED PURSUANT TO A REQEST
FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTIONS HAVE BEEN SEPARATELY FILED
WITH THE COMMISSION.
LICENSE AGREEMENT
This Agreement is effective as of the latest date of signing below and is
by and between Associated Universities, Inc. ("Licensor"), operator of
Brookhaven National Laboratory, Xxxxx, Xxx Xxxx 00000, under contract with the
U.S. Department of Energy, and Progenitor, Inc., which has a principal place of
business at 0000 Xxxxxxxx Xxxx, Xxxxxxxx, Xxxx 00000-0000 ("Licensee").
Licensor represents that it is the owner of the Patent Properties defined
in Article III(a)(1) and has the right to grant the license herein granted;
Licensee desires to secure a non-exclusive license under the aforesaid
Patent Properties to produce expression vectors to express a gene product or
products ("Designated Vectors") which vectors, modifications or derivatives
thereof the Licensee will sell or use commercially;
Licensor is willing to grant the same on the terms and conditions set
forth herein;
Accordingly, in consideration of the premises and the mutual covenants of
this Agreement, the parties hereto agree as follows:
X. XXXXX
(a) Subject to the rights of the U.S. Government, for the T7 Autogene
Patent Properties as defined in PL98-620 and the related implementing
regulations of 37 CFR Part 401 and for the T7 Expression System Patent
Properties as set forth more fully in the waiver document entitled "Statement of
Considerations", attached hereto as ATTACHMENT A, and in the assignment from the
U.S. Government to Licensor, "License, Assignment and Agreement", attached
hereto as ATTACHMENT B, Licensor hereby grants
1
and agrees to grant to Licensee, for the life of this Agreement, a non-exclusive
license under the aforesaid Patent Properties to make, use and sell or dispose
of Licensed Product (as defined in Article III(a)).
(b) Licensee's license includes the right to grant to its Affiliates (as
defined in Article III) sublicenses of the same scope as that of Licensee's
license, provided that all such sublicenses are made to include terms that cause
them to be automatically terminated by termination of Licensee's license for any
reason or cause.
(c) Further, Licensee's license includes the right to grant written,
nonexclusive sublicenses to third parties ("Sublicensees") subject to the
following provisions:
(i) Sublicenses granted by Licensee shall be a grant under
intellectual property rights owned or otherwise controlled by Licensee together
with a grant under the Patent Properties where the Patent Properties are
reasonably required for commercially exploiting the intellectual property rights
owned or otherwise controlled by Licensee;
(ii) Sublicenses granted by Licensee shall be subject to the terms
and conditions of this Agreement, including without limiting effect the
insurance requirement in Article V hereof, and shall contain an express
provision to that effect;
(iii) Licensee guarantees that the Net Sales Proceeds reported and
used in the calculation of the royalties due from the sale or commercial use or
disposition of Licensed Products shall include all billing for each Licensed
Product sold, commercially used or disposed of by Sublicensees;
2
(iv) Sublicenses granted by Licensee shall be made to include terms
that cause the Sublicense to be automatically terminated by termination of
Licensee's license for any reason or cause;
(v) Sublicenses granted by Licensee shall be made to include terms
that prohibit the assignment or transfer of the Sublicense without the prior
written consent of Licensor; and
(vi) Sublicenses granted by Licensee shall be made to include terms
that exclude the right of the Sublicensee to grant sublicenses.
(d) Nothing herein shall be construed to prevent Licensor from licensing
any invention covered by the Patent Properties licensed hereunder to any other
for the purpose of manufacturing, using or selling any such invention.
II. INITIAL LICENSE FEE
Licensee agrees to pay, as a license issuance fee for this License Grant,
the sum of [***], payable by Licensee to Licensor upon execution of this
Agreement by both parties, which sum shall not be applied against additional
royalties required by Article III, below.
III. ROYALTIES AND REPORTS
(a) Definitions:
1) "Patent Properties" means:
(i) United States Patent No. 4,952,496 issued August 28, 1990
in the names of F. Xxxxxxx Xxxxxxx, Xxxxxxxxxx Xxxxxxxx,
Xxxx X. Xxxxxxxxx, Xxxxxxx Xxxxxxx and Xxxx X. Xxxx
3
entitled, "Cloning and Expression of the Gene for
Bacteriophage T7 RNA Polymerase", any continuation, C.I.P
application(s) or divisional application(s) filed
therefrom, and any patent(s) that issue thereon ("T7
Expression System Patent Properties"); and
(ii) United States Patent Application Serial No. [***] any
continuation, C.I.P. application(s) or divisional
application(s) filed therefrom, and any patent(s) that
issue thereon ("T7 Autogene Patent Properties").
2) "Valid Claim" means and includes any claim contained in an
issued Patent within the Patent Properties which has not expired, which has not
been held invalid or unenforceable by final decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
3) "Licensed Product" means and includes Designated Vectors and any
derivatives or modifications thereof and any product produced by use of the
Designated Vectors or by use of any invention covered by an issued patent within
the
4
Patent Properties the manufacture, use or sale of which, but for the license
granted hereunder, would constitute an infringement of one or more Valid Claims.
4) "Net Sales Proceeds" means the accumulated total billing for
each Licensed Product, less the following sums actually paid or credited by
Licensee:
(i) discounts allowed in amount customary in the trade;
(ii) sales or use taxes directly imposed with reference to the
particular sales;
(iii) transportation or insurance charges prepaid or allowed;
and
(iv) amounts allowed or credited on returns.
5) "Affiliate" as used herein means any corporation or other
business entity controlled by Licensee, with "control" meaning ownership of more
than fifty percent (50%) of the voting stock, or receipt of more than fifty
percent (50%) interest in the income, of such corporation or other business
entity.
(b) Licensee, as further consideration for this License Grant, agrees to
pay royalties, as provided for in this Article, on all Licensed Products which
are sold or otherwise commercially used or disposed of by it, its Affiliates, or
Sublicensees during the life of this Agreement.
(c) Commencing in the calendar year 1996, Licensee agrees to make written
reports to Licensor biannually, within sixty (60) days after the first day of
each January and July after the effective date of this Agreement and during the
life of this Agreement and, as of such dates, stating in each such report the
Tradename or other description it, its Affiliates or Sublicensees use in selling
any Licensed Product, and the total Net Sales
5
Proceeds collected by it, its Affiliates or Sublicensees during the preceding
six calendar months and the total royalty due on said Net Sales Proceeds. Each
such report will contain individual sales, commercial use or disposal figures
and royalty figures for each Licensed Product involved. The first such report
shall include all such Net Sales Proceeds billed by Licensee, its Affiliates, or
Sublicensees prior to the date of that report.
(d) Licensee will pay to Licensor royalties on each Licensed Product
according to the following schedule:
1) A royalty of [***] of the Net Sales Proceeds (NSP) of Licensed
Products covered by the T7 Autogene Patent Properties AND the T7 Expression
System Patent Properties.
2) A royalty of [***] of the Net Sales Proceeds (NSP) of Licensed
Products covered by either the T7 Autogene Patent Properties OR the T7
Expression System Patent Properties.
(e) Licensee will pay to Licensor the royalty amounts due at the same
time each biannual sales report is submitted, as required by paragraph (c) above
of this Article.
(f) Licensee further agrees to pay a minimum royalty of [***] for each
calendar year beginning with the calendar year ending December 31, 1996. In the
event that the actual earned royalties for a calendar year exceed this minimum
royalty figure of [***], it is understood that no minimum royalties are to be
paid for that year. In the event that the actual earned royalties paid for a
calendar year are less than this minimum royalty of [***], Licensee shall be
obligated to pay within sixty (60) days after the end of each year the
6
difference between the actual earned royalties it paid during said year and the
minimum royalty of [***], thereby to satisfy this minimum royalty requirement.
(g) Licensee agrees to make a written report to Licensor within sixty
(60) days after the date of any termination of this Agreement, stating in such
report the total Net Sales Proceeds on Licensed Products and the total royalties
due thereon. Concurrently with the making of this report, Licensee will pay to
Licensor the royalties due, including any minimum royalty due.
(h) In the event Licensee is required, as determined by a written legal
opinion from a U.S. patent attorney who is acceptable to Licensor, to pay a
royalty or royalties to any other party or parties for the right to make, use
and sell certain Licensed Product(s) under an issued U.S. patent, Licensee may
offset against the royalties due to Licensor pursuant to III(d) [***] of the
total running royalty or royalties payable to such other party or parties for
the use or sale of said certain Licensed Product(s) during the applicable
accounting period; provided, however, that in no event shall the royalty payable
to Licensor be less than [***] under Article III(d)(1) and no less than [***]
under Article III(d)(2). If the attorney rendering said legal opinion is
unacceptable to Licensor, then before any such offset is applied it will be
necessary for Licensee to obtain a second written legal opinion from a U.S.
patent attorney who is independent from Licensee, except for rendering said
second opinion, and said second legal opinion must fully confirm the first legal
opinion in order to permit such an offset to be applied.
IV. AUDITING
7
(a) Licensee agrees to keep records for a period of three years showing
the sale, commercial disposition or use of Licensed Products by it, its
Affiliates, or Sublicensees under this License Agreement. Licensee shall ensure
that each Affiliate and Sublicensee shall keep full records of Net Sales
Proceeds from its sales of Licensed Products to its customers. Such records
shall be in sufficient detail to enable the royalties payable hereunder by
Licensee to be clearly and fully determined. Licensee further agrees to permit
its, its Affiliates' and Sublicensees' books and records to be examined from
time to time to the extent necessary to verify the reports provided for in
Article III hereof, such examination to be made at the expense of Licensor by an
auditor appointed by Licensor, or at the option and expense of Licensee, by an
independent Certified Public Accountant who may be appointed by Licensor and who
shall be acceptable to Licensee.
(b) Licensor agrees to maintain in confidence the information reported to
it in Licensee's biannual sales reports and any confidential information it
obtains through its audit rights. Licensor will neither disclose this
information outside of its organization nor use this information for any purpose
other than collection of royalties from Licensee under this Agreement.
Licensee agrees that the confidentiality and use provisions of this
Agreement shall not apply to the following:
(i) any information which appears in printed publications or which
otherwise is or becomes generally known in the trade other than through the
fault of Licensor;
8
(ii) any information which Licensor can show by written records was
in its possession prior to the disclosure hereunder; or
(iii) any information which comes into the possession of Licensor
without covenants of secrecy from another party who is under no obligation to
Licensee to maintain the confidentiality of the information.
V. DISCLAIMER, INDEMNIFICATION, AND HOLD HARMLESS AND INSURANCE
(a) Licensor neither makes nor extends any representation or warranty,
either expressed or implied, and no representation or warranty shall be implied
with respect to the Patent License herein granted other than that Licensor has
the right to grant this license. Nothing herein shall be construed as granting
expressly, by implication, estoppel or otherwise any license or rights under
patents of Licensor other than under said Patent Properties.
(b) Licensor shall not be liable for:
1) the adequacy of the patent license granted hereunder; or
2) claims that the use of the T7 expression system, or the
manufacture, use or sale of Licensed Products constitute an infringement of any
property right or patent right of any third party.
(c) Licensor shall not be liable for any injury, losses or damages,
including special or consequential damages or losses incurred by Licensee, nor
for claims for such damages, losses or other injuries asserted or levied against
Licensee, arising out of Licensee's practice of the grant set forth in Article I
of this Agreement. Licensee shall indemnify and hold harmless Licensor and the
U.S. Government from any claims,
9
actions, judgements or awards arising out of Licensee's practice of the grant
set forth in Article I, or out of Licensee's or its Affiliates' or Sublicensees'
manufacture, use, sale or disposition of Licensed Products.
(d) Licensor shall not be obligated to bring, defend or prosecute against
any third party any action or suit for, or arising out of, infringement, or
alleged infringement, of the aforesaid Patent Properties, licensed by it under
this Agreement.
(e) Licensee shall at the time of signing this Agreement have in effect
and shall maintain throughout the life of this Agreement, and for [***] after
this Agreement is terminated, a liability insurance policy in an amount of at
least [***] coverage for claims arising out of the manufacture, use or sale of
Licensed Products by it, its Affiliates, or Sublicensees and Licensee shall have
Licensor and the U.S. Government designated as additional insureds in said
policy, at no expense to Licensor. Licensee shall at the time of signing this
Agreement deliver to Licensor a Certificate of Insurance evidencing such
liability insurance policy and showing Licensor and the U.S. Government as
additional insureds. At each [***] of the effective date of this Agreement,
Licensor shall review the insurance coverage required by this Article and adjust
the coverage, as necessary, to maintain the face value of the coverage within
[***] of the stated [***] adjusted in constant dollars using the effective date
of this Agreement as the starting base for any such adjustment.
VI. SUCCESSOR RIGHTS
(a) The obligations of Licensee hereunder shall run in favor of the
successors, assigns or other legal representatives of Licensor.
10
(b) Licensee's rights under this Agreement and the license herein granted
shall not be assigned for the benefit of creditors of Licensee, or otherwise,
nor shall such rights or license pass to any receiver of Licensee's assets,
except for a person or corporation succeeding to the entire business and good
will of Licensee with respect to the subject matter hereof as the result of a
sale, consolidation, reorganization or otherwise, provided such person or
corporation shall, without delay, accept in writing the provisions of this
Agreement and agree to become in all respects bound thereby in the place and
stead of Licensee. Such rights or license shall not be otherwise transferred or
sub-licensed without the written consent of Licensor.
VII. TERMINATION
(a) If Licensee shall default in the timely payment of the License Fee or
any portion of the royalties, or shall fail to provide biannual sales reports,
or shall make any materially false report, or shall commit any material breach
of any covenant herein contained, and shall fail to remedy any such default or
breach within thirty (30) days after written notice thereof by Licensor, then
Licensor may, at its option, terminate this License Agreement and all other
rights herein granted, by giving notice in writing to such effect.
(b) In the event that Licensee no longer commercially makes, uses or
markets Licensed Products, the Licensee can terminate this Agreement by
providing Licensor with written notice sixty (60) days in advance of
termination. Upon such termination by Licensee, Licensee will submit the report
and pay any royalties due as required in Article III, paragraph (g) hereof.
11
(c) Unless previously terminated in accordance with the foregoing
provisions of this Article VII, this Agreement, the license granted to Licensee
under the aforesaid Patent Properties and all of the rights granted to Licensee
shall become effective as of the date set forth at the outset of this Agreement
and shall run to the full end of the term of the patent(s) that are a part of
said Patent Properties licensed hereunder, and shall thereupon terminate.
VIII. ADVERTISING
Neither the granting of the license or the rights herein granted nor the
acceptance of the license fee or royalty payments hereunder, shall constitute an
approval of, or acquiescence in, advertising or other business practices of
Licensee, its Affiliates or Sublicensees, nor an approval of or acquiescence in,
any use of the corporate name of Licensor, or any use of the name Brookhaven
National Laboratory, or any use of the names of any of the inventors on the
Patent Properties licensed hereunder, or any use of names of any agencies of the
U.S. Government, in connection with the manufacture, advertising, use or sale of
Licensee's products, or services, and Licensor hereby expressly reserves all
rights of actions with respect thereto.
Notwithstanding the above, Licensee may indicate that it is a Licensee of
Licensor of the Patent Properties.
IX. NOTICES
All notices provided for in this License Agreement shall be by letter sent
by certified mail and shall be directed by one party to the other at its
respective address, as follows, and shall be deemed to be given when mailed:
12
Xxxxxxxx X. Xxxxxxxx
Patent Counsel
Brookhaven National Laboratory
Building No. 902C
Xxxxx, Xxx Xxxx 00000
Progenitor, Inc.
0000 Xxxxxxxx Xxxx
Xxxxxxxx, Xxxx 00000-0000
Attn: President
Alternatively, such notices may be delivered to such other address or
addresses as either Licensor or Licensee, respectively, may later establish by
written notice to the other.
X. APPLICABLE LAW
This Agreement shall be construed, interpreted and applied in accordance
with the laws of the United States and of the State of New York.
XI. UNITED STATES GOVERNMENT EXPORT CONTROL REGULATIONS
(a) The Export Control Regulations of the U.S. Department of Commerce
prohibit, except under a special validated license, the exportation from the
United States of technical data relating to certain commodities listed in the
Regulations, unless the exporter has received certain written assurance from the
foreign importer. In order to facilitate the exchange of technical information
under this Agreement, Licensee hereby gives its assurance to Licensor that it
will comply with all of the requirements of the U.S. Export Control Regulations.
(b) Violation of the U.S. Export Control laws or regulations by Licensee,
its Affiliates, or Sublicensees shall constitute grounds for Licensor, in its
sole discretion, to
13
terminate this license agreement. Failure to obtain any needed export control
license may result in criminal liability under United States law.
XII. INTEGRATION CLAUSE
This Agreement contains the entire and only agreement between the parties
respecting the subject matter hereof; and this Agreement supersedes all
pre-existing agreements between such parties respecting the commercial use of
the subject matter hereof; and any representation, promise or condition in
connection therewith not incorporated herein shall not be binding upon either
party. Notwithstanding the previous sentence, this Agreement does not modify or
affect any pre-existing or subsequent separate formal written agreement between
the parties hereto concerning the in-house, non-commercial research use of the
T7 autogene or the in-house, non-commercial research use of the T7 gene
expression system.
The parties hereto have duly executed this Agreement.
LICENSOR:
ASSOCIATED UNIVERSITIES, INC.
By: /s/ Xxxx Xxxxxx
------------------
Xxxx Xxxxxx
Title: Assistant Director - Planning & Policy
Date: 1/8/97
14
LICENSEE:
PROGENITOR, INC.
By: /s/ Xxxxxxx X. Xxxxxxxx
-------------------------
Xxxxxxx X. Xxxxxxxx
Title: Vice President, Corporate Development
Date: 11/21/96
15
ATTACHMENT A
STATEMENT OF CONSIDERATIONS
WAIVER REQUEST BY ASSOCIATED UNIVERSITIES INC. (AUI) OPERATOR OF
BROOKHAVEN NATIONAL LABORATORY (BNL) FOR AN IDENTIFIED INVENTION ENTITLED
"CLONING AND EXPRESSION OF THE GENE FOR BACTERIOPHAGE T7 RNA POLYMERASE"
DOE CASE NO. S-64,618 W(I)-86-027
Associated Universities' request is for a waiver of domestic rights to the above
identified invention for which a patent application has been filed by DOE. A
copy of AUI's waiver petition is attached hereto. As set forth in their
petition of May 13, 1985, Associated Universities has had ongoing negotiations
with several companies directed towards the exclusive licensing of this
invention in particular fields of use. These licenses are intended to take the
basic technology from the laboratory to practical application which will require
substantial private investment. The willingness of private companies to develop
the invention in a particular field is demonstrated by their investing in
examining the clones at their own expense by obtaining the test package made
available by BNL as set forth in the attached letter of February 12.
By the attached letter of April 7, 1986, AUI has set forth procedures it will
utilize to assure that each licensee will pursue development of this invention.
This will include providing in each license a certification of intent to develop
the invention. AUI has an interest in assuring development by the licensee
because of its own financial investment and its desire to receive royalties.
A patent application on this invention was filed on March 26, 1984. In order to
include new work covered by disclosure S-60,863 within the application, a
continuation-in-part application S-64,618 has been filed with the original case
abandoned. The waiver request as set forth in the attached letter of March 14,
1986 is for the invention claimed in the new application.
AUI has agreed that this waiver shall be subject to any terms and conditions
included within their contract in the future to implement Public Law 98-620.
This will make the rights obtained in this invention consistent with those to be
obtained in inventions under P.L. 98-620. Reimbursement to DOE for all costs
related to patent prosecution of the above invention shall be provided by AUI.
The subject matter of these inventions is not classified or sensitive under
section 148 of the Atomic Energy Act of 1954 (42 U.S.C. 2168) as amended, or
under Directive 5230.25, nor were the inventions made under the Uranium
Enrichment or Civilian High Level Nuclear Waste and Spent Fuels Programs.
Accordingly, in view of the statutory objectives to be obtained and the factors
to be considered under DOE statutory waiver policy, all of which have been
considered, it is
concluded that a waiver to the invention identified above will best serve the
interest of the United States and general public and that the waiver should be
granted.
In view of the considerations and objectives for waiver set forth in DOE
PR 9-9.109-6, all of which have been considered, it is believed that a waiver to
the identified invention described above will best serve the United States and
general public and is therefore recommended that the waiver be granted.
/s/ Xxxx X. Xxxxxxxx
-----------------------
Xxxx X. Xxxxxxxx
Assistant Chief
Office of Patent Counsel
Date: 4-8-86
Based on the foregoing Statement of Considerations, it is determined that the
interest of the United States and the general public will best be served by a
waiver of patent rights in the invention described above and therefore the
waiver is granted.
CONCURRENCE: APPROVAL:
/s/ Xxxxxxxxxx Xxxxxx /s/ Xxxxxxx X. Constant
------------------------ --------------------------
Xx. Xxxxxxxxxx Xxxxxx Xxxxxxx X. Constant
Director of Office of Field Assistant General Counsel for Patents, HO
Operations Management
Office of Energy Research
Date: 4/17/86 Date: 4/17/86
2
ATTACHMENT B
LICENSE, ASSIGNMENT AND AGREEMENT
Title: CLONING AND EXPRESSION OF THE GENE FOR BACTERIOPHAGE T7 RNA
POLYMERASE
Inventors: F. Xxxxxxx Xxxxxxx, et al.
Serial No.: 002,408 Filing Date: (U.S.): December 29, 1986
Contractor: Associated Universities
DOE Contract No.: DE-AC02-76CH00016
Foreign Applications filed in or intended to be filed at Contractor's expense in
(countries): None
(1) Whereas the Associated Universities, Inc. (herein called "AUI") has
requested a waiver of title by the Government of the United States of America,
and the Government has granted such waiver by the attached waiver instrument
dated April 17, 1986 with respect to the invention entitled "Cloning and
Expression of the Gene For Bacteriophage T7 RNA Polymerase" identified by DOE
Case No. S-64,618, on which U.S. Patent Application, Serial No. 002,408 was
filed on 12/29/86 and in which the Government has rights pursuant to Xxxxxxxx
Xx. XX-XX00-00XX00000; and
(2) Whereas such waiver provides that the waiver shall be subject to any
terms and conditions to be included in Contract No. DE-AC02-76CH00016 in the
future to implement Public Law 98-620;
(3) Whereas the United States Department of Energy has the right and
authority to assign and transfer to AUI the entire right, title, and interest in
and to said invention, patent(s) and patent application(s) as herein set forth;
(4) Whereas the Government desires to confirm, of record, certain license
and other rights in and to the said invention and any patent(s) or patent
application(s) thereon;
(5) Now, therefore, for good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, the Government of the United States,
as represented by the United States Department of Energy, hereby assigns and
transfers to AUI the entire right, title, and interest in and to said invention
patent(s) and patent application(s) retaining for the Government of the United
States of America and its agencies and instrumentalities a nonexclusive,
nontransferable, irrevocable paid-up license in each patent application filed in
any country on said invention and any resulting patent, including each patent
claiming the filing date priority of the aforesaid patent application, to
practice and have practiced, for or on behalf of the Government of the United
States of America any invention covered by such patent application or patent.
1
(6) AUI hereby confirms the Government's rights in so far as they are set
forth in the aforesaid waiver instrument and as they are to be included in said
contract to implement Public Law 98-620, and agrees that any license,
assignment, or other conveyance made by AUI of a right or interest with respect
to said invention(s) or said patent application(s) or patent(s) shall be subject
thereto.
Approved and granted on behalf of the Government of the United States.
UNITED STATES DEPARTMENT OF ENERGY
By
--------------------------------
Title
-----------------------------
Date
------------------------------
Witness:
-----------------------------------
Approved, accepted and consented to this 9th day of March, 1987.
(SEAL)
ATTEST: ASSOCIATED UNIVERSITIES, INC.
By
--------------------------------
Its Its
------------------------------- -------------------------------
2
STATEMENT OF CONSIDERATIONS
WAIVER REQUEST BY ASSOCIATED UNIVERSITIES INC. (AUI) OPERATOR OF
BROOKHAVEN NATIONAL LABORATORY (BNL) FOR AN IDENTIFIED INVENTION ENTITLED
"CLONING AND EXPRESSION OF THE GENE FOR BACTERIOPHAGE T7 RNA POLYMERASE"
DOE CASE NO. S-64,618 W(I)-86-027
Associated Universities' request is for a waiver of domestic rights to the above
identified invention for which a patent application has been filed by DOE. A
copy of AUI's waiver petition is attached hereto. As set forth in their
petition of May 13, 1985, Associated Universities has had ongoing negotiations
with several companies directed towards the exclusive licensing of this
invention in particular fields of use. These licenses are intended to take the
basic technology from the laboratory to practical application which will require
substantial private investment. The willingness of private companies to develop
the invention in a particular field is demonstrated by their investing in
examining the clones at their own expense by obtaining the test package made
available by BNL as set forth in the attached letter of February 12.
By the attached letter of April 7, 1986, AUI has set forth procedures it will
utilize to assure that each licensee will pursue development of this invention.
This will include providing in each license a certification of intent to develop
the invention. AUI has an interest in assuring development by the licensee
because of its own financial investment and its desire to receive royalties.
A patent application on this invention was filed on March 26, 1984. In order to
include new work covered by disclosure S-60,863 within the application, a
continuation-in-part application S-64,618 has been filed with the original case
abandoned. The waiver request as set forth in the attached letter of March 14,
1986 is for the invention claimed in the new application.
AUI has agreed that this waiver shall be subject to any terms and conditions
included within their contract in the future to implement Public Law 98-620.
This will make the rights obtained in this invention consistent with those to be
obtained in inventions under P.L. 98-620. Reimbursement to DOE for all costs
related to patent prosecution of the above invention shall be provided by AUI.
The subject matter of these inventions is not classified or sensitive under
section 148 of the Atomic Energy Act of 1954 (42 U.S.C. 2168) as amended, or
under Directive 5230.25, nor were the inventions made under the Uranium
Enrichment or Civilian High Level Nuclear Waste and Spent Fuels Programs.
Accordingly, in view of the statutory objectives to be obtained and the factors
to be considered under DOE statutory waiver policy, all of which have been
considered, it is concluded that a waiver to the invention identified above will
best serve the interest of the United States and general public and that the
waiver should be granted.
In view of the considerations and objectives for waiver set forth in DOE
PR 9-9.109-6, all of which have been considered, it is believed that a waiver to
the identified invention described above will best serve the United States and
general public and is therefore recommended that the waiver be granted.
/s/ Xxxx X. Xxxxxxxx
-----------------------
Xxxx X. Xxxxxxxx
Assistant Chief
Office of Patent Counsel
Date: 4-8-86
Based on the foregoing Statement of Considerations, it is determined that the
interest of the United States and the general public will best be served by a
waiver of patent rights in the invention described above and therefore the
waiver is granted.
CONCURRENCE: APPROVAL:
/s/ Xxxxxxxxxx Xxxxxx /s/ Xxxxxxx X. Constant
------------------------ --------------------------
Xx. Xxxxxxxxxx Xxxxxx Xxxxxxx X. Constant
Director of Office of Field Assistant General Counsel for Patents, HO
Operations Management
Office of Energy Research
Date: 4/17/86 Date: 4/17/86
2
