Exhibit 10.12
MATERIAL TRANSFER AND RESEARCH AGREEMENT
THIS AGREEMENT is entered into this 1st day of April 1995, by and between
OSIRIS THERAPEUTICS, INC., a corporation having a place of business at 11100.
Xxxxxx Xxxxxx, Xxxxx Xxxxxxxx, Xxxxxx Xxxxx, Xxxxxxxxx, Xxxx 00000 ("OSIRIS")
and the Xxxx Xxxxxxxxxx Cancer Research Center Foundation, 0000 Xxxxxxxx
Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 ("Recipient"). Recipient as used in this
Agreement means the Xxxx Xxxxxxxxxx Cancer Research Center Foundation and its
successors, assignees, and subcontractors including without limitation Xxxx
Xxxxxxxxxx Cancer Research Center ("Center").
l. Recipient agrees to send or has sent to OSIRIS canine bone marrow samples;
and OSIRIS agrees to provide or has provided to Recipient canine mesenchymal
stem cells (cMSCs") that have been transduced with the retrovirus VMS-LacZ
and then expanded ex vivo, which shall hereinafter be referred to as the
"Material(s)", together with other Materials, if any, described in Exhibit A
attached hereto.
2. Recipient agrees to use reasonable efforts to infuse the Materials back
into the respective donor canines with the purpose of studying the homing of
the Materials to the bone marrow compartment; the effect of the Materials on
bone marrow stroma reconstitution and hematopoiesis following marrow ablation
by gamma-irradiation, as further described in Exhibit B attached hereto (the
"Project"). Recipient shall make no commercial use of the Materials.
3. Recipient shall not distribute or release the Materials to any other
person or entity, unless written permission is obtained in advance from
OSIRIS.
4. THE MATERIALS SHALL NOT BE USED IN HUMANS.
5. OSIRIS agrees to pay Recipient a total of $64,557 to support the Project.
A detailed budget is attached as Exhibit C. Payments for funding the Project
shall be payable by
Osiris Therapeutics, Inc. Material Transfer and Research Agreement
Sponsor to Recipient according to the following schedule:
(a) Four monthly payments of $13,000 due upon the first day of the month
beginning April 1, 1995; and Q)) a final payment of $12,557 due upon
completion of the Project and receipt by OSIRIS of a final report from
Recipient.
Payments will be made in United States funds to:
Xxxx Xxxxxxxxxx Cancer Research Center Foundation
Attn: Accounts Receivable
0000 Xxxxxxxx Xxxxxx, XX-000
Xxxxxxx, XX 00000
Tax ID #: 00-0000000
6. During the term of this agreement, OSIRIS agrees to make Xxxxx Xxxxxx, one
of OSIRISs' employees (or, if Xx. Xxxxxx is no longer available, another
OSIRIS employee reasonably acceptable to the Recipient) ("Loaned Employee")
available on a full-time basis to work on the Project, as described in
Exhibit B and as otherwise requested by the Principal Investigator. OSIRIS
will pay all of the Loaned Employees salary and benefits and any taxes
arising therefrom. OSIRIS agrees to indemnify, defend, and hold the Recipient
harmless from and against any and all negligent or intentional acts or
omissions of the Loaned Employee and any salary, benefits, taxes or
geovemmental fees arising from his or her employment.
7. Recipient shall own all information, data, applications and inventions and
intellectual property rights based thereon which are conceived or made by
Recipient, or its employees or agents, in connection with or in performance
of the Project ("Recipient Inventions"). OSIRIS and recipient shall jointly
own all information, data, applications and inventions and
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
intellectual property rights based thereon which are conceived or made
jointly by (a) Recipient, or its employees or agents, and (b,) OSIRIS, or its
employees or agents, in connection with or in performance of the Project
("Joint Inventions"). Recipient will promptly notify OSIRIS of any Recipient
Inventions or 3oint Inventions of which it is aware. OSIRIS will promptly
notify Foundation of any Joint Invention of which it is aware. OSIRIS will
have sixty (60) days from the date it is notified of any Recipient Invention
to request that a patent application or application for other intellectual
property protection be prepared and filed. Recipient shall promptly prepare,
file, and prosecute each such domestic and foreign application in Recipient's
name. For Joint Inventions, OSIRIS shall promptly prepare, file, and
prosecute each such domestic and foreign application on which the parties
mutually agree. OSIRIS and Recipient will cooperate to ensure that each
application filed will cover all items of commercial interest and importance.
While the party responsible for preparation and filing of the application
shall have sole discretion with respect to decisions regarding the scope and
content of that application and the prosecution thereof; the other party a)
shall be given a reasonable opportunity to review and provide comments
concerning the application; b) shall be kept advised of material developments
with respect to the application and shall be supplied with copies of all
documents received and filed in connection with the prosecution of such
application in sufficient time to comment. Comments by the other party will
be taken into consideration by the party responsible for the application. The
party responsible for the application will be entitled to use reputable
patent counsel of its choice.
8. OSIRIS shall have an exclusive option to a worldwide exclusive license of
all of Recipient's interest in any Recipient Inventions or Joint Inventions,
which will terminate automatically unless it is exercised (including the
execution of a mutually acceptable license agreement) within one (1) year
from the date of notification to OSIRIS of the Recipient Invention. Such
license agreement shall be in a form acceptable to the Recipient, shall
contain provisions protecting the nonprofit tax status of the Recipient,
shall provide for
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
royalties, shall be subject to laws and regulations of and agreements with
the United States government, its agencies and funding organizations and to
National Institute of Health guidelines, and shall indemnify and insure the
Recipient against any liability arising directly or indirectly out of
OSIRIS's, its sublicensee's or its or their customers use or sale of products
related to any property licensed by OSIRIS from the Recipient. Any license
agreement entered into between OSIRIS and the Recipient shall include the
following terms:
8.1 Recipient will grant OSIRIS a sole and exclusive worldwide license to
any Recipient Invention or Joint Invention (the "License") to make, have
made, use and sell any products covered by the License, including the right
to grant sublicenses.
8.2 Any License arising from this Agreement shall be in full force and
effect from the Effective Date of the License and shall remain in effect
until all patents issued in all countries in accordance with the License or
Licenses have expired or until otherwise terminated by operation of law,
whichever is last to occur, or by the acts of the parties in accordance with
the terms of the License.
8.3 Recipient will retain a royalty-free right to use Recipient and Joint
Inventions for nonclinical research, testing or educational purposes. In no
event shall Recipient have any right to use Recipient or Joint Inventions for
any commercial purposes whatsoever.
8.4 As consideration for the License, OSIRIS will pay Recipient a royalty on
sales of all products covered by a License provided that such product or
process where sold is covered by a claim of a granted patent on a Recipient
or Joint Invention ("Licensed Product"), as follows:
(a) no less than two percent (2%) and no more than four percent (4%) of the
net sales of the Licensed Product; and
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
(b) twenty-five percent (25%) of the royalties received by OSIRIS from its
sublicensees on sales of the Licensed Product.
Net sales shall be defined as the amount received from sales of all Licensed
Products less discounts, returns, transportation costs, insurance costs and
taxes of any kind whatsoever. In the event royalties are to be paid by OSIRIS
to a party who is not an affiliate of OSIRIS for a Licensed Product ("Other
Royalties"), for which royalties will also be due to Recipient pursuant to
Section 8.4, then the royalties to be paid to Recipient shall be reduced by
fifty percent (50%) of the amount of such Other Royalties but in no event
shall any royalties due under Section 6.4 be reduced by more than fifty
percent (50%).
9. OSIRIS and Recipient have and will have certain technical, financial and
business information which is owned or controlled by each party and/or which
is received from third parties under an obligation of confidentiality
hereinafter referred to individually and collectively as "CONFIDENTIAL
INFORMATION"). CONFIDENTIAL INFORMATION will be considered to be confidential
and will be maintained in confidence by the receiving party and will not be
transferred or disclosed to any person or entity outside of the receiving
party or used by the receiving party other than for the research being
conducted under this Agreement.
CONFIDENTIAL INFORMATION specifically excluded from the obligations of
confidentiality of the Agreement include: (a) information which at the time
of disclosure is already in the public domain; (b) information which the
receiving party can demonstrate by written evidence was in the possession of
the receiving party prior to the disclosure by the disclosing party; (c)
information which subsequently becomes part of the public domain through no
fault of the receiving party; and (d) information which becomes known to the
receiving party subsequent to the disclosure by the disclosing party through
a third party who is not under any obligation of confidentiality to the
disclosing party. The fact that general
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
information may be in or become part of the public domain, in and of itself
does not exclude any specific information from the obligations of this
Agreement.
10. Recipient will have the right to publish and disclose the results of
research using Materials. In order to balance this right with the proprietary
interests of OSIRIS, Recipient will submit for review to OSIRIS manuscripts,
abstracts or presentations intended for publication or other public
disclosure at least sixty (60) days prior to the date of submission for
publication or the date of public disclosure. OSIRIS will use reasonable
efforts to complete its review promptly, and will complete its review within
thirty (30) days of receipt of the submitted documents. During that time,
OSIRIS shall have the right to (a) review the material for Confidential
Information provided by OSIRIS and Q)) assess the patentability of any
Recipient Invention described in the material. If OSIRIS decides that a
patent application should be filed, the publication or presentation shall be
delayed an additional thirty (30) days or until a patent application is
filed, whichever is sooner.
11. Recipient acknowledges that the Materials are provided WITHOUT WARRANTY OR
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY,
EXPRESS OR IMPLIED. OSIRIS MAKES NO REPRESENTATION THAT THE USE OF THE
MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER
PROPRIETARY RIGHT.
12. OSIRIS shall indemnify, defend, and hold harmless Recipient, and its
respective trustees, officers, professional staffs, employees, agents,
successors, heirs and assigns ("Indemnitees") from and against:
(a) All claims, debts, liabilities and obligations which arise from or are
alleged to arise from i) the acts or omissions of OSIRIS with respect to the
Project; ii) the development, production or distribution of any product,
process or service resulting from
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
information or materials received from or in connection with the Project,
including product liability claims in the form of tort, warranty or strict
liability; or iii) the use of the OSIRIS Material.
(b) Any damage or deficiency resulting directly or indirectly from any
misrepresentation, breach of warranty or nonfulfillment of any covenant of
OSIRIS under this Agreement;
(c) All other actions, suits, proceedings, demands, assessments,
adjustments, costs and expenses incident to the foregoing, including actual
attorneys' fees and other out-of-pocket expenses.
This indemnification shall not apply to the extent that the claims, debts,
liabilities or obligations for which indemnity is sought are caused by the
negligent or intentional acts or omissions of the Indemnitees.
The Indenmitees will give OSIRIS reasonable notice of any claims asserted
against such Indemnitees for which indemnification is brought may be sought
under this Agreement. Failure to give such notice shall not abrogate or
diminish OSIRIS's indemnity obligation if OSIRIS has or receives knowledge of
the existence of a claim by any other means or if such failure does not
prejudice OSIRIS's ability to defend the claim.
In any litigation, administrative proceeding, negotiation or arbitration
pending to any claim for which indemnification is sought under this
Agreement, 0SIRIS shall select competent legal counsel reasonably acceptable
to the Indemnitees to represent the Indemnitees. OSIRIS shall control such
litigation, proceedings, negotiations and arbitration. The Indemnitees shall
at all times have the fight to fully participate in the defense at their own
expense. If OSIRIS shall, within a reasonable time after notice, fail to
defend, the
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
Indemnitees shall have the right, but not the obligation, to undertake the
defense of and to compromise or settle the claim or other matter on behalf;
for the account, and at the risk of OSIRIS. If the claim is one that cannot
by its nature be defended solely by OSIRIS, then the Indemnitees shall make
available all information and assistance OSIRIS may reasonably request at
OSIRIS's expense.
13. All communications, including payments, notices, demands or requests
required or permitted to be given hereunder, shall be given in writing and
shall be: (a) personally delivered; (b) sent by telecopier or other electronic
means of transmitting written documents; or (c) sent to the parties at their
respective addresses indicated herein by registered or certified U.S. mail,
return receipt requested and postage prepaid, or by private overnight mail
courier service. The respective addresses to be used for all such payments,
notices, demands or requests are as follows:
If to OSIRIS: Osiris Therapeutics, Inc.
00000 Xxxxxx Xxxxxx
Xxxxx Xxxxxxxx, Xxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attention: President
Fax No.: (000) 000-0000
If to Recipient: Xxxx Xxxxxxxxxx Cancer Research Center Foundation
0000 Xxxxxxxx Xxxxxx, XX-000
Xxxxxxx, XX 00000
Attention: Xxxxx Xxxxxx, Manager, Grant & Contract
Administration
Fax No.: (000) 000-0000
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
For technical matters: Xxxx Xxxxxxxxxx Cancer Research Center
0000 Xxxxxxxx Xxxxxx, X000
Xxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxxx, M.D.
Fax No.: (000)000-0000
If personally delivered, such communication shall be deemed delivered upon
actual receipt. If electronically transmitted pursuant to this paragraph,
such communication shall be deemed delivered when transmitted. If sent by
overnight courier pursuant this paragraph, such communication shall be deemed
delivered within twenty-four hours of deposit with such courier. If sent by
U.S mail pursuant to this paragraph, such communications shall be deemed
delivered as of the date of delivery indicated on the receipt issued by the
relevant postal service, or, if the addressee fans or refuses to accept
delivery, as of the date of such failure or refusal. Any party to this
Agreement may change their address for the purposes of this Agreement by
giving notice in accordance with this Section.
14. This Agreement and any license entered into under this Agreement shall be
subject to the terms of any and all contracts and grants between Recipient
and any governmental agency, instrumentality or organization, including the
National Institutes of Health ("NIH"), which provide funding to or for the
Recipient relating to work performed under this Agreement. If there is a
conflict between the terms of this Agreement and the terms of any such
funding agreement or grant, or any regulation of the funding organization
applicable to such funding agreement or grant, then the terms of the funding
agreement or grant or the related regulation will control.
15. In the performance of all obligations hereunder, Recipient and OSIRIS
shall be deemed to be independent contractors of one another. Neither party
is authorized or
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Osiris Therapeutics, Inc. Material Transfer and Research Agreement
empowered to act as agent for the other for any purpose and
shall not on behalf of the other enter into any contract, warranty, or
representation as to any matter.
16. Recipient agrees to comply with all government and National Institutes of
Health regulation and guidelines which are applicable to the Recipient's use
of the Materials.
IN WITNESS WHEREOF, the parties, intending to be legally bound, have caused
this Agreement to be executed by their respective duly authorized
representatives.
OSIRIS THERAPEUTICS, INC. RECIPIENT:
XXXX XXXXXXXXXX CANCER
RESEARCH CENTER FOUNDATION
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxxx X. Main
------------------ -------------------
Xxxxx X. Xxxxx
Xxxxxxx X. Main
----------------------------------
(Typed Name)
Title: President and CEO Title: Treasurer
Investigator
By: /s/ Xxxxxx Xxxxxxxxx
--------------------
Xxxxxx Xxxxxxxxx, M.D.
10
AMENDMENT NO. 1
TO OSIRIS MATERIAL TRANSFER AND RESEARCH AGREEMENT
This amendment is entered into Ibis _______ day of _______________, 1995
("Effective Date") between Osiris Therapeutics, Inc. ("OSIRIS") and the Xxxx
Xxxxxxxxxx Cancer Research Center Foundation ("Foundation"). The parties
hereby agree as follows:
l. Amendments. The Material Transfer and Research Agreement between and
Foundation dated April 1, 1995 ("Agreement") is hereby amended as follows:
a. Paragraph 5 is amended in its entirety as follows:
"5. OSIRIS agrees to pay Recipient a total of $124,217 to support the
Project. A detailed budget is attached as Exhibit C. Payments for
funding the Project shall be payable by OSIRIS to Recipient according
to the following schedule: (a) Four monthly payments of $13,000 due upon
the first day of the month beginning April 1, 1995; (b) four monthly
payments of $12,000 due upon the first day of the month beginning
October 1, 1995; and (c) a final payment of $24,217 due upon
completion of the Project and receipt by OSIRIS of a final report
from Recipient. if the Project is terminated prior to completion of
the research program as described in Exhibit B, any unused payments will
be returned to OSIRIS or the final payment will be adjusted
accordingly, as appropriate and mutually agreed upon by the parties."
b. Exhibit C is amended in its entirety. A new Exhibit C is attached.
2. Effective Date and Construction. This Amendment is effective as of the
Effective Date. Except as specifically amended by this Amendment the terms of
the Agreement will remain in fall force and effect. From and after the
Effective Date, references to the Agreement will be deemed to mean the
License Agreement as amended by this Amendment.
XXXX XXXXXXXXXX CANCER OSIRIS THERAPEUTTCS, INC.
RESEARCH CENTER FOUNDATION
/s/ Xxxxxxx X. Main 10/11/95 /s/ Xxxxx X. Xxxxx 11-15-95
------------------- Date ------------------ Date
Signature Signature
Xxxxxxx X. Main By: Xxxxx X. Xxxxx
Treasurer Title: President & CEO
Osiris Agreement Amendment No. 1
page 2
Principal Investigator
/s/ Xxxxxx Xxxxxxxxx 10/12/95
-------------------- Date
Signature
Xxxxxx Xxxxxxxxx, M.D.
Principal Investigator
AGREEMENT AMENDMENT NO.2
TO OSIRIS MATERIAL TRANSFER AND RESEARCH AGREEMENT
This amendment is entered into this 9th day of February, 1996
("Effective Date") between Osiris Therapeutics, Inc. ("OSIRIS") and the Xxxx
Xxxxxxxxxx Cancer Research Center Foundation ("Foundation"). The parties
hereby agree as follows
1. Amendments. The Material Transfer and Research Agreement between OSIRIS
and Foundation dated April 1, 1995 ("Agreement") is hereby amended as follows:
a. Paragraph 5 is amended in its entirety as follows:
"5. OSIRIS agrees to pay Recipient a total of $131,977 to support the
Project. A detail budget is attached as Exhibit C. Payments for funding
the Project shall be payable by OSIRIS to Recipient according to the
following schedule: (a) Four monthly payments of $13,000 due upon the
first day of the month beginning April 1, 1995; (b) four monthly payments
of $12,000 due upon the first day of the month beginning October 1, 1995;
(c) one payment of $7,760 due upon the first day of the month beginning
February 1, 1996 and (d) a final payment of $24,217 due upon completion of
the Project and receipt by OSIRIS of a final report from Recipient if the
Project is terminated prior to completion of the research program as
described in Exhibit B, any unused payments will be returned to OSIRIS or
the final payment will be adjusted accordingly, as appropriate and mutually
agreed upon by the parties."
b. Exhibit C is amended in its entirety. A new Exhibit C is attached.
2. Effective Date and Construction. This Amendment is effective as of the
Effective Date. Except as specifically amended by this Amendment, the terms
of the Agreement will remain in full forte and effect From and after the
Effective Date, references to the Agreement will be deemed to mean the
License Agreement as amended by this Amendment
XXXX XXXXXXXXXX CANCER OSIRIS THERAPEUTICS, INC.
RESEARCH CENTER FOUNDATION
/s/ Xxxxxxx X. Main 2/8/96 /s/ Xxxxxx X. Xxxxxxx 2/9/96
-------------------------- -----------------------------
Signature Date Signature Date
Xxxxxxx X. Main By: Xxxxxx X. Xxxxxxx
Treasurer Title: Sr. Vice President, R & D
Principal Investigator:
/s/ Xxxxxx Xxxxxxxxx 2/22/96
----------------------------
Signature Date
Xxxxxx Xxxxxxxxx, M.D.
Principal Investigator
