EXHIBIT 10.1
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. Alpha 1 Biomedicals, Inc., hereinafter referred to as
"Collaborator," agrees to transfer to PHS's investigator, Dr. Hynda Kleinman,
the following "Research Material":
thymosin beta4 (***)
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
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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.
Model PHS MTA-CRADA
Form 053096 Page 1 of 4
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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 OF MERCHANTABLITY 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 to 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 to 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 to 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 been obtained from a non-Federal
party.
Model PHS MTA-CRADA
Form 053096 Page 2 of 4
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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.
Model PHS MTA-CRADA
Form 053096 Page 3 of 4
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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:
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Harold C. Slavkin, D.D.S. Date
Director, National Institute of Dental Research
Mailing Address for Notices:
Dr. Jacob A. Donkersloot
Technology Development Coordinator, NIDR
US Mail: 30 Convent Drive, MSC 4350 Federal Express etc: NIH, Bg. 30, Rm. 532
Bethesda, MD 20892-4350 Bethesda MD 20892
FOR THE COLLABORATOR:
/s/ Michael L. Berman 5/15/97
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Michael L. Berman, Ph.D. Date
President and Chief Executive Officer, Alpha I Biomedicals, Inc.
Mailing Address for Notices:
Michael L. Berman, Ph.D.
6707 Democracy Blvd.
Suite 111
Bethesda MD 20817
Model PHS MTA-CRADA
Form 053096 Page 4 of 4
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