Exhibit 10.4


 


SERVICES AGREEMENT


 


THIS SERVICES AGREEMENT (“Agreement”),
is made and entered into as of February 27th, 2018 (“Effective Date”), by and between:


 


I.
Baxter Healthcare Corporation, a company duly organized under the laws of Delaware, having a place of business at One Baxter
Parkway, Deerfield, IL 60015 (“Baxter”); and


 


2. Regentis Biomaterials Ltd.,
a company duly organized under the laws of Israel with its principal place of business at 12 Ha’ilan, Northern Industrial Zone, P.O.Box
260, Or-Akiva, 3060000, Israel (“Regentis”).


 


Each of Baxter and Regentis shall sometimes
be referred to as a “Party” and collectively, as the “Parties”.


 


WHEREAS,
Baxter and Teva Medical (Marketing) Ltd. (“Teva”) are parties to a Distribution Agreement dated January 21, 1998
(“Distribution Agreement”) pursuant to which Teva is Baxter’s exclusive agent in Israel for distribution of certain
products, including Baxter’s Tisseel products; and


 


WHEREAS,
Baxter, Regentis and Teva entered into a supply agreement dated July 15, 2008, which was amended and restated on January 6, 2009,
(the “Supply Agreement”) for supply of Tisseel to Regentis for manufacture of Regentis’s product for animal and
human clinical research use and clinical studies (the “Regentis Clinical Product”); and


 


WHEREAS,
Regentis intends to purchase, from Teva, Tisseel for manufacture of Regentis’s product for commercial promotion and sale (the
“Regentis Commercial Product”); and


 


WHEREAS,
Regentis wishes to obtain from Baxter, and Baxter wishes to provide, certain services in connection with the supply of Tisseel for
the Regentis Commercial Product, and the Parties wish to otherwise agree on certain rights and responsibilities pertaining to
such supply.


 


NOW, THEREFORE, in consideration
of the mutual promises and covenants set forth herein the Parties hereby agree as follows:


 


		1.	The Supply Agreement will continue to govern the Parties’ rights and
                                                          responsibilities concerning Tisseel used in the Regentis Clinical Product. This Agreement will govern the Parties’ rights and
                                                          responsibilities concerning Tisseel used in the manufacture of the Regentis Commercial Product. This Agreement imposes no obligation
                                                          on Baxter to supply Tisseel to Regentis for the Regentis Commercial Product, via the Distribution Agreement or otherwise. This
                                                          Agreement imposes no obligation on Regentis to purchase Tisseel from Baxter or Teva for the Regentis Commercial Product.



 


		2.	The term of this Agreement shall commence on the Effective Date and shall remain
in full
force and effect for five (5) years (the “Initial Term”). Thereafter, this agreement shall
renew automatically for further consecutive terms of five (5) years each (the Initial Term
collectively with each additional term shall be referred to as the “Term”), unless either Party
desires to terminate this agreement by written notice at least two (2) years in advance. Either
Party may terminate this Agreement thirty (30) days after written notice to the other Party of
a material breach of the Agreement by such other Party, unless such breach is cured within such thirty (30) day period.



 






     


     


    

 


		3.	The Parties have executed a Quality Agreement dated February 27th, 2018
that is attached as
Exhibit A and hereby incorporated by reference into this Agreement.



 


		4.	(a) From time to time as reasonably requested by Regentis and approved by Baxter,
Baxter
shall provide to Regentis the quality, regulatory, and technical support set forth in the
Quality Agreement for the Regentis Commercial Product, up to a maximum aggregate of
forty (40) man-hours per calendar year for all such support. In consideration of receipt and
availability of such support, Regentis shall pay Baxter $60,000 per year until such time that
Regentis receives FDA approval to market the Regentis Commercial Product in the U.S.
Thereafter, Regentis shall pay Baxter $200,000 per year during the Term of this Agreement.
For the avoidance of doubt, such payments are due regardless of whether Regentis actually
requests any support and/or purchases any Tisseel in a particular year. The first such
payment shall be due thirty (30) days after the Effective Date, with such payment and
corresponding support being pro-rated for the period of the calendar year remaining.
Thereafter, such payments are due by January 15 each year except that in the year that
Regentis receives FDA approval to market the Regentis Commercial Product in the U.S.,
Regentis shall pay the $140,000 balance for that year within thirty (30) days after such
approval. (b) For any quality, regulatory, or technical support reasonably requested by
Regentis and approved by Baxter in its sole discretion beyond forty (40) man-hours in any
calendar year, Regentis will pay Baxter $2,500 per man-hour. Baxter will issue invoices for
any such additional support monthly, and payments are due thirty (30) days from the invoice
date.



 


		5.	In connection with the support services provided by Baxter under this Agreement,
including the Quality Agreement, Baxter may disclose confidential and/or proprietary
information to Regentis (“Confidential Information”). Absent Baxter’s written
consent Regentis shall not disclose Confidential Information to third parties. Regentis
may use Confidential Information as necessary to secure and maintain regulatory
approval for the Regentis Commercial Product, including, notwithstanding the
preceding sentence, disclosing Con6dential Information to an appropriate regulatory body; provided that: (i) Regentis may not use Confidential
Information for any other
purpose; and (ii) if such use/disclosure would make any Confidential Information
publicly available, Regentis must first obtain Baxter’s written consent.



 


		6.	Baxter shall have no liability to Regentis whatsoever in connection with Regentis’s
purchase
of Tisseel from Teva, for third party claims or otherwise. Baxter’s sole liability to Regentis under this Agreement and the Quality Agreement
shall be the re-performance of any service
improperly rendered. IN NO EVENT WILL BAXTER BE LIABLE TO REGENTIS FOR LOST PROFITS OR FOR ANY INDIRECT, INCIDENTAL, SPECIAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING FROM OR IN CONNECTION
WITH THIS AGREEMENT.



 


		7.	Regentis shall defend, indemnify, and hold harmless Baxter, its successors, assigns,
affiliates, directors, officers, agents, and employees (collectively, “Indemnitees”) from and
against any and all liabilities, losses, damages, and expenses (including attorneys’ fees)
resulting from claims, demands, costs or judgments allegedly or actually arising out of or
relating to Regentis’s purchase and use of Tisseel and/or the purchase, possession
manufacture, packaging, distribution use, testing, sale, offer for sale, or other distribution of
the Regentis Commercial Product.



 






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		8.	If at any time during the Term, Regentis decides in good faith to commence negotiations
with any third party for the acquisition of all or substantially all of Regentis’s stock or assets,
Regentis shall provide a written notice to Baxter at least ten (10) business days in advance of
commencing such negotiations.



 


		9.	This Agreement together with the Quality Agreement constitutes the entire agreement
between the Parties relating to the subject matter herein, and all prior proposals, discussions
and writings by and between the Parties relating to the subject matter herein are superseded
hereby. 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.



 


		10.	In the event any portion of this Agreement is declared void or invalid by a court
or tribunal of 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.



 


		11.	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.



 


		12.	This Agreement shall not be assignable without the prior written consent of the
other Party,
which consent shall not be unreasonably withheld, except that Baxter may assign the Agreement in connection with a transfer of the business
to which this Agreement pertains or
to a parent corporation or affiliate under common ownership.



 


		13.	All notices 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 email or by facsimile
                                                                                        transmission with confirmation of receipt or by registered or certified mail, postage prepaid to the addresses listed above




 


Communication between Parties shall be to the
following:


 


	 	To Baxter	 	To Regentis:
	 	Patrick Boyd	 	Alastair Clemow
	 	Senior Director, US Market Development	 	President & CEO
	 	Baxter Healthcare Inc.	 	Regentis Biomaterials, Ltd
	 	Tel: 847 846 7626	 	Tel: 609 759 01313
	 	email: Patrick.boyd@baxter.com	 	email: aclemow@regentis.co.il


 


Or to such other individuals as
the Parties provide notice of.


 






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		14.	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.



 


IN WITNESS WHEREOF, the Parties have signed this
Agreement as of the Effective Date,


 


	Regentis Biomaterials Ltd.	 	Baxter Healthcare Corporation
	 	 	 
	By:	       	 	By:	                    
	Name:	 Alastrair Clemow, Ph.D.	 	Name:	 
	Title:	 President & CEO	 	Title:	 
	Date: 	February 27th, 2018	 	Date:	 


 






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Exhibit A


 


Quality Agreement


 


 


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