Exhibit 10.8


 





CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***,
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION


 







 


 


This Distribution Agreement (“Agreement”)
is entered into on this 20th day of September 2013, (“Effective Date”)



by and between


 


CytoSorbents, Inc., a corporation
having its offices at 7 Deer Park Drive, Suite K, Monmouth Junction, New Jersey 08852, United States, existing under the laws of
the United States (hereinafter referred to as "CytoSorbents")


 


and


 


Biocon Limited, a corporation having
its offices at 20th KM, Hosur Road, Electronics City, Bangalore, India - 560 100 existing under the laws of India (hereinafter
referred to as "Biocon")


 




CytoSorbents and Biocon hereinafter collectively referred to as "Parties" and individually as a “Party”.


 


 


 


 


 


 


 


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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


	Preamble	4
	1.	Appointment, Products, Territory, and Applications	4
	2.	Order Process, Prices and Payment	6
	3.	Stock	9
	4.	Packaging and Labeling	11
	5.	Product Registration	11
	6.	Other Obligations of Biocon	13
	7.	CytoSorbents' Obligations	13
	8.	Relationship of the Parties	14
	9.	Best Efforts	15
	10.	Reporting	16
	11.	Product Returns	18
	12.	Field Assistance	19
	13.	Trademarks, Service Marks and Trade Names; Promotion on Internet	19
	14.	Covenant Not To Compete	20
	15.	Representations and Warranties	21
	16.	Limitations on Liability	26
	17.	Indemnifications	26
	18.	Force Majeure	29
	19.	Confidentiality	30
	20.	Publicity	32
	21.	Term and Termination	32
	22.	Selling Off of Inventory	34
	23.	Notices	35
	24.	Modification	36
	25.	Assignment	36
	26.	Waiver	37
	27.	Validity	37
	28.	Governing Law	37
	29.	Jurisdiction	38



 


 



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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    




 


 


	30.	Entire Agreement	38
	31.	No Rights by Implication	38
	32.	Compliance With Laws	39
	33.	Insurance	39
	34.	Severability	39
	35.	Counterparts	38


 


 


 


 


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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


Preamble


 


WHEREAS, CytoSorbents is a company that
develops and sells blood purification products for the treatment of life-threatening diseases;


 


 


WHEREAS, Biocon is in the business of marketing
and distribution of pharmaceutical products;


 





WHEREAS, CytoSorbents wishes to have Biocon
undertake the distribution of certain such blood purification products for certain applications in the Territory in limited quantities
as a pilot transaction for potential future expansion upon the mutual agreement of the Parties in their sole discretion, with such
distribution to be on an exclusive basis due to such products being new to the Territory and the fact that competing blood filtration
products are available through other distributors.


 





NOW, THEREFORE, In consideration
of the mutual covenants and conditions herein contained, and intending to be legally bound hereby, the Parties mutually agree as
follows:


 


  


		1.	Appointment, Products, Territory, and Applications



 


		1.1	Subject to the terms and conditions of this Agreement, CytoSorbents hereby appoints Biocon on an
exclusive basis as CytoSorbents sole distributor for the sale of the CytoSorbents products listed in Annex 1
(hereinafter referred to as the "Products") solely in the Territory (as defined in Section 1.4) and solely for use in
the Applications (defined in Section 1.3) during the Term of this Agreement. During the Term of this Agreement CytoSorbents shall
not promote or sell in the Territory, itself or through any third party, the Products or any product competing with the Product.
All rights not expressly granted to Biocon under this Agreement, are reserved for CytoSorbents.



 


 



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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    




 


		1.2	Without the prior written consent of CytoSorbents, Biocon shall not sell, market or distribute
any version of any Product other than the version CytoSorbents shall designate from time to time as its most current version, with
sufficient notice to the Biocon to enable the Biocon to sell its stock of the old version of the Product and ensure a smooth transition.
Written consent shall not be unreasonably withheld or delayed.



 


		1.3	Biocon shall use all commercially reasonable efforts to promote and sell the Products to the maximum
number of buyers ("Purchasers") in the Territory. Biocon shall (a) promote Products only for use in the in the applications
identified in Annex 2 as Applications (the "Applications") and not for any other application (including
those listed as Applications Not Included in Annex 2) and (b) promote Products to customers only for use in the Applications.
Biocon shall not promote any Product for application listed among the Applications Not Included (as defined in Annex 2).



 


		1.4	CytoSorbents is appointing Biocon hereunder with respect to the resale of Products to any Purchasers
whose principal place of business is located in the territory and Applications listed in Annex 2 (hereinafter
referred to as the “Territory”). Biocon shall not promote, distribute or sell any Product outside the Territory, nor
to any Purchaser that Biocon knows will export such Product outside the Territory for any purpose.



 


		1.5	Biocon shall not engage in any advertising or promotional activities relating to the Products directed
to customers outside the Territory without prior written consent of CytoSorbents. Biocon shall provide to CytoSorbents copies of
any written statements related to any therapeutic claims that Biocon wishes to use to market or promote the Products at least thirty
(30) days prior to Biocon's planned date of implementation; provided, however, that Biocon shall not make or use any statement
related to any therapeutic claim regarding any Product unless CytoSorbents has expressly approved such statement in writing.



 


 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


		1.6	Biocon shall not actively solicit orders from any prospective purchaser outside the Territory without
prior written consent of CytoSorbents.



 


		1.7	If Biocon receives any order from a prospective purchaser outside the Territory, Biocon shall immediately
refer that order to CytoSorbents. Biocon shall not accept any such orders without prior written consent of CytoSorbents. Consent
shall not be unreasonably withheld for orders received from within India but outside the specific Indian cities that comprise the
Territory. Biocon shall not deliver or tender (or cause to be delivered or tendered) any Product outside the Territory.



 


		1.8	Biocon shall not establish or maintain any branch, warehouse or distribution facility for the Products
outside of the Territory without prior written consent of CytoSorbents.



 


		1.9	CytoSorbents reserves the right, in its sole discretion, (i) upon ninety (90) days' written notice
to Biocon prior to the end of each calendar year, to amend the Products which are covered by this Agreement and described in Annex
1.



 


		1.10	During the Term of this Agreement, the Parties may expand in any manner the Territory upon mutual
agreement by both parties and thirty (30) days' prior written notice.



  


 


		2.	Order Process, Prices and Payment



 


		2.1	For purposes of this Agreement, "Term Year" means the twelve (12) month period beginning
on the date that Biocon obtains the first regulatory approval to promote and sell a Product in the Territory, and each subsequent
twelve (12) month period throughout the Term of this Agreement. "Term Year 1" means the first Term Year; "Term Year
2" means the second Term Year; and "Term Year 3" means the third Term Year.



 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


		2.2	Within thirty (30) days of the Effective Date, Biocon shall be place the first order of Product
set forth in the table in Section 9.1. The Parties shall agree that the Products ordered in the said first order will be shipped
to Biocon within thirty (30) days of the date of the first order. Notwithstanding anything else in this Agreement to the contrary,
Biocon shall pay for the first order in full within thirty (30) days after the Effective Date.



 


		2.3	Within ten (10) days after the first day of Term Year 1, Biocon shall provide to CytoSorbents a
forecast for the next three (3) calendar months of Biocon's anticipated requirements of the Products and indicating the desired
delivery dates. Biocon shall deliver to CytoSorbents a written update to this forecast on a rolling basis within fourteen (14)
days after the beginning of each subsequent calendar quarter.



 


		2.4	Biocon shall order Products from CytoSorbents by submitting a written purchase order identifying
the Products ordered, requested delivery date(s) and any export/import information required to enable CytoSorbents to fulfill the
order. Biocon may enter into contracts with Purchasers for the purchase of Products and may enter into such contracts at any time
during the Term of this Agreement (“Purchaser Contracts”).



 


		2.5	Unless CytoSorbents has a commercially reasonable reason (e.g. force majeure (as defined in Section
18.2) etc.) to refuse an order from Biocon, CytoSorbents shall accept orders from Biocon which are in compliance with the provisions
of this Agreement. Within fifteen (15) days of the delivery of any forecast that exceeds the total yearly amount of Product described
in Section 9.1 for the applicable year in which such forecast is delivered, the Parties shall meet and discuss such forecast. CytoSorbents
will honor, to the best of its ability, product volume in excess of the annual minimum order requirement but is not obligated to
fulfill the excess volume.



 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


		2.6	CytoSorbents shall use commercially reasonable efforts to ship the Product with ***, but in no
event *** of ***.



 


		2.7	The purchase prices for the Products are set forth in Annex 3.



 


		2.8	If a purchase order is accepted in accordance with Section 2.4 above, delivery of such Products
shall be EXW CytoSorbents facility at 7 Deer Park Drive, Suite K, Monmouth Junction, NJ 08852, USA (Incoterms 2010).



 


		2.8.1	CytoSorbents shall be responsible for packaging the product and at Biocon’s request coordinating
shipping logistics between CytoSorbents New Jersey-based warehouse to Biocon’s destination port in India including documentation
required to export from the US.



 


		2.8.2	CytoSorbents shall bill Biocon for delivery charges, which Biocon shall reimburse CytoSorbents
within thirty (30) days of receipt of such bill.



 


		2.8.3	Biocon shall be responsible at its expense for coordinating and costs of Product receipt, import
duties / taxes, and other costs related to delivery to final destination.



 


		2.9	CytoSorbents obligation to deliver Product to Biocon shall be subject to the right and ability
of CytoSorbents to make such sales and obtain required licenses and permits, under all decrees, statutes, rules and regulations
and agencies or instrumentalities thereof presently in effect or which may be in effect hereafter. CytoSorbents shall undertake
commercially reasonable measures to obtain the licenses and permits required for the shipment of orders of Product.



 


		2.10	All payments shall be made by Biocon to CytoSorbents within thirty (30) days of receipt of invoice
by Biocon.



 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


		2.11	Pricing shall be fixed throughout the Initial Term of this Agreement starting from the Effective
Date (as defined in Section 21.1). At the end of Initial Term of this Agreement, CytoSorbents and Biocon will negotiate in good
faith any future pricing.



 


		2.12	Biocon shall be free to establish its own pricing for Products sold to Purchasers.



 


		2.13	If CytoSorbents terminates this Agreement with Biocon or amends the product offering in accordance
with Section 1.9 such that any Product is removed from Annex 1, then CytoSorbents shall continue to supply Biocon
with sufficient applicable removed Product to fulfill any Purchaser Contracts (as defined in Section 2.4) for such removed Product
that are in effect as of the effective date of such termination or product offering amendment until the earlier of either the expiration
of the term of such Purchaser Contract or one (1) year from the termination date of this Agreement. CytoSorbents’ obligations
under this Section 2.12 do not apply to any extensions, subsequent renewals automatic or otherwise described in such Purchaser
Contract. Biocon shall notify CytoSorbents in writing within fifteen (15) days of the effective date of any such termination or
product offering amendment if a Special Extension of Supply Term is required, and shall include a copy of the applicable Purchaser
Contract in such written notice.



 


 


		3.	Stock



 


		3.1	Biocon shall exert commercially reasonable efforts to have a sufficient stock of the Products in
order to be able fulfill purchase orders from Purchasers within 2 days from receipt of such purchase orders, and shall store at
a minimum five percent (5%) of the minimum purchase requirements described in Section 9.1 for the applicable year. Unexpected mass
orders are not subject to this provision.



 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


		3.2	Biocon shall store the Products consistent with product labeling and in accordance with the highest
healthcare industry practices and rules and regulations in India in order to prevent deterioration of the Products and in accordance
with Annex 1.



 


		3.3	Upon CytoSorbents' written direction, associated with a required regulatory or compliance action,
and within twenty (20) days receipt of such written direction, Biocon shall destroy, return to CytoSorbents or make such other
disposition of Product as CytoSorbents shall direct that is permitted under applicable law of any portion of the Products determined
by CytoSorbents. In the event of such return, destruction or other disposition CytoSorbents shall either replace the Products at
no cost to Biocon (provided that the cost of shipping and customs and duties shall be borne by the party responsible for causing
the regulatory or compliance action) or, at Biocon's option, reimburse Biocon in an amount equal to the price paid by Biocon to
CytoSorbents for the Products including the costs of return or destruction. Biocon’s obligations under this Section 3.3 shall
also apply to Product that has any remaining shelf life. In addition, Biocon shall destroy all Products that have passed applicable
expiration dates.



 


		3.4	Except as expressly set forth herein, Biocon agrees that CytoSorbents owns all right, title, and
interest in all of the trade names, inventions, copyrights, know-how, and trade secrets relating to the design, manufacture, operation
or service of the Products. The use by Biocon of any of these property rights is authorized only for the purposes herein set forth,
and upon expiration or termination of this Agreement for any reason such authorization shall cease. Biocon shall not file, nor
permit or encourage others to file, any patent applications covering any Product or component thereof, any process used by any
Product, or any method of use of any Product.



 






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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 





		4.	Packaging and Labeling



 


		4.1	CytoSorbents shall provide Products that are single packed and comply with all applicable labeling
requirements; provided, however, that Biocon shall inform CytoSorbents in writing of all applicable national labeling requirements
in writing and well in advance in order to allow CytoSorbents timely delivery of the Products.



 


		4.2	Biocon shall not package or label the Products or alter any Products or any package or label used
in connection with any Products, except as specifically authorized in writing by CytoSorbents.



 


		4.3	Biocon shall always comply in all respects with the packaging and labeling instructions of CytoSorbents.



 


		4.4	CytoSorbents shall ensure that the Products are packed for delivery and transportation in such
a manner to avoid risk of damage, loss, or other detrimental effects.



 


		4.5	CytoSorbents shall dispatch the Product along with the required documents to ensure un-interrupted
transport and safe delivery of the Product.



 


		4.6	Biocon shall inform CytoSorbents in writing of any Product for which the labeling and / or packaging
does not comply with the requirements within the Territory (“Non-Compliance”) as soon as possible but in no event later
than ten (10)days after the discovery of such Non-Compliance. Biocon and CytoSorbents shall negotiate in good faith to come to
a solution to correct such Non-Compliance and implement a solution as jointly agreed upon.



 


 


		5.	Product Registration



 


		5.1	Biocon shall, at its expense, register the Products with the appropriate governmental agency(s)
in the Territory, reflecting CytoSorbents as the manufacturer of the Product and the Biocon as the marketing authorization holder.
The Biocon shall not, without written permission from CytoSorbents, undertake any such Product registration in any other name including
in Biocon's own name, provided that such registration complies with the technical and legal requirements in the Territories and
provided further that Biocon may be the marketing authorization holder in the Territory. Biocon shall submit all necessary applicable
regulatory applications for registering the Product as follows: (a) within the India Territory no later than two (2) months after
the Effective Date, and (b) within the Sri Lanka Territory no later than six (6) months after the Effective Date, subject to CytoSorbents
providing Biocon the documents described in Annex 8 at least three (3) months prior to regulatory application. Biocon
shall deliver to CytoSorbents copies of all such proposed applications prior to the Biocon filing such applications with the applicable
regulatory authority. CytoSorbents shall have the right to comment on such applications. If such comments are received before filing,
then Biocon shall modify such applications based on such comments. CytoSorbents shall assist in obtaining such registrations and
give Biocon power of attorney for purposes of registration and shall provide reasonably necessary technical support to Biocon to
meet all applicable regulatory requirements in the Territory. If the applicable regulatory agency in the Sri Lanka Territory requires
that additional human clinical trials of the Product be conducted before granting marketing approval for sale of the Product in
the Sri Lanka Territory, then the Parties shall discuss in good faith whether to amend this Agreement to delete Sri Lanka from
the Territory and substitute another country or region that will not require additional human clinical trials of the Product.



 






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		5.2	Biocon shall be responsible for maintaining adequate lot traceability to assure recall of Products,
if necessary, as detailed in Section 10.1.2.3.



 


		5.3	Upon expiration and termination for any reason of this Agreement Biocon shall, at CytoSorbents'
option and at the sole expense of CytoSorbents, either (a) de-register the Product from all government and regulatory authorities
within 30 days, or (b) transfer any and all registrations, import licenses, permits or certificates for the Products to CytoSorbents
or CytoSorbents designee within 30 days. Biocon agrees to affect such transfer and deregistration in accordance with all applicable
local laws. Notwithstanding the foregoing in case of termination of this Agreement by CytoSorbents for breach of the Agreement
by Biocon, Biocon shall be solely responsible for all de-registration expenses.



 






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		6.	Other Obligations of Biocon



 


		6.1	Biocon shall be responsible for promotion, marketing and sales of the Product in the Territories
and Applications.



 


		6.2	Biocon shall employ competent and experienced personnel and maintain an adequate stock of Products
as stated in Section 3 so as to ensure timely delivery of the Products to the Purchasers of the Products in the Territory.



 


		6.3	Biocon shall translate, at its own expense, all user and technical manuals and advertising and
marketing information into the languages of Purchasers and provide CytoSorbents with advance copies of all such materials for approval
by CytoSorbents. Biocon shall assign, and hereby assigns, all copyrights in such translations to CytoSorbents. Biocon shall have
a non-exclusive right to use such translations during the Term of this Agreement in connection with its activities pursuant to
this Agreement.



 


  


		7.	CytoSorbents' Obligations



 


		7.1	CytoSorbents shall provide Biocon with such marketing and technical assistance and Product samples
as CytoSorbents reasonably determines is necessary to assist with the promotion of the Products.



 


 






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		7.2	CytoSorbents will provide Biocon *** in support of marketing promotions of CytoSorbents in the
*** and up to *** in total *** of the agreement ***.



 


		7.3	CytoSorbents shall provide reasonable initial training to Biocon's personnel in connection with
the marketing, sale, installation and support of the Products. CytoSorbents will not charge Biocon for such training. CytoSorbents
and Biocon shall jointly agree on the details of the training.



 


		7.4	CytoSorbents shall designate support personnel to assist Biocon's support personnel in providing
support services; provided, however, that CytoSorbents' personnel spend no more than an aggregate of 16 hours per calendar month
of their time in providing such assistance.



 


		7.5	CytoSorbents agrees to provide reasonable amounts of support to Biocon at medical congresses when
possible.



 


 


		8.	Relationship of the Parties



 


		8.1	Each Party shall be considered to be an independent contractor. The relationship between CytoSorbents
and Biocon shall not be construed to be that of employer and employee nor to constitute a partnership, joint venture or agency
of any kind.



 


		8.2	Biocon shall have no right to enter into any contracts or commitments in the name of, or on behalf
of, CytoSorbents, or to bind CytoSorbents in any respect whatsoever without written prior consent of CytoSorbents.



 


		8.3	CytoSorbents shall have no right to enter into any contracts or commitments in the name of, or
on behalf of, Biocon, or to bind Biocon in any respect whatsoever without prior written consent of Biocon.



 


		8.4	Biocon shall not be entitled to issue or make any affirmations, representations, warranties or
guarantees with respect to the Products to any third party beyond those provided by CytoSorbents. CytoSorbents warrants the products
as defined in the “Instructions For Use” (IFU) and Product Warranty (Annex 4).



 


 



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		9.	Best Efforts



 


		9.1	Biocon shall purchase a sufficient amount of Products from CytoSorbents so as to meet or exceed
the minimum purchase requirements set forth below.



 


	Calendar Year	Minimum Purchase Requirements
	Upon Effective Date 	***
	Term Year 2	***
	Term Year 3	***


 


		9.2	For Term Year 1, the annual minimum order payment is due in full as set forth in Section 2.2. This
represents the Initial Stocking order. For each of Term Year 2 and Term Year 3, the annual minimum order for such years should
be divided into three equal orders per Term Year, unless the Biocon advances a part of the annual minimum order, with the consent
of CytoSorbents, which consent shall not be unreasonably withheld. Biocon shall place such orders at four-month intervals during
such Term Years commencing on the first day of each Term Year.



 


		9.3	In the first Term Year that the applicable minimum is not met, Biocon will have one additional
quarter (Q1 of the next Term Year) to meet minimum requirements of the previous Term Year. Failure to meet such minimum requirements
shall constitute a material breach of this Agreement for the purposes of Section 21 hereof.



 






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		9.4	At least ninety (90) day advance notice is required for any product volume above one hundred twenty
percent (120%) of the applicable annual minimum described in Section 9.1.



 


		9.5	If actual sales volumes exceed forecast value by one hundred fifty percent (150%) and if Biocon
is otherwise in full compliance with its obligations under this Agreement, then both parties agree to evaluate the market pilot
and if mutually agreed between the Parties a full scale commercial partnership agreement may be entered between the Parties.



 


 


		10.	Reporting



 


Biocon shall provide CytoSorbents
with written reports upon request, which shall include business trends and other reports requested by CytoSorbents on justifiable
grounds. Biocon shall provide quarterly and annual market forecasts in accordance with this Agreement and upon CytoSorbents' request.


 


		10.1	In particular, but not limited to, Biocon shall give its best efforts to provide the following
information:



 


		10.1.1	Technical information: Biocon shall forward promptly to CytoSorbents all technical questions
with respect to the Products which it may receive from the Territory and Applications and complaints related to technical or medical
issues that comply with regulatory requirements related to medical products in the Territories.



 


		10.1.2	Post Market Surveillance: Biocon shall appoint a qualified person for post market surveillance
(PMS). PMS includes the following:



 


		10.1.2.1	Product complaints: Complaints shall be recorded in the complaint form provided by CytoSorbents
(Annex 5). Biocon shall report to CytoSorbents in writing and without undue delay any potential serious device
related adverse events.



 






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		10.1.2.2	Marketing and sales data: Biocon shall complete and return the marketing and sales data
reporting form (Annex 6) within fourteen (14) days from the end of each calendar quarter upon request



 


		10.1.2.3	Traceability of batch numbers: In order to fulfill the GMP standard related to product recall,
Biocon shall ensure that all CytoSorbents Products sold by the Biocon can be tracked to the end user. The term "GMP"
means current good manufacturing practices, as defined as described by applicable laws and regulations in the United States and
the European Union, together with any guidance documents issued by the regulatory authorities in such jurisdictions.



 


		10.1.3	Customer data: Unless required by applicable law, Biocon is under no obligation whatsoever
to provide to CytoSorbents names of Purchasers or any other information which may allow CytoSorbents to identify Purchasers.



 


		10.2	Additional market research performance data is to be collected by Biocon and shared with CytoSorbents.
Market research shall include, but not limited to, quantitative measures such as sales volume, price point, time to sale, etc.
and qualitative measures such as physician survey, case study report for first 20 patients where data is available. This data to
be shared with CytoSorbents no later than end of the second term year.



 






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		11.	Product Returns



 


		11.1	Biocon shall examine Products promptly following delivery. Obvious defects to Products shall be
reported by Biocon to CytoSorbents in writing within sixty (60) days from delivery and hidden defects within sixty (60) days from
the date when the defect was discovered. If CytoSorbents agrees with Biocon’s determination regarding such defect, then CytoSorbents
shall replace such defective Product at no cost to Biocon; provided, however that replacement of Product for which Biocon has discovered
a defect after the applicable sixty (60) day period shall be at the sole discretion of CytoSorbents.



 


		11.2	In case CytoSorbents disagrees with the Biocon’s determination regarding such defects, the
Parties shall submit the samples retained from the applicable batch of the Product to a mutually agreed upon independent competent
laboratory or institution selected by the Parties, whose adjudication as to whether the Product has defect, or not, shall be final
and binding on the Parties. The expenses incurred for such third party determination shall be borne by the Party against whom the
findings are made. If the defect or poor quality of the Product is confirmed by the independent test all expenses borne by such
test shall be covered by CytoSorbents.



 


		11.3	Except in case of Product defects, regulatory recall or compliance action, CytoSorbents shall only
accept returns of product with more than ***, subject to the Product having a remaining *** of minimum of *** at the time of shipping,
in the event this Agreement is terminated by CytoSorbents.



 


		11.4	Regarding product recalls or defective product, CytoSorbents costs will be limited to either provide
a credit for the defective product or replace it directly. In the case of recalled product, CytoSorbents at its discretion may
request the product be shipped back to the US at its expense. Biocon at its expense will be responsible for recalling and recovering
product involved in a recall in the Territory.



 


 



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		12.	Field Assistance



 


		12.1	CytoSorbents shall provide, in its discretion, appropriate field technical assistance to Biocon
and Purchasers.



 


 


		13.	Trademarks, Service Marks and Trade Names; Promotion on Internet



 


		13.1	Right to Use. Biocon may use CytoSorbents' trademarks, trade names and service marks listed in
Annex 7 (hereinafter referred to as the "Trademarks") on a non-exclusive basis in the Territory only
for the Term of this Agreement and for the purpose of this Agreement. Biocon shall not at any time do or permit any act to be done
which may in any way impair the rights of CytoSorbents in the Trademarks. All goodwill arising from Biocon’s use of the Trademarks
shall inure to the benefit of CytoSorbents. CytoSorbents shall have the right to request examples or specimens of the use of the
Trademarks to confirm that they comply with CytoSorbents usage policies and guidelines. Biocon agrees that it shall revise any
use of the Trademarks as CytoSorbents may require in order to comply with CytoSorbents usage policies and guidelines. All Trademarks
remain owned by CytoSorbents and Biocon shall not take any action that may adversely affect CytoSorbents rights in the Trademarks.
Notwithstanding anything in this Agreement to the contrary, all intellectual property rights owned or controlled by Biocon prior
to the Effective Date remain the property of Biocon.



 


		13.2	Quality Control: In order to comply with CytoSorbents' quality control standards, Biocon shall:
(i) use the Trademarks in compliance with all relevant laws and regulations; (ii) accord CytoSorbents the right to inspect during
normal business hours, by giving the Biocon prior written notice, Biocon's facilities used in connection with efforts to sell the
Products in order to confirm that Biocon's use of such Trademarks is in compliance with this Section; and (iii) not modify any
of the Trademarks in any way and not use any of the Trademarks on or in connection with any goods or services other than the Products.



 






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		13.3	Biocon shall follow CytoSorbents’ instructions with respect to each of the following: (i)
use of any information about CytoSorbents or the Products available on the Internet; (ii) linking of any site on the Internet to
any site on the Internet established, operated or sponsored by CytoSorbents; and (iii) use of any of the Trademarks on any site
on the Internet. Biocon acknowledges that it shall cease the activities described in (i), (ii) and/or (iii) above within reasonable
time, if so instructed by CytoSorbents and immediately in case of termination. In no event shall Biocon establish, operate, sponsor
or contribute content to any site on the Internet which incorporates the CytoSorbents' domain name@ as its URL address
or any part of such address. Biocon shall discuss in advance with CytoSorbents the use of CytoSorbents' company name, product name
or any Trademark held by CytoSorbents’ in any promotional material.



 


 


		14.	Covenant Not To Compete



 


		14.1	During the Term of this Agreement and, to the extent permissible under applicable law, for six
(6) months thereafter, Biocon shall not market and or sell directly or indirectly assist third parties to market or sell products
that are competing the Product, for the Application with in the Territory . This provision shall not cover the products distributed
or sold by Biocon before signing this Agreement.



 


		14.2	CytoSorbents shall not appoint directly or indirectly by itself or through its affiliates any distributor
in the Territory to sell or offer for sale any competitive product during the term of this agreement and for six (6) months following
the termination of this Agreement.



 






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		14.3	Biocon agrees to review future product offerings from other suppliers for the treatment of conditions
mediated by the inflammatory response and used in extracorporeal therapy with CytoSorbents at least 3 months before introduction.
The Biocon agrees not sell new product offering related to extracorporeal treatment of inflammatory conditions without CytoSorbents’
prior written approval.



 


		14.4	Biocon shall disclose all partnerships, product offerings and potential competitive conflicts of
interest to CytoSorbents in writing prior to execution of an agreement for such partnerships and product offerings.



 


 


		15.	Representations and Warranties



 


		15.1	Mutual Representations and Warranties. Each Party hereby represents and warrants
that (a) this Agreement is a legal and valid obligation binding upon such Party and is enforceable in accordance with its terms,
except as enforceability may be limited by bankruptcy and by general equitable principles and public policy; (b) such Party is
duly organized and validly existing under the laws of the state of its incorporation and has full corporate power and authority
to enter into this Agreement and to carry out the provisions hereof; (c) such Party is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder, and the person executing this Agreement on its behalf has been duly authorized
to do so by all requisite corporate actions; (d) the execution, delivery and performance of this Agreement by such Party does not
conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it may be bound,
nor violate any applicable law.



 


		15.2	Representations, Warranties and Covenants Regarding Anti-Corruption/Anti-Bribery



 






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		15.2.1	Compliance with Anti-Corruption/Anti-Bribery Laws: Each Party represents, warrants and agrees
that it has been at all times and will continue to be in compliance with all potentially applicable anti-corruption/anti-bribery
laws, including but not limited to the U.S. Foreign Corrupt Practices Act of 1977, the U.K.’s Bribery Act 2010, and any anti-corruption/anti-bribery
laws in the Territory. Each Party represents, warrants and agrees that no bribes, payments, kickbacks, gifts, hospitality, donations,
loans, or anything of value have been or will be made or received, offered, promised, or authorized, directly or indirectly, to
improperly influence any act or decision of any person or entity, induce any person or entity to do or omit to do any act in violation
of any person’s or entities’ lawful duties, or secure any improper advantage.



 


		15.2.2	Compliance Program and Policies: Each Party agrees to have and enforce anti-corruption/anti-bribery
compliance policies and programs applicable to all employees and other persons acting on their respective behalf. In case of change
in the applicable anti-corruption/anti-bribery laws, the Parties agree to update each other and comply with the said changes in
the applicable laws.



 


		15.2.3	Documentary Support for Fees and Expenses: Biocon will maintain accurate and complete documentary
support for all fees and expenses it incurs related to CytoSorbents or this Agreement based on the Biocons internal accounting
practice.



 


		15.2.4	The Biocon shall provide all documentary support to enable CytoSorbents to respond to any regulatory
requirements and investigation under the applicable laws.



 


		15.2.5	Use of Sub-distributor, Affiliates, Agents and Other Third Parties: Biocon cannot bind CytoSorbents
to any third parties, and cannot engage sub-distributor, affiliates or agents to perform services related to this Agreement without
CytoSorbents’ prior written consent. If Biocon does engage, with CytoSorbents’ prior written consent, any sub-distributor,
affiliates or agents to perform services related to this Agreement, Biocon agrees to the following:



 






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		15.2.5.1	Biocon agrees to require the proposed sub-distributor, affiliate or agent to be bound by the same
obligations imposed on Biocon under this Section 15.2 and its subsections regarding compliance with anti-corruption/anti-bribery
laws, and



 


		15.2.5.2	Biocon hereby agrees to indemnify, defend and hold harmless CytoSorbents, its affiliates and all
officers, directors, employees and agents thereof from all liabilities, claims, damages, losses, costs, expenses, demands, suits
and actions (including without limitation attorneys' fees, expenses and settlement costs) arising from or in connection with the
acts or omissions of any sub-distributor, affiliate or agent. Notwithstanding anything to the contrary contained in any agreement
between Biocon and any sub-distributor, affiliate or agent, all rights of a sub-distributor, affiliate or agent related to this
Agreement shall terminate upon the expiration or termination of this Agreement.



 


		15.2.6	Form of Payments Under the Agreement: All payments contemplated by this Agreement will be
made by via electronic wire to the following account:



 


	Electronic Wire Instructions
	***










 






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		15.2.7	Suspected Violations: Biocon agrees to immediately notify CytoSorbents of any actual, suspected
or reported violation of any potentially applicable anti-corruption/anti-bribery law by Biocon or any employee or other person
acting on behalf of Biocon, or that relates in any way to this Agreement or CytoSorbents.



 


		15.2.8	Termination: Either Parties failure to strictly comply with this Section 15.2 and
its subsections will constitute a material breach of this Agreement.



 


		15.3	Additional Representations, Warranties and Covenants of Biocon. Biocon represents,
warrants and covenants to CytoSorbents that:



 


		15.3.1	Biocon shall comply with all applicable laws and regulations in performing its obligations under
this Agreement;



 


		15.3.2	Biocon shall not modify or alter any Product, including any packaging or labeling, that is received
by Biocon under this Agreement, except pursuant to CytoSorbents' express prior written authorization;



 


		15.3.3	Biocon shall obtain and at all times during the Term of this Agreement shall maintain, (a) all
licenses and permits necessary for Biocon to promote and sell Products in the Territory. As of the Effective Date of this Agreement
the Biocon has sufficient resources and personnel to perform Biocon's obligations under this Agreement in a professional and competent
manner.



 


 


		15.4	Product Warranty 



 


		15.4.1	CytoSorbents' warranties with respect to the Products are set out in Annex 4
hereto. EXCEPT AS SET FORTH IN Annex 4, CYTOSORBENTS DISCLAIMS ALL OTHER WARRANTIES RELATED TO THE PRODUCT, INCLUDING
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.



 






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		15.4.2	The warranties set forth in Annex 4 shall only apply to any Product which has
been used as per the written Instruction For Use provided by CytoSorbents on the Product. Notwithstanding any other provision in
this Agreement, CytoSorbents shall not be held responsible for any damage which may result from a defective product except for
the replacement of such product as set forth in Annex 4.



 


		15.4.3	In case of defective Products, CytoSorbents costs will be limited to either provide a credit for
the defective product or replace it directly. In the case of defective product, CytoSorbents will evaluate complaint samples and
determine if the product is defective and provide replacement, free of cost to the Biocon. CytoSorbents represents and warrants
that the Product delivered and supplied to the Biocon under this Agreement are supplied and sold free from any liens or encumbrances
or the like, and



 


		15.4.3.1	The manufacturing facility is approved by the applicable regulatory authorities and has the requisite
licenses and approvals to be operated for the manufacturing of pharmaceutical products and specifically the Product



 


		15.4.3.2	Products is CE Mark approved and manufactured under ISO 113485 certified facilities. Polymer beads
conform to ISO 10993 standards.



 


		15.4.4	CytoSorbents hereby further represents and warrants to the Biocon, without any obligation to inquire,
as of the Effective Date that CytoSorbents is not aware that the importing, distribution or sale of the Product in the Territory
as permitted under this Agreement would infringe issued patent rights of any third party.



 






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		15.4.5	The provisions of the foregoing warranties and the warranties contained elsewhere in this Agreement
are in lieu of any other warranty, whether express or implied, written or oral (including any warranty of merchantability or fitness
for particular purpose). Written warranties in effect at the time product(s) are purchased shall remain in effect until those materials
are used or expiration dating is surpassed.



 


		15.5	Disclaimer. EXCEPT AS SET FORTH IN THIS SECTION 15, THE PARTIES DISCLAIM ALL OTHER REPRESENTATIONS
AND WARRANTIES.



 


 


		16.	Limitations on Liability



 


		16.1	In no event shall either Party be liable to the other Party or any other person or entity for punitive,
exemplary, special, incidental or consequential damages (including, but not limited to, loss of profits, loss of data or loss of
use damages) arising out of the manufacture, sale or supplying of the Products, even that Party has been advised of the possibility
of such damages or losses.



 


		16.2	Section 16.1 shall not apply to damages caused by intent or gross negligence of CytoSorbents or
Biocon.



 


 


		17.	Indemnifications



 


		17.1	Indemnification of CytoSorbents



 


		17.1.1	Biocon hereby agrees to indemnify, defend and hold harmless CytoSorbents, its affiliates and all
officers, directors, employees and agents thereof from all liabilities, claims, damages, losses, costs, expenses, demands, suits
and actions made by a third party (including without limitation attorneys' fees, expenses and settlement costs) (collectively,
"Damages") arising from (i) any willful act or gross negligence of Biocon whether related to damage or injury to property
or to persons, (ii) any failure of Biocon to comply with applicable law, rules, and regulations, and (iii) Biocon’s breach
of this Agreement.



 






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		17.2	Indemnification of Biocon



 


		17.2.1	CytoSorbents hereby agrees to indemnify, defend and hold harmless Biocon, its affiliates and all
officers, directors, employees and agents thereof from all Damages arising out of:



 


(i) CytoSorbents'
failure to comply with relevant laws and regulations after receiving proper notice of same from Biocon as required herein; (ii)
Biocon's importing, storing or reselling of the Products in the Territory infringing on the intellectual property rights of third
parties or constituting a misappropriation of any third party's trade secrets, provided that Biocon notifies CytoSorbents in writing
immediately after becoming aware of any potential infringement or misappropriation claims, permits CytoSorbents to control the
defense and settlement of such claims and cooperates with CytoSorbents in the defense of such claims, at CytoSorbents sole cost;
(iii) CytoSorbents’ breach of this Agreement, (iv) any actual or alleged injury to person or property or death resulting
from the possession, use by any person of any Product or sample supplied by CytoSorbents under this Agreement to the Biocon that
is caused by improper manufacturing, packaging or wrong labeling of the Product by CytoSorbents, whether such claims are based
on negligence, warranty, strict liability, failure to warn or any other theory (v) CytoSorbents' grossly negligent act or omission;
(vi)  failure of CytoSorbents to comply with applicable laws, rules, regulations, ordinances, permits or licenses, including
the cGMPs and (vii) a regulatory enforcement action, inspection of the Product or recall of the Product, to the extent resulting
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		17.2.2	The limitations on and exclusions of warranty or liability set forth in Section 16 above shall
not apply to claims against Biocon from third parties that arise from fraudulent conduct, willful misconduct, or gross negligence.



 


		17.3	In the event that any Product imported, promoted, distributed or sold in the Territory in compliance
with this Agreement is held in a suit or proceeding to infringe any intellectual property rights of a third party and the use or
reselling of such Product in the Territory under this agreement is enjoined, or CytoSorbents reasonably believes that it is likely
to be found to infringe or likely to be enjoined, then CytoSorbents shall, at its sole cost and expense without limiting CytoSorbents
obligations under 17.2.1, either (1) procure for Biocon the right to continue reselling such Product; or (2) modify such Product
so that it becomes non-infringing. If neither (1) nor (2) is practicable, then without prejudice to any other rights or remedies
that the Biocon may have under law or contract or tort, CytoSorbents may, in its sole discretion, remove such Product from this
Agreement upon repurchasing Biocon's inventory of such Product which are in the original packages. If CytoSorbents notifies Biocon
that any such Product(s) shall be removed from this Agreement, then Biocon shall (a) cease all importation, promotion and sales
of such Product(s) immediately upon receipt of such notice, and (b) require that all of Biocon's affiliates, sub-distributors or
agents; (i) immediately cease importation, promotion and sales of such Product(s) and (ii) return to Biocon all inventory of such
Product(s) as promptly as possible but in no event later than thirty (30) days after Biocon receives CytoSorbent's notice. Any
such repurchase of Biocon's inventory of Products shall be at the price paid to CytoSorbents' at the time of the purchase by the
Biocon and the applicable duties and levies paid by the Biocon for importing the Product. Such repurchased inventory shall be shipped
by Biocon freight prepaid, according to CytoSorbents' instructions. CytoSorbents shall pay Biocon for such repurchased Products
within thirty (30) days after CytoSorbents receives those Products in one of its facilities. If all Products are removed from this
Agreement under this Section 17.3, then CytoSorbents may terminate the Agreement immediately upon written notice to Biocon.



 


 



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		17.3.1	CytoSorbents shall have no obligation for any claim of infringement arising from: (1) any combination
of Products with products not supplied or approved in writing by CytoSorbents, where such infringement would not have occurred
but for such combination; (2) the adaptation or modification of Products, where such infringement would not have occurred but for
such adaptation or modification; or (3) the use of a Product in an application for which it was not designed or intended, where
such infringement would not have occurred but for such use.



 


 


		18.	Force Majeure



 


		18.1	Neither CytoSorbents nor Biocon shall be liable in damages, or shall be subject to termination
of this Agreement by the other party, for any delay or default in performing any obligation hereunder if that delay or default
is due to any cause beyond the reasonable control and without fault or negligence of that party; provided that, in order to excuse
its delay or default hereunder, a party shall notify the other of the occurrence or the cause, specifying the nature and particulars
thereof and the expected duration thereof; and provided, further, that within fifteen (15) days after the termination of such occurrence
or cause, such party shall give notice to the other party specifying the date of termination thereof. All obligations of both parties
shall return to being in full force and effect upon the termination of such occurrence or cause (including without limitation any
payments which became due and payable hereunder prior to the termination of such occurrence or cause). If a Force Majeure continues
for more than 6 months either party may terminate this Agreement.



 






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		18.2	For the purposes of this Section 18, "force majeure" or a "cause beyond the reasonable
control" of a party shall include, without limiting the generality of the phrase, any act of God, act of any government or
other authority or statutory undertaking, industrial dispute, fire, explosion, accident, power failure, flood, riot, act of terrorism,
or war (declared or undeclared).



 


 


		19.	Confidentiality



 


		19.1	The Party receiving Proprietary Information (as defined below) agrees and acknowledges that the
disclosing Party has a proprietary interest in any information provided to the receiving Party, whether in connection with this
Agreement or otherwise, whether in written, oral or visual form, which is (i) a trade secret, confidential or proprietary information,
(ii) not publicly known, and (iii) annotated by a legend, stamp or other written identification as confidential or proprietary
information, or if disclosed orally or visually, is followed by a written statement within thirty (30) days after its disclosure
that it is confidential or proprietary (hereinafter referred to as "Proprietary Information"). The receiving Party shall
disclose the Proprietary Information only to those of its agents and employees to whom it is necessary in order properly to carry
out their duties as limited by the terms and conditions hereof. Both during and after the Term of this Agreement, all disclosures
by the receiving Party to its agents and employees shall be held in strict confidence by such agents and employees. During the
Term and for a period of ten (10) years after the expiration or termination of this Agreement, the receiving Party, its agents
and employees shall not use the Proprietary Information for any purpose other than in connection with the sale and distribution
of the Products in the Territory pursuant to this Agreement. The receiving Party shall, at its expense, return to the disclosing
Party the Proprietary Information as soon as practicable after the termination or expiration of this Agreement. All such Proprietary
Information shall remain the exclusive property of the disclosing Party during the Term of this Agreement and thereafter. This
Section 19 shall also apply to any consultants or subcontractors that the receiving Party may engage in connection with its obligations
under this Agreement. The terms of this Agreement shall be considered Proprietary Information.



 






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		19.2	Notwithstanding anything contained in this Agreement to the contrary, the receiving Party shall
not be liable for a disclosure of the Proprietary Information, if the information so disclosed: (i) was in the public domain at
the time of disclosure without breach of this Agreement; or (ii) was known to or contained in the records of the receiving Party
from a source other than the disclosing Party at the time of disclosure by the disclosing Party to the receiving Party and can
be so demonstrated; or (iii) was independently developed and is so demonstrated promptly upon receipt of the documentation and
technology by the receiving Party; or (iv) becomes known to the receiving Party from a source other than the disclosing Party without
breach of this Agreement by the receiving Party and can be so demonstrated; or (v) must be disclosed pursuant to a contract or
subcontract with a governmental agency in order to obtain/retain a procurement contract; or (vi) was disclosed pursuant to court
order or as otherwise compelled by law.



 


		19.3	The receiving party agrees that any threatened or actual breach of the terms of Section 19 of this
Agreement by the receiving party may cause irreparable loss to the disclosing party and the said loss may not be compensated by
monetary compensation and, in addition to all other rights and remedies that the disclosing party may have under law and equity,
the disclosing party will have the right to seek appropriate injunctive relief and/or specific performance of the receiving party’s
obligations from Courts of competent jurisdiction.



 


 



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		20.	Publicity



 


			Biocon agrees that any publicity or advertising which shall be released by it in which CytoSorbents
is identified in connection with the Products shall be in accordance with the terms of this Agreement and with any information
or data which CytoSorbents has furnished in connection with this Agreement. Copies of all such publicity and advertising shall
be forwarded promptly to CytoSorbents.



 


 


		21.	Term and Termination



 


		21.1	The term of this Agreement shall begin on the Effective Date and shall continue until the date
that is 36 months from the first day of the first Term Year ("Initial Term") or such longer period as may be mutually
agreed in writing by both parties (the "Term"), unless terminated earlier by either Party pursuant to the terms of this
Section.



 


		21.2	Either Party may terminate this Agreement upon the occurrence of a material breach or default as
to any obligation hereunder by the other party and the failure of the breaching party to (within thirty (30) days after receiving
written notice thereof from the non-breaching party) cure such material breach or default, such termination being immediately effective
upon the delivery of such notice of termination.



 


		21.3	After the first twelve months of this Agreement, either Party may terminate this Agreement for
convenience upon sixty (60) days’ written notice.



 


		21.4	Upon the filing of a petition in bankruptcy, insolvency or reorganization against or by either
party, or either party becoming subject to a composition for creditors, whether by law or agreement, or either party going into
receivership or otherwise becoming insolvent (such party hereinafter referred to as the "insolvent party"), this Agreement
may be terminated by the other party by giving written notice of termination to the insolvent party, such termination immediately
effective upon the giving of such notice of termination.



 






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		21.5	Upon the occurrence of a change in control or management or operating personnel of either party
(the "changed party"), which has, or in the reasonable opinion of the other party could have, a material adverse effect
on the business, prospects or operations, this Agreement may be terminated by the other party by giving written notice of termination
to the changed party, such termination being immediately effective upon the giving of such notice of termination.



 


		21.6	In the event that Either Party is suspected of violating any potentially applicable laws, including
but not limited to the U.S. Foreign Corrupt Practices Act of 1977, the U.K.’s Bribery Act 2010, or any other potentially
applicable anti-corruption/anti-bribery law, or otherwise fails to strictly comply with Section 15.3 and its subsections, the other
party may terminate this Agreement immediately upon written notice and without any further obligations.



 


		21.7	In the event of a termination pursuant to any of subsections 21.3 (if terminated by CytoSorbents)
through 21.6 or upon expiration of this Agreement, CytoSorbents shall not have any obligation to Biocon, or to any employee of
Biocon, for compensation or for damages of any kind, whether on account of the loss by Biocon or such employee of present or prospective
sales, investments, compensation or goodwill. Termination of this Agreement shall not affect the obligation of Biocon to pay CytoSorbents
all amounts owing or to become owing as a result of Products tendered or delivered to Biocon on or before the date of such termination,
as well as interest thereon to the extent any such amounts are paid after the date they became or will become due pursuant to this
Agreement.



 


 



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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    




 


		22.	Selling Off of Inventory: Repurchase of Inventory



 


			Upon termination or expiration of this Agreement(other than termination covered by section 21.6),
Biocon shall have the right to market and sell off its remaining inventory of Products for a period of six (6) months after expiration
or sooner termination of this Agreement ("Sell-Off-Period"); provided, however, that Biocon shall comply with all terms
and conditions of this Agreement. Within thirty (30) days after the said period of 6 (six) months, CytoSorbents shall have the
option, at its sole discretion, to either (a) repurchase the remaining stock of the Product from the Biocon at the applicable Repurchase
Price (defined below), or b) extend the Sell Off Period by a period mutually agreed in writing by the parties but not to exceed
three (3) additional months. Under no circumstances is CytoSorbents obligated to extend the Sell-Off Period to more than nine (9)
months in total. Nothing in this Agreement shall obligate CytoSorbents to repurchase any inventory of Products in Biocon's possession
or control at the end of the Sell-Off Period. CytoSorbents shall neither directly nor indirectly market or sell the Products in
the Territory during the Sell-Off-Period without Biocon's consent. For purposes of repurchasing Product under this Section 22,
the price shall be as follows (the "Repurchase Price"):



 


(a) the transfer
price paid by Biocon to CytoSorbents including applicable taxes, duties, levies and shipping costs in case of (i) termination
by CytoSorbents other than for breach of this Agreement by Biocon, or (ii) termination by Biocon for breach of this Agreement by
CytoSorbents; or


 


(b) the transfer
price paid by Biocon to CytoSorbents excluding applicable taxes, duties, levies and shipping costs in case of (i) expiration,
(ii) termination by Biocon other than for breach of this Agreement by CytoSorbents, or (iii) termination by CytoSorbents for breach
of this Agreement by Biocon.


 


 



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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    




 


		23.	Notices



 


		23.1	All notices given under this Agreement shall be in writing and shall be addressed to the parties
at their respective addresses set forth below:



 


		23.1.1	If to Biocon:



 


	BIOCON
	
        Contact person: Shukrit Chimote

        Title: Vice President, Branded Formulations

        Address:
        Biocon House, Semicon Park, Electronic City, Phase II, Bangalore-560100, India

         

        Copy to : Head, Legal

        Address:  20th KM, Hosur Road

                          Electronics City, Bangalore-
        560 100, India

         

        Phone: 91 80 6775 6775, extn: 1101

        Fax: 91 80 6775 7028

        URL: www.biocon.com

        Email: shukrit.chimote@biocon.com



 

		23.1.2	If to CytoSorbents:



 


	
        Contact person: Chris Cramer

        Title: Vice President, Business Development

         

        Address: 7 Deer Park Drive, Suite K

                          Monmouth Junction,
        NJ 08852

         

        Phone: 732-329-8885, ext: *835

        Fax: 732-329-8650

        URL: www.cytosorbents.com

        Email: ccramer@cytosorbents.com

        Skype: chris.m.cramer

         

        Copy to : CEO CytoSorbents, Phil Chan

        ext: *823

        URL: www.cytosorbents.com

        Email: pchan@cytosorbents.com

         

	 


 






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		23.2	Either party may change its address or its contact information for purposes of this Agreement by
giving the other party written notice or by email its new address or contact information. Any such notice if given or made by registered
or recorded delivery international air mail letter shall be deemed to have been received on the earlier of the date actually received
and the date fifteen (15) days after the same was posted (and in proving such it shall be sufficient to prove that the envelope
containing the same was properly addressed and posted as aforesaid) and if given or made by telecopy transmission shall be deemed
to have been received at the time of dispatch, unless such date of deemed receipt is not a business day, in which case the date
of deemed receipt shall be the next such succeeding business day.



 


 


		24.	Modification



 


			No modification or change may be made in this Agreement, including any modification or change to
this Section 4, except by written instrument duly signed by Biocon and by a duly authorized representative of CytoSorbents.



 


 


		25.	Assignment



 


			This Agreement and the rights and obligations hereunder may not be assigned, delegated or transferred
by either party without the prior written consent of the other party. This Agreement shall inure to the benefit of the permitted
successors and assigns of CytoSorbents. The Biocon may assign a part of whole of its obligations under this Agreement to its affiliate
on the prior written consent of CytoSorbents, which consent of which shall not be unreasonably withheld.



 


 






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		26.	Waiver



 


		26.1	None of the conditions or provisions of this Agreement shall be held to have been waived by any
act or knowledge on the part of either party, except by an instrument in writing signed by a duly authorized officer or representative
of such party.



 


		26.2	Further, the waiver by either party of any right hereunder or the failure to enforce at any time
any of the provisions of this Agreement, or any rights with respect thereto, shall not be deemed to be a waiver of any other rights
hereunder or any breach or failure of performance of the other party.



 


 


		27.	Validity



 


CytoSorbents
and Biocon covenant and warrant that they will each advise the other of any changes in their respective laws of which they become
aware if such changes might or will impair the validity of all or any part of this Agreement.


 


 


		28.	Governing Law



 


			This Agreement and all rights and obligations there under shall be exclusively governed and exclusively
construed in accordance with the laws of the United Kingdom, without regard to the choice of law under explicit exclusion of the
United Nations Convention on Contracts for the International Sale of Goods (CISG).



 


 



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		29.	Dispute Resolution



 


The
Parties agree that they shall in good faith work towards implementation of this Agreement and any dispute arising out of or in
relation to this Agreement shall be first attempted to be resolved amicably by mutual negotiations. Failing which such dispute
shall be finally settled exclusively under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators
appointed in accordance with said Rules. The place of arbitration shall be London. The language of arbitration shall be English.
The arbitral award shall be final, conclusive and binding on the Parties and shall be enforceable in any court of competent jurisdiction.


 


 


		30.	Entire Agreement



 


			This Agreement supersedes and cancels any previous agreements or understandings, whether oral,
written or implied, heretofore in effect and sets forth the entire agreement between CytoSorbents and Biocon with respect to the
subject matter hereof. All agreements related to confidentiality and or non-disclosure shall remain in force.



 


 


		31.	No Rights by Implication



 


			No rights or licenses with respect to the Products or the Trademarks are granted or deemed granted
hereunder or in connection herewith, other than those rights expressly granted in this Agreement.



 


 



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		32.	Compliance With Laws



 


			Each of Biocon and CytoSorbents covenants that all of its activities under or pursuant to this
Agreement shall comply with all applicable laws, rules and regulations.



 


		33.	Insurance



 


CytoSorbents
will maintain, for the Term of this Agreement, insurance in an amount adequate to the Product liability, and upon written request
of the Biocon will provide a memorandum of insurance showing that such insurance is in place.


 


 


		34.	Severability



 


			If any provision of this Agreement is declared invalid or unenforceable by a court having competent
jurisdiction, it is mutually agreed that this Agreement shall endure except for the part declared invalid or unenforceable by order
of such court. The parties shall consult and use their best efforts to agree upon a valid and enforceable provision which shall
be a reasonable substitute for such invalid or unenforceable provision in light of the intent of this Agreement.



 


 


		35.	Counterparts



 


This
Agreement and any amendments or supplement hereto or thereto, may be executed in any number of counterparts and any party may execute
any such counterpart, each of which when executed and delivered shall be deemed to be an original. The execution of any such amendment
or supplement by any party will not become effective until counterparts have been executed by all the parties hereto or thereto.


 


(Signature
Page to Follow)




 


 



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IN WITNESS WHEREOF, the parties
hereto have signed this Agreement.


 


 


 


CytoSorbents, Inc.


 


By: /s/ Phillip Chan                 


 


 


 


Name: Phillip Chan, MD, PhD


 


Title: CEO


 


 


 


Biocon Limited


 


 


 


		1)	By: /s/ Rakesh Bamzai                     



 


Name: Rakesh Bamzai


 


Title: Authorized Signatory


  


 


 


		2)	By: /s/ Murali Krishnan
K.N.                   



 





Name: Murali Krishnan K. N.


 


Title: Authorized Signatory


 


 


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


Annex 1


 


Product


 


List of Products


 


		1.	CytoSorb 300 ml Device case of 12 – Part #30-011-03



 


		2.	Pole Clamp, each – Part #08-09-71



 


		3.	Female/Female Connector set, 6 pack – Part #30-0031-00



 


 


 


Storage Conditions


 


CytoSorb 300ml: 5 ̊C to 40 ̊C


 


 


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

Annex 2


 


Territory and Applications


  


		A.	Territory



 


		1.	India (only as to the following cities):



 


		o	DELHI



 


		o	JAIPUR



 


		o	CHANDIGARH



 


		o	AMRITSAR



 


		o	ROHTAK



 


		o	KOLKOTTA



 


		o	PUNE



 


		o	MUMBAI



 


		o	INDORE



 


		o	NAGPUR



 


		o	CHENNAI



 


		o	BANGALORE



 


		o	HYDERABAD



 


		2.	Sri Lanka



 


 


 


		B.	Application



 


		1.	Applications Included:



 


		o	Critical Care including Sepsis



 


 


 


		2.	Applications Not Included: 



 


		o	Cardiac Surgery, including Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO),
Graft vs. Host Disease, Allogeneic Bone Marrow Transplant, Organ Transplant, and Hemorrhagic Fever.



 




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Annex 3


 


Product Prices


 


	Product	Price (in USD)
	
        CytoSorb 300ml,

         

        (12 units per case)

         
	
        ***

         

        ***

         

	Pole Clamp	***
	Female/Female Connector	***


 


 


 


 


 


 


 


 


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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION



    

 


Annex 4


 


CytoSorbents Warranties and Instructions
for Use


 


 


 


		1.	Instructions For Use (Separately Attached)



 


 


 


		2.	Warranty (Separately Attached)



 


 


 


 


 


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Annex 5


 


Products Complaints Reporting Form


 


(CytoSorbents SOP - 02-028-02)


 


 


 


(Separately Attached)


 


 


 


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Annex 6


 


Marketing and Sales Data Reporting
Form


 


 


 


(Separately Attached)


 


 


 


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Annex 7


 


List of Trademarks


 


 


 


 


 


CytoSorb


 


HemoDefend


 


 


 


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Annex 8


 


List of Documents


 


 


 


(Separately Attached)


 


 


 


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