Certain portions of this
exhibit have been
omitted based upon
a request for confidential
treatment. Omitted portions
have been separately filed
with the Securities and
Exchange Commission.
AGREEMENT
BETWEEN
OSIRIS THERAPEUTICS, INC.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
AND
DEFENSE ADVANCED RESEARCH PROJECTS AGENCY
0000 XXXXX XXXXXXX XXXXX
XXXXXXXXX, XX 00000-0000
CONCERNING
SEQUENTIAL RELEASE OF VACCINES USING MESENCHYMAL STEM CELLS
TWO-COMPONENT CELL SYSTEMS USING MESENCHYMAL STEM CELLS
Agreement No.: MDA972-96-3-0018
ARPA Order No.: D850/00
Total Amount of the Agreement: $ 3,006,356.00
Total Estimated Government Funding of the Agreement: $2,000,000.00
Funds Obligated: $2,000,000.00
Authority: 10 U.S.C. ~ 0000
Xxxx xx Xxxxxxxxxxxxx:
XX 0000000 1320 D850 P6D1O 2525 DPAC 6 5145 503733: $1,359,500.00
AB 9760400 1320 D850 P6Y1O 2525 DPAC 6 5145 503733: $640,500.00
This Agreement is entered into between the United States of America,
hereinafter called the Government, represented by The Defense Advanced
Research Projects Agency (DARPA), and OSIRIS
THERAPEUTICS, INC. pursuant to and under U.S. Federal law.
FOR OSIRIS THERAPEUTICS, INC. FOR THE UNITED STATES OF AMERICA
DEFENSE ADVANCED RESEARCH
PROJECTS AGENCY
/s/ Xxxxx X. Xxxxx 6/11/96 /s/ Xxx X. Register
(Name, Title) XXX X. REGISTER
Deputy Director, Management
Xxxxx X. Xxxxx
President & CEO
TABLE OF CONTENTS
ARTICLES PAGE
ARTICLE I Scope of the Agreement 3
ARTICLE II Term 8
ARTICLE III Management of the Project 9
ARTICLE IV Agreement Administration 11
ARTICLE V Obligation and Payment 12
ARTICLE VI Disputes 14
ARTICLE VII Patent Rights 16
ARTICLE VIII Data Rights 22
ARTICLE IX Foreign Access to Technology 24
ARTICLE X Civil Rights Act 27
ARTICLE XI Execution 27
ATTACHMENTS
ATTACHMENT 1 Statement of Work
ATTACHMENT 2 Report Requirements
ATTACHMENT 3 Schedule of Payments and Payable Milestones
ATTACHMENT 4 Funding Summary (NOT APPLICABLE)
ATTACHMENT 5 List of OSIRIS Therapeutics, Inc. Representatives
ARTICLE I: SCOPE OF THE AGREEMENT
A. BACKGROUND
The Secretary of Defense has determined that there exists (1) a formidable
disparity between the magnitude of the biological weapons threat faced by the
warfighter, and his or her ability to react to their use by an adversary, and
(2) a critical and urgent need to reduce, if not eliminate, that disparity in
part through the development of advanced real-time sensing technologies, and
advanced biological countermeasures. [See Testimony, Director of DARPA, SASC
Subcommittee on Acquisition and Technology, 20 March 1996.] The Mesenchymal
Stem Cells (MSC) Program, a subset of DARPA Biological Warfare Defense
Program, exists to address these disparities and these critical needs.
Traditional biological warfare defense technology has relied upon sensors,
physical barriers, and the use of pre- and post-exposure drugs. The
application of stem cell biology to the development of biological warfare
defenses is, in itself, an advanced concept. The further application of MSC
to the development of biological warfare defenses is truly revolutionary. The
majority (--greater than--95%) of the research done to date in this area has
concentrated on the use of modified hematopoietic stem cells (HSC). HSCs are
progenitor cells that give rise to blood cells; current work in the field has
demonstrated their potential to act as effective agents in identifying and
neutralizing blood-based pathogens. Bio-threat agents, however, are capable
of significant damage beyond the bloodstream, i.e., inside body tissues. At
this crucial biological battlefield, it is expected that mesenchymal stem
cells (progenitor cells for tissue and cartilage) have the potential to spawn
a complementary breakthrough, resulting in MSCs that can effectively identify
and neutralize bio-threat agents before they enter and destroy target
tissues. At the present time, no significant work with MSCs is being done to
exploit this potential, therefore, the MSC Program expects to fill this
critical R&D shortfall.
[*CONFIDENTIALITY REQUESTED*]
B. Scope
1. OSIRIS Therapeutics, Inc. (OSIRIS) shall perform a research and
development program (Program) designed to develop a mesenchymal stem cells
program. The research shall be carried out in accordance with the Statement
of Work incorporated in this Agreement as Attachment 1. OSIRIS shall submit
or otherwise provide all documentation required by Attachment 2, Report
Requirements.
2. OSIRIS shall be paid for each Payable Milestone accomplished in
accordance with the Schedule of Payments and Payable Milestones set forth in
Attachment 3 and the procedures of Article V. Both the Schedule of Payments
and the Funding Schedule set forth in Attachments 3 and 4 respectively may be
revised or updated in accordance with Article III.
3. The Government and OSIRIS (Parties) estimate that the Statement of Work
of this Agreement can only be accomplished with an OSIRIS aggregate resource
contribution of [*CONFIDENTIALITY REQUESTED*] from the effective date of this
Agreement through [*CONFIDENTIALITY REQUESTED*] thereafter. OSIRIS intends
and, by entering into this Agreement, undertakes to cause these funds to be
provided. OSIRIS contributions will be provided as set forth in Attachment 3.
If either DARPA or OSIRIS is unable to provide its respective total
contribution, the other Party may reduce its project funding by a
proportional amount.
C. Goals/Objectives
1. DARPA's overall goal of its Biological Warfare Defense Program is to
remove the threat of biological weapons as a factor in the planning for and
conducting military operations. The specific goals for its MSC Program are:
(a) To develop one or more technologies that detect and detoxify a
biological agent through the use of OSIRIS's Two-Component Cell System.
(b) To develop one or more stable platforms for delivering vaccines at
several sequential time points.
2. The Government will have continuous involvement with OSIRIS. The
Government will also obtain access to research results and certain rights in
data and patents pursuant to Articles VII and VIII. DARPA and OSIRIS are
bound to each other by a duty of good faith and best research effort in
achieving the goals of the Program.
3. This Agreement is an "other transaction" pursuant to 10 U.S.C.
Section 2371. The Parties agree that the principal purpose of this Agreement
is for the Government to support and stimulate OSIRIS to provide its best
efforts in advanced research and technology development and not for the
acquisition of property or services for the direct benefit or use of the
Government. The Federal Acquisition Regulation (FAR) and Department of Defense
FAR Supplement (DFARS) apply only as specifically referenced herein. This
Agreement is not a procurement contract or grant agreement for purposes of
FAR Subpart 31.205-18.
ARTICLE II: TERM
A. The Term of this Agreement
The Program shall commence on the date of the last signature hereon, and shall
continue for thirty-six (36) months, which term, for the purpose of
performance, progress measurement and funding, shall be divisible into three
twelve (12) month periods. For each period, if all funds are expended prior
to the twelve (12)-month duration, the Parties have no obligation to continue
performance and may elect to cease development at that point. Provisions of
this Agreement, which, by their express terms or by necessary implication,
apply for periods of time other than specified herein, shall be given effect,
notwithstanding this Article.
B. Termination Provisions
Subject to a reasonable determination that the program will not produce
beneficial results commensurate with the expenditure of resources, either
Party may terminate this Agreement by written notice to the other Party,
Provided that such written notice is preceded by consultation between the
Parties. In the event of a termination of the Agreement, it is agreed that
disposition of Data developed under this Agreement, shall be in accordance
with the provisions set forth in Article VIII, Data Rights. The Government
and OSIRIS will negotiate in good faith a reasonable and timely adjustment
of all outstanding issues between the Parties as a result of termination.
Failure of the Parties to agree to a reasonable adjustment will be resolved
pursuant to Article VI, Disputes. The Government has no obligation to
reimburse OSIRIS beyond the last completed and paid milestone if OSIRIS
decides to terminate.
C. Extending the Term
The Parties may extend by mutual written agreement the term of this Agreement
if funding availability and research opportunities reasonably warrant. Any
extension shall be formalized through modification of the Agreement by the
Agreements Officer and the OSIRIS' Administrator.
ARTICLE III: MANAGEMENT OF THE PROJECT
A. Management and Program Structure
OSIRIS shall be responsible for the overall technical and program management
of the Program, and technical planning and execution shall remain with
OSIRIS. The DARPA Program Manager shall provide recommendations to Program
developments and technical collaboration and be responsible for the review and
verification of the Payable Milestones
B. Program Management Planning Process
Program planning will consist of an Annual Program Plan with inputs and review
from OSIRIS and DARPA management, containing the detailed schedule of research
activities and payable milestones. The Annual Program Plan will consolidate
quarterly adjustments in the research schedule, including revisions/
modification to payable milestones.
l. Initial Program Plan: OSIRIS will follow the initial program
plan that is contained in the Statement of Work (Attachment 1), and the
Schedule of Payments and Payable Milestones (Attachment 3).
2. Overall Program Plan Annual Review
(a) OSIRIS, with DARPA Program Manager review, will prepare
an overall Annual Program Plan in the first quarter of each Agreement year.
(For this purpose, each consecutive twelve (12) month period from (and
including) the month of execution of this Agreement during which this
Agreement shall remain in effect shall be considered an "Agreement Year".)
The Annual Program Plan will be presented and reviewed at an annual site
review which will be attended by OSIRIS Management, the DARPA Program Manager,
Senior DARPA management as appropriate, and other DARPA program managers and
personnel as appropriate. OSIRIS, with DARPA participation and review, will
prepare a final Annual Program Plan.
(b) The Annual Program Plan provides a detailed schedule of
research activities, commits OSIRIS to use its best efforts to meet specific
performance objectives, includes forecasted expenditures and describes the
Payable Milestones. The Annual Program Plan will consolidate all prior
adjustments in the research schedule, including revisions/modifications to
payable
milestones. Recommendations for changes, revisions or modifications to the
Agreement which result from the Annual Review shall be made in accordance
with the provisions of Article III, Section C.
C. Modifications
l. As a result of quarterly meetings, annual reviews, or at
any time during the term of the Agreement, research progress or results may
indicate that a change in the Statement of Work and/or the Payable Milestones,
would be beneficial to program objectives. Recommendations for modifications,
including justifications to support any changes to the Statement of Work
and/or the Payable Milestones, will be documented in a letter and submitted by
OSIRIS to the DARPA Program Manager with a copy to the DARPA Agreements
Officer. This documentation letter will detail the technical, chronological,
and financial impact of the proposed modification to the research program.
OSIRIS shall approve any Agreement modification. The Government is not
obligated to pay for additional or revised Payable Milestones until the
Payable Milestones Schedule (Attachment 3) is formally revised by the DARPA
Agreements Officer and made part of this Agreement.
2. The DARPA Program Manager shall be responsible for the
review and verification of any recommendations to revise or otherwise modify
the Agreement Statement of Work, Schedule of Payments or Payable Milestones,
or other proposed changes to the terms and conditions of this Agreement.
3. For minor or administrative Agreement modifications
(e.g. changes in the paying office or appropriation data, changes to
Government or OSIRIS personnel identified in the Agreement, etc.) no signature
is required by OSIRIS.
ARTICLE IV: AGREEMENT ADMINISTRATION
Unless otherwise provided in this Agreement, approvals permitted or required
to be made by DARPA may be made only by the DARPA Agreements Officer.
Administrative and contractual matters under this Agreement shall be referred
to the following representatives of the parties:
DARPA: C. Xxxx Xxxxxxxxx (Agreements Officer)
(000) 000-0000
OSIRIS: Xxxxxx X. Xxxxxx (Administrator)
(000) 000-0000
Technical matters under this Agreement shall be referred to the following
representatives:
DARPA: CDR Xxxxx X. Xxxxx, MC, USN (Program Manager)
(000) 000-0000
OSIRIS: Xxxxxx X. Xxxxxxx, Ph.D
(000) 000-0000
Each party may change its representatives named in this Article by written
notification to the other party.
ARTICLE V: OBLIGATION AND PAYMENT
A. Obligation
l. The Government' 5 liability to make payments to OSIRIS
is limited to only those funds obligated under the Agreement or by
modification to the Agreement. DARPA may obligate funds to the Agreement
incrementally.
2. If modification becomes necessary in performance of
this Agreement, pursuant to Article III, paragraph B, the DARPA Agreements
Officer and OSIRIS Administrator shall execute a revised Schedule of Payable
Milestones consistent with the then current Program Plan.
B. Payments
l. OSIRIS has an established and agrees to maintain an
established accounting system which complies with Generally Accepted
Accounting Principles and the requirements of this Agreement, and shall ensure
that appropriate arrangements have been made for receiving, distributing and
accounting for Federal funds. An acceptable accounting system is one in which
all cash receipts and disbursements are controlled and documented properly.
2. OSIRIS shall document the accomplishments of each
Payable Milestone by submitting or otherwise providing the Payable Milestones
Report required by Attachment 2, Part D. OSIRIS shall submit an original and
one (1) copy of all invoices to the Agreements Officer for payment approval. -
After written verification of the accomplishment of the Payable Milestone by
the DARPA Program Manager, and approval by the Agreements Officer, the
invoices will be forwarded to the payment office within fifteen (15) calendar
days of receipt of the invoices at DARPA. Payment approval for the final
Payable Milestone will be made after reconciliation of DARPA funding with
actual OSIRIS contributions. Payments will be made by XXX-XX XXXXXXX/FS, 000
Xxxx Xxxxxx, Xxxx 000, Xxxxxxx XXX, XX 00000-0000 within fifteen (15) calendar
days of DARPA' s transmittal. Subject to change only through written
Agreement modification, payment shall be made to the address of the OSIRIS
Administrator set forth below.
3. Address of Payee:
OSIRIS THERAPEUTICS, INC.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
4. Limitation of Funds: In no case shall the Government' s
financial liability exceed the amount obligated under this Agreement
5. Financial Records and Reports: OSIRIS shall maintain
adequate records to account for Federal funds received under this Agreement
and shall maintain adequate records to account for OSIRIS funding provided for
under this Agreement. Upon completion or termination of this Agreement,
whichever occurs earlier, the OSIRIS Administrator shall furnish to the
Agreements Officer a copy of the Final Report required by Attachment 2, Part
E. OSIRIS' relevant financial records are subject to examination or audit on
behalf of DARPA by the Government, by an auditing agency mutually agreeable to
both parties, for a period not to exceed three (3) years after expiration of
the term of this Agreement. The Agreements Officer or designee shall have
direct access to sufficient records and information of OSIRIS, to ensure full
accountability for all funding under this Agreement. Such audit, examination,
or access shall be performed during business hours on business days upon prior
written notice and shall be subject to the security requirements of the
audited party.
ARTICLE VI: DISPUTES
A. General
The Parties shall communicate with one another in good faith and in a timely
and cooperative manner when raising issues under this Article.
B. Dispute Resolution Procedures
l. Any disagreement, claim or dispute between DARPA and
OSIRIS concerning questions of fact or law arising from or in connection with
this Agreement, and, whether or not involving an alleged breach of this
Agreement, may be raised only under this Article.
2. Whenever disputes, disagreements, or misunderstandings
arise, the Parties shall attempt to resolve the issue(s) involved by
discussion and mutual agreement as soon as practicable. In no event shall a
dispute, disagreement or misunderstanding which arose more than three (3)
months prior to the notification made under subparagraph B.3 of this article
constitute the basis for relief under this article unless the Director of
DARPA in the interests of justice waives this requirement.
3. Failing resolution by mutual agreement, the aggrieved
Party shall document the dispute, disagreement, or misunderstanding by
notifying the other Party (through the DARPA Agreements Officer or Consortium
Administrator, as the case may be) in writing of the relevant facts, identify
unresolved issues, and specify the clarification or remedy sought. Within
five (5) working days after providing notice to the other Party, the aggrieved
Party may, in writing, request a joint decision by the DARPA Deputy Director
for Management and Xxxxx X Xxxxx, President and Chief Executive Officer,
OSIRIS. The other Party shall submit a written position on the matter(s) in
dispute within thirty (39) calendar days after being notified that a decision
has been requested. The Deputy Director for Management and the senior
executive shall conduct a review of the matter(s) in dispute and render a
decision in writing within thirty (30) calendar days of receipt of such
written position. Any such joint decision is final and binding.
4. In the absence of a joint decision, upon written request
to the Director of DARPA, made within thirty (30) calendar days of the
expiration of the time for a decision under subparagraph B.3
above, the dispute shall be further reviewed. The Director of DARPA may elect
to conduct this review personally or through a designee or jointly with Xxxxx
X Xxxxx, President and Chief Executive Officer, OSIRIS. Following the review,
the Director of DARPA or designee will resolve the issue(s)and notify the
Parties in writing. Such resolution is not subject to further administrative
review and, to the extent permitted by law, shall be final and binding.
5. Subject only to this article and 41 U.S.C. 321-322, if
not satisfied with the results of completing the above process, either Party
may within thirty (30) calendar days of receipt of the notice in subparagraph
B.4 above pursue any right and remedy in a court of competent jurisdiction.
C. Limitation of Damages
Claims for damages of any nature whatsoever pursued under this Agreement shall
be limited to direct damages only up to the aggregate amount of DARPA funding
disbursed as of the time the dispute arises. In no event shall DARPA be
liable for claims for consequential, punitive, special and incidental damages,
claims for lost profits, or other indirect damages. (OSIRIS disclaims any
liability for consequential, indirect, or special damages, except when such
damages are caused by willful misconduct of OSIRIS personnel In no event
shall OSIRIS's liability under this Agreement exceed the funding it has
received up to the time of incurring such liability.
ARTICLE VII: PATENT RIGHTS
A. Definitions
l. "Invention" means any invention or discovery which is or
may be patentable or otherwise protectable under Title 35 of the United
States Code.
2. "Made" when used in relation to any invention means the
conception or first actual reduction to practice of such invention.
3. "Practical application" means to manufacture, in the
case of a composition of product; to practice, in the case of a process or
method, or to operate, in the case of a machine or system; and, in each case,
under such conditions as to establish that the invention is capable of being
utilized and that its benefits are, to the extent permitted by law or
Government regulations, available to the public on reasonable terms.
4. "Subject invention" means any invention conceived or
first actually reduced to practice in the performance of work under this
Agreement.
B. Allocation of Principal Rights
Unless OSIRIS shall have notified DARPA (in accordance with subparagraph C.2
below) that OSIRIS does not intend to retain title, OSIRIS shall retain the
entire right, title, and interest throughout the world to each subject
invention consistent with the provisions of this Article and 35 U.S.C. 202.
With respect to any subject invention in which OSIRIS retains title, DARPA
shall have a nonexclusive, nontransferable, irrevocable, paid-up license to
practice or have practiced on behalf of the United States the subject
invention throughout the world.
C. Invention Disclosure, Election of Title, and Filing of Patent Application
l. OSIRIS shall disclose each subject invention to DARPA
within four (4) months after the inventor discloses it in writing to his
company personnel responsible for patent matters. The disclosure to DARPA
shall be in the form of a written report and shall identify the Agreement
under which the invention was made and the identity of the inventor(s). It
shall be sufficiently complete in technical detail to convey a clear
understanding to
the extent known at the time of the disclosure, of the nature, purpose,
operation, and the physical, chemical, biological, or electrical
characteristics of the invention. The disclosure shall also identify any
publication, sale, or public use of the invention and whether a manuscript
describing the invention has been submitted for publication and, if so,
whether it has been accepted for publication at the time of disclosure.
OSIRIS shall also submit to DARPA an annual listing of subject inventions.
2. If OSIRIS determines that it does not intend to retain
title to any such invention, OSIRIS shall notify DARPA, in writing, within
eight (8) months of disclosure to DARPA. However, in any case where
publication, sale, or public use has initiated the one (1)-year statutory
period wherein valid patent protection can still be obtained in the United
States, the period for such notice may be shortened by DARPA to a date that
is no more than sixty (60) calendar days prior to the end of the statutory
period.
3. OSIRIS shall file its initial patent application on a
subject invention to which it elects to retain title within one (1) year after
election of title or, if earlier, prior to the end of the statutory period
wherein valid patent protection can be obtained in the United States after a
publication, or sale, or public use. OSIRIS may elect to file patent
applications in additional countries (including the European Patent Office and
the Patent Cooperation Treaty) within either ten (10) months of the
corresponding initial patent application or six (6) months from the date
permission is granted by the Commissioner of Patents and Trademarks to file
foreign patent applications, where such filing has been prohibited by a
Secrecy Order.
4. Requests for extension of the time for disclosure
election, and filing under Article VII, paragraph C, may, at the discretion of
DARPA, and after considering the position of OSIRIS, be granted.
D. Conditions When the Government May Obtain Title
Upon DARPA' s written request, OSIRIS shall convey title to any subject
invention to DARPA under any of the following conditions:
l. If OSIRIS fails to disclose or elects not to retain
title to the subject invention within the times specified in paragraph C of
this Article; provided, that DARPA may only request title within sixty (60)
calendar days after learning of the failure of OSIRIS to disclose or elect
within the specified times.
2. In those countries in which OSIRIS fails to file patent
applications within the times specified in paragraph C of this Article;
provided, that if OSIRIS has filed a patent application in a country after the
times specified in paragraph C of this Article, but prior to its receipt of
the written request by DARPA, OSIRIS shall continue to retain title in that
country; or
3. In any country in which OSIRIS decides not to continue
the prosecution of any application for, to pay the maintenance fees on, or
defend in reexamination or opposition proceedings on, a patent on a subject
invention.
E. Minimum Rights to OSIRIS and Protection of OSIRIS's Right to File
l. OSIRIS shall retain a nonexclusive, royalty-free license
throughout the world in each subject invention to which the Government
obtains title, except if OSIRIS fails to disclose the invention within the
times specified in paragraph C of this Article. The OSIRIS license extends
to the domestic (including Canada) subsidiaries and affiliates, if any, within
the corporate structure of which OSIRIS is a party and includes the right to
grant licenses of the same scope to the extent that OSIRIS was legally
obligated to do so at the time the Agreement was awarded. The license is
transferable only within the approval of DARPA, except when transferred to
the successor of that part of the business to which the invention pertains.
DARPA approval for license transfer shall not be unreasonably withheld.
2. The OSIRIS domestic license may be revoked or modified
by DARPA to the extent necessary to achieve expeditious practical application
of the subject invention pursuant to an application for an exclusive license
submitted consistent with appropriate provisions at 37 CFR Part 404. This
license shall not be revoked in that field of use or the geographical areas in
which OSIRIS has achieved practical application and continues to make the
benefits of the invention reasonably accessible to the public. The license in
any foreign country may be revoked or modified at the discretion of DARPA to
the extent OSIRIS, its licensees, or the subsidiaries or affiliates have
failed to achieve practical application in that foreign country.
3. Before revocation or modification of the license, DARPA
shall furnish OSIRIS a written notice of its intention to revoke or modify the
license, and OSIRIS shall be allowed thirty (30) calendar days (or such other
time as may be authorized for good
cause shown) after the notice to show cause why the license should not be
revoked or modified.
F. Action to Protect the Government's Interest
l. OSIRIS agrees to execute or to have executed and
promptly deliver to DARPA all instruments necessary to (i) establish or
confirm the rights the Government has throughout the world in those subject
inventions to which OSIRIS elects to retain title, and (ii) convey title to
DARPA when requested under paragraph D of this Article and to enable the
Government to obtain patent protection throughout the world in that subject
invention.
2. OSIRIS agrees to require, by written agreement, its
employees, other than clerical and nontechnical employees, to disclose
promptly in writing to personnel identified as responsible for the
administration of patent matters and in a format suggested by OSIRIS each
subject invention made under this Agreement in order that OSIRIS can comply
with the disclosure provisions of paragraph C of this Article. OSIRIS shall
instruct employees, through employee agreements or other suitable educational
programs, on the importance of reporting inventions in sufficient time to
permit the filing of patent applications prior to U.S. or foreign statutory
bars.
3. OSIRIS shall notify DARPA of any decisions not to
continue the prosecution of a patent application, pay maintenance fees, or
defend in a reexamination or opposition proceedings on a patent, in any
country, not less than thirty (30) calendar days before the expiration of the
response period required by the relevant patent office.
4. OSIRIS shall include, within the specification of any
United States patent application and any patent issuing thereon covering a
subject invention, the following statement: "This invention was made with
Government support under Agreement No. MDA972-96-3-0018 awarded by DARPA.
The Government has certain rights in the invention."
G. Lower Tier Agreements
OSIRIS shall include this Article, suitably modified, to identify the Parties,
in all subcontracts or lower tier agreements, regardless of tier, for
experimental, developmental, or research work.
H. Reporting on Utilization of Subject Inventions
OSIRIS agrees to submit, during the term of the Agreement, periodic reports no
more frequently than annually on the utilization of a subject invention or on
efforts at obtaining such utilization that are being made by OSIRIS or
licensees or assignees of the inventor. Such reports shall include
information regarding the status of development, date of first commercial sale
or use, gross royalties received by OSIRIS, and such other data and
information as the agency may reasonably specify. OSIRIS also agrees
to provide additional reports as may be requested by DARPA in connection
with any march-in proceedings undertaken by DARPA in accordance with
paragraph J of this Article. Consistent with 35 U.S.C. 202(c) (5), DARPA
agrees it shall not disclose such information to persons outside the
Government without permission of OSIRIS.
I. Preference for American Industry
Notwithstanding any other provision of this clause, OSIRIS agrees that it
shall not grant to any person the exclusive right to use or sell any subject
invention in the United States or Canada unless such person agrees that any
product embodying the subject invention or produced through the use of the
subject invention shall be manufactured substantially in the United States or
Canada. However, in individual cases, the requirements for such an agreement
may be waived by DARPA upon a showing by OSIRIS that reasonable but
unsuccessful efforts have been made to grant licenses on similar terms to
potential licensees that would be likely to manufacture substantially in the
United States or that, under the circumstances, domestic manufacture is not
commercially feasible.
J. March-in Rights
OSIRIS agrees that, with respect to any subject invention in which it has
retained title, DARPA has the right to require OSIRIS, an assignee, or
exclusive licensee of a subject invention to grant a non-exclusive license to
a responsible applicant or applicants, upon terms that are reasonable under
the circumstances, and if OSIRIS, assignee, or exclusive licensee refuses such
a request, DARPA has the right to grant such a license itself if DARPA
determines that:
l. Such action is necessary because OSIRIS or assignee has
not taken effective steps, consistent with the intent of this Agreement, to
achieve practical application of the subject invention;
2. Such action is necessary to alleviate health or safety
needs which are not reasonably satisfied by OSIRIS, assignee, or their
licensees;
3. Such action is necessary to meet requirements for public
use and such requirements are not reasonably satisfied by OSIRIS, assignee,
or licensees; or
4. Such action is necessary because the agreement required
by paragraph (I) of this Article has not been obtained or waived or because a
licensee of the exclusive right to use or sell any subject invention in the
United States is in breach of such Agreement.
ARTICLE VIII: DATA RIGHTS
A. Definitions
l. "Government Purpose Rights", as used in this article,
means rights to use, duplicate, or disclose Data, in whole or in part and in
any manner, for Government purposes only, and to have or permit others to do
so for Government purposes only.
2. "Unlimited Rights", as used in this article, means
rights to use, duplicate, release, or disclose, Data in whole or in part, in
any manner and for any purposes whatsoever, and to have or permit others to
do so.
3. "Data", as used in this article, means recorded
information, regardless of form or method of recording, which includes but is
not limited to, technical data, software, trade secrets, and mask works. The
term does not include financial, administrative, cost, pricing or management
information and does not include subject inventions included under Article VII.
B. Allocation of Principal Rights
l. This Agreement shall be performed with mixed Government
and OSIRIS funding. The Parties agree that in consideration for Government
funding, OSIRIS intends to reduce to practical application items, components
and processes developed under this Agreement.
2. OSIRIS agrees to retain and maintain in good condition
until five (5) years after completion or termination of this Agreement, all
Data necessary to achieve practical application. In the event of exercise of
the Government's March-in Rights as set forth under Article VII or
subparagraph B.3 of this article, OSIRIS agrees, upon written request from the
Government, to deliver at no additional cost to the Government, all Data
necessary to achieve practical application within sixty (GO) calendar days
from the date of the written request. The Government shall retain Unlimited
Rights, as defined in paragraph A above, to this delivered Data.
3. OSIRIS agrees that, with respect to Data necessary to
achieve practical application, DARPA has the right to require OSIRIS to
deliver all such Data to DARPA in accordance with its reasonable directions if
DARPA determines that:
(a) Such action is necessary because OSIRIS or
assignee has not taken effective steps, consistent with the intent of this
Agreement, to achieve practical application of the technology developed
during the performance of this Agreement;
(b) Such action is necessary to alleviate health or
safety needs which are not reasonably satisfied by OSIRIS, assignee, or
their licensees; or
(c) Such action is necessary to meet requirements
for public use and such requirements are not reasonably satisfied by OSIRIS,
assignee, or licensees.
4. With respect to Data delivered pursuant to Attachment
2 (and listed below), the Government shall receive Government Purpose Rights,
as defined in paragraph A above. With respect to all Data delivered, in the
event of the Government's exercise of its right under subparagraph B.2 of this
article, the Government shall receive Unlimited Rights.
C. Marking of Data
Pursuant to paragraph B above, any Data delivered under this Agreement shall
be marked with the following legend:
Use, duplication, or disclosure is subject to the restrictions as stated in
Agreement MDA972-96-3-0018 between the Government and OSIRIS.
D. Lower Tier Agreements
OSIRIS shall include this Article, suitably modified to identify the Parties,
in all subcontracts or lower tier agreements, regardless of tier, for
experimental, developmental, or research work.
ARTICLE IX: FOREIGN ACCESS TO TECHNOLOGY
This Article shall remain in effect during the term of the Agreement and for
five (5) years thereafter.
A. Definition
l. "Foreign Firm or Institution" means a firm or
institution organized or existing under the laws of a country other than the
United States, its territories, or possessions. The term includes, for
purposes of this Agreement, any agency or instrumentality of a foreign
government; and firms, institutions or business organizations which are
owned or substantially controlled by foreign governments, firms,
institutions, or individuals.
2. "Know-How" means all information including, but not
limited to discoveries, formulas, materials, inventions, processes, ideas,
approaches, concepts, techniques, methods software, programs, documentation,
procedures, firmware, hardware, technical data, specifications, devices,
apparatus and machines.
3. "Technology" means discoveries, innovations, Know-How
and inventions, whether patentable or not, including computer software,
recognized under U.S. law as intellectual creations to which rights of
ownership accrue, including, but not limited to, patents, trade secrets,
maskworks, and copyrights developed under this Agreement.
B. General
The Parties agree that research findings and technology developments arising
under this Agreement may constitute a significant enhancement to the national
defense, and to the economic vitality of the United States. Accordingly,
access to important technology developments under this Agreement by Foreign
Firms or Institutions must be carefully controlled. The controls contemplated
in this Article are in addition to, and are not intended to change or
supersede, the provisions of the International Traffic in Arms Regulation
(22 CFR pt. 121 et seq.), the DOD Industrial Security Regulation (DoD
5220.22-R) and the Department of Commerce Export Regulation (15 CFR pt. 770 et
seq.)
C. Restrictions on Sale or Transfer of Technology to Foreign Firms or
Institutions
l. In order to promote the national security interests of
the United States and to effectuate the policies that underlie the regulations
cited above, the procedures stated in subparagraphs C.2, C.3, and C.4 below
shall apply to any transfer of Technology. For purposes of this paragraph, a
transfer includes a sale of the company, and sales or licensing of
Technology. Transfers do not include:
(a) sales of products or components, or
(b) licenses of software or documentation related to
sales of products or components, or
(c) transfer to foreign subsidiaries of OSIRIS for
purposes related to this Agreement, or
(d) transfer which provides access to Technology to
a Foreign Firm or Institution which is an approved source of supply or
source for the conduct of research under this Agreement provided that such
transfer shall be limited to that necessary to allow the firm or institution
to perform its approved role under this Agreement.
2. OSIRIS shall provide timely notice to DARPA of any
proposed transfers from OSIRIS of Technology developed under this Agreement
to Foreign Firms or Institutions. If DARPA determines that the transfer may
have adverse consequences to the national security interests of the United
States, OSIRIS, its vendors, and DARPA shall jointly endeavor to find
alternatives to the proposed transfer which obviate or mitigate potential
adverse consequences of the transfer but which provide substantially
equivalent benefits to OSIRIS.
3. In any event, OSIRIS shall provide written notice to the
DARPA Program Manager and Agreements Officer of any proposed transfer to a
foreign firm or institution at least sixty (60) calendar days prior to the
proposed date of transfer. Such notice shall cite this Article and shall
state specifically what is to be transferred and the general terms of the
transfer. Within thirty (30) calendar days of receipt of OSIRIS's written
notification, the DARPA Agreements Officer shall advise OSIRIS whether it
consents to the proposed transfer. In cases where DARPA does not concur or
sixty (60) calendar days after receipt
and DARPA provides no decision, OSIRIS may utilize the procedures under
Article VI, Disputes. No transfer shall take place until a decision is
rendered.
4. Except as provided in subparagraph C.1 above or in the
event the transfer of Technology to Foreign Firms or Institutions is approved
by DARPA, OSIRIS shall (a) refund to DARPA funds paid for the development of
the Technology and (b) negotiate a license with the Government to the
Technology under terms that are reasonable under the circumstances.
D. Lower Tier Agreements
OSIRIS shall include this Article, suitably modified, to identify the Parties,
in all subcontracts or lower tier agreements, regardless of tier, for
experimental, developmental, or research work.
ARTICLE X: CIVIL RIGHTS ACT
This Agreement is subject to the compliance requirements of Title VI of the
Civil Rights Act of 1964 as amended (42 U.S.C. 2000-d) relating to
nondiscrimination in Federally assisted programs. OSIRIS has signed an
Assurance of Compliance with the nondiscriminatory provisions of the Act.
ARTICLE XI: EXECUTION
This Agreement constitutes the entire agreement of the Parties and supersedes
all prior and contemporaneous agreements, understandings, negotiations and
discussions among the Parties, whether oral or written, with respect to the
subject matter hereof. This Agreement may be revised only by written consent
of OSIRIS and the DARPA Agreements Officer. This Agreement, or modifications
thereto, may be executed in counterparts each of which shall be deemed as
original, but all of which taken together shall constitute one and the same
instrument.
ATTACHMENT 1
STATEMENT OF WORK
OSIRIS THERAPEUTICS, INC
[*CONFIDENTIALITY REQUESTED*]
ATTACHMENT 2
REPORT REQUIREMENTS
A. QUARTERLY REPORT
On or before ninety (90) calendar days after the effective date of the
Agreement and quarterly thereafter throughout the term of the Agreement,
OSIRIS shall submit or otherwise provide a quarterly report. Two (2) copies
shall be submitted or otherwise provided to the DARPA Program Manager, one (1)
copy shall be submitted or otherwise provided to the DARPA Agreements Officer
and one (1) copy shall be submitted or otherwise provided to DARPA/Defense
Sciences Office (DSO), Attn: CDR Xxxxx X. Xxxxx, MC, USN (Program Manager).
The report will have two (2) major sections
l. Technical Status report. The technical status report
will detail technical progress to date and report on all problems, technical
issues, major developments, and the status of external collaborations during
the reporting period.
2. Business Status report. The business status report
shall provide summarized details of the resource status of this Agreement,
including the status of OSIRIS contributions. This report will include a
quarterly accounting of current expenditures as outlined in the Annual Program
Plan. Any major deviations shall be explained along with discussions of the
adjustment actions proposed. This report shall also identify any interest
earned on government funds on account.
B. ANNUAL PROGRAM PLAN DOCUMENT
OSIRIS shall submit or otherwise provide to the DARPA Program Manager one (1)
copy of a report which describes the Annual Program Plan as described in
Article III, Section B. This document shall be submitted not later than thirty
(30) calendar days following the Annual Site Review as described in Article
III, Section B.
C. SPECIAL TECHNICAL REPORTS
As agreed to by OSIRIS and the DARPA Program Manager, OSIRIS shall submit or
otherwise provide to the DARPA Program Manager one (1) copy of special reports
on significant events such as significant target accomplishments by OSIRIS,
significant tests, experiments, or symposia.
D. PAYABLE MILESTONES REPORTS
OSIRIS shall submit or otherwise provide to the DARPA Program Manager,
documentation describing the extent of accomplishment of Payable Milestones.
This information shall be as required by Article V, paragraph B and shall be
sufficient for the DARPA Program Manager to reasonably verify the
accomplishment of the milestone of the event in accordance with the Statement
of Work.
E. FINAL REPORT
l OSIRIS shall submit or otherwise provide a Final Report
making full disclosure of all major developments by OSIRIS upon completion of
the Agreement or within sixty (60) calendar days of termination of this
Agreement. With the approval of the DARPA Program Manager, reprints of
published articles may be attached to the Final Report. Two (2) copies shall
be submitted or otherwise provided to the DARPA Program Manager and one (1)
copy shall be submitted or otherwise provided to DARPA/Defense Sciences Office
(DSO), Attn: CDR Xxxxx X. Xxxxx, MC, USN (Program Manager). One (1) copy shall
be submitted to the Defense Technical Information Center (DTIC) addressed to
Xxxx. 0/Xxxxxxx Xxxxxxx, Xxxxxxxxxx, XX 00000.
2. The Final Report shall be marked with a distribution
statement to denote the extent of its availability for distribution, release,
and disclosure without additional approvals or authorizations. The Final
Report shall be marked on the front-page in a conspicuous place with the
following marking:
"DISTRIBUTION STATEMENT B Distribution authorized to U.S. Government
agencies only to protect information not owned by the U.S. Government and
protected by a contractor' S "limited rights" statement, or received with
the understanding that it not be routinely transmitted outside the U.S.
Government. Other requests for this document shall be referred to DARPA/
Technical Information Officer.
ATTACHMENT 3
SCHEDULE OF PAYMENTS AND
PAYABLE MILESTONES
[*CONFIDENTIALITY REQUESTED*]
ATTACHMENT 5
LIST OF GOVERNMENT
AND
OSIRIS THERAPEUTICS, INC. REPRESENTATIVES
GOVERNMENT: C. Xxxx Xxxxxxxxx
DARPA/CMO
0000 X. Xxxxxxx Xxxxx
Xxxxxxxxx, XX 00000-0000
phone: (000) 000-0000
FAX: (000) 000-0000
Email: xxxxxxxxxx@xxxxx.xxx
CDR Xxxxx X. Xxxxx, MC, USN
DARPA/DSO
0000 X. Xxxxxxx Xxxxx
Xxxxxxxxx, XX 00000-0000
phone: (000) 000-0000
FAX: (000) 000-0000
Email: xxxxxx@xxxxx.xxx
OSIRIS: Xxxxxx X. Xxxxxxx, Ph.D
OSIRIS Therapeutics, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
phone: (000) 000-0000
FAX: (000) 000-0000
Email:
Xxxxxx X. Xxxxxx
Vice President
Finance & Administration
OSIRIS Therapeutics, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
phone: (000) 000-0000
FAX: (000) 000-0000
Email:
An Agreement Between
OSIRIS THERAPEUTICS, INC.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
And
DEFENSE ADVANCED RESEARCH PROJECTS AGENCY
0000 Xxxxx Xxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Concerning
SEQUENTIAL RELEASE OF VACCINES USING MESENCHYMAL STEM CELLS & TWO-
COMPONENT CELLS SYSTEMS USING MESENCHYMAL STEM CELLS
Agreement No: MDA972-96-3-0018
Modification No: 0001
DARPA Order No: N/A (Admin)
Total Amount of Agreement: No Change
Total Estimate, Government Funding: No Change
Funds Obligated: No Change
Authority: 10 U.S.C. 2371
Line(s) of Accounting: N/A (Admin)
l. Purpose. To change the identification of the Paying Office, and
to add information in support of payment by Electronic Funds Transfer (EFT)
2. Paying Office. The identification and address of the Paying
Office that appears in Article V, Paragraph B2, is changed to read: Defense
Accounting Office, DAO/DFAS-IN-AKA, Attn: Vendor Pay, 0000 Xxxx 00xx Xxxxxx,
Xxxxxxxxxxxx, Xxxxxxx 00000-0000.
3. Electronic Funds Transfer. The Contractor shall be paid by EFT.
The data in support of paying the Contractor in this manner is attached
hereto, and made part of this Agreement 5 Exhibit A to Article V.
For the United States: /s/ C. Xxxx Xxxxxxxxx 11/27/96
C XXXX XXXXXXXXX
AGREEMENTS OFFICER
