SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) - March 13, 1997
Advanced Viral Research Corp.
(Exact name of registrant as specified in its charter)
Delaware 33-2262-A 59-2646820
(State or other juris- (Commission File (IRS Employer
diction of incorporation) Number) Identification No.)
1250 East Hallandale Beach Blvd.
Suite 501
Hallandale, Florida 33009
(Address or principal executive offices (zip code)
Registrant's telephone number, including area code: (954) 458-7636
NONE
(Former name or former address, if changed since last report)
Item 1. Changes in Control of Registrant
Not Applicable
Item 2. Acquisition or Disposition of Assets
Not Applicable
Item 3. Bankruptcy or Receivership
Not Applicable
Item 4. Changes in Registrant's Certifying Accountant
Not Applicable
Item 5. Other Events
On March 13, 1997 Advanced Viral Research Corp.
("ADVR") signed a Materials Development Agreement -
Cooperative Research and Development Agreement with the
National Cancer Institute ("NCI") of the National Institutes
of Health. Under the terms of the Agreement, NCI researchers
and ADVR will collaborate to elucidate the molecular mechanism
by which Reticulose, ADVR's peptic nucleic acid preparation
affects the transcription of the gamma interferon gene.
Item 6. Resignation of Registrant's Directors
Not Applicable
Item 7. Financial Statements and Exhibits
(a) Financial statements of business acquired
None
(b) Pro forma financial information
None
(c) Exhibits
10(t) Materials Transfer Agreement - Cooperative
Research and Development Agreement dated
March 13, 1997 between ADVR and the National
Cancer Institute of the National Institutes
of Health
Item 8. Change in Fiscal Year
Not Applicable
[This Space Intentionally Left Blank]
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
ADVANCED VIRAL RESEARCH CORP.
(Registrant)
By: /s/ William Bregman
-------------------
William Bregman,
Secretary-Treasurer
Date: March 13, 1997
LIST OF EXHIBITS
10(t) Materials Transfer Agreement - Cooperative Research and Development
Agreement dated March 13, 1997 between ADVR and the National Cancer
Institute of the National Institutes of Health
PUBLIC HEALTH SERVICE
MATERIAL TRANSFER AGREEMENT-COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT
This Material Transfer Agreement-Cooperative Research and Development Agreement
("MTA-CRADA") has been adopted for use by the National Institutes of Health
("NIH"), the Food and Drug Administration ("FDA"), and the Centers for Disease
Control and Prevention ("CDC"), collectively referred to herein as the Public
Health Service ("PHS"), for transfers of essential research material ("Research
Material") not otherwise reasonably available for PHS research.
1. Advanced Viral Research Corporation. hereinafter referred to as
"Collaborator," agrees to transfer to PHS's investigator, Dr. Howard Young. the
following "Research Material":
RETICULOSE (a peptide nucleic acid drug)
This MTA-CRADA involves no other exchange of personnel or resources.
2. This Research Material will be used solely in connection with the
research plan ("Research Plan"), attached as Appendix A, by PHS's investigator
in his/her laboratory under suitable containment conditions.
2(a). Are the Research Materials of human origin?
Yes
X No
2(b). If Yes in 2(a), were the Research Materials collected according
to 45 CFR Part 46, "Protection of Human Subjects?"
Yes (Please provide Assurance Number: )
No
2(c). Will the Research Materials be used in human subjects?
Yes (Please provide Assurance Number: )
X No
3. In all oral presentations or written publications concerning the
Research Plan, PHS will acknowledge Collaborator's contribution of this Research
Material unless requested otherwise. To the extent permitted by law, PHS agrees
to treat in confidence, for a period of three (3) years from the date of the
disclosure to the PHS, any of Collaborator's written information about this
Research Material that is stamped "CONFIDENTIAL" or any of Collaborator's oral
information about this Research Material that is identified in writing as
"CONFIDENTIAL" within ten (10) days of the oral disclosure, except for
information that was previously known to PHS or that is or becomes publicly
available or which is disclosed to PHS without a confidentiality obligation. PHS
may publish or otherwise publicly disclose the results of the Research Plan, but
if Collaborator has given CONFIDENTIAL information to PHS such public disclosure
may be made only after Collaborator has had thirty (30) days to review the
proposed disclosure to determine if it contains any CONFIDENTIAL information,
except when a shortened time period under court order or the Freedom of
Information Act pertains.
4. This Research Material represents a significant investment on the part
of Collaborator and is considered proprietary to Collaborator. PHS's
investigator therefore agrees to retain control over this Research Material, and
further agrees not to transfer the Research Material to other people not under
her or his direct supervision without advance written approval of Collaborator.
Collaborator reserves the right to distribute the Research Material to others
and to use it for its own purposes. When the Research Plan is completed or one
(1) year has elapsed, whichever occurs first, or the MTA-CRADA is terminated,
the Research Material will be disposed of as directed by Collaborator.
5. This Research Material is provided as a service to the research
community. IT IS BEING SUPPLIED TO PHS WITH NO WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Collaborator makes no representations that the use of the Research Material will
not infringe any patent or proprietary rights of third parties. It is the
intention of PHS that Collaborator not be liable for any claims or damages
arising from PHS's use of the Research Material; however, no indemnification is
provided or intended.
6. The PHS shall promptly report to Collaborator in writing each Subject
Invention and any patent applications filed thereon resulting from the research
conducted under this MTA-CRADA that is reported to PHS by its employees. Subject
Invention means any invention, conceived or first actually reduced to practice
in the performance of the research plan during the term of this MTA-CRADA, that
is or may be patentable under 35 U.S.C. ss. 101 or ss. 161, protectable under 7
U.S.C. ss. 2321, or otherwise protectable by other types of U.S. or foreign
intellectual property rights.
7. With respect ot Government intellectual property rights to any Subject
Invention not made solely by the Collaborator's employees for which a patent or
other intellectual property application is filed, PHS hereby grants to the
Collaborator an option to elect an exclusive or nonexclusive commercialization
license, which is substantially in the form of the appropriate model PHS license
agreement. This option does not apply to Subject Inventions conceived prior the
effective date of this CRADA that are reduced to practice under this CRADA, if
prior to that reduction to practice, PHS has filed a patent application on the
invention and has licensed it or offered to license it to a third party. The
terms of the license will fairly reflect the nature of the invention, the
relative contributions of the Parties to the invention and the CRADA, the risks
incurred by the Collaborator and the costs of subsequent research and
development needed to bring the invention the marketplace. The field of use of
the license will be commensurate with the scope of the research plan.
8. Within three (3) months after PHS provides notice to the Collaborator
that the patent or other intellectual property application is filed, the license
option must be exercised by written notice mailed to the designated PHS
official. Exercise of this option by the Collaborator initiates a license
negotiation period that expires nine (9) months after the patent or other
intellectual property application filing date. If the last proposal by the
Collaborator has not been responded to in writing by PHS within this nine (9)
month period,the negotiation period shall be extended to expire one (1) month
after PHS so responds, during which month the Collaborator may accept in writing
the final license proposal of PHS. In the absence of such acceptance, PHS will
be free to license such intellectual property rights to others. In the event
that Collaborator elects the option for an exclusive license, but no such
license is executed during the negotiation period, PHS agrees not to make an
offer on more favorable terms to third party for a period of six (6) months
without first offering Collaborator those more favorable terms. These times may
be extended at the sole discretion of PHS upon good cause shown in writing by
the Collaborator.
9. Pursuant to 15 U.S.C. 3710a(b)(1)(A), for inventions made by PHS
employees or jointly with a Collaborator under this MTA-CRADA, the Collaborator
grants to PHS a nonexclusive, nontransferable, irrevocable, paid-up license to
practice the invention or have the invention practiced throughout the world by
or on behalf of the Government. In the exercise of such license, the Government
shall not publicly disclose trade secrets or commercial or financial information
that is privileged or confidential within the meaning of 5 U.S.C. 552(b)(4) or
which would be considered as such if it had obtained from a non-Federal party.
10. Pursuant to 15 U.S.C. 3710a(b)(2), for inventions made solely by
Collaborator employees under this MTA-CRADA, the Collaborator grants to PHS a
nonexclusive, nontransferable, irrevocable, paid-up license to practice the
invention or have the invention practiced throughout the world by or on behalf
of the Government for research or other Government purposes.
11. Pursuant to 15 U.S.C. 3710a(1)(B), if PHS grants an exclusive license
to a Subject Invention made wholly by PHS employees or jointly with a
Collaborator under this MTA-CRADA, the Government shall retain the right to
require the Collaborator to grant to a responsible applicant a nonexclusive,
partially exclusive, or exclusive sublicense to use the invention in
Collaborator's licensed field of use on terms that are reasonable under the
circumstances; or if the Collaborator fails to grant such a license, to grant
the license itself. The exercise of such rights by the Government shall only be
in exceptional circumstances and only if the Government determines (i) the
action is necessary to meet health or safety needs that are not reasonably
satisfied by Collaborator, (ii) the action is necessary to meet requirements for
public use specified by Federal regulations, and such requirements are not
reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed
to comply with an agreement containing provisions described in 15 U.S.C.
3710a(c)(4)(B). The determination made by the Government under this paragraph is
subject to administrative appeal and judicial review under 35 U.S.C. 203(2).
12. Any dispute arising under this MTA-CRADA that is not disposed of by
agreement of the Principal Investigators shall be submitted jointly to the
signatories of this MTA-CRADA. If the signatories are unable to jointly resolve
the dispute within thirty (30) days after notification thereof, the Assistant
Secretary for Health (or his/her designee or successor) shall propose a
resolution. Nothing in this article shall prevent any Party from pursuing any
additional administrative remedies that may be available and, after exhaustion
of such administrative remedies, pursuing all available judicial remedies.
13. The illegality or invalidity of any provisions of this MTA-CRADA shall
not impair, affect or invalidate the other provisions of this MTA-CRADA.
14. Neither this MTA-CRADA nor any rights or obligations of any Party
hereunder shall be assigned or otherwise transferred by either Party without the
prior written consent of the other Party.
15. All notices pertaining to or required by this MTA-CRADA shall be in
writing and shall be signed by an authorized representative and shall be
delivered by hand or sent by certified mail, return receipt requested, with
postage prepaid, to the addresses indicated on the signature page for each
Party. Notices regarding the exercise of license options shall be made pursuant
to Article 8. Any Party may change such address by notice given to the other
Party in the manner set forth above.
16. By entering into this MTA-CRADA, PHS does not directly or indirectly
endorse any product or service provided, or to be provided, whether directly or
indirectly related to either this MTA-CRADA or to any patent or other
intellectual property license or agreement which implements this MTA-CRADA by
its successors, assignees, or licensees. The Collaborator shall not in any way
state or imply that this MTA-CRADA is an endorsement of any such product or
service by the U.S. Government or any of its organizational units or employees.
17. Either the PHS or the Collaborator may unilaterally terminate this
entire Agreement at any time by giving written notice at least thirty (30) days
prior to the desired termination date.
18. This MTA-CRADA constitutes the entire agreement between the Parties
concerning the subject matter of this MTA-CRADA and supersedes any prior
understanding or written or oral agreement.
19. This MTA-CRADA shall be construed in accordance with Federal law as
applied by the Federal courts in the District of Columbia.
20. The undersigned expressly certify and affirm that the contents of any
respective statements made or reflected in this MTA-CRADA are truthful and
accurate.
21. This MTA-CRADA shall be effective upon execution by the Parties. Under
the terms of the Federal Technology Transfer Act, PHS has thirty (30) days to
disapprove this MTA-CRADA in which case it shall be considered terminated from
the date of such disapproval. The term of this MTA-CRADA is twelve (12) months
from execution.
22. The provisions of Articles 3, 5-10, 14 and 20 shall survive the
termination of this MTA-CRADA.
FOR PHS:
/s/ Dr. Alan Rabson 2/27/97
- ------------------- -------
Dr. Alan Rabson Date
Deputy Director, NCI
Mailing Address for Notices:
The National Cancer Institute
Office of Technology Development
Executive Plaza South, Room 450
6120 Executive BLVD MSC 7182
Bethesda MD 20892-7182
Phone: 301-496-0477
FAX: 301-402-2117
FOR THE COLLABORATOR:
/s/ Shalom Z. Hirschman 3/4/97
- ----------------------- ------
Shalom Z. Hirschman, MD Date
President & CEO
Mailing Address for Notices:
Advanced Viral Research Corporation
5240 Blackstone Avenue
Riverdale, NY 10471
Phone: 718-601-8890
FAX: 718-601-8892
APPENDIX A
RESEARCH PLAN
Peptide nucleic acids (PNAs) are newly appreciated molecules consisting of both
amino acids and nucleosides that already have been shown to have interesting
properties such as antisense activity. RETICULOSE, is a PNA preparation that had
been used for many years to treat human viral infections such as influenza.
Dr. Howard Young has been investigating the molecular regulation of interferon-y
(IFN-y) gene expression for over 13 years. This gene has been chosen because
expression of IFN-y is largely restricted to two cell types, T cells and CD3
LGLs. Current work has focused on identifying those regions of DNA that are
involved in the response to various stimuli and the data indicates that there
are multiple enhancer-like/repressor elements in the human IFN-y genomic DNA.
The region 5' to the coding sequence contains both enhancer and repressor
protein binding regions while the first intron contains a second enhancer that
may also be involved in association of IFN-y genomic DNA with the nuclear
matrix. His laboratory has mapped the specific nucleotide sequences that
interact with the DNA binding proteins for each of these regions and we have
identified NFkB and NFAT family members, AP-1, CREB family members and
Yin-Yang-1 as interacting with both the 5' and intronic enhancer regions.
Current studies are focused on identifying the biochemical signaling events that
lead to the induction or inhibition of IFN-y gene expression in response to
interferons, interleukins 2, 4, 7, 12, 13, 15, and anti-CD28 stimulation and
determining the alterations in specific DNA binding proteins that occur in
response to these treatments. He is also attempting to identify DNA binding
proteins which may differentially interact with the IFN-y and IL-4 promoters.
Dr. Young has extended these studies to evaluate the control of gene expression
in T cells obtained from tumor bearing mice, cancer patients and AIDS patients.
This MTA-CRADA will provide a novel reagent which has apparent effects on IFN-y
gene expression and it is the purpose of this agreement for Dr. Young to
determine the molecular mechanism by which RETICULOSE may specifically enhance
transcription of the IFN-y gene.
APPENDIX B
EXCEPTIONS OR MODIFICATIONS TO THIS MTA-CRADA
Please note: additions to the Model MTA-CRADA are shown by underlining and
deletions are shown by strikeout.
Paragraph 14 shall be modified as follows:
14. Neither this MTA-CRADA nor any rights or obligations of any Party hereunder
shall be assigned or otherwise transferred by either Party without the prior
written consent of the other Party, provided however, that Collaborator may
assign or otherwise transfer this agreement to a purchaser or acquirer of
substantially the entire business of Collaborator to which this Agreement
pertains with the written consent of the NCI, which consent shall not
unreasonably be withheld.