SPONSORED RESEARCH AGREEMENT
Exhibit 10.40
This Sponsored Research Agreement (“Agreement”), effective as of the 28th day of November, 2018 (the “Effective Date”) is made by and between The University of Texas M. D. Xxxxxxxx Cancer Center, (“MD Xxxxxxxx”), a member institution
of The University of Texas System (“System”), with a place of business at 0000 Xxxxxxxx Xxxx., Xxxxxxx, Xxxxx, 00000, and Cell Source, a corporation with a
place of business at 00 Xxxx 00xx Xxxxxx, Xxxxx 000, Xxx Xxxx, XX 00000. (“Sponsor”).
MD Xxxxxxxx and Sponsor hereinafter may be referred to each as a “Party” and collectively as the “Parties.”
RECITALS
A. MD Xxxxxxxx and Sponsor are interested in pursuing research in the area of stem cells.
B. Sponsor desires to collaborate with MD Xxxxxxxx and is willing to sponsor MD Anderson’s research study entitled “Tolerance Induction by Veto Cells” (“Study”), as described in Exhibit A, attached hereto.
C. Sponsor and MD Xxxxxxxx are entering into this Agreement to set forth the rights and obligations of the Parties with respect to the Study.
NOW THEREFORE, in consideration of the mutual covenants and promises herein contained, MD Xxxxxxxx and Sponsor agree as
follows:
1. TERM
This Agreement shall be effective as of the Effective Date, and shall continue in effect for a period
of three (3) years following the Effective Date (“Term”) unless such Term is extended by mutual written agreement of the Parties, or the Agreement is earlier
terminated in accordance with Section 11 of this Agreement.
2. STUDY CONDUCT
2.1 MD Xxxxxxxx will use its own facilities and its reasonable best efforts to conduct the Study under the direction of Xx. Xxxx Xxxxxxx, or his/her successor as mutually agreed to
by the Parties (the “Principal Investigator”) in accordance with
Exhibit A and applicable laws and regulations. In the event of any conflict between Exhibit A and this Agreement, this Agreement shall control. Unless expressly set forth herein, MD Xxxxxxxx shall provide all necessary personnel, equipment,
supplies, facilities and resources to perform the Study, and shall be fully responsible for the activities of any MD Xxxxxxxx personnel to whom Study activities are delegated.
2.2 Sponsor understands and acknowledges that MD Anderson’s primary mission is the development and dissemination of scientific knowledge, and that MD Xxxxxxxx makes no
representations, warranties, or guarantees with respect to any specific results of the Study.
2.3 Sponsor understands and acknowledges that MD Xxxxxxxx may be involved in similar research through other researchers on behalf of itself and others. Nothing in this Agreement
will limit or prohibit MD Xxxxxxxx or any of its personnel, including the Principal Investigator, from conducting any research or for performing research for or with any entity or person, including any other outside sponsors. Sponsor acknowledges
that this provision is intended to preserve the academic freedom and integrity of MD Xxxxxxxx and its faculty and to ensure that MD Xxxxxxxx and its faculty are not regarded as captive researchers for Sponsor. Despite the above, it is agreed that
if the Principal Investigator conducts any research or if any other research is conducted at MD Xxxxxxxx that breaches this agreement inasmuch as such research uses confidential materials or information as defined below as “Confidential
Information” in Paragraph 6.1 of this agreement that is provided by Sponsor and that is associated with the Study outside of the Study without Sponsor’s written permission, Sponsor shall then be entitled to all the rights it has under this
agreement with respect to the results of such research.
2.4 . MD Xxxxxxxx will provide a written report every * months to the Sponsor in terms of progress in the Research being conducted. Furthermore, MD Xxxxxxxx will provide a current
annual advance work plan * for each annual period which must be approved in advanced in writing by the Sponsor. In the event that MD Xxxxxxxx wishes to propose curtailing or modifying an existing research stream between update periods, any change
of this kind must be pre-approved in writing by the Sponsor.
3. STUDY BUDGET
3.1 Sponsor agrees to pay MD Xxxxxxxx an amount equal to its expenditures and reasonable overhead in conducting the Study in the amount of US$1,507,352.33 (“Budget”). The schedule and procedure of payments under the Budget shall be made as set
forth in Exhibit B, attached hereto. In the event of any conflict between Exhibit B and this Agreement, this Agreement shall control.
4. DATA
4.1 MD Xxxxxxxx shall own all data and results generated in the conduct of the Study (“Data”),
and shall have the right to use such Data for any purpose, and to publish such Data as set forth in Section 5 hereunder.
4.2 MD Xxxxxxxx shall provide Data to Sponsor in the form of Study reports as described in section 2.4 above. Sponsor shall have the right to use Data for its own purposes,
provided that Sponsor shall maintain such Data in confidence until the earlier of: (a) publication or public disclosure of such Data by MD Xxxxxxxx and/or Principal Investigator; or (b) twelve (12) months following the completion of the Study; or
(c) under non-disclosure agreements with business associates or regulatory bodies as needed.
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5. PUBLICATION AND PUBLICITY
5.1 MD Xxxxxxxx and Principal Investigator shall have the right to publish or present Data in scientific journals and/or at scientific meetings at MD Anderson’s and/or the Principal
Investigator’s sole discretion, and to submit Data to a public data registry. MD Xxxxxxxx and Principal Investigator shall provide Sponsor with a copy of a proposed publication or presentation for review and comment sixty (60) days prior to
publication by the publishing source or at least forty (40) days prior to presentation at a scientific meeting or conference. MD Xxxxxxxx and Principal Investigator shall have the final authority to determine the scope and content of any
presentation and/or publication of Data. At Sponsor’s request, MD Xxxxxxxx will delay the publication or presentation for up to sixty (60) additional days in order to allow Sponsor to protect its proprietary interests.
5.2 Except for MD Anderson’s right to publish the Data as set forth in Section 5.1 and subject to applicable law and regulations, neither Party will reference the other party’s name
or disclose the results (including interim findings) of the Study in a press release or any written statement except as agreed in advance by both parties. In the event that the Sponsor wishes to issue a press release sharing findings and/or status
of the Study, a draft press release will be circulated to MD Xxxxxxxx for approval or editorial comments and MD Xxxxxxxx will respond promptly. In any permitted statements, the Parties shall describe the scope and nature of their participation
accurately and appropriately.
6. CONFIDENTIAL INFORMATION
6.1 In conjunction with the Study, the Parties may wish to disclose certain of their respective confidential and/or proprietary information (“Confidential Information”) to each other. Each Party will use Confidential Information of the other Party solely for the purpose of conducting the Study, and shall use
reasonable efforts to prevent the disclosure of such other Party's Confidential Information to third parties during the Term and for a period of three (3) years after expiration or termination of this Agreement, provided that the receiving Party's
obligation of confidentiality and nonuse hereunder shall not apply to information that: (a) is already in the receiving Party's possession at the time of disclosure; (b) is or later becomes part of the public domain through no fault of the
receiving Party; (c) is received from a third party having no obligations of confidentiality or nonuse to the disclosing Party; (d) independently developed by the receiving Party; (e) is required by law or regulation to be disclosed; (f) is
published in accordance with Section 5 of this Agreement; (g) is necessary to disclose in order to file a patent application or enforce a patent related to this Agreement; or (h) is communicated to MD Anderson's scientific and/or institutional
review committees.
6.2 In the event that information is required to be disclosed pursuant to Section 6.1(e), the Party required to make disclosure shall notify the other Party to allow the other Party
to assert whatever exclusions or exemptions may be available to such Party under applicable law or regulation.
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6.3 In the event that Sponsor shall come into contact with any “Protected Health Information” (as such term is defined under HIPAA) of MD
Xxxxxxxx or any information which could be used to identify any of MD Anderson’s patients or research subjects, Sponsor shall maintain any such Protected Health Information or other information confidential in accordance with laws and regulations
as applicable to MD Xxxxxxxx, including without limitation HIPAA, and shall not use or disclose any such Protected Health Information or other information in any manner that would constitute a violation of any applicable law or regulation if such
use or disclosure was made by MD Xxxxxxxx.
7. INTELLECTUAL PROPERTY
7.1 Sponsor and MD Xxxxxxxx understand and agree that the performance of the Study may require use of information and/or materials that may be protected by patents or other
proprietary rights owned by or licensed to either Party (“Background Intellectual Property”). Nothing in this Agreement will be deemed or construed to convey or transfer to either Party any rights or license with respect to the Background
Intellectual Property of the other Party except insofar as contemplated by this Agreement.
7.2 Title to any inventions or discoveries arising from the performance of the Study (“Inventions”)
and conceived and reduced to practice solely by MD Xxxxxxxx employees shall be owned by MD Xxxxxxxx and shall be disclosed in writing to Sponsor. Title to any Inventions conceived and reduced to practice jointly by MD Xxxxxxxx and Sponsor shall be
owned jointly by MD Xxxxxxxx and Sponsor. MD Xxxxxxxx, consistent with the MD Anderson's patent policy, will offer to grant the Sponsor an exclusive royalty-bearing license for MD Anderson's rights in Inventions. *
8. INDEMNIFICATION
8.1 Sponsor agrees to indemnify, hold harmless, and subject to the statutory duties of the Texas State Attorney General defend MD Xxxxxxxx, System, their Regents, officers, agents
and employees (“MD Xxxxxxxx Indemnitees”) from any liability, loss
or damage they may suffer as a result of claims, demands, costs or judgments against them arising out of Sponsor’s rights and obligations under this Agreement, including but not limited to Sponsor’s use of Data; provided, however, that Sponsor
shall not be obligated to hold harmless any MD Xxxxxxxx Indemnitee from claims arising out of the negligence or willful malfeasance of any MD Xxxxxxxx Indemnitee.
8.2 To the extent authorized by the constitution and laws of the State of Texas, MD Xxxxxxxx agrees to indemnify and hold harmless Sponsor, its officers, agents and employees (“Sponsor Indemnitees”) from any liability, loss or damage they may suffer as a result of claims, demands, costs or judgments against them arising out of MD
Anderson’s negligence in conducting the Study, provided, however, that MD Xxxxxxxx shall not be obligated to hold harmless any Sponsor Indemnitee from claims arising out of the negligence or willful malfeasance of any Sponsor Indemnitee.
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8.3 Both Parties agree that upon receipt of a notice of claim or action arising out of the Study, the Party receiving such notice will notify the other Party promptly.
9. INDEPENDENT CONTRACTOR
For the purposes of this Agreement and the Study, the Parties shall be, and shall be deemed to be,
independent contractors and not agents or employees of the other Party. Neither Party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on the other Party, except
as may be expressly provided for herein or authorized in writing.
10. TERMINATION
10.1 This Agreement may be terminated: (a) immediately by the written agreement of both Parties; (b) by the Sponsor at the end of each twelve month period following the commencement
of the Study, with sixty (60) days' notice to MD Xxxxxxxx; (c) by MD Xxxxxxxx for health, safety or regulatory reasons or if Sponsor breaches this Agreement and fails to cure such breach within fifteen (15) business days of notice of such breach by
MD Xxxxxxxx; or (d) immediately by either Party if at any time Principal Investigator becomes unable to conduct the Study, and the Parties cannot agree upon a mutually acceptable successor to the Principal Investigator.
10.2 In the event that either Party shall be in default of its material obligations under this Agreement and shall fail to remedy such default within thirty (30) days after receipt
of written notice thereof, this Agreement shall terminate upon expiration of the thirty (30) day period.
10.3 Termination or cancellation of this Agreement shall not affect the rights and obligations of the Parties accrued prior to termination. Upon termination: (a) Sponsor shall pay MD
Xxxxxxxx for all reasonable expenses incurred or committed to be expended as of the effective termination date, including salaries for appointees for the remainder of the current quarter, for the proportion of their appointment allocated to the
Sponsor as applicable; and (b) each Party shall return to the other Party or destroy any Confidential Information of such other Party remaining in the Party’s possession, provided that such Party may retain one (1) copy of such Confidential
Information for purposes of compliance with this Agreement and with applicable laws and regulations.
10.4 Any provisions of this Agreement which by their nature extend beyond expiration or termination of the Agreement shall survive such termination.
11. MISCELLANEOUS PROVISIONS
11.1 This Agreement may not be assigned by either Party without the prior written consent of the other Party.
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11.2 This Agreement constitutes the entire and only agreement between the Parties relating to the Study, and all prior negotiations, representations, agreements and understandings
are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by means of a written document signed by the duly authorized representatives of the Parties.
11.3 Principal Investigator and Sponsor may be parties to a consulting agreement or other outside agreement to which MD Xxxxxxxx is not a party. Sponsor acknowledges and agrees that
MD Xxxxxxxx has no involvement with or responsibility for these consulting or outside agreements.
11.4 Any notice required by this Agreement shall be given by prepaid, first class, certified mail, return receipt requested, addressed in the case of MD Xxxxxxxx to:
The University of Texas
M. D. Xxxxxxxx Cancer Center
0000 Xxxxxxxx Xxxx., Xxxx 0000
Office of Research Administration
Attn: Executive Director, Research Administration
Xxxxxxx, XX 00000
With a copy to:
The University of Texas System
M. D. Xxxxxxxx Cancer Center
0000 Xxxxxxxx Xxxx., 0000
Xxxxx Services
ATTN: Chief Xxxxx Xxxxxxx
Xxxxxxx, XX 00000
or in the case of Sponsor to:
00 Xxxx 00xx Xxxxxx, Xxxxx 000
Xxx Xxxx, XX 00000
ATTN: XXXXXX XXXXXXX, Chief Executive Officer)
FAX: 0 000 000-0000
PHONE: 0 000 000-0000
or at such other addresses as may be given from time to time in accordance with the terms of this notice provision.
11.5 This Agreement shall be governed by, construed, and enforced in accordance with the laws of the State of Texas.
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11.6 MD Xxxxxxxx is an agency of the State of Texas and under the Constitution and laws of the State of
Texas possesses certain rights and privileges and only such authority as is granted to it under the Constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing herein is intended to be, nor will it be construed to
be, a waiver of the sovereign immunity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas. Moreover, notwithstanding the generality or specificity of any
provision hereof, the provisions of this agreement as they pertain to MD Xxxxxxxx are enforceable only to the extent authorized by the Constitution and laws of the State of Texas.
11.7 Neither MD Xxxxxxxx nor Sponsor will be required to perform any act or to refrain from any act or be bound to any act that would violate any state or federal law applicable to
it. In this regard, this Agreement is subject to, and MD Xxxxxxxx and Sponsor agree to comply with, all applicable local, state, federal, national and international laws, statutes, rules and regulations. Any provision of any law, statute, rule or
regulation that invalidates any provision of this Agreement, that is inconsistent with any provision of this Agreement, or that would cause one or any of the Parties hereto to be in violation of law will be deemed to have superseded the terms of
this Agreement. MD Xxxxxxxx and Sponsor, however, will use all reasonable efforts to accommodate the terms and intent of this Agreement to the greatest extent possible consistent with the requirements of the law and negotiate in good faith toward
amendment of this Agreement in such respect. If the Parties cannot reach agreement on an appropriate amendment, then this Agreement may be immediately terminated by either Party.
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized
representatives.
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SPONSOR
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THE UNIVERSITY OF TEXAS
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M. D. XXXXXXXX CANCER CENTER
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By
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By
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Name: Xxxxxx Xxxxxxx
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Name: Xxxxx Xxxxxx
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Title: Chief Executive Officer
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Title: Assistant Director of Sponsored Programs
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READ AND UNDERSTOOD BY:
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Xx. Xxxx Xxxxxxx
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Principal Investigator
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* Information has been redacted and is subject to a request for confidential treatment
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EXHIBIT A
*
* Information has been redacted and is subject to a request for confidential treatment
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EXHIBIT B
STUDY BUDGET
Funding Agency: Cell Source
Principal Investigator: Xxxx Xxxxxxx
Title:
Project Dates: TBD
Protocol(s): N/A
Total Patients: N/A
*
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Total Costs
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Year 1
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Year 2
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Year 3
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Grand Total
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||||||||||||
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$
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499,673.60
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$
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499,703.81
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$
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507,974.92
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$
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1,507,352.33
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|||||||||
PAYMENT PLAN (Effective 01/01/2019)
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YEAR 01
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YEAR 02
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YEAR 03
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||||||||||
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Quarterly payments*
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$
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124,918.40
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$
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124,925.95
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$
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126,993.73
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||||||
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Total
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$
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499,673.60
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$
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499,703.81
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$
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507,974.95
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||||||
*Payments to be made quarterly by first of each quarter
* Information has been redacted and is subject to a request for confidential treatment
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