UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): December 15, 2015
Bio-Matrix
Scientific Group, Inc.
(Exact
Name of Company as Specified in Charter)
Commission File Number:
0-32201
| |
|
| Delaware |
33-0824714 |
|
(State or Other Jurisdiction of
Incorporation) |
(IRS Employer Identification
Number) |
4700
Spring Street, St 304
La
Mesa California, 91942
(Address
of Principal Executive Offices, Zip Code)
Company’s
telephone number, including area code: (619) 702-1404
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry Into A Material Definitive Agreement
On December 15, 2015 Regen Biopharma, Inc. (“Regen”)
entered into an agreement (“Agreement”) with the National Center for Advancing Translational Sciences (“NCATS”),
which is a component of the National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human
Services , pursuant to the following terms and conditions:
Regen and NCATS shall collaborate to screen for small molecule compounds
that activate or inhibit the orphan nuclear receptor, NR2F6 (“Research Project”).
NR2F6 orphan nuclear receptor cell lines will be provided by Regen.
NPC and LOPAC compound libraries will be used to screen this receptor
at NCATS.
Inventions made in the course of the Research Project will be owned
by the Party employing the inventor or inventors. Inventions that are invented jointly by employees of both Parties will be owned
jointly.
The Parties, moreover, agree to enter into an inter-institutional
agreement with respect to joint inventions, which shall authorize Regen to have primary control and responsibility for any patenting
and commercialization activities and shall be negotiated in good faith based on the respective parties’ contributions to
each Joint Invention.
The term of this Agreement is for 3 years from December 16, 2015.
This Agreement may be extended as mutually agreed by the Parties. This Agreement may be terminated upon thirty days written notice
by the terminating Party to the other Party.
Regen is a controlled subsidiary of Bio Matrix Scientific Group,
Inc.
The foregoing description of the Agreement is not complete
and is qualified in its entirety by reference to the text of the Agreement , which is attached to this Current Report on Form 8-K
as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
| Item 9.01 |
Financial Statements and Exhibits. |
Exhibit No. Description
Item 10.1 Agreement
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
| |
Bio Matrix Scientific Group, Inc. |
| |
|
| Dated: December 16, 2015 |
By: /s/ David Koos |
| |
David Koos |
| |
Chief Executive Officer |
Exhibit
10.1
RESEARCH
COLLABORATION AGREEMENT
This
Agreement is between the National Center for Advancing Translational Sciences (“NCATS”), which is a component of the
National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human Services, having offices
located at 9800 Medical Center Drive, Rockville, MD 20850, and Regen Biopharma, Inc. (“Collaborator”), having a principal
place of business at 4700 Spring Street, Suite 304, La Mesa, CA 91942 (collectively, the “Parties”). This Agreement
is neither a funding agreement as defined in 35 U.S.C. § 201(b) nor a cooperative research and development agreement authorized
under the Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. §§ 3710a et seq., and Executive Order
12591 of April 10, 1987. NCATS enters into this Agreement pursuant to the authority of the Public Health Services Act of 1944,
as amended (42 U.S.C. § 241).
Background
| 1. | NCATS
and Collaborator want to collaborate on a research project; and |
| 2. | NCATS
and Collaborator want to transfer between the laboratories of their investigators, during
the term of this Agreement, confidential information and proprietary research materials
required to conduct the research project. |
Terms
and Conditions
Article
1 DEFINITIONS
| 1.1 | “Confidential
Information” includes scientific, business, or financial information pertaining
to the Research Project (defined below) that is designated as confidential by Provider
(defined below). Confidential Information does not include information that: (i) is in
the public domain other than as a result of a disclosure by Recipient (defined below)
or any of Recipient’s representatives in violation of this Agreement; (ii) was
in the possession of Recipient before disclosure by the Provider; (iii) is acquired by
Recipient from a third party having no obligation of confidentiality to Provider; (iv)
is hereafter independently developed by Recipient, without reference to Confidential
Information received from Provider; or (v) Provider expressly authorizes Recipient to
disclose. |
| 1.2 | “Invention”
means any invention or discovery that is or may be patentable or protectable under applicable
laws. |
| 1.3 | “Investigator”
means the principal researcher designated by a Party to direct the Research Project. |
| 1.4 | “Material”
means compounds and cell lines listed in Appendix A. |
| 1.5 | “Progeny”
means unmodified descendent from Material, such as virus from virus, cell from cell,
or organism from organism. |
| 1.6 | “Provider”
means the Party that provides Material or discloses Confidential Information to the other
Party under this Agreement. |
| 1.7 | “Recipient”
means the Party that receives Material or Confidential Information from the other Party
under this Agreement. |
| 1.8 | “Research
Project” means the collaborative research described in Appendix A. |
Article
2 COLLABORATIVE RESEARCH
| 2.1 | NCATS
and Collaborator agree to collaborate on the Research Project. The Investigator for NCATS
will be Menghang Xia and the Investigator for Collaborator will be Harry M. Lander. |
| 2.2 | Nothing
in this Agreement will be construed to limit the freedom of either Party from engaging
in similar research with other parties, providing the research does not create a conflict
with the Parties’ obligations under this Agreement, especially with regard to Article
3. |
| 2.3 | The
Parties recognize that the Research Project describes the collaborative research to be
conducted under this Agreement and that the goals set forth in Appendix A are good faith
guidelines. If events occur that require substantial modification of the Research Project,
the Parties may amend Appendix A according to Paragraph 6.2.1 of this Agreement. |
Article
3 CONFIDENTIALITY; PUBLICATIONS
3.1 Confidential
Information
| 3.1.1 | Either
Party may disclose or receive Confidential Information under this Agreement. |
| 3.1.2 | All
Confidential Information exchanged between the Parties must conspicuously bear the words
“Confidential Information” or “Confidential.” Confidential Information
exchanged orally or through observation must be reduced to writing and marked “Confidential
Information” or “Confidential” within 30 days after disclosure to be
considered Confidential Information. |
| 3.1.3 | Recipient
will maintain Confidential Information in confidence for a period of 3 years from the
effective date of this Agreement and will protect Confidential Information with the same
degree of care as Recipient uses to protect its own Confidential Information. |
| 3.1.4 | Recipient
may disclose Confidential Information to its employees, consultants, or contractors to
whom it is necessary to disclose this information for the purpose of the Research Project;
Recipient may make these disclosures only under terms at least as restrictive as those
specified in this Agreement. Recipient agrees that disclosure of Confidential Information
may not be made to any party not listed herein unless Provider grants prior written approval
to Recipient. |
| 3.1.5 | Recipient
may disclose Provider’s Confidential Information if required to do so by law, regulation,
or court order. If Recipient, or anyone to whom it discloses Confidential Information
in accordance with Article 3, becomes legally required to disclose any Confidential Information,
Recipient will provide timely notice to Provider and, to the extent practicable, consult
with Provider prior to any disclosure. |
| 3.1.6 | Either
Party may disclose the Abstract of the Research Project (in Appendix A) to the public. |
3.2 Publications;
Press Releases
| 3.2.1.1 | In
addition to the specific goals of the Research Project, the Parties view dissemination
of research findings, both by publication and oral presentation, as an essential objective
of the Research Project. Authorship will be decided according to commonly accepted conventions
for scientific publications. |
| 3.2.1.2 | The
Parties are encouraged to make publicly available the results of the Research Project.
Before either Party submits a paper or abstract for publication or otherwise intends
to publicly disclose information about any Invention made in the course of the Research
Project, the other Party will have 30 days to review proposed manuscripts and 3
days to review proposed abstracts to assure that its Confidential Information is protected.
Either Party may request in writing that the proposed publication or other disclosure
be delayed for up to 30 additional days as necessary to file a patent application. |
| Neither party will,
without written consent of the other party, issue press releases that reference or rely upon the
Research Project under this Agreement, permission of which will not be unreasonably withheld. Press
release shall be provided by the releasing party at least 7 days prior to publication. |
Article
4 INVENTIONS; DATA
4.1 Inventions
| 4.1.1 | The
Parties acknowledge the possibility that Inventions may be made in the course of the
Research Project. Inventorship of those Inventions will be determined in accordance with
applicable U.S. laws and regulations. The term made, as used in reference to any invention,
means the conception or first actual reduction to practice of such invention. |
| 4.1.2 | Inventions
made in the course of the Research Project will be owned by the Party employing the inventor
or inventors. Inventions that are invented jointly by employees of both Parties will
be owned jointly. |
| 4.1.3 | Each
Party will report to the other Party, in writing, all Inventions made during the Research
Project no later than 3 months from the time the invention is disclosed to a Party by
its Investigator. The reports will be written in sufficient detail to determine inventorship
and will be treated as Confidential Information in accordance with Article 3. The Parties
will confer with each other regarding a patent filing strategy for jointly made Inventions.
If either Party files a patent application on a jointly made Invention, then the filing
Party will include a statement in the patent application that clearly identifies the
Parties and states that the Invention was made jointly under this Agreement. The Parties,
moreover, agree to enter into an inter-institutional agreement with respect to Joint
Inventions, which shall authorize Collaborator to have primary control and responsibility
for any patenting and commercialization activities and shall be negotiated in good faith
based on the respective parties’ contributions to each Joint Invention. |
4.2 Data
| | Each
Party will disclose to the other Party a summary of all data generated under this Agreement.
Subject to the restrictions in Article 3, both Parties will have free access to and use
of any data generated under this Agreement. |
Article
5 THE TRANSFER AND USE OF MATERIAL
5.1 Mechanics
of Transfer
| | Either
Party may provide or receive Material under this Agreement. Provider will send Material
to Recipient with a cover letter as described in Appendix B. The letter will refer to
this Agreement and identify Material. If either Party transfers to the other Party a
material not listed in Appendix A, the Parties will amend this Agreement to include the
additional material. |
5.2 Conditions
of Use
| 5.2.1 | RECIPIENT
WILL NOT USE MATERIAL IN RESEARCH INVOLVING HUMAN SUBJECTS. |
| 5.2.2 | Recipient’s
Investigator will use Material solely in connection with the Research Project in the
Investigator’s laboratory. If Recipient wants to use Material for commercial purposes,
Recipient agrees to first obtain the appropriate commercial use or commercialization
license from Provider. |
| 5.2.3 | Recipient
agrees that Recipient’s Investigator will retain control over Material and further
agrees that Recipient’s Investigator will not transfer Material to people not under
the Investigator’s direct supervision without advance written approval of Provider. |
| 5.2.4 | Recipient
will use Material in compliance with all applicable laws, regulations and policies. |
| 5.2.5 | Provider
reserves the right to distribute its Material to others and to use its Material for its
own purposes. |
| 5.2.6 | Upon
termination of this Agreement, Recipient agrees that Recipient’s Investigator will
return any and all remaining Material unless Provider gives Recipient’s Investigator
directions for disposing of Material by another means. |
| 5.2.7 | Nothing
in this Agreement will be construed as conferring on Recipient any implied license to
Material, or option to license Material, any technology, or any patent or patent application
owned by Provider and will not create any obligation, by implication or otherwise, of
either Party to enter into any further agreement with the other Party. |
Article
6 TERMINATION AND GOVERNANCE
6.1 Effective
Date
This
Agreement will be effective on the date of the last authorized signature below.
6.2 Term
and Termination
| 6.2.1. | The
Parties agree that this Agreement will be effective for 3 years from the date of the
last authorized signature below and may be extended as mutually agreed by the Parties
in a written amendment to this Agreement. |
| 6.2.2 | This
Agreement will terminate immediately upon the mutual agreement of the Parties in writing. |
| 6.2.3 | This
Agreement will terminate in 30 days after either Party receives written notice of the
other Party’s desire to terminate this Agreement. |
6.3 Representations,
Warranties, and Liability
| 6.3.1 | Material
is understood to be experimental in nature and may have hazardous properties. MATERIAL
IS BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider makes no representations
that the use of Material will not infringe any patent or other proprietary rights of
third parties. |
| 6.3.2 | No
indemnification for any loss, claim, damage, or liability is intended or provided by
either Party under this Agreement. Each Party will be liable for any loss, claim, damage,
or liability that the Party incurs as a result of its activities under this Agreement,
except that NCATS, as an agency of the U.S. Government, assumes liability only to the
extent provided under the Federal Tort Claims Act, 28 U.S.C. §§ 2671 et
seq. |
6.4 Assignment
Neither
this Agreement nor any rights or obligations of either Party hereunder may be assigned or otherwise transferred by either Party
without the prior written consent of the other Party. This Agreement will be binding upon the Parties and their respective successors
and permitted assigns.
6.5 Non-endorsement
By
entering into this Agreement, NCATS does not directly or indirectly endorse any product or service that is or will be provided,
whether directly or indirectly related to this Agreement, by Collaborator, its successors, permitted assigns, or licensees. Collaborator
will not in any way state or imply that this Agreement is an endorsement of any such product or service by the U.S. Government
or any of its organizational units or employees.
6.6 Survivability
Articles
3, 4, 6.3, 6.5, 6.6 and 6.8 will survive expiration or earlier termination of this Agreement.
6.7 Severability
The
illegality or invalidity of any provisions of this Agreement will not impair, affect, or invalidate the other provisions of this
Agreement.
6.8 Governing
Law
The
construction, validity, performance, and effect of this Agreement will be governed by federal law as applied by the federal courts
in the District of Columbia. Federal law and regulations will preempt any conflicting or inconsistent provisions in this Agreement.
6.9 Entire
Agreement
This
Agreement, together with all appendices, constitutes the entire agreement between the Parties and supersedes any prior or contemporaneous
oral or written agreements or communications between them with respect to the subject matter hereof. This Agreement may be amended
only by written instrument signed by authorized representatives of NCATS and Collaborator.
6.10
Notices
All
notices pertaining to or required by this Agreement shall be in writing, shall be signed by an authorized representative and shall
be delivered to the addresses indicated on the signature page for each Party.
SIGNATURES
BEGIN ON THE NEXT PAGE
FOR
NCATS:
| /s/ Lila Portilla |
|
12/15/2015 |
| Lili M. Portilla, MPA |
|
Date |
| Director, Office of Strategic Alliances, NCATS |
|
| |
|
|
| Mailing Address for Notices: |
|
| Lili M. Portilla, MPA |
|
| National Center for Advancing Translational Sciences, NIH |
|
| 9800 Medical Center Drive, Room B 311 |
|
| Bethesda, MD 20892-3370 |
|
| Phone: 301-217-2589 |
|
| Fax: 301-217-5736 |
|
Acknowledgment
by NCATS’s Investigator:
| /s/ Menghang Xia |
|
12/16/2015 |
| Menghang Xia, Ph.D. |
|
Date |
| Group Leader, Toxicology, NCATS |
|
|
| |
|
|
| |
|
|
FOR
COLLABORATOR:
| /s/ Harry Lander |
|
12/15/2015 |
| Harry Lander, Ph. D. |
|
Date |
| President and Chief Scientific Officer, Regen Biopharma, Inc. |
|
| |
|
|
| Mailing Address for Notices: |
|
| Harry Lander, Ph.D. |
|
| Regen Biopharma, Inc. |
|
| President and Chief Scientific Officer |
|
| 4700 Spring Street, Suite 304 |
|
| La Mesa, CA 91942 |
|
| 917-696-1991 |
|
| Harry.Lander@regenbiopharma.com |
|
Acknowledgment
by COLLABORATOR’s Investigator:
| /s/ Harry Lander |
|
12/15/2015 |
| Harry M. Lander |
|
Date |
| President and Chief Scientific Officer |
|
| |
|
|
| |
|
|
APPENDIX
A
Research
Project Summary
I.
Abstract of the Research Project – for Public Release
Either
party may, without further consultation or permission, release this abstract to the public.
Project
Title: Identification of possible ligands for the NR2F6 orphan nuclear receptor.
Project
Abstract: These studies are designed to screen for small molecule compounds that activate or inhibit the orphan nuclear receptor,
NR2F6. Small molecule compounds from the NCATs compound libraries will be screened against cell lines expressing either the ligand
binding domain or the full length protein of NR2F6 fused to a luciferase-based reporter construct and stably expressed in HEK293
cells.
II.
Goal(s) of Project: To identify possible ligands for the NR2F6 orphan nuclear receptor by screening
the reporter gene assay of NR2F6 cell lines using known compound libraries, NPC and LOPAC. Such ligands that show specificity
for NR2F6 may lead to the development of novel immunotherapy treatments.
III.
Background: The immunotherapy of cancer has completely changed the clinical management of various
tumors and has dramatically improved the survival rates in those people with melanoma and lymphoma. The key discovery of this
field was the identification of immune checkpoints – molecules whose expression leads to the shutting down of the immune
system’s natural ability to kill cancerous cells. There are currently three checkpoint proteins that have been identified
and for which there are now clinically useful drugs which target these. All of these proteins are expressed as cell surface proteins
and the treatments involve injection of antibodies to these proteins.
Regen
has identified a nuclear receptor, NR2F6, which has properties very much like the known checkpoint proteins. So far, the only
ways to inhibit this receptor include the use of gene silencing techniques or knock outs in mice. Identification of a small molecule
which could inhibit this receptor would potentially provide a major new avenue for immunotherapy of cancer.
IV.
Respective Contributions of the Parties
Material
Contributed by NCATS: NPC and LOPAC compound libraries will be used to screen this receptor
at NCATS.
Material
Contributed by Collaborator: NR2F6 orphan nuclear receptor cell lines will be provided by Regen.
These lines will be HEK293 lines stably expressing NR2F6 ligand binding domain or the full-length NR2F6 protein as well as a positive
control line expressing the estrogen receptor. Each of these target nuclear receptors will be fused to a luciferase-based reporter
gene assay vector.
V.
Experimental Plan: Cell lines (LBD, Full-length and positive control ER) will be transferred
onto screening robotic system. Compound libraries will be screened at various concentrations. After the primary screening, the
potential hits will be cherry-picked and confirmed in the follow up studies.
APPENDIX
B
Sample
Material Transfer Cover Letter
A
sample letter follows.
Date
Provider
Organization Name
Provider
Organization Address
Tel:
Fax:
Recipient
PI
Recipient
Organization
Recipient
Organization Address
| RE: | Transfer
of Material(s) under Collaboration Agreement between NCATS and [name of Collaborator]
dated [month/year] |
Dear
Dr. [Name of NCATS PI or Collaborator PI]:
The
[NCATS or Collaborator] is pleased to provide you with the following material: [Describe material]. The material developed by
[insert name], are being shipped to you by [NCATS/Collaborator].
The
material may only be used for research conducted between NCATS and [Collaborator] under the Collaboration Agreement referenced
above. In addition, you understand that any remaining material will be returned to [NCATS/Collaborator] or disposed of according
to the written instructions of [NCATS/Collaborator] when the Collaboration Agreement expires, unless [NCATS/Collaborator] obtains
permission from [NCATS/Collaborator] to continue using the materials.
Please
acknowledge receipt of the material(s) by signing below. At your earliest convenience, please fax a copy of this letter to your
technology transfer office at [NCATS/Collaborator].
Sincerely,
NCATS/Collaborator
[Provider]
Title
cc:
Acknowledged
by NCATS/Collaborator PI [Recipient]
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| Signature |
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Date |
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| Printed Name and Title |
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Signature Date
Printed
Name and Title