EXHIBIT 10.1



 


BONE
BIOLOGICS CORPORATION


 


September 
24, 2015


 


Bone Biologics
Corporation


321 Columbus
Ave.


Boston,
MA 02116


 


Attention:
Founders


 


Dear Drs.
Soo, Ting and Wu:


 


		1.	This
                                         letter agreement has been written to confirm our understanding regarding the past work
                                         product and past data related to Nell-1. By executing this Agreement Ben Wu, Chia Soo
                                         and Eric Kang Ting (the “Founders”) hereby agree to deliver all past work
                                         product and past data related to Nell-1 (the “Data”) which Bone Biologics
                                         Corporation (“Bone Bio”) deems to have value to Bone Bio as it progresses
                                         to and commences the manufacturing of Nell-1 (the “Data”), as set forth on
                                         Schedule I attached hereto. The Founders are not asked to perform additional research
                                         or produce new data. The Founders agree that Bone Biologics shall have the right to use
                                         the Data in its sole discretion, within the applicable licensing rights granted by the
                                         University of California, beginning as of the date hereof and that such right shall not
                                         be subject to termination in any way by the Founders. Absent any additional agreement
                                         between Bone Bio and the Founders, it is understood that the Founders will have no further
                                         obligation to Bone Bio to provide work product or any other services beyond what is contained
                                         herein as defined in Schedule I.



 


Bone
Bio agrees to issue 1,153,846 shares of restricted common stock to the Founders in the percentages set forth on Annex I attached
hereto (the “Shares”) on the earlier to occur of (i) the third anniversary of the date hereof and (ii) a “Liquidity
Event” which shall mean Bone Bio’s initial public offering or APO/OTCB/PIPE/PPM/PREFERRED CONVERT or sale in exchange
for reasonable efforts by Founders to provide the work product and data set forth in Schedule I attached hereto. For transactions
and liquidity events that involve customary lockup periods, the Shares shall vest on the expiration date of the lock-up period.
The Founders agree to accept the Shares in full satisfaction for the delivery of the Data.


 


The
Founders understand that the Shares are restricted and may not be sold, transferred or otherwise disposed of without registration
under the Securities Act of 1933, as amended (the “Securities Act”) or an exemption therefrom, and that in the absence
of an effective registration statement covering the Shares or an available exemption from registration under the Securities Act,
the Shares must be held indefinitely. Bone Bio will register these Shares on behalf of the Founders at the earliest opportunity
as permitted under the Securities Act of 1933 (the “Act”). The certificate or certificates representing the Shares
shall bear the following legends (as well as any legends required by applicable state and federal corporate and securities laws);
provided however, that once the Shares are registered for resale pursuant to the Act such legend will be removed upon the sale
of such Shares:


  




    	 



    	 



    

 


THE
SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT
AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE EFFECTED
WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT
SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.


 


The
Founders represent and warrant to Bone Bio that each is an “accredited investor,” as such term is defined in Rule
501(a) of Regulation D of the Securities Act.


 


In
the event that Bone Bio pursues an equity financing of common stock, inclusive of, and not limited to, any exercise of warrant
options Bone Bio shall request that the placement agent include an aggregate of up to $2,250,000 worth of common stock owned by
the Founders (the “Founders Shares”) in such equity financing. If the placement agent advises Bone Bio that in their
opinion the Founders Shares requested to be included in such private placement exceeds the number of shares of common stock which
can be sold in such offering on behalf of the Company without adversely affecting the marketability of such offering for the Company,
the Company will include common stock in such financing in accordance with the following formula: for each $1,000,000, the Founders
shall be allowed to sell $250,000 of Founders common shares until the Founders Shares as defined herein are sold provided that
Bone Bio fully discloses in the use of proceeds the intent to sell such Founders Shares to the Placement Agent or the investor(s),
as applicable. Founders agree that the foregoing right shall not be applicable to any public offering of the Company’s securities,
which would be subject to customary restrictions and lock-up periods required by the Company’s underwriter in connection
with such public offering. Founders acknowledge that the Company makes no warranties to Founders that any Founder Shares will
be sold, and any such sale is subject to acceptance by Placement Agent or the investor(s), as applicable.





 


		2.	The
                                         Founders will deliver the Data to:



 


Stephen
LaNeve


Bone
Biologics Corporation


321
Columbus Ave


Boston,
MA 02116


 




    	 



    	 



    

 


All
Data provided may be used in Bone Bio’s discretion within the applicable licensing rights granted by the University of California.


 


The
parties shall comply with all applicable laws, rules and regulations, including the federal false claims statute (31 U.S.C. 3729)
and anti-kickback statute (42 U.S.C. 1320a-7 (b)) and the related safe harbor regulations. Accordingly, no part of any consideration
paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items
or services. If any portion of this Agreement is found by any court or agency with jurisdiction over the subject matter hereof
not to be in compliance, that portion of the Agreement shall be deemed retroactively amended and reformed as necessary to comply
and the parties shall cooperate in taking such actions as are necessary and desirable to ensure such compliance.


 


		3.	Miscellaneous



 


a.
This Agreement constitutes the sole, full and complete agreement by and between the parties with regard to the subject of this
Agreement, and no amendments, changes, additions, deletions, or modifications of this Agreement will be valid unless reduced to
writing, signed by the parties, and attached hereto.


 


b.
This Agreement will not be considered accepted, approved, or otherwise effective until the signature of each party is affixed
in the space provided below and written documentation of Bone Bio Board approval for this Agreement is also obtained. Please be
advised that a fully executed Agreement with Bone Bio approval must be received by Founders and Bone Bio within 7 business days
of the above date. If not received within that period, either party reserves the right to re-evaluate the terms of this Agreement.


 


c.
This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument
and shall become effective when counterparts have been signed by each party and delivered to the other parties hereto, it being
understood that all parties need not sign the same counterpart. Execution may be made by delivery by facsimile or via electronic
format.


 


All
communications hereunder, except as may be otherwise specifically provided herein, shall be in writing and shall be mailed, hand
delivered, sent by a recognized overnight courier service such as Federal Express, or sent via facsimile/electronic mail and confirmed
by letter, to the party to whom it is addressed at the following addresses or such other address as such party may advise the
other in writing:


 


To
Bone Bio: as set forth on the signature page hereto.


 


To
the Founders: as set forth on the signature page hereto.


 


All
notices hereunder shall be effective upon receipt by the party to which it is addressed.


 


d.
Any rights or obligations contained herein that by their nature should survive termination of this Agreement shall survive, including,
but not limited to, acknowledgments and use of Data.


 




    	 



    	 



    

 


e.
This Agreement shall be governed by and construed in accordance with the laws of California without regard to choice of law principles.
The parties hereby consent to jurisdiction in the State of California and agree that the courts within California shall have exclusive
jurisdiction over any issue regarding this Agreement.


 


f.
The parties may modify or amend this Agreement only pursuant to written agreement signed by all parties.


 


g.
If any provisions of this Agreement or application to any party or circumstances shall be determined by any court of competent
jurisdiction to be invalid and unenforceable to any extent, the remainder of this Agreement, or the application of such provisions
or circumstances other than those as to which it is determined to be invalid or unenforceable shall not be affected thereby, and
each provision hereof shall be valid and shall be enforced to the fullest extent permitted by law.


 


h.
The failure of any party to insist upon a strict performance of or to seek remedy of any one of the terms or conditions of this
Agreement or to exercise any right, remedy or election set forth herein or permitted by law shall not constitute nor be construed
as a waiver or relinquishment for the future enforcement of such term, condition, right, remedy or election, but such items shall
continue and remain in force and effect. All rights or remedies of any party specified in this Agreement and all other rights
or remedies that either party may have at law, in equity or otherwise shall be distinct, separate and cumulative rights or remedies,
and no one of them, whether exercised by the party seeking enforcement or not, shall be deemed to be in exclusion of any other
right or remedy of such party. Any consent, waiver or approval by either party of any act or matter must be in writing and shall
apply only to the particular act or matter to which such consent or approval is given.


 




    	 



    	 



    

 


If
the foregoing terms meet with your approval, kindly confirm your acceptance by dating, signing and returning to us the copy of
this letter enclosed for that purpose.


 


	 	Very
    truly yours,
	 	 
	 	Bone Biologics
    Corporation


 


	 	By:
    	/s/
    Stephen R. LaNeve
	 	Name:	Stephen R. LaNeve
	 	Title:	CEO
	 	Date:	October 8, 2015


 


	 	Address
    for Notice:
	 	321 Columbus Ave
	 	Boston, MA 02116


 


AGREED
AND ACCEPTED:


 


	By:
    	/s/
    Dr. Chia Soo	 	Date: 10/1/15
	Name:
    	Dr.
    Chia Soo	 	 	 
	Title:
    	Founder	 	 	 





	 	Address
    for Notice:
	 	 
	 	 


 


	By:
    	/s/
    Dr. Eric Kang Ting	 	Date: 10/1/15
	Name:
    	Dr.
    Eric Kang Ting	 	 	 
	Title:
    	Founder	 	 	 


 


	 	Address
    for Notice:
	 	 
	 	 


 


	By:
    	/s/
    Dr. Ben Wu	 	Date: 10/8/15
	Name:
    	Dr.
    Ben Wu	 	 	 
	Title:
    	Founder	 	 	 





	 	Address
    for Notice:
	 	 
	 	 


 




    	 



    	 



    

 


Annex
1


 


	Founder	 	 	Percentage	 
	 	 	 	 	 
	Ben Wu	 	 	33
                                         1/3	%
	 	 	 	 	 
	Chia Soo	 	 	33
                                         1/3	%
	 	 	 	 	 
	Eric Kang Ting	 	 	33
                                         1/3	%



 




    	 



    	 



    

 


Schedule
1


 


		1.	Full
                                         access to Aragen’s Data from Aragen’s efforts to produce Nell-1 from 2009
                                         to present for technology transfer package for CDMO. Bone Bio acknowledges the fact that
                                         the Founders have no control over Aragen’s records and lab notebooks, and can only
                                         provide access.



 


		a.	Analytical
                                         data for each step of the process to gain an understanding of what worked and what has
                                         not worked regarding the assays, bioreactor runs, purification runs, etc.



 


		b.	Inoculum
                                         scale up data such as age of the culture at the time of bioreactor inoculation



 


		c.	Bioreactor
                                         profile parameters



 


		i.	 	DO
                                         setting



		ii.	 	pH



		iii.	 	titer



		iv.	 	growth
                                         curve



		v.	 	expression
                                         curve



		vi.	 	nutrient
                                         utilization



		vii.	 	Td



		viii.	 	medium
                                         supplements during culture



		ix.	 	protein
                                         concentration



		x.	 	ratio
                                         of pass to fail runs



 


		d.	Final
                                         cell density, viability and titer before clarification at harvest



 


		e.	Clarification
                                         process



 


		i.	 	Run
                                         time parameters such as length of time to clarify, temperature, any concentration steps
                                         used



		ii.	 	Type
                                         of clarification material used



		iii.	 	Titer
                                         post clarification



		iv.	 	Hold
                                         time between harvest, clarification and initial capture step



 


		f.	Data
                                         on Nell-1 stability during viral inactivation steps as part of the purification process



 


		i.	 	Low
                                         pH



		ii.	 	Detergents



		iii.	 	Nano
                                         filtration



 


		g.	Capture
                                         column parameters



 


		i.	 	Protein
                                         loading (concentration per mL loaded)



		ii.	 	Total
                                         protein loaded per run



		iii.	 	Column
                                         size



		iv.	 	Flow
                                         rate (residence time)



		v.	 	Pre
                                         and post yield



		vi.	 	Binding
                                         capacity of resin



 




    	 



    	 



    

  


		vii.	 	Yield
                                         loss (pass through Nell-1 that did not bind to column)



		viii.	 	Titer
                                         post capture



		ix.	 	Potency
                                         (active molecule) post capture



		x.	 	SDS-PAGE
                                         and SDS analysis



		xi.	 	Co-purifying
                                         proteins



		xii.	 	Other
                                         analytics employed to provide data



 


		h.	Polishing
                                         steps



 


		i.	 	Data
                                         for removal of HCP, DNA/RNA



		ii.	 	Pre
                                         and post data



 


		i.	Purified
                                         Nell-1



 


		i.	 	Final
                                         purity of each lot



		ii.	 	Protein
                                         of each lot



		iii.	 	Potency
                                         of each lot



 


		j.	Nano
                                         filtration process



 


		k.	Aseptic
                                         sterilization process



 


		l.	Formulation
                                         of final bulk product



 


		i.	 	How
                                         was this determined



		ii.	 	How
                                         long and under what parameters can the product be held without compromising quality



 


		m.	Hold
                                         times and conditions at each step of the process



 


		i.	 	Is
                                         there data that could be used to develop the initial hold time parameter at each step



 


		n.	Characterization
                                         of Nell-1 at various production steps



 


		i.	 	Any
                                         attempts and data where non-denatured GEL bands were separated and analyzed for activity



		ii.	 	Any
                                         attempts and data to separate higher order species via SEC and analyzed for activity



		iii.	 	Any
                                         attempts and data to prevent aggregation of Nell-1 into higher species



		iv.	 	Any
                                         data on deamination or oxidation of Nell-1



		v.	 	Any
                                         data on the effect of endogenous proteases



 


		o.	What
                                         lots produced acceptable product and what lots did not produce acceptable product



 


	 			Any
                                         discussions with Aragen on possible solutions



 


		2.	Lyophilization



 


		a.	Any
                                         initial data on the development of a lyo cycle



		b.	Any
                                         initial data on the development of a lyo formulation



		c.	Stability
                                         data on lyophilized Nell-1



		d.	Any
                                         know effects of moisture or temperature on the lyophilized Nell-1



		e.	Capacity
                                         of apatite coated TCP for Nell-1



		f.	Elution
                                         profile of Nell-1 from apatite coated TCP



		g.	Assay
                                         to monitor active Nell-1 eluted from TCP



		h.	Thoughts
                                         on delivery device



 




    	 



    	 



    

  


		3.	Potency
                                         assay SOP as run at UCLA.



 


		a.	List
                                         of all reagents and their sources



		b.	Data
                                         on how control was established



		c.	Actual
                                         protocol for potency assay



		d.	Data
                                         on the performance of each Nell-1 lot evaluated



		e.	Have
                                         there been times when the assay did not work on a sample, but upon re-running the sample
                                         worked (MTBF)



		f.	Have
                                         there been times when the control also failed in the assay



		g.	How
                                         was this assay qualified



		h.	Will
                                         need their assistance during any equivalence testing between their current assay and
                                         any newly developed potency assay



 


		4.	Performance
                                         data on how the quality of regenerated bone post exposure to Nell-1 was measured and
                                         determined



 


		a.	In
                                         the rodent models



		b.	In
                                         the sheep models



		c.	In
                                         the monkey models



 


		5.	Nell-1
                                         antibody data



 


		a.	Data
                                         on host antibody production after the application of Nell-1 during early research in
                                         rodent models



		b.	Similar
                                         data for the sheep and monkey experiments



 


		6.	Nell-1
                                         Distribution data



 


		a.	Data
                                         on the distribution of Nell-1 after local application in rodent models



		b.	Similar
                                         data for the sheep and monkey experiments



 


		7.	Dosing
                                         Data



 


		a.	Methods
                                         for establishing dosing for rodents, sheep, monkey



		b.	Dosing
                                         range estimate for humans and methodology for such



		c.	Effects
                                         noted or anticipated for overdosing



 


		8.	Biocompatibility
                                         data for protein



 


		9.	Absorption,
                                         distribution, metabolism and excretion (ADME) data in rodent, sheep and monkey studies



 


		10.	Nell-1
                                         + DMX



 


		a.	Stability
                                         data of Nell-1 once mixed with DBX (initial time post mixing that should not be exceeded
                                         prior to application)



		b.	Protocol
                                         or current thinking on how to obtain uniform mixing of powdered Nell-1 with DBX



		c.	Half
                                         life of Nell-1 in DBX after implantation in rodent, sheep and monkey models



 




    	 



    	 



    

  


		11.	Bone
                                         Biologics & UCLA Discovery Grant No bio07-10677.



 


		a.	Beyond
                                         a summary letter and can find no records in the files



		b.	Need
                                         deliverable of data produced during this project.



 


		i.	 	Bioassays
                                         to Confirm UCB Bioactivity



		ii.	 	Synthetic
                                         Carriers to enhance UCB bioactivity



		iii.	 	UCB
                                         is safer than BMP-2



		iv.	 	UCB
                                         supports stem cell growth and differentiation



		v.	 	UCB
                                         can potentially work within osteoporotic environment



		vi.	 	In-depth
                                         MicroCT Analysis of UCB induced Bone Formation in Sheep and Primate Models



 


		12.	Sheep
                                         Study



 


		a.	Written
                                         and approved protocol



		b.	Completed
                                         protocol



		c.	Data
                                         from SF9 derived Nell-1



		d.	Data
                                         from CHO derived Nell-1



		e.	All
                                         radiograms



		f.	Final
                                         report from Colorado State University



		g.	Summary
                                         of what the founders believe are the key points of the data



 


		13.	Rhesus
                                         monkey data



 


		a.	Written
                                         and approved protocol



		b.	Completed
                                         protocol



		c.	Data
                                         from SF9 derived Nell-1



		d.	Data
                                         from CHO derived Nell-1



		e.	All
                                         radiograms



		f.	Final
                                         report of China company who ran the studies



		g.	Summary
                                         of the key points of the data