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

2.1NCATS 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.

2.2Nothing 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.

2.3The 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

3.1.1Either Party may disclose or receive Confidential Information under this
Agreement.

3.1.2All 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.

3.1.3Recipient 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.

3.1.4Recipient 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.

3.1.5Recipient 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.

3.1.6Either Party may disclose the Abstract of the Research Project (in Appendix
A) to the public.

3.2 Publications; Press Releases

3.2.1Publications

3.2.1.1In 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.

3.2.1.2The 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.

3.2.2Press Releases

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

4.1.1The 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.

4.1.2Inventions 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.

4.1.3Each 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

5.2.1RECIPIENT WILL NOT USE MATERIAL IN RESEARCH INVOLVING HUMAN SUBJECTS.

5.2.2Recipient’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.

5.2.3Recipient 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.

5.2.4Recipient will use Material in compliance with all applicable laws,
regulations and policies.

5.2.5Provider reserves the right to distribute its Material to others and to use
its Material for its own purposes.

5.2.6Upon 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.

5.2.7Nothing 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.

6.2.2This Agreement will terminate immediately upon the mutual agreement of the
Parties in writing.

6.2.3This 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

6.3.1Material 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.

6.3.2No 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]

 

      Signature   Date             Printed Name and Title    

 

 

Signature Date

 

Printed Name and Title