Document:

vrca-ex1019_161.htm

Exhibit 10.19

SECOND AMENDMENT TO SERVICES AGREEMENT

THIS SECOND AMENDMENT TO SERVICES AGREEMENT (the “Second Amendment”), effective as of January 1, 2019 (the “Effective Date”), is between Verrica Pharmaceuticals Inc., a Delaware Corporation (the “Company”) and PBM Capital Group, LLC, a Delaware limited liability company (“PBM”). Company and PBM are collectively the “Parties”.

RECITALS

WHEREAS, the Parties entered into a Services Agreement effective August 14, 2016 (the “Services Agreement”) where, in pertinent part, the Company retained PBM to provide certain accounting, back office support, and other services (the “Services”) to the Company;

WHEREAS, the Parties subsequently executed an Amendment to Services Agreement on March 29, 2018 (the “First Amendment”) to adjust the fee set forth in the Services Agreement to reflect the Company’s then current utilization of the Services under the Services Agreement; and

WHEREAS, the Company has reduced and/or eliminated its need for certain Services since the execution of the First Amendment and, accordingly, the Parties now desire to adjust the fee set forth in the Services Agreement to reflect the Company’s current utilization of such Services, as set forth below.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing, the mutual promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree to amend the Services Agreement as follows:

1.Incorporation of Recitals by Reference.  The above Recitals are hereby incorporated into this Second Amendment.

2.Effective Date.  The Parties agree that the changes agreed upon in this Second Amendment shall be effective in all respects as of the above-referenced Effective Date.

3.Amendment of Fee.  The Parties agree that, upon the Effective Date, Section 4 of the Services Agreement shall be amended to remove “$50,000 per month” in such Section and replace it with “$26,333 per month (the “Fee”).”

4.Amendment of Termination Provisions.  The Parties agree that, upon the Effective Date, Section 5(c) of the Services Agreement shall be amended to:

a.Remove both the functional area and fee adjustment line item in its entirety for (i) Accounting Management and (ii) Accounting Staff; and 

 

 

b.Revise the fee adjustment in the functional area of Contract Administration and Legal Support by removing the “11,500.00” number in such line item in such Section and replacing it with “$1,500.00.”    

5.Effect of Amendment.  Except as otherwise provided herein, all other provisions of the Services Agreement are hereby ratified and confirmed and all the terms, conditions, and provisions thereof remain in full force and effect.

IN WITNESS WHEREOF, the Company and PBM have caused this Second Amendment to Services Agreement to be duly executed as of the Effective Date first above written.

 

					
	
 
	
 
	
COMPANY:

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Verrica Pharmaceuticals Inc.

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
By:
	
 
	
/s/ Ted White

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Ted White, CEO

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
PBM:

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
PBM Capital Group, LLC

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
By:
	
 
	
/s/ Paul Manning

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Paul B. Manning, CEO

 

2Exhibit 10.23

 

CytoSorbents Exclusive Distribution Agreement EU

 

Confidential treatment has been requested with respect to portions
of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Distribution
Agreement

 

between

 

CytoSorbents Europe GmbH, a corporation
having its offices at Bölschestraße 116, 12587 Berlin, Germany, existing under the laws of Germany

 

(hereinafter referred to as "
the Company")

 

and

 

AFERETICA s.r.l., a corporation having
its offices at Via Spartaco 10, 40138 Bologna, Italy, existing under the laws of Italy, Europe.

 

(hereinafter referred to as "Distributor").

 

The Company and Distributor hereinafter
collectively referred to as "Parties"

 

     

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

Table
of Contents

 

	Preamble	4
	 	 
	1.	Appointment, Products and Territory	4
	 	 	 
	2.	Order Process, Prices and Payment	6
	 	 	 
	3.	Stock	8
	 	 	 
	4.	Packaging and Labelling	9
	 	 	 
	5.	Product Registration	9
	 	 	 
	6.	Other Obligations of Distributor	9
	 	 	 
	7.	The Company's Obligations	9
	 	 	 
	8.	Relationship of the Parties	10
	 	 	 
	9.	Best Efforts	11
	 	 	 
	10.	Reporting	12
	 	 	 
	11.	Field Assistance	13
	 	 	 
	12.	Trademarks, Service Marks and Trade Names; Promotion on Internet	13
	 	 	 
	13.	Covenant Not To Compete	14
	 	 	 
	14.	Product Warranty	14
	 	 	 
	15.	Limitations on Liability	15
	 	 	 
	16.	Indemnification	16
	 	 	 
	17.	Force Majeure	17

 

    	 	 	Page 2 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

	18.	Confidentiality	18
	 	 	 
	19.	Publicity	19
	 	 	 
	20.	Term and Termination	19
	 	 	 
	21.	Selling Off of Inventory	21
	 	 	 
	22.	Notices	21
	 	 	 
	23.	Modification	22
	 	 	 
	24.	Assignment	23
	 	 	 
	25.	Waiver	23
	 	 	 
	26.	Validity	23
	 	 	 
	27.	Governing Law	23
	 	 	 
	28.	Jurisdiction	24
	 	 	 
	29.	Entire Agreement	24
	 	 	 
	30.	No Rights by Implication	24
	 	 	 
	31.	Compliance With Laws	24
	 	 	 
	32.	Severability	24

  

    	 	 	Page 3 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

Preamble

 

WHEREAS, CytoSorbents
Europe GmbH, (“the Company”) a 100% subsidiary of CytoSorbents Corp., USA (an American corporation) which manufactures
 “CytoSorb cytokine adsorbers” introducing its CytoSorb therapy to intensive care markets and coordinates commercialization
and market development,

 

WHEREAS, Aferetica
s.r.l. (“Distributor”) is a Bologna, Italy, based trading company and distributor, specialized in marketing of highly
sophisticated medical products and devices, especially extracorporeal therapies to the critical care, cardiac surgery and liver
disease markets,

 

WHEREAS, the
Company desires to appoint Distributor as its exclusive distributor of the Product in

 

		·	Italy

 

		·	San Marino and

 

		·	the Vatican

 

(the “Territory”)
and Distributor desires to import, promote, distribute and sell the Product in the Territory,

 

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 and Territory

 

		1.1	The Company hereby appoints Distributor on an exclusive basis as its distributor for the sale of
the products listed in Annex 1 (hereinafter the "Products") during the term of this Agreement.

 

    	 	 	Page 4 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

 

		1.2	Fields of application and medical speciality covered by Distributor (hereinafter the "Application
Fields") include all CRRT, dialysis and hemoperfusion machine run treatments in:

 

		·	Intensive Care Medicine and Emergency Medicine (including burn, trauma
and medical units)

 

		·	Post-surgical care in general

 

		·	Post-cardio/thoracic -surgical care

 

		·	Nephrology

 

		·	Gastroenterology

 

		·	Toxicology

 

		1.3	Fields of application and medical speciality covered by Distributor do not include:

 

		·	Intraoperative treatments run in a cardio-pulmonary bypass (on heart-lung-
machines)

 

		1.4	Distributor shall not, without the prior written consent of the Company sell, market or distribute
any version of any of the Products other than the version the Company shall designate from time to time as its most current version.

 

		1.5	Distributor shall use all commercially reasonable efforts to promote and sell the Products to the
maximum number of customers in the Territory and Application Fields.

 

		1.6	The Company is appointing Distributor hereunder with respect to the resale of Products to any purchasers
whose principal place of business is located in the Territory and Application Fields.

 

		1.7	Distributor shall not engage in any advertising or promotional activities relating to the Products
directed primarily to customers outside the Territory and Application Fields without prior written consent of the Company. Distributor
shall provide to the Company any and all statements (for advertising or other purpose) related to therapeutic or other claims it
may make related to Products for written approval by the Company prior to use.

 

    	 	 	Page 5 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

 

		1.8	Distributor shall not actively solicit orders from any prospective purchaser outside the Territory
and Application Fields.

 

		1.9	If Distributor receives any order from a prospective purchaser outside the Territory or Application
Fields, Distributor shall immediately refer that order to the Company. Distributor shall not accept any such orders. Distributor
may not deliver or tender (or cause to be delivered or tendered) any Product outside of the Territory and Application Fields.

 

		1.10	Distributor shall refrain from establishing or maintaining any branch, warehouse or distribution
facility for the Products outside of the Territory.

 

		1.11	The Company reserves
the right, in at any time upon [***] ([***])
days' prior written notice to Distributor, and with the agreement of Distributor to expand or reduce in any manner the Products
which are covered by this Agreement. The Company also reserves the right, in its sole discretion, at any time upon [***]
([***])
days' prior written notice to Distributor, to expand or reduce in any manner the Territory and the Application Fields, as defined
in this Agreement.

 

		2.	Order Process, Prices and Payment

 

		2.1	On the Effective Date,
Distributor shall provide to the Company a forecast for the next [***] of
Distributor's anticipated requirements of the Products and indicating the desired delivery dates. Distributor shall update this
forecast on a rolling basis within [***] ([***])
business days after the beginning of each new calendar quarter.

 

		2.2	Distributor shall thereafter
[***] place firm orders with the Company at least
[***] ([***])
days before the requested delivery dates.

 

		2.3	Unless the Company has an important reason to refuse an order from Distributor, the Company shall
accept orders from Distributor which are in compliance with the provisions of this Agreement, in particular, but not limited to,
with the forecast pursuant to Section 10.

    	 	 	Page 6 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		2.4	The purchase prices for the Products shall be as set forth in Annex 2 as amended from time
to time.

 

		2.5	If a purchase order is
accepted in accordance with clause 2.3 above, the prices for Products covered by such purchase order shall be the Company's net
distributor prices [***] or at the designated
Company logistic facility in Europe, which are in effect on the date of the Company's acceptance. The Company may from time to
time change those prices, such change being effective immediately upon Distributor's receipt of notice thereof; provided, however,
that no price change shall affect purchase orders offered by Distributor and accepted by the Company prior to the date such price
change becomes effective.

 

		2.6	In case of purchase orders
with an order amount of less than [***] EUR, the
Company shall be entitled to charge an additional handling fee of [***] EUR
per purchase order. The forgoing does not apply to purchase orders related to spare parts for the Products.

 

		2.7	Distributor shall be
free to establish its own pricing for Products sold to its customers. Net end customer ASP (Average Selling Price) should not be
below [***] EUR.

 

		2.8	The ultimate shipment of orders to Distributor shall be subject to the right and ability of the
Company 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.

 

		2.9	Payment by Distributor
shall be made within [***] days of shipment of
the ordered Products or within [***] days to be
entitled for [***], unless the Company agrees
in writing to other terms.

 

		2.10	All payments should be made in EUROs against stated payment terms.

 

		2.11	If the Distributor fails to pay the price for any Products on the due date the Company shall be
entitled (without prejudice to any other right or remedy it may have) to:

 

    	 	 	Page 7 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		2.11.1	Cancel or suspend any further delivery to the Distributor under any order;

 

		2.11.2	Sell or otherwise dispose of any Products which are the subject of any order by the Distributor,
whether or not appropriated thereto, and apply the proceeds of sale to any overdue payment; and

 

		2.11.3	Take such other action as may be necessary to ensure the continuing supply of Products to customers
in the Territory.

 

		2.11.4	Should payment not be
received within [***] days of the agreed payment
date, then this non-payment will be classified as an breach of the Agreement by the Distributor.

		3.	Stock

 

		3.1	Distributor shall always
keep a sufficient stock of the Products in order to be able fulfill purchase orders from customer within 2 business days from receipt
of such purchase orders. Sufficient stock is defined as [***] boxes
of 12 adsorbers or [***]% of the annual projected
sales (see section 9). Unexpected mass orders are not subject to this provision.

 

		3.2	Distributor shall always
store the Products consistent with product labelling and in accordance with the highest healthcare industry practices and product
labelling in order to prevent deterioration of the Products. Upon request of the Company, Distributor shall destroy, return to
the Company or make such other disposition as the Company shall direct of any portion of the Products determined by the Company
to be out-dated or otherwise to require such disposition. In the event of such return or destruction, the Company shall either
replace the Products or reimburse Distributor in an amount equal to the price paid by Distributor to the Company for the Products.
The Company shall have no liability for material that has less than [***] shelf
life as the result of Distributor`s inventory management practices.

 

    	 	 	Page 8 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		4.	Packaging and Labelling

 

Distributor shall not package
or label the Products and shall not alter any Products or any package or label used in connection with any Products, except as
specifically authorized in writing by the Company. Distributor shall always comply in all respects with the packaging and labelling
instructions of the Company. If the labelling and or packaging do not comply with in-country requirements, Distributor shall promptly
inform the Company. Distributor and the Company shall work together to find a solution to correct any discrepancies in labelling
or packaging as required by National law and implement a solution as jointly agreed upon.

 

		5.	Product Registration

 

		5.1	Distributor shall, if necessary, register the Products with the appropriate governmental agency
but shall not, without written permission from the Company undertake any such Product registration in its own name, provided that
aforesaid comply with the technical and legal requirements in-country. The Company shall assist in obtaining such registrations
and give Distributor power of attorney for purposes of registration.

 

		5.2	Upon expiration of this Agreement Distributor shall transfer any and all registrations, import
licenses, permits or certificates for the Products to the Company.

 

		6.	Other Obligations of Distributor

 

		6.1	Distributor shall translate, if necessary, at its own expense, all user and technical manuals and
advertising and marketing information into the languages of its customers and provide the Company with advance copies of all such
materials for approval by the Company. Distributor shall assign all copyrights in such translations to the Company. Distributor
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.	The Company's Obligations

 

		7.1	The Company shall provide
Distributor, without charge, with such marketing and technical assistance and Product samples, as the Company may in its discretion
consider necessary to assist with the promotion of the Products. The Company will provide to Distributor on a one-time basis
[***] cases [***] devices
free of charge for marketing purposes.

 

    	 	 	Page 9 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		7.2	The Company shall provide initial training to Distributor's personnel in connection with the marketing,
sale, installation and support of the Products. The Company will not charge Distributor for such training. The Company and Distributor
shall jointly agree on the details of the training.

 

		7.3	The Company shall designate
support personnel to assist Distributor's support personnel in providing support services; provided, however, that the Company's
personnel shall spend no more than an aggregate of [***] hours
per calendar month of their time in providing such assistance, and shall not be required to provide such support in the Territory.

 

		8.	Relationship of the Parties

 

		8.1	Distributor shall be considered to be an independent contractor. The relationship between the Company
and Distributor shall not be construed to be that of employer and employee or to constitute a partnership, joint venture or agency
of any kind.

 

		8.2	Distributor shall not enter into any contracts or commitments in the name of, or on behalf of,
the Company, and shall have no authority to bind the Company in any respect whatsoever. The Company shall have no right to enter
into any contracts or commitments in the name of, or on behalf of, Distributor, or to bind Distributor in any respect whatsoever.

 

		8.3	In
addition, Distributor shall not obligate or purport to obligate the Company by issuing or making any affirmations, representations,
warranties or guaranties with respect to the Products to any third party. Distributor shall not be entitled to issue or make any
affirmations, representations, warranties or guarantees with respect to the Products to any third beyond those provided by the
Company.

 

		8.4	The Company warrants the Products as defined in the “Instructions For Use” (IFU) and
Product Warranty (Annex 6).

 

    	 	 	Page 10 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

 

		8.5	Both parties have to agree about terms and conditions of possible upcoming tenders in writing.
Distributor will inform the Company about the announced tenders for the products from Annex A. Distributor will provide the company
crucial data about the tender specifications and requirements to assure the successful participation and eventual tender contract.
The company will do the best to ensure that the Distributor can fulfil the tender.

 

		9.	Best Efforts

 

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

 

	Calendar 

Year	 	Minimum Purchase Requirements
	 	 	 
	Initial order	 	[***] boxes of 12 adsorbers ([***] adsorbers)
	 	 	 
	Year 1	 	[***] adsorbers (initial order included)
	 	 	 
	Year 2	 	[***] adsorbers
	 	 	 
	Year 3	 	[***] adsorbers

 

Distributor strives to place roughly
equal purchase orders per quarter over the year.

 

		9.2	Failure to meet such minimum requirements shall constitute
a material breach of this Agreement for the purposes of Clause 20 hereof; provided, however, that in lieu of terminating this
Agreement pursuant to Clause 20 based on such breach, the Company may instead elect in its sole discretion to change the exclusive
rights granted to Distributor under Clause 1 hereof to non-exclusive rights, in which case the Company shall then have the right
to appoint additional non-exclusive distributors in the Territory and the right to sell the Products itself in the Territory,
either directly (including without limitation with the assistance of sales representatives) or through one or more of its affiliates.
Notwithstanding anything contained in this provision to the contrary unless there are extenuating circumstances.

 

    	 	 	Page 11 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		10.	Reporting

 

		10.1	Distributor shall provide the Company with written short quarterly reports, which shall include
summarized reports (number of customers, new customers etc.), activities, business trends, and market forecasts.

 

		10.2	In particular, but not limited to, Distributor shall provide the following information:

 

		10.2.1	Technical information: Distributor shall forward promptly to the Company all technical questions
with respect to the Products, which it may receive from the Territory and complaints, related to technical or medical issues.

 

		10.2.2	Product complaints: Distributor shall report any and all information about Product related
complaints directly to the Company using the product complaint reporting form (Annex 3).

 

		10.2.3	Pharmacovigilance: Distributor shall appoint a qualified person for pharmacovigilance and
implement a vigilance system for the Product as it is necessary for medical devices.

 

		10.2.4	Marketing and sales
data: Distributor shall complete and return the marketing and sales data reporting form (Annex 4) within [***]
from the Effective Date.

 

		10.2.5	Traceability of batch numbers: In order to fulfil the GMP standard, Distributor shall ensure
that all Products delivered by Distributor to its customers can be identified on a batch number and serial number basis.

 

		10.2.6	Customers’ data: Distributor is under no obligation whatsoever to provide information
to the Company concerning Distributor's customer contact data and details.

 

    	 	 	Page 12 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		11.	Field Assistance

 

The Company shall provide, in
its discretion, appropriate field technical assistance to Distributor and Distributor's customers.

 

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

 

		12.1	Right to Use. Distributor may use the Company' trademarks, trade names and service marks listed
in Annex 5 (hereinafter referred to as the "Trademarks") on a non- exclusive basis in the Territory and for the
Application Fields only for the duration of this Agreement and solely for display or advertising purposes in connection with selling
and distributing the Products in accordance with this Agreement. Distributor shall not at any time do or permit any act to be done
which may in any way damage or impair the rights of the Company in the Trademarks.

 

		12.2	Quality Control: In order to comply with the Company's quality control standards, Distributor shall:
(i) use the Trademarks in compliance with all relevant laws and regulations; (ii) accord the Company the right to inspect during
normal business hours, with reasonable advance notice, Distributor's facilities used in connection with efforts to sell the Products
in order to confirm that Distributor'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.

 

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

 

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CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		13.	Covenant Not To Compete

 

		13.1	During the term of this Agreement, Distributor shall not market and or sell directly or indirectly
assist third parties to market or sell products in the Territory, which are competitive with the Products. This provision shall
not cover the products distributed or sold by Distributor before signing this Agreement as listed in Annex 7 and approved
in writing by the Company.

 

		13.2	Distributor agrees to review future product offerings from other suppliers for the treatment of
conditions mediated by the inflammatory response and/or used in extracorporeal therapy with the Company at least 3 months before
introduction. The Distributor agrees not to sell new product offering related to extracorporeal treatment of inflammatory conditions
without the Company’s approval.

 

		14.	Product Warranty

 

		14.1	The Company's warranties to users with respect to the Products are set out in Annex 6

 

hereto.

 

		14.2	Under no circumstances shall the warranties set forth in Annex 6 apply to any Product which
has been used with unapproved assemblies or sub-assemblies or to any Product which has been customized or modified, damaged or
misused. Notwithstanding any other provision in this Agreement, the Company shall not be held responsible for any damage which
may result from a defective part except for the replacement of such part as set forth in Annex 6.

 

		14.3	In case of product recalls or defective Products, the Company costs will be limited to either provide
a credit for the defective product or replace it directly. Credit or replacement for recalled product will apply to product in
Distributors possession. In the case of defective product, the Company will evaluate complaint samples and determine if the product
is defective and provide credit or replacement. In the case of a recalled Product, the Company at its discretion may request the
Product be shipped back to the US at the Company expense. Distributor at its expense will be responsible for recalling and recovering
Product involved in a recall.

    	 	 	Page 14 of 32

    
CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		14.4	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).

 

		15.	Limitations on Liability

 

		15.1	The Company's liability to Distributor arising out of the manufacture, sale or supplying of the
products or their use or disposition, whether based upon warranty, contract, tort or otherwise, shall not exceed the actual net
purchase price as paid by Distributor for the Product(s). Distributor’s sole remedy hereunder shall be replacement of any
defective Product(s) by the Company or a credit against future purchases, as Distributor shall select.

 

Distributor
shall have [***] ([***]) days from receipt of any Product(s) from the Company to require replacement of said Product if defective.
Thereafter replacement shall be at the sole discretion of the Company. Any request for replacement shall be made in writing.

 

		15.2	In no event shall the Company be liable to Distributor or any other person or entity for 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 if the Company has been advised of the possibility of such damages or losses.

 

Section 15.1
and Section 15.2 shall neither apply to damages caused by intent or gross negligence of the Company.

 

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CytoSorbents Exclusive Distribution Agreement EU
 
Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    

  

		16.	Indemnifications

 

		16.1	Indemnification of the Company

 

Distributor
hereby agrees to indemnify, defend and hold harmless the Company, 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) (collectively, "Damages") arising from any wilful act or negligence of
Distributor whether related to damage or injury to property or to persons, and whether arising from (i) its marketing or sales
activities, (ii) its receipt, storage, and/or transportation, of the Product(s), (iii) any representations or warranties of Distributor
regarding the Product(s) not authorized by the Company hereunder, failure to comply with the Company’ instructions or recommendations
set forth in the Product label and/or the Instructions For Use, (v) any failure of Distributor to comply with the relevant UK law,
rules, and regulations, or (vi) otherwise.

 

		16.2	Indemnification of Distributor

 

The Company
hereby agrees to indemnify, defend and hold harmless Distributor, its affiliates and all officers, directors, employees and agents
thereof from all Damages arising out of:

 

		(i)	The Company's failure to comply with relevant laws and
regulations after receiving proper notice of same from Distributor as required herein; and (ii) Distributor's reselling of the
Products infringing on the intellectual property rights of third parties or constituting a misappropriation of any third party's
trade secrets;

 

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		16.3	In the event that any
Product 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 is enjoined, or the Company reasonably believes that it is likely to be found to infringe or likely to be enjoined,
then the Company shall, at its sole cost and expense, either (1) procure for Distributor 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 the Company
may, in its sole discretion, remove such Product from this Agreement upon repurchasing Distributor's inventory of such Product
which are saleable and in the original packages and unaltered from their original form and design, subject to the Company' inspection,
test, and acceptance. Any such repurchase of Distributor's inventory of Products shall be at the price paid to the Company' at
the time of the original purchase. Such repurchased inventory shall be shipped by Distributor freight prepaid, according to the
Company' instructions. The Company shall pay Distributor for such repurchased Products within thirty (30) days after the Company
receives those Products in one of its facilities.

 

		16.3.1	The Company 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 the Company, 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; (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; or (4) a claim based on intellectual property rights
owned by the Company or any of its Affiliates.

 

		17.	Force Majeure

 

		17.1	Neither the Company nor Distributor 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)
calendar 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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		17.2	For the purposes of this Section 17, 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 or war (declared or undeclared).

 

		18.	Confidentiality

 

		18.1	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 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 shall also apply to any consultants or subcontractors that the receiving Party may engage in connection
with its obligations under this Agreement.

 

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		18.2	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 by tangible historical evidence 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.	Publicity

 

Distributor
agrees that any publicity or advertising, which shall be released by it, in which the Company is identified in connection with
the Products shall be in accordance with the terms of this Agreement and with any information or data, which the Company has furnished
in connection with this Agreement. Copies of all such publicity and advertising shall be sent to the Company prior to use and the
Company shall respond within a commercially reasonable time. Any publicity or advertising shall only start after announcing this
agreement in a common press release.

 

		20.	Term and Termination

 

		20.1	The term of this Agreement shall begin on the date that the Company accepts and signs this Agreement
such date being referred to as the "Effective Date"). The term of this Agreement shall expire on 31 December 2017, unless
terminated earlier pursuant to the provisions of this Section. The term of this Agreement shall be extended for one additional
period of 12 months upon mutual agreement to continue. At the end of such 12 months period, this Agreement shall be extended for
another additional 12 months period upon mutual agreement to continue.

 

		20.2	Upon the occurrence of a material breach or default as to any obligation hereunder by either party
and the failure of the breaching party to promptly pursue (within thirty (30) days after
receiving written notice thereof from the non-breaching party) a reasonable remedy designed to cure (in the reasonable judgment
of the non-breaching party) such material breach or default, this Agreement may be terminated by the non- breaching party by giving
written notice of termination to the breaching party, such termination being immediately effective upon the giving of such notice
of termination.

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		20.3	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.

 

		20.4	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 of such changed party and the failure of such changed
party to promptly pursue (within 90 days after receiving written notice thereof from the other party) a remedy designed to cure
(in the sole judgment of the other party) the other party's objections to such change, 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.

 

		20.5	In the event of a termination pursuant to any of subsections 20.2, 20.5 or 20.6 above or upon expiration
of this Agreement pursuant to either of subsections 20.2 or 20.3 above, the Company shall not have any obligation to Distributor,
or to any employee of Distributor, for compensation or for damages of any kind, whether on account of the loss by Distributor or
such employee of present or prospective sales, investments, compensation or goodwill. Distributor, for itself and on behalf of
each of its employees, hereby waives any rights, which may be granted, to it or them under the laws and regulations of the Territory
or otherwise which are not granted to it or them by this Agreement. Distributor hereby indemnifies and holds the Company harmless
from and against any and all claims, costs, damages and liabilities whatsoever asserted by any employee, agent or representative
of Distributor under any applicable termination, labour, social security or other similar laws or regulations.

 

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		20.6	Termination of this Agreement shall not affect the obligation of Distributor to pay the Company
all amounts owing or to become owing as a result of Products tendered or delivered to Distributor 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.

 

		20.7	In case of termination of the agreement, Company will provide Products to Distributor to fulfill
the tenders signed before termination. Distributor will provide to Company official documents related to all tenders. Distributor
will inform Company during the duration of this agreement about tenders, which exceed quantities of 200 pieces immediately after
signature.

 

		21.	Selling Off of Inventory

 

Distributor
shall have the right to sell off its remaining inventory of Products for a period of [***] ([***]) months after expiration of this
Agreement ("Sell-Off-Period"); provided, however, that Distributor shall comply with all terms and conditions of this
Agreement restricting such reselling activities in effect immediately prior to such termination or expiration. In case the Company
terminated the Agreement, the Company shall neither directly nor indirectly sell the Products in the Territory during the Sell-Off-Period

 

		22.	Notices

 

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

 

		22.1.1	If to Distributor:

 

Contact
person: [***]

Title:
[***] 

 

Address:

Via Spartaco 10

40138 Bologna

Italy

 

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Phone: +390587489723

Fax:+390587489808

URL: www.aferetica.com

Email:
[***]

 

		22.1.2	If to the Company:

 

Contact person: Dr. Christian Steiner

Title: Managing
Director 

CytoSorbents Europe GmbH, Bölschestraße 116,
12587 Berlin,

Germany 

 

Fax: +49-30-654.99.146

 

		22.2	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) calendar 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.

 

		23.	Modification

 

No modification
or change may be made in this Agreement, including any modification or change to this Section 23, except by written instrument
duly signed by Distributor and by a duly authorized representative of the Company.

 

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		24.	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 the Company.

 

		25.	Waiver

 

		25.1	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.

 

		25.2	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.

 

		26.	Validity

 

		26.1	The Company warrants that this Agreement is lawful and may be performed in accordance with its
terms under all laws in force in the Federal Republic of Germany at the time of execution of this Agreement.

 

		26.2	Distributor warrants that this Agreement is lawful and may be performed in accordance with its
terms under all laws in force in the countries comprising the Territory. The Company and Distributor each covenant and warrant
that they will advise each 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.

 

		27.	Governing Law

 

This Agreement
and all rights and obligations thereunder shall be exclusively governed and exclusively construed in accordance with the laws of
the Federal Republic of Germany under explicit exclusion of the United Nations Convention on Contracts for the International Sale
of Goods (CISG).

 

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		28.	Jurisdiction

 

Any and all
disputes, claims or litigation arising from or related in any way to this Agreement, including its formation, shall be exclusively
submitted to and resolved by the courts of Berlin, Germany.

 

		29.	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 the Company and Distributor with respect to the subject matter hereof.

 

		30.	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.

 

		31.	Compliance With Laws

 

Each of Distributor
and the Company covenants that all of its activities under or pursuant to this Agreement shall comply with all applicable laws,
rules and regulations. In particular, but without limitation, Distributor shall be responsible for obtaining all licenses, permits
and approvals which are necessary or advisable for sales of the Products in the Territory and for the performance of its duties
hereunder.

 

		32.	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.

 

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

 

	CytoSorbents Europe GmbH:	 
	 	 	 
	By:	/s/
    Dr. Christian Steiner          	 
	 	 	 
	Name:	Dr. Christian Steiner	 
	 	 	 
	Title:	Managing Director	 
	 	 	 
	Aferetica s.r.l.:	 
	 	 	 
	By:	/s/ Mauro Atti	 
	 	 	 
	Name:	Mauro Atti	 
	 	 	 
	Title:	amministratore unico	 

  

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Annex 1

 

List of Products 

 

	Order Number	 	Article	 	Units per box
	 	 	 	 	 
	30-0011	 	CytoSorb®  Adsorber 300ml	 	12
	 	 	 	 	 
	30-0021	 	CytoSorb®  Adsorber 300ml	 	6
	 	 	 	 	 
	1500-0100-11	 	CytoSorb®  Adapter 1	 	6
	 	 	 	 	 
	1500-0200-11	 	CytoSorb®  Adapter 2	 	6
	 	 	 	 	 
	1500-0300-11	 	CytoSorb®  Adapter 3	 	6
	 	 	 	 	 
	1500-1100-11	 	CytoSorb®  PRIMING Adapter 1	 	6
	 	 	 	 	 
	1500-1200-11	 	CytoSorb®  PRIMING Adapter 2	 	6
	 	 	 	 	 
	30-0041	 	CytoSorb® Holder	 	1

 

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Annex 2

 

Product Prices 

 

	Order Number	 	Article	 	Units per box	 	Price per unit
	 	 	 	 	 	 	 
	30-0011	 	CytoSorb®  Adsorber 300ml	 	12	 	[***] EUR*
	 	 	 	 	 	 	 
	30-0021	 	CytoSorb®  Adsorber 300ml	 	6	 	[***] EUR*
	 	 	 	 	 	 	 
	1500-0100-11	 	CytoSorb®  Adapter 1	 	6	 	[***] EUR
	 	 	 	 	 	 	 
	1500-0200-11	 	CytoSorb®  Adapter 2	 	6	 	[***] EUR
	 	 	 	 	 	 	 
	1500-0300-11	 	CytoSorb®  Adapter 3	 	6	 	[***] EUR
	 	 	 	 	 	 	 
	1500-1100-11	 	CytoSorb®  PRIMING Adapter 1	 	6	 	[***] EUR
	 	 	 	 	 	 	 
	1500-1200-11	 	CytoSorb®  PRIMING Adapter 2	 	6	 	[***] EUR
	 	 	 	 	 	 	 
	30-0041	 	CytoSorb® Holder	 	1	 	[***] EUR

 

2 boxes of
6 adsorbers are equivalent to 1 box of 12 adsorbers.

 

*Adsorber
price is reduced to [***] EUR for all orders above
[***] adsorbers per year.

 

(If a purchase
order is accepted in accordance with clause 2.3 above, the prices for Products covered by such purchase order shall be the Company's
net distributor prices [***], which are in effect on the date of the Company's acceptance. The Company may from time to time change
those prices, such change being effective immediately upon Distributor's receipt of notice thereof; provided, however, that no
price change shall affect purchase orders offered by Distributor and accepted by the Company prior to the date such price change
becomes effective.)

 

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Annex 3

 

Products Complaints Reporting Form The
Company’s SOP - 02-028 

 

CytoSorbents Distributor Complaint Handling
Procedure

 

Distributor should complete those items
highlighted in yellow and return to CytoSorbents by one of the following Methods:

 

		1.	Email: regulatory@cytosorbents.com

		2.	FAX to DE +49 (0)30 30 654 99 146 or US +01-732-329-8650

 

	ATTENTION	 

  

Reportable Events Timeline: 24 Hour Reportable
and 5 Day Reportable

 

24 Hour Reportable Event

Serious Public Health Threat
 – Any event that results in imminent risk of death, serious deterioration in state of health (life-threatening illness, permanent
impairment of a body function or permanent damage to a body structure, a condition necessitating medical or surgical intervention
to prevent the previously listed conditions, fetal distress, fetal death, or any congenital abnormality or birth defects) or serious
illness that requires prompt remedial action.

		·	Immediately, but not later than 24 hours after awareness of the threat.
Contact should be via email to regulatory@cytosorbents.com and fax to CytoSorbents
DE +49 (0)30 30 654 99 146.

 

5 Day Reportable Event

Any malfunction or deterioration
in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which,
directly or indirectly, might lead to or might have led to the death of a patient, or USER or of other persons or to a serious
deterioration in their state of health.

 

All complaints must be reported
as soon as possible to CytoSorbents!!! Patient injury or death thought to be associated with the device must be dealt with promptly.
Please collect the information regarding circumstances surrounding the death and device association with the incident. 

 

Complaint Handling Form

 

	Complaint Reference Number: CRN -      -
	Type
    of Complaint:    ̈ Clinical    ̈
    Functional    ̈ Other:   
	Complaint Received By:	Date:
	
        Complaint
        Received From: (Name, Title (if applicable) and Address)

         

         

         

         

	Complaint
    Reported By:    ̈
    Physician   ̈ Patient    ̈
    Customer    ̈ Other:
	Mode
    of Communication of Complaint:    ̈
    Phone    ̈ Facsimile    ̈
    Letter    ̈ Other:
	Device Name:	
        Lot
        and Serial Number (if applicable):

         

	
        Device License Number (if applicable):

        NA

	Quantity Delivered:	Quantity Defective:
	Quantity Returned:	
        Date
        of Receipt:

         

        Received
        By:

	Comments:
	Complaint:
	 	 	 

 

 

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Annex 4

 

Marketing and Sales Data Reporting
Form

 

Will be filled in quarterly

 

 

 

 

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Annex 5

 

List of Trademarks

 

CytoSorb®

 

CytoSorbents®

 

HemoDefend®

 

DrugSorb®

 

ContrastSorb®

 

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Annex 6

 

Company’s Warranties to Users

 

Attached:

 

		·	Label

 

		·	Instructions for Use (IFU)

  

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Annex 7

 

List of possibly competitive
products marketed by the Distributor before this 

Agreement, which are approved by the Company

 

Competitive products:

 

 

 

    	 	 	Page 32 of 32

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