Exhibit 10.3


 


AMENDED AND RESTATED SUPPLY AGREEMENT


 


This Amended and Restated Supply Agreement
(this “Agreement”) is entered into, effective as of January 6, 2009 (the “Effective Date”) by and between


 


		(1)	Baxter Healthcare Corporation, a company duly organized under the laws of Delaware, having a place of
business at One Baxter Way, Westlake Village, California 91362-3811 (“Baxter”); and



 


		(2)	Regentis Biomaterials Ltd., company duly organized under the laws of Israel with its principal place of
business at 2 Ha’ilan, Northern Industrial Zone, P.O.Box 260, Or-Akiva, 30600, Israel (“Buyer”); and



 


		(3)	Teva Medical (Marketing) Ltd., a company duly organized under the laws of Israel
with its principal place of business at Sapir IND Zone, Netanya 42504, Israel (“Teva”).



 


PREAMBLE


 


WHEREAS:


 


(A) Baxter
and Buyer entered into a Supply Agreement dated July 15, 2008 such Supply Agreement is contained herein as Exhibit E, whereby Baxter has
agreed to supply TisseelTM VHSD fibrin sealant Kit (the “Tisseel”) to Buyer (“Original Agreement”); and


 


(B) Baxter
and Teva entered into a Distribution Agreement dated 21 January 1988 whereby Teva has agreed to act as Baxter’s exclusive agent
in Israel of certain products, and inter alia in the distribution of TisseelTM VHSD fibrin sealant Kits in Israel (“Distribution
Agreement”); and


 


(C) Buyer
wishes to purchase TisseelTM VHSD fibrin sealant Kit (the “Tisseel”) from Teva as described with registration details
in Exhibit A, which is attached hereto and incorporated herein by reference, and


 






     


     


    

 


NOW THEREFORE, Teva and Baxter are willing to
sell and transfer the Tisseel only upon the following conditions:


 


1. PURCHASE/PURPOSE


 


Buyer represents and warrants
that the Tisseel purchased under this Agreement is for animal and human clinical research use and clinical studies relating to Buyer’s
product as outlined in Exhibit B as will be conducted in different countries on a world wide basis (the “Project”). Buyer
further agrees that the Tisseel will not be used nor sold to others for any use other than that stated in this Agreement. Baxter agrees
to notify the United States Food and Drug Administration (FDA) by way of a written notice, on which Buyer is copied, that Baxter is authorizing
Buyer to reference the data within the Tisseel Biologics License Application, FDA Submission Tracking Number (the “Tisseel Specifications”),
as well as European regulatory authorities and other authority as needed. A sample of such written notice is contained herein as Exhibit
C. Baxter represents and warrants that it is GMP approved for the manufacturing of Tisseel and that it’s entering to this Agreement
or its execution, and Buyer’s intended use of Tisseel, does not, to Baxter’s best knowledge, infringe on third party rights.
Baxter agrees to provide Buyer with documentation and assistance relating to Tisseel, as reasonably requested by Buyer, as necessary for
Buyer to seek and obtain approvals from US regulatory authorities, European regulatory authorities and other authority for the Project.


 


2. PAYMENT, PURCHASE ORDERS, LIABILITY


 


The price and payment terms
that Buyer and Teva have agreed upon are listed in Exhibit D. Any purchase order accepted by Teva shall be filled subject to the terms
and conditions of this Agreement. Any use of the Tisseel shall be in accordance with this Agreement. Nothing herein shall be construed
as a commitment of any kind by Baxter and/or Teva to supply the Tisseel to Buyer neither at any time nor as a commitment by Buyer to purchase
Tisseel, except under firm purchase order issued by Buyer and confirmed by Teva to Buyer in writing. Without derogating from the above,
Baxter and/or Teva shall provide Buyer with a 180 day prior written notice of any change in the specifications of Tisseel to be supplied
to Buyer, or if Baxter ceases to produce the Tisseel.


 


3. REPRESENTATIONS
AND WARRANTIES


 


The Tisseel described in Exhibit A as provided
by Baxter is a finished medicinal product, registered in various jurisdictions, and subject to different regulatory requirements, compositions,
applications, indications, dosages and availabilities. The Tisseel is not registered in Israel however it is imported to Israel under
the Pharmacy Act, clause 29 A 3 (known as 29 C). Baxter represents and warrants that the Tisseel will conform to the Tisseel Specifications
and will be free of manufacturing defects. Baxter further represents to the best of its knowledge that the entering into and performance
of this Agreement will not conflict with any agreement to which Baxter is a party or obligation to which Baxter is subject. Except as
otherwise set forth in this Agreement, there are no expressed or implied warranties, including any warranty of merchantability of fitness
for a particular purpose or the regulatory status accompanying the sale of this Tisseel. In particular, there is no express or implied
warranty of fitness of the Tisseel for the combination with Buyer’s products or substances.


 


Except as may arise under any indemnification
hereunder, none of the parties shall be liable to the other parties for any proximate, incidental or consequential damages arising from
or in connection with this Agreement or from the use of the Tisseel by Buyer or otherwise.


 






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4.  SHIPMENT
AND DELIVERY


 


(a) Shipment Terms. Teva shall
ship all products to Buyer’s delivery location specified in the Purchase Order, freight pre-paid. Additional charges for emergency
of overnight deliveries will be the responsibility of Buyer and will be added to the invoice. Teva agrees to ship orders for Tisseel within
thirty (30) days after receipt by Teva of a Purchase Order from Buyer, which Purchase Orders may, in the aggregate during the term of
this Agreement, equal up to the Maximum Quantity. Shipments shall be accompanied with certificates of analysis applicable to each Tisseel
shipment.


 


5. INFECTIOUS
AGENTS


 


Buyer specifically acknowledges
that when products prepared from human blood or plasma (including the Tisseel) are administered, the potential for the transmission of
infectious agents (such as viruses or other infectious particles, and including infectious agents that may not have been discovered or
characterized at this time) cannot be totally eliminated, despite stringent controls applied in the selection of blood and plasma donors
and prescribed manufacturing standards used at blood and plasma collection centers, testing laboratories and fractionation facilities.
Buyer agrees that any claims resulting from or alleging such transmission of infectious agents are intended to be covered by indemnification
provisions of Article 8(a), except in cases where such claims arise from a failure of Baxter follow the Quality Assurance Procedures in
Exhibit A, in which case, such claims are intended to be covered by Article 8(b).


 


6. RECALL


 


If, in Baxter’s sole
discretion, or as a consequence of regulatory requirements, Baxter decides to undertake a recall of certain lots of the Tisseel, Buyer
shall cooperate fully with Baxter in Baxter’s recall strategy. If Baxter should notify Buyer of a recall, Buyer shall promptly notify
all of its customers who received the Tisseel. Such notification shall be in a manner commensurate with the hazard and the recall strategy,
in accordance with the applicable regulatory agency guidelines for recalls and product withdrawals. Any claims resulting from or alleging
failure of Buyer to so notify Buyer’s customers are intended to be covered by the provisions of Article 8(a) and any such claims
resulting from or alleging failure of Baxter to undertake a recall are intended to be covered by the provisions of Article 8(b). Baxter
shall bear the costs, damages, lost profits or any other expenses relating to recalling the Tisseel from Buyer and its customers.


 


Whenever a recall of the Tisseel
in Israel is being contemplated for any reason, each party shall, without prejudice to its obligations under any applicable governmental
regulation Israel, promptly consult with the other with the view to deciding the appropriate action to take with respect thereto. Without
derogating from the foregoing, Teva shall follow all reasonable instructions of Baxter with regard to recall of the Product. In the event
a recall is due to the negligence or improper action of Buyer, Buyer shall bear costs related to the recall. Except as specifically noted,
all costs in respect of any recall for any reason shall be at the costs of Baxter.


 






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7.  CONFIDENTIALITY/PUBLICATIONS


 


(a) The parties do not intend
to disclose to each other confidential information during the performance of this Agreement. However, if at any anytime a party desires
to disclose confidential information to the other party, then the parties will at such time enter into a mutual non-disclosure agreement,
in form mutually agreed by the parties. Accordingly, all information regarding Tisseel provided by Baxter to Buyer, and information otherwise
available to Buyer from third party sources, may be used by Buyer in its submissions to regulatory authorities.


 


(b) Public Announcement.
No party (nor any affiliate of either party) will originate any written publicity, news release or other public announcement, relating
to this Agreement without the prior written approval of the other parties, which approval shall not be unreasonably delayed.


 


8.  INDEMNIFICATIONS


 


(a) Buyer
shall defend, indemnify and hold harmless Baxter, its successors, assigns, affiliates, directors, officers, agents and employees (collectively
“Baxter” For the purposes of this Article), from and against any and all liabilities, losses, damages and expenses (including
attorney’s fees) as the result of claims, demands, costs or judgments which may be made or instituted against any of them by third
parties arising out of Buyer’s purchase, possession, processing, packaging, distribution, use, testing, sale or other disposition
of products which were manufactured with the Tisseel. This indemnification shall not apply, however, to the extent any such liabilities,
losses, damages or expenses are caused by the gross negligence or willful misconduct of Baxter or any other claim that would not have
arisen had the Buyer’s product not included the Tisseel, or claims otherwise covered by Article 8(b). Buyer shall have the right
to control the defense of any action that is to be indemnified by Buyer hereunder, including the right to select counsel reasonably acceptable
to Baxter to defend Baxter, and to settle any claim. Buyer will not enter into any settlement that would admit any fault of Baxter or
place any blame on the Tisseel without the prior written consent of Baxter. The provisions of this Article 8(a) shall survive and remain
in full force and effect after any termination, expiration or cancellation of this Agreement and Buyer’s obligation hereunder shall
apply whether or not such claims are rightfully brought.


 


(b) Baxter shall defend, indemnify
and hold harmless Buyer and Teva and their successors, assigns, affiliates, directors, officers, agents and employees (collectively “Buyer”.
For the purposes of this Article), from and against any and all liabilities, losses, damages and expenses (including attorney’s
fees) as the result of claims, demands, costs or judgments which may be made or instituted against any of them by third parties arising
out of (i) Baxter’s failure to manufacture the Tisseel to FDA approved specifications, and (ii) claims that the Tisseel infringes
the intellectual or other property rights of any third party. Baxter shall have the right to control the defense of any action that is
to be indemnified by Baxter hereunder, including the right to select counsel reasonably acceptable to Buyer to defend Buyer, and to settle
any claim. Baxter will not enter into any settlement that would admit any fault of Buyer without the prior written consent of Buyer. The
provisions of this Article 8(b) shall survive and remain in full force and effect after any termination, expiration or cancellation of
this Agreement and Buyer’s obligation hereunder shall apply whether or not such claims are rightfully brought.


 






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(c) For this purpose, during
the term of this Agreement and thereafter, either party shall hold and maintain an adequate insurance policy to cover its responsibilities
and liabilities according to this Agreement and any applicable laws and regulation. Notwithstanding the above, the Parties agree that
prior to the initiation by the Buyer of human clinical trials using Tisseel purchased under this Agreement (including trial batch preparation),
the Buyer shall deliver a copy of the certificate of insurance made by Buyer for such clinical trials which insurance certificate shall
be attached as an appendix to this Agreement and shall include coverage required by applicable laws and regulation. In case no such certificate
is provided this Agreement shall be null and void.


 


(d) An indemnified party shall
promptly notify the indemnifying party of any loss, claim, damage, liability or action in respect of which an indemnified party intends
to claim indemnification under this Article 8, and the indemnifying party shall assume the defense thereof at the indemnifying party’s
expense. The indemnified party may elect to be represented by additional counsel of its choosing at its own expense. The indemnified party
shall cooperate fully with the indemnifying party and its legal representatives in the investigation of any action, claim or liability
covered by this indemnification.


 


(e) Teva will not indemnify
either Baxter or Buyer under the terms of this Agreement. Baxter will indemnify Teva under the terms of its Distribution Agreement with
Baxter.


 


9.  TERM
AND TERMINATION


 


(a) Term. The term
of this Agreement shall commence on the Effective Date and shall remain in full force and effect for an initial term (the “Initial
Term”) of April 1, 2008 and end on April 1, 2011. This Agreement shall be automatically renewed thereafter for consecutive one-year
terms (each, a “Renewal Term”) after the expiration of the Initial Term on the same terms and conditions as set out herein,
with the exception of Pricing which will be renegotiated ninety (90) days prior to the expiration of the Initial or Renewal Term, unless
Buyer or Baxter notifies the other in writing of its intention not to renew this Agreement at least ninety (90) days before the end of
the Initial Term or any Renewal Term.


 


(b) Termination without
Cause. Notwithstanding any of the other provisions in this Article 9 regarding termination of this Agreement, Baxter has the right
to terminate this Agreement with ninety (90) days prior written notice to the other parties.


 






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(c) Termination
with Cause. Notwithstanding any of the other provisions in this Article 9 regarding termination of this Agreement, no party may terminate
this Agreement, effective immediately at its option in the event of:


 


(i) Voluntary
Liquidation Events. The other party shall (a) seek the liquidation, reorganization, dissolution or winding up of itself or the composition
or readjustment of all or substantially all of its debts, (b) apply for or consent to the appointment of, or the talking of possession
by, a receiver, custodian, trustee or liquidator of itself or of all or substantially all of its assets, (c) make a general assignment
for the benefit of its creditors, (d) commence a voluntary case under applicable bankruptcy or insolvency law, (e) file a petition seeking
to take advantage of any other law relating to bankruptcy, insolvency, reorganization, winding-up or composition or readjustment of debts.


 


(ii) Material
Breach. Defaults in the performance of any of the material covenants or obligations contained in this Agreement, shall be considered
material breach. If such default is not capable of rectification, then termination should be effective the date that notice of such breach
is received by the defaulting party. If such breach is capable of rectification, then the defaulting party will have thirty (30) days
after receipt of written notice of such default, to rectify the breach.


 


(iii) Effect
of Expiration and Termination. Subject to Article 10, expiration or termination of this Agreement shall terminate all rights granted
hereunder but shall not relieve the parties of any obligation accruing prior to such expiration or termination (including, but not to,
the Buyer payments to Baxter).


 


10. SURVIVAL
CLAUSE


 


The obligations of the parties
contained in Articles 5, 6, 8, 9, 10, 14 and 15 shall survive termination of this Agreement and remain in full force and effect indefinitely.


 


11. ENTIRE
AGREEMENT


 


This Agreement and the attached
Exhibits A-D constitute the entire agreement between the parties relating to the subject matter herein, and all prior proposals, discussions
and writings by and between the parties and relating to the subject matter herein are superseded hereby, except for confidentiality agreements
previously entered into, the Distribution Agreement and the Original Agreement. None of the terms of this Agreement shall be deemed to
be waived by either party or amended unless such waiver or amendment is written and signed by both parties, and recites specifically that
it is a waiver of, or amendment to, the terms of this Agreement.


 


12.  SEVERABILITY


 


In the event any portion of
this Agreement is declared void or invalid by a court of tribunal or competent jurisdiction, such provision shall be modified or severed
from this Agreement, and the remaining provisions shall remain in effect, unless the effect of such severance would be to alter substantially
this Agreement or the obligations of the parties, in which case this Agreement may be immediately terminated.


 






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13.  SUPPLY
SHORTFALL


 


Should Baxter be precluded
from supplying all or part of the Tisseel provided for in this Agreement temporarily, indefinitely, or permanently due to acts of God,
regulatory measures or law such as, riots, strikes, natural disaster, acts of terrorism shortage of product, lack of batch releases of
regulatory authorities, or other cause outside of the reasonable control of Baxter, then this Agreement shall be suspended to the extent
necessary and for the time necessary to allow for the remedy of the situation causing the disruption of sale or use of the product. Buyer
agrees that in such events Baxter, without liability to Buyer, may allocate products among all of its customers. In the event the supply
shortfall exceeds an aggregate of sixty (60) days, Buyer may terminate this Agreement by written notice of such termination at least thirty
(30) days prior to the termination date. Should Baxter become unable, for any reason, to supply the Tisseel to Buyer, or if it changes
the characteristics of the Tisseel so that Buyer has to purchase the Tisseel from another supplier, Baxter shall assist Buyer in such
a transition phase, including all assistance required vis a vie the FDA.


 


14. GOVERNING
LAW


 


This Agreement shall be governed
by and construed in accordance with the laws of the State of Delaware, without reference to any rules of conflict of laws. This Agreement
shall not be construed against the party preparing it, but shall be construed as if the parties jointly prepared it.


 


15. ASSIGNMENT


 


This Agreement shall not be
assignable without the prior written consent of the other party, which consent shall not be unreasonably withheld by either party, except
for an assignment accompanying a transfer of the business to which this Agreement pertains or to a parent corporation or affiliate under
common ownership with the transferring party.


 


16. NOTICES


 


All notice to either party
hereunder shall be in writing and shall be deemed to have been duly given if delivered personally to such party or sent to such party
by facsimile transmission with confirmation of receipt or by registered or certified mail, postage prepaid to the following addresses:


 


	 	If to Buyer:	Regentis Biomaterials Ltd.
	 	 	2 Ha’ilan Street
	 	 	Northern Industrial Zone, P.O.Box 260
	 	 	Or-Akiva, 30600, Israel
	 	 	 
	 	Attn: 	Yehiel Tal, Chief Executive Officer
	 	Telephone:	972.4.626.5502
	 	Facsimile: 	972.4.626.5504
	 	 	 
	 	If to Baxter:	Baxter Healthcare Corporation
	 	 	One Baxter Way
	 	 	Westlake Village, California 91356-3811
	 	Attn: 	Bill Tawil
	 	Telephone: 	805 372 3588
	 	Facsimile: 	805 372 3592
	 	 	 
	 	If to Teva:	Teva Medical Ltd.
	 	 	Sapir IND Zone
	 	 	Netanya 42504, Israel
	 	Attn: 	Yossi Ofek
	 	 	 



 


17.  COUNTERPARTS


 


This Agreement may be executed
by the parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed an original and all of which
counterparts taken together shall constitute but one and the same instrument.


 


Deliberately left blank.


 






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IN WITNESS HEREOF, the PARTIES have caused this
Agreement to be executed by their duly authorized representatives as of the Effective Date written above.


 


	Regentis Biomaterials Ltd.	 	BAXTER HEALTHCARE CORPORATION
	 	 	 	 	 
	By:	 	 	By:	                              
	 	 	 	 	 
	Name:	 	 	Name:	  
	 	 	 	 	 
	Title:	 	 	Title:	 
	 	 	 	 	 
	Date:	 	 	Date:	 
	 	 	 	 	 
	TEVA MEDICAL (MARKETING) LTD.	 	 	 
	 	 	 	 	 
	By:	 	 	 	 
	 	 	 	 	 
	Name: 	                              	 	 	 
	 	 	 	 	 
	Title:	 	 	 	 
	 	 	 	 	 
	Date:		 	 	 



 






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EXHIBIT A


 


Description Tisseel


 


Tisseel consists of key plasma derivatives from
the last stages in the natural coagulation pathway where soluble Tisseel is converted into a sold fibrin matrix. The Tisseel works as
a two-component system. Controlled and precise application is facilitated by the use of the Duploject applicator, which serves to hold
components in separate syringes and provides simultaneous mixing and delivery to the surgical site. Within 3 to 5 minutes from the time
of delivery, a solid coagulum with superior elasticity, tensile strength, and adhesiveness is created.


 


Baxter follows the following “Quality Assurance
Procedures”: The Tisseel is manufactured as part of an integrated, three-stage viral safety program. The program consists of (1)
donor-selection procedures, (2) serologic testing for viral contaminants, and (3) viral inactivation by two-step vapor heating. Prior
to acceptance, donor plasma must pass two rounds of testing for antibodies against HIV and hepatitis. The tests are separated by a three-month
interval to check for seroconversion. Viral inactivation of the pooled plasma is performed by two-step vapor heating, a process that has
been shown to reduce viral titers by a cumulative log reduction factor of up to 12.8 for HIV. After more than two decades of international
use and more than 5 million doses, not a single case of confirmed viral transmission has been detected from Tisseel.


 






     


     


    

 


EXHIBIT B


 


Regentis Biomaterials has developed a technology platform called Gelrin
for tissue regeneration. Gelrin is an in-situ photopolymerizable hydrogel material comprised of PEGylated fibrinogen.


 






     


     


    

 


EXHBIT C


Notice to FDA


 


______________________


U.S. Food and Drug Administration


Division of Blood Applications HFM-370


Center for Biologics Evaluation


And Research (CBER)


1401 Rockville Pike


Rockville, Maryland 20852-1448


 


	RE:	Right
of Reference to Tisseelâ VH
Kit Biologics License Application



Submission Tracking Number
(STN) 103231,


CBER Reference Numbers: 87-0508
and 87-0509


 


[please revise to suite use of Tisseel]


 


Dear ____________________,


 


Baxter
Healthcare Corporation, through Baxter AG (previously Immuno AG), a joint stock company duly organized and existing under the laws of
Austria, is the owner of STN 103231 for the fibrin sealant, trade name Tisseelâ
VH Kit.


 


By way of this notice, Baxter
AG hereby grants __________________ a right of reference to the data contained within Biologics License 2.55, STN 103231, CBER Reference
Numbers: 87-0508 and 87-0509.


 


The existence of this notice
and other information that it contains are confidential, and the protection afforded to such confidential information by 18 USC 1905,
21 USC 331(j), 5 USC 552, and other applicable laws is hereby claimed.


 


If there are any questions
regarding this submission, please direct them to my attention at _____________.


 


Sincerely,


 


Baxter Healthcare Corporation


 






     


     


    

 


EXHIBIT D


Price and Payment Schedule


 


		a)	The amounts of Tisseel to be supplied during the Initial Term, subject to Purchase Orders issued by Buyer,
shall be: 1,000 kits of the 2ml kit (new terminology), or 500 kits of the 4 ml kit (new terminology) or 200 kits of the 10 ml kits (new
terminology) per year. (the “Maximum Quantity”). Buyer is not obligated to purchase the Maximum Quantity, but may issue Purchase
Orders up to this amount, and such Purchase Orders shall be fulfilled by Baxter in accordance with the terms of the Agreement.



 


The supply is
subject to firm orders provided by Buyer during the term and confirmed by Baxter by Baxter that such orders conform to the terms of the
Agreement.


 


		b)	The purchase price shall be fixed at $ 136.00 U.S. per unit for the Initial Term only. The unit here is
defined as 2 ml kit (new terminology)



The purchase price
will be re-negotiated for each Renewal Term.


 


		c)	Terms and conditions for purchase of Tisseel shall be those of Teva as set forth below:



 


ORDERING PROCEDURE


 


It is agreed by all parties that Teva
shall not held any amount of Tisseel in its stock, and each order shall be on ad-hoc basis. In this respect the Buyer shall send an order
to Teva’s Diagnostic Unit, attention: the head of the Diagnostic Unit. Shipment against any purchase order does not constitute acceptance
by Teva of the terms and conditions or prices stipulated on the purchase order. Shipment of any order, including standing order, will
be made in accordance with terms, conditions and prices in effect, as stated herein, unless otherwise agreed to in writing by all parties
concerned. Teva cannot guarantee maximum product expiration dating on any Products upon delivery. Specific dating needs may be discussed
with Customer Service at time of order placement.


 


PAYMENT TERMS AND CONDITIONS


 


Payment terms are net 30 days from date of invoice. Customer shall pay Teva a service charge of 1% per month,
12% per year, (or the highest amount allowed by law, if lower) on all amounts past due. In the event Customer is delinquent in payment
or any amounts to Baxter, whether or not related to this Agreement, Teva may, at its option, declare all amounts owed to it under all
agreements as due and payable immediately and terminate this Agreement.


 






     


     


    

 


EXHIBIT E


Supply Agreement