Document:

ThermoEnergy
Corporation

 

Security
Agreement

 

This Security Agreement (this “Agreement”)
is dated as of August 22, 2013, and is entered into by and among ThermoEnergy Corporation, a Delaware
corporation having its principal place of business in Worcester, Massachusetts (the “Borrower”) and the persons
and entities named on Schedule I hereto (collectively, the “Secured Parties) and Empire Capital Partners, LP, one of the
Secured Parties, as agent for itself and the other Secured Parties (the “Agent”). Capitalized terms not otherwise defined
herein are used as defined in the Massachusetts Uniform Commercial Code on the date of this Agreement (the “UCC”).

 

Whereas, the Borrower is, on or about the
date hereof, executing and delivering to the Secured Parties a series of 12% Secured Promissory Notes of even date herewith in
the initial aggregate principal amount of $4,000,000.00 (the “Notes”); and

 

Whereas, the Secured Parties have, as a
condition to the making of the loans evidenced by the Notes, required that the Borrower execute and deliver to the Secured Parties
a security agreement in substantially the form hereof; and

 

Whereas, the Borrower wishes to grant a
security interest in favor of the Secured Parties as herein provided;

 

Now, therefore, in consideration of the
promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties hereto agree as follows:

 

Section 1.              Grant of Security Interest.
The Borrower hereby grants and otherwise pledges to the Secured Parties a continuing security interest in all of the present and
future rights, title and interests of the Borrower in and to the following property, and each item thereof, all whether now or
hereafter existing, or owned or acquired by the Borrower, or now or hereafter arising or due or to become due, wherever such property
may be located, together with all substitutions for, replacements of, additions to, accessions to, and products, Proceeds and records
of any and all of the following (collectively, the “Collateral”):

 

		(i)	all Accounts;

		(ii)	all Inventory;

		(iii)	all Equipment;

		(iv)	all Fixtures;

		(v)	all Contracts;

		(vi)	all Chattel Papers;

		(vii)	all Documents;

		(viii)	all Instruments;

		(ix)	all Investment Property;

		(x)	all Deposit Accounts;

		(xi)	all General Intangibles;

		(xii)	all Supporting Obligations

 

    	 

    	 

    

 

		(xiii)	all Commercial Tort Claims;

		(xiv)	all Intellectual Property; and

		(xv)	all other items of tangible and intangible personal property of any and every kind and description which are not otherwise
described herein.

 

Section 2.              Security for Obligations.
This Agreement secures, and the Collateral is collateral security for the prompt payment in full (including, without limitation,
amounts that would become due but for the filing of a petition in bankruptcy) of, all amounts when due under the Notes, as well
as the Borrower’s performance and observance of all covenants contained herein and in the Notes (the “Obligations”).

 

Section 3.              Agent as Agent of Secured
Parties.

 

(a)              The Agent shall serve and act as
agent for all Secured Parties and shall take such action on their behalf under the provisions of this Agreement and shall exercise
such powers and perform such duties as are expressly delegated to the Agent by the terms of this Agreement, together with such
powers as are reasonably incidental thereto. Notwithstanding any provision to the contrary contained elsewhere in this Agreement,
the Agent shall not have any duties or responsibilities except those expressly set forth herein.

 

(b)              The Secured Parties, the Agent and
the Borrower acknowledge and agree that each Note is secured by a security interest in the Collateral and that the priorities of
the security interests which secure each Secured Party’s respective Note and its or his rights in and to the Collateral which
secures such Notes shall at all times be equal and that each Secured Party shall share and be equal in priority and rights with
the other Secured Parties in proportion to the then outstanding principal amounts of, plus the accrued but unpaid interest on,
their respective Notes.

 

(c)              In the event that an Event of Default
occurs, and a Secured Party gives the Agent notice thereof, the Agent shall immediately thereafter (i) give written notice of the
Event of Default to all Secured Parties, and (ii) commence enforcement, collection (including judicial or nonjudicial foreclosure)
or similar proceeding with respect to the Collateral; provided that while the Agent may take immediate action in its discretion
in order to attempt to preserve the rights of the Secured Parties hereunder, the Agent (a) shall not be required to take any action
hereunder unless and until, if requested by the Agent, the Agent receives direction from 662⁄3% in interest of the Secured
Parties (determined on the basis of the outstanding principal amounts of the Notes), and (b) shall take such all such actions to
enforce this Agreement and to realize upon, collect and dispose of the Collateral or any portion thereof as may be directed by
662⁄3% in interest of the Secured Parties; provided that the Agent shall not be required to take any action that is contrary
to law or to the terms of this Agreement, or that would subject it or any of its employees or agents to liability.

 

(d)              The Agent acknowledges and agrees
that this Agreement and the terms and provisions hereof are solely for the benefit of the Secured Parties and shall not benefit
in any way any other person or entity, including, without limitation, the Borrower or any of its guarantors. Nothing in this Agreement
is intended to affect, limit or in any way diminish the security interests which the Secured Parties claim in the assets of the
Borrower insofar as the rights of the Borrowers and third parties are concerned. The Agent, on behalf of all Secured Parties, specifically
reserves any and all of their respective rights, security interests and rights to assert security interests against the Borrowers
and any third parties, including guarantors.

 

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(e)              The Borrower, the Secured Parties
and the Agent acknowledge and agree that each Secured Party’s respective rights and priorities with respect to the Collateral
shall exist and be enforceable against the Collateral only by the Agent on behalf of all Secured Parties in accordance with the
terms hereof, independent of the time or order of attachment or perfection of such Secured Party’s respective security interest,
or the time or order of filing of financing statements. The subordinations, agreements and priorities set forth in this Agreement
shall remain in full force and effect regardless of whether any Secured Party in the future seeks to rescind, amend, terminate
or reform, by liquidation or otherwise, its or his respective agreements with the Borrower.

 

(f)              The Borrower, the Secured Parties
and the Agent acknowledge and agree that the indebtedness and payment obligations of the Borrower with respect to each Note shall
be of equal priority, no Note shall have a priority of payment over or be subordinate to any other Note, and any and all property,
Proceeds or other payments received by the Agent in connection with its enforcement of the Secured Parties’ security interests
as contemplated herein shall be applied promptly by the Agent to the payment to the Secured Parties pari passu of all outstanding
amounts owed under their respective Notes.

 

(g)              Subject to the shared priority and
respective rights of the Secured Parties set forth in this Agreement, the Agent, on behalf of the Secured Parties, shall be entitled
to obtain loss payee endorsements and additional insured status with respect to any and all policies of insurance now or hereafter
obtained by the Borrower insuring against casualty or other loss to any property of the Borrower in which any Secured Party may
have a security interest, and, in connection therewith, may file claims, settle disputes, make adjustments and take any and all
other action otherwise then permitted to each Secured Party with regard thereto, which it may deem advisable with respect to any
assets of the Borrower.

 

(h)              Neither the Agent nor any officer
or agent thereof shall be liable to the Borrower or the Secured Parties for monetary damages for any action taken or omitted to
be taken by the Agent except for liability (i) for acts or omissions not in good faith or which involve intentional misconduct
or a knowing violation of law or (ii) for any transaction from which the Agent or such officer or agent thereof derived an improper
personal benefit.

 

(i)              The Borrower shall indemnify and
hold harmless the Agent for any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs,
expenses or disbursements (including reasonable attorneys’ fees) of any kind whatsoever which may be imposed on, incurred
by or asserted against the Agent in connection with or in any way arising out of this Agreement; provided, however, that the Borrower
shall not be liable to the Agent for any portion of such liabilities, obligations, losses, damages, penalties, actions, judgments,
suits, costs, expenses or disbursements resulting from the Agent’s gross negligence or willful misconduct as determined by
a final judgment of a court of competent jurisdiction. The Borrower shall upon demand pay to the Agent the amount of any and all
reasonable expenses, including the reasonable fees and expenses of its counsel and of any experts and agents, that the Agent may
incur in connection with (i) the administration of this Agreement, (ii) the custody, preservation, use or operation of, or the
sale of, collection from or other realization upon, any of the Collateral, (iii) the exercise or enforcement of any of the rights
of the Agent or the Secured Parties hereunder, or (iv) the failure by the Borrower to perform or observe any of the provisions
hereof. In the event the Borrower fails to comply with its obligations under this Section 3(i), after commercially practicable
efforts by the Agent to obtain such compliance, each of the Secured Parties agrees to contribute and pay to the Agent its or his
pro rata share of all such obligations

 

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Section 4.              Representations, Warranties
and Covenants. The Borrower represents, warrants and covenants as follows:

 

(a)              The Borrower is a corporation existing
and in good standing under the laws of the State of Delaware.

 

(b)              The Borrower is duly empowered and
authorized to enter into and perform its obligations under this Agreement and all other instruments and transactions contemplated
hereby or relating hereto. The Borrower is duly empowered and authorized to own and to grant security interests in the Collateral.
The execution, delivery and performance by the Borrower of this Agreement, of the Notes and of all other instruments contemplated
hereby do not and will not violate any law or any provision of, nor be grounds for acceleration under, any agreement, indenture,
note or instrument which is binding upon the Borrower, including without limitation, the Borrower’s Certificate of Incorporation,
By-Laws and any other loan or security agreements to which the Borrower is a party or by which the Borrower or its property is
bound.

 

(c)              Assuming the due filing of a financing
statement in proper form with the Secretary of State of the State of Delaware, the security interest granted to the Secured Parties
pursuant to this Agreement is a valid, perfected security interest in the that portion of the Collateral in which a security interest
may be perfected by filing under the UCC.

 

(d)              The Borrower shall not hereafter
transfer, assign or otherwise dispose of the Collateral, except in the ordinary course of business, without the Agent’s prior
written consent. The Borrower shall not create, permit or suffer to exist, and shall take such other action as is necessary to
remove, any claim to or interest in the Collateral, and shall defend the right, title and interest of the Secured Parties in and
to the Collateral against all claims and demands of all persons and entities at any time claiming the same or any interest therein.

 

Section 5.              Agent’s Appointment
as Attorney-in-Fact. The Borrower hereby irrevocably constitutes and appoints, from and after the occurrence of a default by
the Borrower in the Obligations, the Agent and any officer or agent thereof, with full power of substitution, as the Borrower’s
true and lawful attorney-in-fact with full irrevocable power and authority in the place and stead of the Borrower and in the name
of the Borrower or in the Agent’s own name as agent hereunder for the Secured Parties, from time to time in the Agent’s
discretion, for the purpose of carrying out the terms of this Agreement, to take any and all appropriate action and to execute
any and all documents and instruments that may be necessary or desirable to accomplish the purposes of this agreement and, without
limiting the generality of the foregoing, hereby grant to the Agent the power and right, on behalf of the Borrower, without notice
to or assent by the Borrower to execute, file and record all such financing statements, certificates of title and other certificates
of registration and operation and similar documents and instruments as the Agent may deem necessary or desirable to protect, perfect
and validate the Secured Parties’ security interest.

 

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The Borrower hereby ratifies all that such
attorneys shall lawfully do or cause to be done by virtue hereof. This power of attorney is a power coupled with an interest and
shall be irrevocable so long as any amount of principal or accrued interest under the Notes remains unpaid.

 

The powers conferred upon the Agent hereunder
are solely to protect the interests of the Secured Parties in the Collateral and shall not impose any duty upon the Agent to exercise
any such powers. The Agent shall be accountable only for amounts that the Agent actually receives as a result of the exercise of
such powers and neither the Agent nor any of its partners, officers, directors, employees or agents shall be responsible to the
Borrowers or the other Secured Parties for any act or failure to act, except for the Agent’s own gross negligence or willful
misconduct.

 

Section 6.              Remedies. If a default
by the Borrower in the Obligations shall have occurred and be continuing (an “Event of Default”), the Agent shall have
all of the rights and remedies which secured parties may have under the UCC or other applicable law or at equity, and may do, at
its option, one or more of the following, with or without further notice to the Borrower:

 

(a)              Accelerate and declare all or any
part of the Obligations to be immediately due, payable and performable;

 

(b)              Appropriate, set off and apply to
any or all of the Obligations, any or all Collateral in such manner as the Agent may determine; and/or

 

(c)              Foreclose the security interest created
under this Agreement or under any other agreement relating to the Collateral by any procedure permitted under the UCC, with or
without judicial process.

 

Section 7.              Termination of Security
Interest. The Secured Parties’ security interest in the Collateral shall be extinguished when the Borrower completes
performance of all Obligations.

 

Section 8.              Governing Law; Venue. This
Agreement and the rights of the parties shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts
applicable to agreements executed and to be performed wholly within such state and without regard to principles of conflicts of
law. Each party irrevocably (a) consents to the jurisdiction of the federal and state courts situated in or having jurisdiction
over Boston, Massachusetts in any action that may be brought for the enforcement of this Agreement, and (b) submits to and accepts,
with respect to its properties and assets, generally and unconditionally, the in personam jurisdiction of the aforesaid courts,
waiving any defense that such court is not a convenient forum In any such litigation to the extent permitted by applicable law,
each party waives personal service of any summons, complaint or other process, and agrees that the service thereof may be made
either (i) in the manner for giving of notices provided in the Notes or (ii) in any other manner permitted by law.

 

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Section 9.              Severability. In case any
provision in or obligation under this Agreement shall be invalid, illegal or unenforceable in any jurisdiction, the validity, legality
and enforceability of the remaining provisions or obligations, or of such provision or obligation and in any other jurisdiction,
shall not in any way be affected or impaired thereby.

 

Section 10.              General. No Secured Party
shall be deemed to have waived any of its respective rights hereunder or under any other agreement, instrument or paper signed
by the Borrower unless such waiver be in writing and signed by the Agent (with respect to the Secured Parties’ rights and
interest under the Notes or under this Agreement) or by such Secured Party (with respect to any other rights). No delay or omission
on the part of the Agent in exercising any right shall operate as a waiver of such right or any other right. All of the Secured
Parties’ rights and remedies, whether evidenced hereby or by any other agreement, instrument or paper, shall be cumulative
and may be exercised singularly or concurrently. The provisions hereof shall, as the case may require, bind or inure to the benefit
of, the respective heirs, successors, legal representatives and assigns of the Borrower, the Agent and the Secured Parties.

 

Section 11.              Amendments. This Agreement
may be amended or modified only by a written instrument executed by each party hereto.

 

Section 12.              Counterparts. This Agreement
may be executed in any number of counterparts, each of which shall be deemed an original and together shall constitute one and
the same instrument.

 

[Signature Page follows]

 

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In witness whereof,
the Borrower, the Agent and the other Secured Parties have caused this Agreement to be duly executed as of the date first above
written.

 

	 	 	For itself and as Agent for the other Secured Parties:
	ThermoEnergy Corporation	 	 
	 	 	Empire Capital Partners, lp
	 	 	By: Empire gp, llc, its General Partner
	By:	/s/ Gregory M. Landegger	 	 
	 	Gregory M. Landegger	 	By:	/s/ Peter J. Richards
	 	Chief Operating Officer	 	 	Peter J. Richards
	 	and Interim Chief Financial Officer	 	 	Managing Member
	 	 	 	 	 
	 	 	and
	 	 	 	 
	 	 	By:	 /s/ Scott Fine
	 	 	 	Scott A. Fine
	 	 	 	Managing Member
	 	 	 
	Empire Capital Partners, ltd	 	Empire Capital Partners Enhanced Master Fund, ltd
	By: Empire Capital Management, llc,	 	By: Empire Capital Management, llc,
	its Investment Manager	 	its Investment Manager
	 	 	 
	By:	/s/ Peter J. Richards	 	By:	/s/ Peter J. Richards
	 	Peter J. Richards	 	 	Peter J. Richards
	 	Managing Member	 	 	Managing Member
	 	 	 	 	 
	and	 	and
	 	 	 	 	 
	By:	/s/ Scott Fine	 	By:	/s/ Scott Fine
	 	Scott A. Fine	 	 	Scott A. Fine
	 	Managing Member	 	 	Managing Member
	 	 	 
	 	 	/s/ Robert S. Trump
	 	 	Robert S. Trump

 

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ThermoEnergy
Corporation

 

Security
Agreement

 

Schedule I

 

Secured Parties

 

Robert S. Trump

Empire Capital Partners, LP

Empire Capital Partners, Ltd.

Empire Capital Partners Enhanced Master Fund Ltd.

 

    	8Exhibit 10.15

SUPPLY AGREEMENT

 

PARTIES

	
        GE Healthcare entity (thereinafter ”GEHC”), previously
        known as Amersham Health AS:

         

        GE HEALTHCARE AS

         

        Address

         

        Nycoveien 1-2

        0401 OSLO

        NORWAY

         
	
        Other Party (thereinafter the “Supplier”), previously
        known as Organichem Corporation:

         

        AMRI Rensselaer, Inc.

         

        Address

         

        26 Corporate Circle

        Albany, New York 12203

        USA

	AGREEMENT	GEHC REF:

	
        The Parties hereby agree that the following terms and conditions
        shall apply:

         

        A.Agreement

        The Supplier shall sell
        to GEHC, and GEHC shall purchase from the Supplier the products meeting the specifications referred to in Attachment A (the “Product”)
        in such amounts as GEHC may order from time to time on the terms and conditions set out in this Agreement . GEHC shall pay the
        price of the Product and any Additional Charges, if any, specified in Attachment A (together, the “Prices”).

         

        B.Documents

        The following attachments
        are an integral part of this Agreement (the “Attachments”). The provisions of each Attachment shall be incorporated
        by reference into and deemed to be part of this Agreement:

         

        Attachment A - Products and Prices

        Attachment B - Special Terms and Requirements

        Attachment C - Commercial Terms and Conditions

        Attachment D - Supplier Integrity Statement

        Attachment E – Quality Assurance Agreement
        including specification (Annex 4) of April 4th, 2010

        Attachment F -   Documentation requirement for
        supply of ABA Hcl.

        Attachment G - Aminobisamide Packaging Specifications

         

        C.Term

        Effective Date: January
        1st 2012

        Length of contract:
        This Agreement shall take effect retrospectively from the Effective Date and, subject to the rights of termination in clause 1
        of Attachment C, shall continue until December 31st 2016. The Parties shall meet on or before 2 years prior to the expiration
        of the Term to decide whether to renew this Agreement. If the Agreement is not extended prior to the date of termination, the Agreement
        will terminate at the expiration of the term.

         

        The Agreement supersedes
        and replaces the Supply Agreement between the Amersham Health AS and Organichem Corporation of August 31st 2005 and
        the Amendment between GE Healthcare AS and AMRI Rensselaer, Inc of December 22nd 2008.

	
         

        This Agreement has been duly executed by each of the Parties

	
        Signed for and on behalf of GEHC AS

        Signature  /s/ Bard Reiholdtsen

        Name (capitals) BARD REINHOLDTSEN

        Title Global Sourcing Leader
	
        Signed for and on behalf of AMRI Rensselaer, Inc. 

        Signature  /s/ Thomas D’Ambra

        Name (capitals) THOMAS D’AMBRA

        Title President & CEO

 

 

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Attachment A

Products and Prices

 

 

	Product name	
        GEHC 

        Art No
	
        Supplier 

        Art No
	Spec No or Attachment ref.	Unit Size	Unit price	Lead time	Shelf Life
	Aminobisamide Hcl (“ABA Hcl”)	1002075	 	Ref Attachment E, QA Agreement	Kg	See below:	POs to be sent [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] or more prior to date of shipment	[/*[CONFIDENTIAL TREATMENT REQUESTED]*/]from date of production

 

Currency:USD

 

Delivery term for international transports (Incoterms 2010):
CIP Kristiansand, Norway. Title of Product passes to GEHC upon shipment from Supplier’s plant. 

 

Contract price and volumes

 

	 	2012*	2013	2014	2015	2016
	Base volume (Tons)	----------- [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]------------------------
	Price ($/Kg)	----------- [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]------------------------

 

* [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]

 

 

Price - volume adjustment:

		a)	No adjustment if volume changes less than or equal to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

		b)	If the volume decreases between [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], then the percent price increase will be equal to
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

		i.	*Example: [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

		c)	If the volume decreases more than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] then the percent price increase will be [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/].

		i.	Example: [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

		d)	If the volume increases by more than than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] then the percent price decrease will be
equal to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

		i.	Example: [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

 

 

For the avoidance of doubt, GEHC is under no obligation to buy
any minimum quantity, but GEHC shall purchase [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of its requirements from AMRI in 2012 and
2013. GEHC shall have the right to obtain up to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of the required volume from other sources
in 2014 and up to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of the required volume from other sources in 2015 and 2016.

 

If GEHC decides to exercise the option of buying volumes from
other sources in 2014-2016, the price from AMRI will increase by [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]. GEHC shall give AMRI
notice six months prior to the purchase from other sources, indicating volume, and other relevant information as necessary to account
for the calculation of price increase.

		i.	Example: [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

 

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If GEHC in any given year spends with AMRI [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/], the price of ABA Hcl for that year is reduced by [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]. If GEHC in
any given year spends with AMRI [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], the price of ABA Hcl for that year is reduced by [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]. This additional spend [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] from AMRI.

 

 

Any increase in price based on volume or alternative sourcing under this section shall be invoiced with
the next invoice for Product shipped following the date on which the increase was incurred. Any decrease in price based on volume
or base spend under this section shall be credited towards the next invoice for Product shipped following the date on which the
decrease was incurred; any excess credit shall be applied towards the following invoice(s) until the full credit is satisfied.
For the avoidance of doubt, no cash refund shall be paid to GEHC in connection with any credit earned under this section, except
as may apply upon termination or expiration of this Agreement.

 

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Attachment B

Special Terms and Requirements

 

		1.	Specification

 

The Products to be supplied
in accordance with the terms of this Agreement are set forth in Attachment A. A technical specification in relation to a specific
Product is referred to as the “Specification” and is set forth in Attachment E, Quality Assurance Agreement
including specification (Annex 4) of April 4th, 2010

 

		2.	Delivery Documentation 

 

The Supplier shall ensure that
the documents listed in Attachment F – Documentation Requirements for supply of raw materials to GEHC, Lindesnes plant attached
all shipments of the Product.

 

The Supplier shall ensure that
Safety Data Sheets (SDS) are updated in accordance with current European law and regulations. The Supplier is responsible for automatically
sending revised SDS to GEHC in Norwegian language.

 

 

		3.	Packaging and Shipping Requirements 

 

The Product shall be packaged
in accordance with the packaging specifications shown in Attachment G.

 

 

		4.	Testing Requirements 

 

GEHC shall test the Product
according to the QA Agreement and Specifications set forth in Attachment E.

 

 

		5.	Labelling Requirements

 

When the Global Harmonized System
for classification and labelling come into force, the labelling of the products has to be in compliance with the EU regulations.

 

The Supplier confirms that it
is aware of the Regulation No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH). The Supplier will comply with the requirements of REACH.

 

The Product should also be labelled
according to the QA Agreement set forth in Attachment E.

 

		6.	Invoicing Requirements 

 

The invoice shall contain the
Purchase Order number, item number, invoice quantity, unit of measure, unit price, total invoice amount, Purchaser’s Norwegian
Tax/VAT number and Seller’s name/phone number, address to which remittance should be sent, and other information required
by law.

Invoice is not considered as
having been received until it complies with these conditions.

Purchaser shall provide Seller
with its Norwegian Tax/VAT number.

 

		7.	Prices and payment terms

 

		a.	Firm prices. Prices are fixed for the Term of this Agreement except as amended in accordance
with Attachment A. Except where expressly specified otherwise in Attachment A, the Prices include all costs relating to the supply
of the Products including, but not limited to, insurance (except as otherwise provided in Attachment C), and packaging costs. GEHC
shall not be obliged to reimburse the Supplier for any Additional Charges or any other costs relating to the supply of the Products
that are not specified in Attachment A or otherwise agreed in writing by the Parties. In no event shall the Prices be increased
by the Supplier without the express written consent of GEHC, except as set forth in Exhibit A, in which case no consent shall be
required.

 

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		b.	Intentionally left blank..

 

		c.	Intentionally left blank.

 

		d.	Taxes. Unless prohibited by law, the Supplier will separately indicate
on its Invoice any tax that is required to be imposed on the sale of Products.

 

		e.	Payment Terms. GEHC shall settle any undisputed invoices arising under
this Agreement within [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] days from invoice date, subject to receiving an invoice prepared
in accordance with the terms of this Agreement. All sums to be paid by GEHC under this Agreement shall be in the currency specified
in Attachment A.

 

 

 

		8.	Forecast/Commitment/Quantities

 

		a.	Forecasting. Before the end of each year, and on a rolling basis before the first day of
each calendar month, GEHC shall submit to the Supplier forecasts in writing for its estimated needs of the Products during the
subsequent twelve month period. The Supplier shall promptly provide any approved subcontractors with the forecast.

 

		b.	Non-binding and Binding Forecasts. Any twelve month forecast provided by GEHC or mutually
developed by the Parties for GEHC’s requirements for Products shall not be binding in any way on GEHC and GEHC may modify
any such forecast at any time in its sole discretion, except that the forecast for the first [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]of
any given twelve month forecast shall constitute a binding order for the Product (“Firm Period Forecast”) and GEHC
shall be required to “take or pay,” accordingly, unless otherwise agreed to in writing by the Parties. The Supplier
shall confirm within five (5) days of receiving any Firm Period Forecast of its ability to satisfy such order. Upon such confirmation,
the Supplier represents and warrants that it has the capacity and expertise necessary to manufacture and deliver to GEHC the base
volume forecast (ref Attachment A) of Products, and any increased volume of up to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] greater
than the base volume. Notwithstanding this, the Supplier shall make commercially reasonable efforts to accommodate GEHCs request
for volumes greater than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of the base volume . In the event that the Supplier is unable
to supply volumes in accordance with GEHCs forecasts, GEHC shall be relieved of its obligation to purchase only to the extent that
is required to meet GEHCs needs in the current calendar year for volumes that cannot be supplied by the Supplier. In
the event that AMRI is not able to deliver volumes according to the commitments in this Agreement and GEHC will need to source
the Product from a different source, [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].

 

 

		9.	Business Continuity plan

 

At GEHCs request, the Supplier
must share with the Parties a Business Continuity plan that includes Suppliers’ plan for 24/7 communication with the Parties.
The Business Continuity plan will also include basic information on Suppliers’ upstream Supply Chain. For instance, this
information will include who Suppliers’ Tier 1 are, where they are located and the means of transportation for this Supply
Chain. GEHC shall not be entitled to information about pricing or other commercial terms.

 

The Supplier agrees to provide
to GEHC an annual review and update of the Suppliers Business Continuity plan which shall include a risk assessment on how the
Supplier will meet their obligations as set forth in this Agreement. The Business Continuity plan, including the risk profile,
shall be reviewed at Suppliers’ expense at least every two years by a third party agreed upon by the parties.

 

    	5

    	 

    

 

In connection with the Business
Continuity plan, the Supplier agrees not to single source (single source shall not include suppliers with multiple sites that have
proven capability of providing such material) any key raw materials without the prior written consent of GEHC, such consent shall
not be unreasonably withheld or delayed.

 

 

		10.	Security Stock of the Product

 

The Supplier shall maintain
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] supply [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of the Product based on purchases made
by GEHC in the preceding calendar year. In the event GEHC calls upon the full supply of security stock within a [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] period, Supplier shall replace such security stock as soon as reasonably practicable. Upon termination
of this Agreement, GEHC shall immediately purchase and pay for this security stock at the then-current price under Attachment A.

 

 

		11.	Communication and Contract Managers 

 

		a.	Contract Managers. Both the Supplier and GEHC will appoint a contract manager to manage
their respective obligations under this Agreement, to act as focal points between the two organisations and review progress on
a quarterly basis. The contract manager shall be as specified below or such other person as subsequently communicated to the other
Party.

 

GEHC:Bård Reinholdtsen

SUPPLIER:

 

		b.	Legal Notices.

 

GEHC:

 

GE Healthcare AS

Lindesnes fabrikker

4521 Lindesnes

NORWAY

 

With a copy to:

 

Legal Services

Pollards Wood (PW/19)

Nightingales Lane

Chalfont St Giles

Buckinghamshire

HP8 4SP

United Kingdom

Fax: +44 (0) 1494 498045

 

Supplier:

 

 

AMRI

Attn: Legal Dept.

26 Corporate Circle

Albany, NY 12212

 

    	6

    	 

    

 

		c.	Crisis communication. The Supplier must maintain the ability to contact or receive contact
from GEHC on a twenty-four (24) hour per day, seven (7) day per week basis including public holidays in order to communicate and
manage crisis situations that threaten to or interrupt the supply chain.

 

		12.	Additional Terms

 

		a.	Upon notification to Supplier that GEHC has received a complaint or inquiry regarding the safety
or efficacy of Product, Supplier shall, upon request of GEHC and within a reasonable period, consistent with its own policies,
supply GEHC with a chemical analysis of retained samples of any lot that is subject of such complaint or inquiry. Supplier shall
retain all records and samples with respect to the Product in accordance with its own record retention policies.

		b.	Supplier and GEHC shall meet in person or by telephone conference at least once per Quarter during
the Term of the Agreement to review each Party’s performance hereunder.

 

		13.	Order of Precedence

 

The Parties agree that in the event of any conflict
or inconsistency between the terms and conditions of this Agreement, the order of precedence shall be (listed with the highest
precedence first):

 

The Supply Agreement

Attachment A - Products and Prices

Attachment B - Special Terms and Requirements

Attachment C - Commercial Terms and Conditions

Attachment D - Supplier Integrity Statement

Attachment E – Quality Assurance Agreement
including specification (Annex 4) of April 4th, 2010 (except that QAA shall take precedence over Attachment C in case
of conflict regarding quality requirements relating to the Material)

Attachment F - Documentation requirement for
supply of ABA Hcl.

Attachment G - Aminobisamide Packaging Specifications

 

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Attachment C

Commercial Terms and Conditions

 

 

		1.	Termination

 

		1.1	Mutual Termination.Either party may terminate
this Agreement:

 

		a.	at any time upon written notice if the other party (the “Defaulting
Party”) materially defaults in the performance of one or more of its obligations hereunder and the Defaulting Party fails
to cure the default within thirty (30) days after receiving written notice of such; or

 

		b.	upon thirty (30) days written notice if any proceeding under the bankruptcy
or insolvency laws is brought against the Defaulting Party, a receiver is appointed for the Defaulting Party or the Defaulting
Party makes an assignment for the benefit of creditors.

 

		1.2	Termination For Cause. Either party shall have the right to terminate
this agreement and/or, at either party’s discretion, relevant Purchase Orders, with immediate effect in the event of (i)
material breach by the Supplier of Attachment D; (ii) a repeated material breach of any term of this Agreement; (iii) consistent
failure by the Supplier to meet required delivery dates; or (v) ownership and control of the Supplier has been transferred to a
third party without GEHC ́s written approval.

 

		1.3	Intentionally left blank

 

		1.4	Purchase Orders.

 

		a.	If GEHC terminates this Agreement in accordance with clause 1.2, it may also
terminate all unfilled Purchase Orders without any liability except for the price of any Products previously delivered and accepted
by GEHC.

 

		b.	If this Agreement expires without renewal at the end of the Term, GEHC and
the Supplier each recognize and agree that any unfilled Purchase Orders issued prior to such termination or expiry but not yet
delivered, shall survive until fully performed.

 

		1.5	Termination of this Agreement shall not relieve the Defaulting Party of its
obligations and the non-defaulting party shall retain all legal and equitable remedies after such termination.

 

		2.	Risk Material and Safety Stock

 

		2.1	Risk Material. The Supplier must ensure that sufficient quantity of
Risk Materials (as detailed in the Attachment B), if any, are stocked to satisfy the requirements of this Agreement and to fulfil
forecasts.

 

		2.2	Security stock. Supplier shall maintain at its own cost and risk the
security stock agreed as set forth in Attachment B. The security stock shall be managed in accordance with FIFO principle.

 

		3.	Purchase Orders 

 

		3.1	Purchase Order Contents GEHC shall issue purchase orders to the Supplier
stating the quantity and delivery date for Products (a “Purchase Order”). The Purchase Orders shall be written
and sent by fax, e-mail or other agreed method, no less than ten weeks in advance of requested delivery date, and for such quantities
of Product as described in the Firm Period Forecast.

 

		3.2	Orders from Affiliates and Obligation to Purchase

 

		a.	From time to time Affiliates of GEHC may also issue purchase orders for Products
and, if requested by such Affiliate, the Supplier agrees to supply Products to such Affiliate on substantially similar terms as
of this Agreement.

 

		b.	For the purposes of this Agreement, an Affiliate of a party shall mean any
company controlled by or under common control with the relevant party where “control” means direct or indirect ownership
of at least 50% of the voting stock or interest in a company or control of the composition of the board of directors.

 

		c.	Subject to Attachment A, it is the express understanding of the Parties that
GEHC shall have no obligation to purchase Products exclusively from the Supplier or to purchase any minimum amount of Product,
and may use other suppliers for any and all Products or similar products. Accordingly, GEHC’s commitment to purchase Products
from the Supplier shall be limited to Purchase Orders released by GEHC.

 

		3.3	Changes to Purchase Order. GEHC may make changes to the terms of a
Purchase Order including, but not limited to, quantities ordered and delivery dates, or terminate in whole or in part a Purchase
Order provided that it confirms such changes or termination in writing at least 10 weeks prior to Shipment, and in any event, shall
not modify the quantities of Product required by any Firm Period Forecast.

 

		3.4	Acceptance of Purchase Order. The Supplier shall accept a Purchase
Order upon receipt from GEHC so long as the terms are consistent with those stated in this Agreement. The Supplier shall confirm
compliance with the Purchase Order in writing, including without limitation fax and e-mail, within five (5) Business Days of receipt
of Purchase Order.

 

    	8

    	 

    

 

		4.	Quality 

 

		4.1	Quality Plans The Parties are committed to quality in the performance of this Agreement. Accordingly, all Products shall
conform to the quality assurance requirements set forth in Attachment E.

 

		4.2	Audit and Inspection.

 

		a.	GEHC and/or its representatives shall have the right to enter the Supplier's
premises at reasonable periodic intervals to:

 

i.inspect the manufacturing
facilities and the equipment used by the Supplier in the manufacture of the Products except any information related to pricing
unless required by law in the possession or control of the Supplier relating to the performance of its obligations under this Agreement
or other applicable legal requirements (including the right to take copies at GEHC’s reasonable discretion);

 

ii.inspect the raw materials,
the packaging and the Products (including the right to take samples at GEHC’s reasonable discretion);

 

iii.inspect stock levels
of raw materials, packaging and the Products;

 

iv.audit the Supplier’s
quality system.

 

		b.	Inspections carried out pursuant to clause 4.2a shall be carried out during
business hours on reasonable notice to the Supplier, provided that, in the event of an emergency, the Supplier shall grant GEHC
and/or its representatives immediate access to its premises.

 

		c.	GEHC may also request periodic, joint quality assurance meetings at the Supplier’s
facility to update the status of product quality and reliability.

 

		5.	Packaging

 

		5.1	The Supplier shall be responsible, at its own expense, for the safe and suitable
packaging and labelling of the Products, for complying with the requirements of the Packaging Requirements in Attachment B, if
any, and all applicable laws and regulations relating to the packaging and transport of the Products.

 

		6.	Transportation and Title and Risk of Loss

 

		6.1	Unless otherwise agreed:

 

		a.	the Products will be delivered to the GEHC address stated in the Purchase
Order and title and risk of loss will pass to GEHC in accordance with the delivery terms set forth in Attachment A;

 

		b.	the price of the Products shall include all transportation costs, if in accordance
with the delivery terms and clauses set forth in Attachment A.

 

		6.2	If the supply of Products is international then the Products shall be delivered
according to the Incoterm stated in Attachment A. Such term of delivery shall be construed according to the edition of Incoterms
in force at the Effective Date.

 

		6.3	Deliveries shall not be regarded as completed until the Delivery Documentation
in Attachment B has been provided.

 

		7.	Delivery.

 

		7.1	The Supplier shall ship the Products on the date and in the quantity set
forth on the applicable Purchase Order. The Supplier shall not ship the Products more than five (5) Business Days in advance of
the specified shipment date without the prior written consent of GEHC. In the last week of a calendar Quarter, the Supplier shall
not ship the Products prior to the specified shipment date unless prior approval has been obtained from GEHC.

 

		7.2	The lead time for the Product shall count from issue of GEHC Purchase Order
to completion of delivery of the Products, including any agreed documentation.

 

		7.3	In the event that the Supplier anticipates or expects a delay in delivery
it shall immediately notify GEHC and at the same time explain the causes and the steps that it is taking to minimise the delay.
If the delivery is delayed by more than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] then GEHC may: [/*[CONFIDENTIAL TREATMENT REQUESTED]*/].
The Parties confirm that this sum represents a genuine pre-estimate of the loss that GEHC would suffer in the event that delivery
is delayed by more than the period specified in this clause.

 

		7.4	If Products are delivered to GEHC in excess of the quantities ordered GEHC
shall not be bound to pay for the excess and any excess shall be and shall remain at the Supplier’s risk and shall be returnable
at the Supplier’s expense or shall be held by GEHC and credited against future invoices.

 

 

    	9

    	 

    

 

		8.	Inspection Period.

 

		8.1	All Products delivered to GEHC by the Supplier must meet the terms and conditions
of this Agreement. All Products shall be received subject to GEHC’s acceptance or rejection on or before the end of the Inspection
Period. GEHC may reject an entire batch of Product based upon a reasonable sampling of such batch of Products.

 

		8.2	“Inspection Period” means a reasonable time after delivery of
any Products, to allow for the performance of any inspection, installation activities, testing or trials, but shall in no event
be less than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] or greater than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] Business Days.

 

		8.3	Partial or total payment by GEHC for Products under this Agreement prior
to the end of the Inspection Period shall not remove the Supplier’s responsibility for any non-conforming items.

 

		9.	Health and Safety.

 

		9.1	The Supplier shall ensure that all information held by or reasonably available
to it regarding any potential hazards known or believed to exist in the transport, handling, or use of any Products and/or performance
of any services shall be received by GE Healthcare in writing prior to delivery of the Products and/or performance of the services.

 

		9.2	The Supplier shall be responsible, where relevant, to ensure that tank containers
and other transport equipment are appropriately cleaned before filling or loading.

 

		9.3	Employees, agents and representatives of the Supplier visiting any of GEHC’s
sites shall be subject to such safety and security regulations as may be in force on that site.

 

		10.	Invoices

 

		10.1	The Supplier’s Invoices shall contain the GEHC Purchase Order number,
line reference and other such information as may be required by law or requested from time to time by GEHC. Invoices shall be addressed
to GEHC or the GEHC Affiliate who has placed the purchase order with the Supplier.

 

		11.	Late Payment 

 

Interest for late payment
shall apply at a rate of [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]. Interest for late payment shall not apply to payments that GEHC
contests in good faith and shall in no event exceed any applicable statutory interest rate.

 

		12.	Warranty 

 

		12.1	Product Warranty. The Supplier represents and warrants that the Products
at the time title and risk of loss pass to GEHC will:

 

		a.	conform strictly to and be manufactured in accordance with the Quality Agreement
and Specifications referred to in Attachment A; and shall for the Shelf life of the Product

be free from defects, whether
latent or otherwise; and

 

		b.	have received all applicable regulatory certifications, as required, to carry
out the Supplier’s obligations under this Agreement.

 

 

		12.2	Intellectual Property Warranty. The Supplier represents and warrants
that its intellectual property incorporated into Products, if any, will not infringe any patent, copyright, trade secret, trademark,
or other proprietary right of any third party. The Supplier also warrants that it has not and will not use or incorporate into
Products any intellectual property of others without the party's prior written consent, and that no other third party holds any
property rights or security interests in any Products.

 

		12.3	Execution and Performance of Agreement. The Supplier represents and
warrants that it has the full right, power, and authority to enter into and perform its obligations under this Agreement. The Supplier
further represents and warrants that the performance of its obligations under this Agreement will not result in a violation or
breach of, and will not conflict with or constitute a default under any agreement, contract, commitment, or obligation to which
such party or any of its Affiliates are a party or by which it is bound and that it has not granted and will not grant during the
term of this Agreement or any renewal thereof, including any conflicting rights, license, consent, or privilege with respect to
the rights granted herein.

 

		12.4	Survival of Warranties. The Supplier agrees that the warranties set
forth in section 12.1 shall be effective during the Inspection Period, and the additional warranties set forth in this section
shall survive the inspection, acceptance, and use of the Products by GEHC, its distributors and sub distributors for a period of
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] from completion of delivery of the Purchase Order (“Warranty Period”) and
that they (i) are for the benefit of GEHC and its successors and assigns; and (ii) are in addition to any warranties and remedies
to which the Supplier may otherwise agree or which are provided by law. The Supplier agrees to extend to GEHC any warranties received
from the Supplier’s supplier. The Supplier warrants Products only as set forth in this Agreement and disclaims all other
warranties.

 

    	10

    	 

    

 

		12.5	OTHER THAN THE WARRANTIES EXPRESSLY SET FORTH HEREIN, SUPPLIER MAKES NO WARRANTIES
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A SPECIFIC PURPOSE OR NON-INFRINGEMENT
OF ANY INTELLECTUAL PROPERTY RIGHTS WITH RESPECT TO ANY MATERIALS, INFORMATION, SERVICES OR PRODUCTS IT PROVIDES.

 

		12.6	Returns. GEHC may return to the Supplier any Product that does not
conform to the Specifications. GEHC is required to notify Supplier of such non-conformance within the Inspection Period. Any such
Product shall be returned to the Supplier with complete explanation and details of analysis demonstrating the failure of Product
to conform. If Supplier agrees with, or if Supplier disagrees but an independent laboratory selected by mutual agreement of the
Parties confirms, GEHC’s assertion that Product did not conform to Specifications at the time title and risk of loss to Product
passed to GEHC, such Product shall then be replaced, repaired, reprocessed or reworked (as applicable) and returned to GEHC at
the Supplier’s expense (including all transportation and insurance). In such event, the Supplier will, at its cost, and as
soon as reasonably practicable replace, repair, reprocess or rework the returned Product to bring the Product in conformance with
the warranty, and will return the replacement, repaired, reprocessed or reworked Product as soon as possible, but in any event
within [thirty (30) days], after confirmation of the Product’s non-conformance. If the Supplier is unable to replace, repair,
reprocess or rework (as applicable) and return the Product within [thirty (30) days], the Supplier shall provide GEHC a refund
as defined in clause 12.9 below. Notwithstanding anything express or implied to the contrary in this Agreement, the remedies set
forth in this section 12.6 shall be the sole remedies for any breach of warranty pursuant to section 12.1.

 

		12.7	Complaints. Any complaints shall be regarded as having been timely
lodged if GEHC notifies the Supplier of the fault within the Warranty period and provides a complete explanation and details of
analysis demonstrating the basis for such complaint. Within two weeks after any complaint lodged by GEHC concerning a defective
Product the Supplier shall make a detailed report to GEHC on the action that has been or will be taken to avoid any recurrence.

 

		12.8	Recalls. The Supplier shall maintain a documented reporting system
to GEHC when the Supplier has knowledge of any product issue related to safety or quality that results in stopping shipment or
requires a recall. Any actions taken by the Supplier to report a recall to a regulated agency must be communicated to GEHC immediately.
GEHC has the right to request the Supplier to provide all documents regarding the specific issue including the analysis, root cause
and corrective action taken to minimise any risk to GEHC customers.

 

		12.9	Credits/Refunds. If applicable in accordance with this section 12,
the Supplier shall promptly refund GEHC by wire transfer or cheque for any portion of payment GEHC made with respect to such Product.

 

		12.10	Remedies. The remedies contained in this section 12 are in addition
to all other remedies available at law or in equity.

 

		13.	Indemnification 

 

		13.1	Supplier’s Indemnity Obligations. The Supplier agrees to defend,
indemnify, protect, and hold harmless GEHC and GEHC’s Affiliates, employees, agents, servants, and representatives from and
against any and all third party claims, damages, losses, liabilities, and reasonable expenses of whatever nature (“Claim”)
relating to: (i) the breach by the Supplier of any warranty set forth in this Agreement; or (ii) any claim that the Supplier’s
intellectual property incorporated in or used in the manufacture of the Products infringes any patent, copyright, trade secret,
trademark, or other proprietary right of any third party; or (iii) the breach by the Supplier of its obligations under clause 14.1
of this attachment C; or (iv) any grossly negligent act or omission, or wilful misconduct of the Supplier or its agents, employees,
or subcontractors, except to the extent such Claim is caused by GEHC’s negligent act or omission or wilful misconduct of
GEHC or its agents, employees or subcontractors. GEHC shall as soon as practicable notify the Supplier of any such claim, suit,
or proceeding, and will assist (at the Supplier’s expense) in the defence of the same.

 

		13.2	GEHC’s Indemnity Obligations. GEHC agrees to defend, indemnify, protect, and hold
harmless Supplier and Supplier’s Affiliates, employees, agents, servants, and representatives from and against any Claims,
relating to: (i) a claim that the use or sale of a Product infringes or otherwise violates an intellectual property right of any
third party; and (ii) the distribution, use, manufacture or sale by GEHC of Product or formulated products containing Product,
including, but not limited to, its commercial sale or use in clinical trials, or any side effects, contraindications, illness,
injury and/or death resulting from use of Product or formulated products containing Product; except to the extent such Claim is
caused by Supplier’s negligent act or omission or misconduct of Supplier or its agents, employees or subcontractors, or to
the extent such Claim is due to Supplier’s breach of the warranties contained in section 12.1. The Supplier shall as soon
as practicable notify GEHC of any such claim, suit, or proceeding, and will assist (at GEHC’s expense) in the defence of
the same.

 

 

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		14.	Compliance

 

		14.1	Applicable laws. GEHC and Supplier represent, warrant, certify, and
covenant that its performance under this Agreement and the Products will comply with all applicable laws and regulations, and all
conventions and standards issued by relevant authorities; and that the Supplier has obtained all applicable permits and licences
necessary to perform its obligations under this Agreement

 

		14.2	The Supplier shall at GEHC’s request and expense give all reasonable
assistance necessary to obtain any licences required by GEHC with respect to the importation, exportation or use of the Products
and provide GEHC with all information in relation to the Products which may be required by any regulatory authority.

 

		14.3	Security Measures .The Supplier agrees that it will adopt industry
standard security measures which are consistent with its legal obligations regarding Product (including, if applicable, the Customs-Trade
Partnership Against Terrorism (“C-TPAT” where applicable).

 

		14.4	Export Restrictions. If any Products are subject to export restrictions
in the country of manufacture or shipment the Supplier shall supply GEHC prior to despatch with any relevant ECCN numbers and copies
of any export licences or other certificates required in the country of manufacture or shipment and, where Products contain US
components, details of the value as a percentage of the Products price.

 

		14.5	Country of Origin.  The Supplier will mark each Product, and, as appropriate,
Product packaging, labels, or invoices with the country of origin for the Product, in accordance with the applicable trade and
customs laws. The Supplier will also provide acceptable and auditable documentation that establishes the country of origin for
Product, including without limitation, certifications of origin for Products qualifying for NAFTA preferential duty provisions,
as applicable.

 

		14.6	WEEE, RoHS And Equivalent Directives. The Supplier shall provide to
GEHC in writing a list of any Products containing any: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB),
polybrominated diphenyl ethers (PBDE), or any other hazardous substances the use of which is restricted under EU Directive 2002/95/EC
(27 January 2003) (“RoHS Directive”), as amended, or under any equivalent directives or regulations. The Supplier represents,
warrants, and certifies that (i) except as specifically listed in a separate document attached to this Agreement, none of the Products
are “electrical or electronic equipment” under EU Directive 2002/96/EC (27 January 2003) (“WEEE Directive”)
or under any equivalent directive and (ii) none of the Products contain any arsenic, asbestos, benzene, polychlorinated biphenyls
(PCBs), carbon tetrachloride, or any chemical restricted under the Montreal Protocol on ozone-depleting substances.

 

		15.	Changes to Products

 

		15.1	GEHC Proposed Changes. GEHC may propose changes to the Specifications
by submitting the proposed changes to the Supplier in accordance with the Quality Assurance Agreement. The Supplier shall respond
in writing to GEHC within [thirty (30)] days after receipt of such changes with the following information, as applicable: (i) time
required to implement proposed changes; (ii) impact of proposed changes on pricing of Product; and (iii) impact of proposed changes
on the lead time of the Product. If the Parties agree on the changes to the Specification they shall amend this Agreement accordingly.
If the Parties fail to agree on the amendments to be made to the Agreement (to reflect the changes to the Specification) the terms
in effect prior to commencement of the negotiations shall remain in full force and effect and the Supplier shall continue to supply
the Product to the existing Specification, or GEHC, at its election, may remove the affected Product from this Agreement with no
liability to GEHC, except as may be required pursuant to the termination provisions of this Agreement.

 

		15.2	Supplier’s Proposed Changes. The Supplier may propose but shall
not implement, a change to the Specifications (including, but not limited to, changes which may affect quality, form, fit, function,
reliability, regulatory compliance, safety or interface capability with GEHC products) or a change in its manufacturing method
(including, but not limited to changes of sources of materials and changes in manufacturing processes or locations) without the
prior written consent of GEHC, which shall not be unreasonably withheld. The Supplier shall make such proposals in writing explaining
the reason for the changes and providing reasonable detail sufficient for GEHC to evaluate the proposal. The Supplier shall also
provide an estimated reduction or increase in price and lead times for the affected Products. GEHC shall be notified [three (3)
months] three (3) months in advance of the proposed implementation date to allow for evaluation by GEHC, unless the change is required
by a regulatory authority on shorter notice. At the request of GEHC, Supplier shall provide samples of the Products manufactured
according to the proposed new specification or manufacturing method for evaluation purposes.

 

 

    	12

    	 

    

 

		15.3	New Products. The Supplier shall notify GEHC of other product offerings
it has and, if both Parties are interested in adding such products to this Agreement, and the Parties are able to agree upon pricing
terms, such products will be added to the Attachment B of this Agreement by amendment.

 

		15.4	New Technology.  If during the Term, the Supplier develops and markets
a product that would be a replacement for any Product provided hereunder or an upgrade of any Product, the Supplier agrees to sell
said product to GEHC at GEHC’s option, for a price to be negotiated in good faith between the Parties. Both Parties also
agree that all appropriate provisions of this Agreement will apply to any such replacement or upgraded product. Nonetheless, except
as otherwise expressly provided by this Agreement, the Supplier agrees to continue to make the original Product available to GEHC
through the end of the Term.

 

		16.	Intentionally left blank

 

		17.	Electronic Data Interchange

 

		17.1	Access. GEHC, in its sole discretion, may permit the Supplier to have
on-line access to designated computer systems of GEHC in order to facilitate the Supplier's ability to perform its obligations
under this Agreement. Such access shall also be subject to the Supplier entering into a systems access agreement if so requested
by GEHC. If such access is granted, the Supplier shall give to GEHC the names of the Supplier's employees who have a legitimate
business need for such access to GEHC's computer systems, and GEHC shall provide a separate user identification code for each person.
The Supplier, at its own expense, shall provide and maintain any hardware, telecommunications services and software not furnished
by GEHC, which are needed to communicate reliably with GEHC's computer systems. GEHC, in its sole discretion, may terminate the
Supplier's access to GEHC's computer network at any time.

 

		17.2	Use Restrictions. The Supplier shall ensure that: (i) computer access
is limited to those employees with a legitimate business need whose names have been furnished to GEHC; and (ii) such employees
with access agree to keep any information so obtained strictly confidential, to use such information only to perform the Supplier's
contract obligations to GEHC and to cease accessing GEHC's computer systems when no longer required to perform work under this
Agreement. The Supplier shall promptly notify GEHC if it becomes aware of any unauthorized access to GEHC's computer systems or
unauthorized use of the information on the systems.

 

		18.	Confidentiality 

 

		18.1	During the Term, each party (the “Recipient”) may receive or
have access to certain information of the other party (the “Discloser”) that is Confidential Information of the Discloser.
For purposes of this Agreement, “Confidential Information” shall mean any information disclosed by the Discloser to
the Recipient, whether technology-related or business-related, whether furnished before or after the Effective Date and irrespective
of the form of communication, that is considered competitive, confidential or proprietary in nature together with any notes, summaries,
reports, analyses, or other material derived by the Recipient or its Representatives (defined below) in whole or in part from such
information in whatever form. The Recipient will protect the Confidential Information with the same degree of care as the Recipient
uses for its own similar information, but no less than a reasonable degree of care. Confidential Information may only be used by
those employees, contractors and advisors of the Recipient and its Affiliates (“Representatives”) who have a need to
know such information for the purposes related to this Agreement and who are bound by equivalent obligations as to confidentiality,
and the Recipient shall inform such Representatives of the confidential nature of such Confidential Information and the obligations
of the Recipient hereunder. The Recipient shall be responsible for any breach of this Agreement by it or any Representative to
the same extent as though such Representatives were Parties hereto. The Parties acknowledge that Confidential Information that
a party identifies as a trade secret is deemed Confidential Information to be protected indefinitely. The Parties also agree that
all other information, including but not limited to technical information (which is not a trade secret) and forecasts disclosed
during the Term or prior to the formation of this Agreement are deemed Confidential Information to be protected for a term of ten
(10) years from the date of disclosure.

 

		18.2	Visits. In the event of the Supplier visiting any of the establishments
of GEHC or its associated companies, the Supplier undertakes that any further Confidential Information which may come to the Supplier’s
knowledge, as a result of any such visit, shall be kept strictly confidential and that any such information will not be divulged
to any third party and will not be made use of in any way by the Supplier under any circumstances.

 

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		18.3	Exclusions. The undertakings in clauses this clause 18 shall not apply
to:

 

		a.	information which at the time of disclosure is published or otherwise generally
available to the public;

 

		b.	information which is published or becomes generally available to the public,
otherwise than through an act or omission on the part of the Recipient;

 

		c.	information which the Recipient can show by reasonable written record was
in his possession at the time of disclosure and which was not acquired directly or indirectly from the Discloser;

 

		d.	information rightfully acquired from a third party who did not obtain it
under a pledge of secrecy to the Discloser or another;

 

		e.	information which has been developed by the Recipient independently of the
Confidential Information received from the Discloser; or

 

		f.	information which the Recipient notifies the Discloser is required to be
disclosed by the Recipient pursuant to a legally enforceable order, direction or other regulation but any disclosure shall only
be so far as necessary to give effect thereto.

 

		18.4	Confidential Information shall not be deemed to be in the public domain merely
because any part of said Confidential Information is embodied in general disclosures or because individual features, components
or combinations thereof are known to the public.

 

		18.5	Return of Confidential Information. All Confidential Information supplied
to or acquired by each party and all copies thereof (in any media) shall be returned to the other party within fourteen (14) days
after termination of this Agreement All information consisting of documents, notes and other writings prepared by one party based
on non-public data of the other party shall be destroyed.

 

		18.6	Development. – The confidentiality terms in this section shall
not be construed to limit either party’s right to independently develop or acquire products without use of the other’s
Confidential Information.

 

		18.7	Restrictions on Use of Design Materials and Know How During and after
the Term the Supplier shall be prohibited from selling to any third party any Product or equivalent product that is either (i)
developed for GEHC under this Agreement; (ii) incorporates any GEHC Confidential Information; or (iii) is specifically designed
or configured for use with GEHC’s products using information received or know how developed in connection with this Agreement.

 

		19.	GEHC Tangible and Intellectual Property

 

		19.1	GEHC Property. All tools, equipment, materials or other proprietary
information and all intellectual property rights in the foregoing which GEHC furnishes to the Supplier, or which is developed or
acquired at GEHC’s expense or at its direction in the performance of the work hereunder if agreed at the time of development
or acquisition, shall be GEHC Property. The Supplier shall take all such steps as GEHC shall direct in relation to such GEHC Property,
including, but not limited to, in respect of tangible property marking, separately storing, maintaining, insuring and returning
the property at Supplier’s own cost. In no event shall GEHC Property include Supplier Property.

 

		19.2	Supplier Property. All tools, equipment, materials or other proprietary
information with respect to Supplier’s manufacturing methods or processes and all intellectual property rights in the foregoing,
owned by Supplier as of the effective date of this agreement or developed or improved during the Term, that are not GEHC Property
pursuant to section 19.1, shall be deemed Supplier Property, with all rights thereto owned exclusively by Supplier.

 

		19.3	Intellectual Property. No rights are granted to the either party under
any patents, copyrights, trade secrets, or other property rights of the other party, except as may be expressly agreed to in writing.

 

		19.4	Co-operation. The Supplier shall reasonably cooperate with GEHC to
secure any intellectual property rights to GEHC Property developed under this Agreement by, for example, assisting in the filing
and prosecution of patent applications, and executing such documents as GEHC may reasonably request, and at GEHC’s expense.

 

		20.	Notices 

 

		20.1	All notices required under this Agreement shall be in writing and in English
or accompanied by a properly prepared translation into English and shall be sufficiently served if delivered by hand (including
by courier) or if sent by pre-paid first class post or recorded delivery, or pre-paid air mail (requiring signature on delivery).

 

		20.2	In all cases notices shall be delivered to the respective Parties at the
addresses specified in Attachment B or such other address as that party may notify to the other, in accordance with the provisions
of this clause, any such change to take effect five (5) Business Days after the notice is deemed to have been received or, if later,
on the date specified in that notice.

 

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		20.3	A notice shall be deemed to have been received:

 

		a.	if delivered by hand (including by courier), at the time of delivery;

		b.	in the case of pre-paid first class post or registered mail, 9.00am two Business
Days after the date of posting

		c.	in the case of pre-paid airmail, 9.00am four Business Days after the date
of posting.

 

		20.4	For the purposes of this clause:

 

		a.	all times are to be read as local time in the place of deemed receipt; and

 

		b.	if deemed receipt under this clause is not within business hours (meaning
9.00 am to 5.30 pm Monday to Friday on a day that is not a public holiday in the place of receipt), the notice is deemed to have
been received when business next starts in the place of receipt.

 

		20.5	For the avoidance of doubt, notices under this Agreement may not be served
by fax or email, unless the Parties agree at the time of service.

 

		20.6	The provisions of this clause shall not apply to the service of any proceedings
or other documents in any legal action.

 

		21.	Dispute Resolution

 

		21.1	Arbitration – The Parties will attempt to resolve any dispute,
controversy or claim relating to this Agreement through good faith negotiations, within forty-five (45) days, failing which the
dispute may be submitted by either party for arbitration in accordance with the American Arbitration Association, which Rules are
deemed to be incorporated by reference into this clause. The tribunal shall consist of one arbitrator, and the seat of the arbitration
shall be in New York. The language of the arbitration shall be English, if requested by either Party. The cost of the arbitration
will be shared equally by the Parties. The arbitrator will have the authority to apportion liability between the Parties, but will
not have the authority to award any damages or remedies not available under the express terms of this Agreement. With regards to
any action for breach of confidentiality or intellectual property obligations, nothing in this section shall preclude either party
from seeking interim equitable relief but such request shall not be deemed a waiver of the obligation to arbitrate hereunder.

 

		22.	Business Contingency Planning

 

		22.1	Business Contingency Plan. Upon GEHC’s request, the Supplier
shall provide to GEHC a Business Contingency Plan that outlines the Supplier’s internal contingency arrangements to ensure
GEHC continuity of supply if the Supplier or any of the Supplier’s suppliers are unable to provide Products or components
to such Products to GEHC.

 

		23.	Insurance and Liability

 

		23.1	Insurance Each party undertakes to maintain a comprehensive liability
insurance policy with a reputable insurer including cover for commercial general liability and product liability on terms customary
to the business. Such insurance shall be for an insured sum of not less than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] and each
party shall supply the other with a Certificate of Insurance evidencing such coverage.

 

		23.2	Liability IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY
FOR LOST PROFITS, LOSS OF USE, LOSS OF BUSINESS, BUSINESS INTERRUPTION, LOSS OF DATA, COST OF COVER OR ANY INDIRECT, SPECIAL, CONSEQUENTIAL,
INCIDENTAL, OR PUNITIVE DAMAGES OF ANY NATURE WHATSOEVER, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY WHETHER BASED IN CONTRACT,
WARRANTY, TORT (INCLUDING WITHOUT LIMITATION, NEGLIGENCE), STRICT LIABILITY, STATUTORY OR OTHERWISE, ARISING OUT OF OR IN CONNECTION
WITH THIS AGREEMENT EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

		23.3	No exclusion Nothing in this Agreement, including in 23.2, limits
or excludes the liability of either party for death or personal injury caused by the negligence of its employees, or for fraud,
or shall be deemed to limit either party’s indemnity obligations.

 

		24.	Miscellaneous.

 

		24.1	Independent Contractor. The relationship of the Parties hereunder
shall be that of independent contractors. Nothing in this Agreement shall be deemed to create a partnership, joint venture, or
similar relationship between the Parties, and no party shall be deemed to be an agent of the other party. The Supplier shall indemnify,
defend, and hold harmless GEHC from and against any and all claims by the Supplier’s employees, contractors, or subcontractors
regarding entitlement to any compensation or benefits from GEHC or that GEHC was for any purpose their employer or co-employer,
including any claim for taxes or related penalties.

 

		24.2	Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of New York without regard to its conflicts of law principles. In the event of any issues arising that
supersedes arbitration, the federal or state courts of New York shall have exclusive jurisdiction thereto.

 

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		24.3	Force Majeure

 

		a.	The obligations of either party hereunder shall be excused or suspended to
the extent performance is prevented or delayed by any future condition, which (i) is beyond the reasonable control, and without
the fault or negligence, of the party affected thereby, (ii) was not foreseeable by such party at the time this Agreement was entered
into, and (iii) could not have been prevented by such party taking reasonable steps. Such conditions shall include, but not be
limited to, war mobilisation, riots, fire, explosion, flood, insurrection, embargo, currency restriction, and acts or omissions
of governments in their sovereign capacity.

 

		b.	The party invoking relief hereunder, shall, within thirty (30) days after
commencement of the condition there mentioned, give written notice thereof and of the anticipated consequences thereof, to the
other party.

 

		c.	In the event of any such condition, the Party affected thereby shall take
all reasonable measures to mitigate and minimise the effect of the condition, and to resume as promptly as possible the diligent
performance of its obligations under this Agreement, however GEHC shall be permitted during such time to acquire substitute or
replacement items from one or more alternative sources. If the delay lasts more than sixty (60) days GEHC may terminate this Agreement
and any applicable Purchase Orders.

 

		d.	Notwithstanding anything in this Agreement to the contrary, no delay or failure
of a party to perform its obligations hereunder shall be excused if and to the extent that it is caused by labour problems of such
party, such as strikes.

 

		24.4	Assignment. This Agreement is personal to the Parties and no party
shall without the prior written consent of the other party, assign, transfer, mortgage, charge, declare a trust of or deal in any
other manner with this Agreement or any part of it, or purport to do any of the same. Any such action shall be declared null and
void. No party shall sub-contract or delegate in any manner any or all of its obligations under this Agreement to a third party
or agent without the other party’s written consent.

 

		24.5	Notwithstanding clause 24.4, either party may assign its rights and obligations
under this Agreement without the other’s consent: (i) to an Affiliate; or (ii) incidental to the transfer of all or substantially
all of its business or that part to which this Agreement relates.

 

		24.6	This Agreement shall be binding upon and shall inure to the benefit of the
Parties hereto and their respective heirs, successors, and permitted assigns.

 

		24.7	Publicity. The Supplier shall not issue any press release or announcement,
use any of GEHC’s products or its name, logos or trademarks in promotional activity, or otherwise publicly announce or comment
on this Agreement without GEHC prior written consent.

 

		24.8	Amendment; Waiver; Survival. This Agreement may be modified only by
a writing signed by both Parties. Any failure to enforce any provision of this Agreement is not a waiver of that provision or of
either party’s right to later enforce each and every provision. The terms of this Agreement that by their nature are intended
to survive its expiration will continue in full force and effect after its expiration.

 

		24.9	Severability. If any provision of this Agreement is determined to
be legally unenforceable or invalid, it shall not affect the validity or enforceability of the remainder of the Agreement, and
the remaining provisions will continue in full force and effect. The Parties will substitute a provision that most closely approximates
the economic intent of the invalid provision.

 

		24.10	Battle of the Forms This Agreement contains the entire agreement and
understanding of the Parties and supersedes all prior agreements, understandings or arrangements (both oral and written) relating
to the subject matter of this Agreement. Any Orders placed under this Agreement shall be solely governed by the terms and conditions
of this Agreement. No general terms and conditions of either party referred to in purchase orders, order confirmations or elsewhere
shall apply, unless expressly agreed in writing.

 

		24.11	Interpretation. In this Agreement, reference to a clause, section
or Attachment are, except where otherwise stated, a reference to an Attachment of this Agreement and a clause or section of the
relevant Attachment. Clause, section or Attachment headings in this Agreement and any descriptive notes in brackets are for convenience
only and shall not affect the construction or interpretation of this Agreement. References to the words "include(s)"
or "including" shall be construed without limitation to the generality of the preceding words. Unless the context otherwise
requires, references to the singular include the plural and vice versa, references to any gender include all other genders and
references to “persons” shall include individuals, bodies corporate, unincorporated associations, businesses and partnerships.
Any reference to a day shall be to a calendar day unless specified otherwise. Any reference to a Business Day shall mean any day
which is not a Saturday, Sunday or public holiday in the country in which GEHC or its relevant Affiliate or the Supplier is situated
unless specified otherwise.

 

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		24.12	Rights of Third Parties. A person who is not a party to this Agreement
has no right under the Contracts (Rights of Third Parties) Act 1999to enforce any term of this Agreement, other than GEHC Affiliates
where they are permitted to purchase Products pursuant to the terms of this Agreement, but this does not affect any right or remedy
of a third party which exists or is available apart from that Act.

 

 

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Attachment D

Supplier Integrity, Business Conduct,
and Compliance Requirements 

 

 

A. Supplier agrees: (i) to comply
with all applicable legal, as well as GE policies contained herein, requirements, including those relating to labor, the environment,
health and safety, intellectual property rights and improper payments; (ii) that Supplier is responsible for ensuring that its
employees, contractors, representatives and sub-suppliers understand and comply with the same legal and GE policy requirements;
and (iii) that Supplier will not engage in unacceptable practices, including:

 

(1) Minimum Age. Employing
workers younger than sixteen (16) years of age or the applicable required minimum age, whichever is higher.

(2) Forced Labor. Using
forced, prison or indentured labor, or workers subject to any form of compulsion or coercion, or the trafficking in persons in
violation of the US Government’s zero tolerance policy or other applicable laws or regulations.

(3) Environmental Compliance.
Lack of commitment to observing applicable environmental laws and regulations. Actions that GE will consider evidence of a lack
of commitment to observing applicable environmental laws and regulations include:

(i) failure to maintain and enforce
written and comprehensive environmental management programs, which are subject to periodic audit;

(ii) failure
to maintain and comply with all required environmental permits; and

(iii) permitting any discharge
to the environment in violation of law, issued/required permits, or that would otherwise have an adverse impact on the environment.

(4) Health & Safety.
Failure to provide workers a workplace that meets applicable health, safety and security standards.

(5) Human Rights. Failure
to (i) respect human rights of Supplier’s employees; (ii) observe applicable laws and regulations governing wage and hours;
(iii) allow workers to freely choose whether or not to organize or join associations for the purpose of collective bargaining as
provided by local law or regulation; and/or (iv) prohibit discrimination, harassment and retaliation.

(6) Code of Conduct. Failure
to maintain and enforce GE policies requiring adherence to lawful business practices, including a prohibition against bribery of
government officials.

(7) Business Practices and
Dealings with GE. Offering or providing, directly or indirectly, anything of value, including cash, bribes, gifts, entertainment
or kickbacks, to any GE employee, representative or customer or to any government official in connection with any GE procurement,
transaction or business dealing. Such prohibition includes Supplier offering or providing of any consulting, employment or similar
position to any GE employee (or their family member or significant other) involved with a GE procurement. Supplier will not offer
or provide GE employees, representatives or customers or any government officials with any gifts or entertainment, other than those
of nominal value to commemorate or recognize a particular business transaction or activity involving GE. In particular, Supplier
shall not offer, invite or permit GE employees and representatives to participate in any contest, game or promotion conduct or
sponsored by Supplier.

(8) Business Entertainment
of GE Employees and Representatives. Failure to respect and comply with the business entertainment (including travel and living)
policies established by GE and governing GE employees and representatives. Supplier is required to understand the business entertainment
policies of the applicable GE business component or affiliate before offering or providing any GE employee or representative any
business entertainment. Business entertainment should never be offered to any GE employee or representative by Supplier under circumstances
that create the appearance of an impropriety.

(9) Collusive Conduct and
GE Procurements. Sharing or exchanging any price, cost or other competitive information or the undertaking of any other collusive
conduct with any other third party to GE with respect to any proposed, pending or current GE procurement.

(10) Intellectual Property
& other Data and Security Requirements. Failure to respect the intellectual and other property rights of others, especially
GE. In that regard, Supplier shall:

(i) only use GE information and
property (including tools, drawings and specifications) for the purpose for which they are provided to Supplier and for no other
purposes;

(ii) take appropriate steps to
safeguard and maintain the confidentiality of GE proprietary information, including maintaining it in confidence and in secure
work areas and not disclosing it to third parties (including other customers, subcontractors, etc.) without the prior written permission
of GE.

(iii) if
requested to encrypt and send data over the Internet, encrypt all such data;

 

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(iv) observe and respect all GE
patents, trademarks and copyrights and comply with such restrictions or prohibitions on their use as GE may from time to time establish;

(v) comply
with all applicable rules concerning cross-border data transfers; and

(vi) maintain all personal and
sensitive data, whether of GE employees or its customers in a secure and confidential manner, taking into account both local requirements
and the relevant GE policies provided to Supplier.

(11) Trade Controls & Customs Matters.
The transfer of any GE technical information to any third party without the express, prior written permission of GE. Failure to
comply with all applicable trade control laws and regulations in the import, export, re-export or transfer of goods, services,
software, technology or technical data including any restrictions on access or use by unauthorized persons or entities, and failure
to ensure that all invoices and any customs or similar documentation submitted to GE or governmental authorities in connection
with transactions involving GE accurately describe the goods and services provided or delivered and the price thereof.

(12) Use Subcontractors or Third Parties to Evade
Requirements. The use of subcontractors or other third parties to evade legal requirements applicable to Supplier and any of
the requirements set forth herein.

 

How to Raise an Integrity Concern.
Subject to local laws and any legal restrictions applicable to such reporting, Supplier will promptly inform GE of any integrity
concern involving or affecting GE, whether or not the concern involves Supplier, as soon as Supplier has knowledge of such integrity
concern. Supplier shall also take such steps as GE may reasonably request to assist GE in the investigation of any integrity concern
involving GE and Supplier.

(i) Define Supplier’s concern:
(a) who or what is the concern; (b) when did it arise; and (c) what are the relevant facts?

(ii) Prompt reporting
is crucial, and Supplier may raise an integrity concern by:

(a) discussing
with a cognizant GE manager;

(b) calling
the GE Integrity Helpline: +1 800-227-5003 or +1 203-373-2603;

(c) emailing
ombudsperson@corporate.ge.com; or

(d) contacting
any compliance resource (e.g., GE legal counsel or auditor).

 

Changes and Questions. GEHC policy requirements, including
those enumerated above, are subject to modification by GEHC at any time. Supplier agrees to contact its GEHC representative if
Supplier has any questions about the foregoing and/or their application to particular circumstances.

 

B. Where
the Products or Services being procured from Supplier are in support of a US government end customer, GEHC shall advise Supplier
in advance, in writing, and Supplier agrees to comply with the terms of FAR 52.212-5 (e) or 52.244-6 and (where the US government
end customer is the DoD) DFARS 252.212-7001(c) or DFARS 252.244-7000 to the extent those terms are applicable to the COTS or commercial
items being procured from the Supplier and as appropriate for the dollar value of the applicable order. The version of such terms
shall be those that are in effect as of the Effective Date of this Agreement. Supplier shall provide immediate notice to GEHC in
the event of being suspended, debarred or declared ineligible by any federal agency, or upon receipt of notice of proposed debarment
during the performance of this Agreement. Supplier agrees to comply with the requirements of section 27 of the “Office of
Federal Procurement Policy Act” (41U.S.C. 423), as amended by section 814 of Public Law 101-189, and with the implementing
regulations contained in FAR 3.104, and agrees to indemnify GEHC for any costs and liabilities incurred by GEHC as a result of
violations of the act or regulations by Supplier, its employees, its agents, its consultants, or subcontractors, or their employees.

 

C. Products
provided by Supplier may be subject to environmental, health and safety laws and regulations. As a result, Supplier agrees to the
following without limitation:

 

(1) Supplier represents, warrants,
certifies and covenants that Supplier shall perform all activities required under this Agreement in compliance with all applicable
national, EU, state/provincial and local labor, environmental, health and safety laws and regulations.

(2) Supplier represents, warrants,
certifies and covenants that each chemical substance constituting or contained in Products sold or otherwise transferred to GEHC
hereunder is:

(i) on the list of chemical substances
compiled and published by (a) the Administrator of the Environmental Protection Agency pursuant to the Toxic Substances Control
Act (15 USC Section 2601 et seq.) as amended; and (b) the equivalent lists in the other jurisdictions to which GEHC informs Supplier
or Supplier knows the Products will likely be shipped to or through; or is exempt from the foregoing lists, in which case Supplier
shall provide adequate documentation of the validity of the claimed exemption;

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(ii) manufactured, imported, used
and supplied in full compliance with the provisions of Regulation (EC) No 1907/2006 (“REACH”); and

(iii) pre-registered or registered,
if required, under REACH; is not restricted under Annex XVII of REACH; and if subject to authorization under REACH Annex XIV, is
authorized for GEHC’s use. In each case, Supplier will timely provide GEHC with supporting documentation, including without
limitation, (a) pre-registration numbers for each such substance, (b) the exact weight by weight percentage of any REACH candidate
list substance constituting or contained in the Products, (c) all relevant information that GEHC requires to meet the obligations
under REACH to communicate safe use to GEHC’s customers, and (d) the actual authorization for GEHC’s use of an Annex
XIV substance.

(3) Supplier shall notify GEHC
in writing if Supplier decides not to register substances that are subject to registration under REACH and constituting or contained
in Products supplied to GEHC at least twelve (12) months before their registration deadline. Supplier will monitor the publication
by the European Chemicals Agency of the list of substances meeting the criteria for authorization under REACH (the “candidate
list”) and immediately notify GEHC in writing if any of the Products supplied to GEHC are manufactured by Supplier with or
contains a substance officially proposed for listing on the candidate list. Supplier shall provide GEHC with the name of the substance,
as well as with sufficient information to allow GEHC to safely use the Products or fulfill GEHC’s own obligations under REACH.

(4) Supplier represents, warrants,
certifies and covenants that none of the Products supplied under this Agreement contain any above limits stated in law: (i) lead,
mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) or any other
hazardous substances the use of which is restricted under EU Directive 2002/95/EC (27 January 2003) (RoHS Directive), as amended;
(ii) arsenic, asbestos, benzene, polychlorinated biphenyls (PCBs), or carbon tetrachloride; (iii) any chemical restricted under
the Montreal Protocol on ozone-depleting substances; (iv) any substance listed on the REACH candidate list, subject to authorization
and listed on Annex XIV of REACH, or restricted under Directive 76/769/EEC and when it shall be repealed, Annex XVII of REACH;
or (v) any other chemical or hazardous material the use of which is restricted in any other jurisdictions to which GEHC informs
Supplier or Supplier knows the Products are likely to be shipped to or through, unless GEHC expressly agrees otherwise in writing
to Supplier referencing this Agreement and Supplier identifies an applicable exemption from any relevant legal restriction on the
inclusion of such chemicals or hazardous materials in the Products sold or transferred to GEHC. Upon GEHC’s request and subject
to the confidentiality provisions of this Agreement and GEHC’s ability to meet its compliance obligations, Supplier will
provide GEHC with the chemical composition, including proportions, of any substance, preparation, mixture, alloy or goods supplied
under this Agreement and any other relevant information or data regarding the properties, including, without limitation, test data
and hazard information.

(5) Supplier represents, warrants,
certifies and covenants that, except as specifically listed in a written document issued by GEHC that references this Agreement,
none of the Products supplied under this Agreement are (i) subject to electrical or electronic reuse or recycling take back requirements
pursuant to applicable national law, or (ii) contain batteries or accumulators subject to labeling or take back requirements pursuant
to applicable national law.

(6) Supplier represents, warrants,
certifies and covenants that Supplier has established an effective program to ensure that the activities of any suppliers it utilizes
to provide any chemicals, substances, goods or services that will be incorporated into the Products supplied under this Agreement
will be conducted in conformance with Sections C(1) to C(5) above.

(7) With respect to any Products
or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall provide all relevant information, including
without limitation, safety data sheets in the language and the legally required format of the location to which the Products will
be shipped and mandated labeling information, required pursuant to applicable requirements such as: (i) the Occupational Safety
and Health Act (OSHA) regulations codified at 29 CFR 1910.1200; or (ii) REACH or EU Directive 67/548/EEC, as amended, if
applicable, and (iii) any other applicable law, rule or regulation or any similar requirements in any other jurisdictions to which
GEHC informs Supplier that the Products are likely to be shipped.

(8) With respect to any Products or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall notify GEHC
in writing of the presence of any nanoscale material (defined for these purposes as any substance with at least one dimension of
such substance known to be less than 100 nano meters in length). With respect to all such nanoscale materials, Supplier shall provide
a description of its legal status in the relevant jurisdiction, and any safety data or other notifications that are appropriate
in the EU, US and the relevant jurisdiction.

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(9) For any Products specifically listed in a written document referencing this Agreement and provided by GEHC as indicated in
Section C(5) above, Supplier assumes responsibility for taking back those Products in the future upon GEHC’s request and
treating or otherwise managing them in accordance with all applicable laws, rules and regulations.

 

D.
Supplier represents and warrants that it shall have and comply with a security and
crisis management policy (which policy shall be revised and maintained proactively) with respect to security and crisis risks relevant
to Supplier’s business, and that Supplier has developed and implemented security procedures pertaining said policy (“Security
and Crisis Management Policy” or “SCMP”). At a minimum, the Security and Crisis Management Policy shall identify,
and require Supplier’s personnel to take measures necessary to do the following:

(a) provide for the physical
security of the people working on Supplier’s premises and others working for or on behalf of Supplier;

(b) provide for the physical
security of Supplier’s facilities and physical assets related to the performance of work, including (including the protection
of Supplier’s mission critical equipment and assets);

(c) protect from the loss of,
misappropriation of, corruption of, and/or other damage to software related to the performance of work;

(d) protect from the loss of,
misappropriation of, corruption of, and/or other damage to GEHC’s and Supplier’s drawings, technical data, and other
proprietary information related to the performance of work;

(e) provide for the prompt recovery
(including through preparation, adoption, and maintenance of a disaster recovery plan) of facilities, physical assets, software,
drawings, technical data, other intellectual property, and the Supplier’s business operations in the event of a security
breach, incident, crisis or other disruption of Supplier’s ability to use the necessary facilities, physical assets, software,
drawings, technical data, or other intellectual property or to continue operations; and

(f) ensure the physical integrity
and security of all shipments against the unauthorized introduction of harmful or dangerous materials (such measures include, but
are not limited to, (1) physical security of manufacturing, packing and shipping areas, (2) restrictions on access of unauthorized
personnel to such areas, and (3) personnel screening; and maintenance of procedures to protect the integrity of shipments).

GEHC reserves the right to inspect Supplier’s
SCMP and to conduct on-site audits of Supplier’s facility and practices to determine whether Supplier’s SCMP and implementation
thereof are reasonably sufficient to protect GEHC’s property and interests. If GEHC reasonably determines that Supplier’s
SCMP and/or implementation thereof is/are insufficient to protect GEHC’s property and interests, GEHC may give Supplier notice
of such determination. Upon receiving such notice, Supplier shall have thirty (30) days thereafter to make the policy changes and
take the implementation actions reasonably requested by GEHC. Supplier’s failure to take such actions shall give GEHC the
right to terminate this Agreement with cause immediately without further notice or compensation to Supplier.

 

Supplier agrees that it will review the
Customs-Trade Partnership Against Terrorism (C-TPAT) and the Authorized Economic Operator for Security (“EU AEO”) requirements
appropriate for its business and that it will maintain a written plan for security procedures in accordance with them (“Security
Plan”). The Security Plan shall address security criteria such as container security and
inspection, physical access controls, personnel security, procedural security, security training and threat awareness and information
technology security. Upon request of GEHC, Supplier shall: (i) certify in writing that it has read the C-TPAT and EU AEO security
criteria, maintains a written Security Plan consistent with those criteria and has implemented appropriate procedures pursuant
to it’s Security Plan; (ii) identify an individual contact responsible for Supplier’s facility, personnel and shipment
security measures, and provide GEHC with such individual’s name, title, address, email address and telephone and fax numbers;
and (iii) inform GEHC of its C-TPAT or EU AEO membership status. Where Supplier does not exercise control of manufacturing, storage
or transportation of goods destined for delivery to GEHC or its customers in international trade, Supplier agrees to communicate
the recommendations to its suppliers and transportation providers and to use commercially reasonable efforts to ensure that such
suppliers and transportation providers implement such recommendations. Further, upon advance notice by GEHC to Supplier and during
Supplier’s normal business hours, Supplier shall make its facility available for inspection by GEHC’s representative
for the purpose of reviewing Supplier’s compliance with the C-TPAT security recommendations and with Supplier’s Security
Plan. Each party shall bear its own costs in relation to such inspection and review. Supplier shall bear all other costs associated
with development and implementation of Supplier’s Security Plan and SCMP compliance.

    	21

    	 

    

 

Attachment E

[Quality Assurance Agreement] [PMQR]

 

 

 

    	22

    	 

    

 

QUALITY ASSURANCE
AGREEMENT - GE Healthcare

 

PARTIES

 

	
        GE Healthcare entity (hereinafter
        "GEHC") 

         

        Lindesnes Site

         

        Address
       N-4521 Spangereid

                               Norway

         
	
        Other Party (hereinafter
        "Supplier")
        Insert full legal
        name

         

        AMRI Rensselaer, Inc.

         

        Address            33 Riverside Avenue

        Rensselaer,
        NY 12144

        USA

         

 

Each a "Party"
and together the "Parties"

 

BACKGROUND

 

The
purpose of this agreement ("QA
Agreement'') is to define the
duties, procedures and responsibilities between GEHC
and the Supplier to
ensure that any material
supplied by the Supplier
will be manufactured and controlled to meet the required
quality standards agreed upon between GEHC and the Supplier.

 

AGREEMENT

 

	A. Agreement

 

In
consideration of GEHC purchasing the Material pursuant
to the contract between GEHC and the Supplier for the manufacture
and sale of the Material, the Supplier
agrees to comply with the terms and
conditions set out in
this QA Agreement in its manufacture, control, testing
and supply of the Materials to
GEHC.

 

B.Material

 

Aminobisamide Hydrochloride
(ABA-HCI)

	c.	
         

        Term
	
         

        Start Date
	
         

        Expiry
        Date• 31.
        12.2013

	 	 	1.02.2010	*see Annex 1

	D.General
terms

The following Annexes
are an integral part of this QA Agreement (the "Annexes").
The provisions of each
Annex shall be incorporated
by reference into and deemed
to be part of this QA
Agreement:

 

Annex 1 General Terms
and Conditions

Annex
2 Contacts

Annex 3 Manufacturing
Principles

Annex 4 Material Specifications

Annex 5 Sampling Requirements

Annex 6 Labelling,
Packaging and Transportation
Requirements

Annex
7 Sample Renewal Form

 

	This QA Agreement has
been executed in two
copies whereof the Parties have retained
one each

         

	Signed for and on behalf of GEHC	 	Signed for and on behalf of the Supplier
	
        Signature

         
	 	Signature	 
	
        Name (capitals)

        /s/ Asb0rn Jortveit
	Asbj0rn Jortveit	
        Name (capitals)

        /s/ Junan Guo
	Junan  Guo, Ph. D.
	Title	QA Manager	Title	Senior  Director, Pharmaceutical and Quality Services

 

 

 

	 

                            GEHC
Internal use only All Quality Assurance Agreements
require the internal
approval of the responsible
GEHC Quality Control manager for each GEHC Affiliate purchasing
Material from the Supplier or any
Supplier Affiliate pursuant to Clause 3.1 of Annex
1. You should name
the staff who have given approval,
none of which shall
be a party to this Quality Assurance Agreement.

                            

GEHC
Affiliate __________ Approving Quality
Control Manager ______ Date____

GEHC Affiliate __________ Approving Quality Control
Manager ______ Date ____

                            

                            

 

 

 

    	23

    	 

    

DRAFT SUBJECT TO CONTRACT

 

ANNEX 1 -GENERAL TERMS AND CONDITIONS

 

		1	DEFINITIONS AND INTERPRETATION

 

		1.1	The definitions in this Clause apply in this QA Agreement
(unless the context requires otherwise):

 

	Affiliate	
        Affiliates of the Supplier
        shall be deemed to include any company controlled by or under common

        control
        with the Supplier where control means direct or indirect ownership of at least 50% of the voting stock or interest in a company
        or control of the composition of the board of directors. Affiliates of GEHC shall be deemed to include any company: (i) which from
        time to time forms part of the GE Healthcare business of the group of companies whose ultimate parent is General Electric Company
        and (ii) controlled by or under common control with GEHC where control means direct or indirect ownership of at least 50% of the
        voting stock or interest in a company or control of the composition of the board of directors;

	AQL Document	means  a  separate written  document which may  be  agreed  by  the Parties, stated to be  an AQL Document and describing the acceptance quality levels against which the Supplier shall release a batch of the Materials in accordance with Clause 6 and/or GEHC may sample or test in accordance with Clause 6 and/or the Supply Agreement, if any, or any other contract for the supply of the Materials between Supplier and GEHC;
	
        Confidential

        Information
	
        means all information of
        a commercial or proprietary nature disclosed whether before or after the date of

        this
        QA Agreement which by its nature or manner of disclosure reasonably should be regarded as confidential, together with any notes,
        summaries, reports, analysis or other material derived by the Recipient (defined below) in whole or in part from such information
        in whatever form. Without limitation, Confidential Information may be disclosed orally or in writing or it may be acquired during
        site visits;

	
        Competent

        Authority
	means any government agency or regulatory or inspection authority in any country where GEHC holds a manufacturing license, marketing authorization, an application for either of the foregoing, a new drug application or other authorization or application for a Product where Material is an ingredient in such Product;
	Expiry Date	
        means either (i) the expiry date specified in Section
        C on page 1 or in any Renewal Form (defined

        below in Clause 2.2, or if none, (ii) the date of
        expiry or termination of the Supply Agreement and the

        "expiry" of this QA Agreement shall be construed
        accordingly;

	Major Change	has the meaning ascribed to it in Annex 3 of this Quality Assurance Agreement;
	Material	
        means the material or assembled or manufactured
        goods described in Section B that meet the

        Specification;

	Product	means any GEHC product which uses the Material either in its manufacture or as a component thereof	
         

         

	
        Raw Materials

        Critical

        Materials
	
        means any chemicals, solvents, and packaging materials
        used in the manufacture and supply of

        Material;

        Critical Materials means starting materials and
        other materials deemed critical for the quality of Material

        In the case of ABA-HCI, the critical materials are
        APD and DME.

	Specification	
        means the specification of the Material set out in
        Annex 4, as may be amended in accordance with this

        QA Agreement;

	
        Supply

        Agreement

         

         
	
        means any written agreement(s) entered into by GEHC
        or any of its Affiliates and the Supplier for the

        manufacture and sale of the Material to GEHC
        and/or its Affiliates which has been signed by both parties thereto.

 

		1.2	The headings in this QA Agreement are inserted for convenience
only and shall not affect its construction.

 

		1.4	References
to the words "include(s)" or "including" shall be construed without limitation to the generality of the preceding
words.

 

		1.3	References
to Sections and Annexes are references to a Section of page 1 and Annexes of and to this QA Agreement. References to Clauses are,
unless otherwise stated, references to Clauses of the Annex in which the reference appears.

 

		1.5	Unless
the context otherwise requires, references to the singular include the plural and vice versa, references to any gender include
all other genders and references to "persons" shall include individuals, bodies corporate, unincorporated associations,
businesses and partnerships.

 

 

    	24

    	 

    

 

DRAFT SUBJECT TO CONTRACT

 

		1.6	This QA Agreement shall be an annex of and incorporated by reference into the Supply Agreement,
if any, and any other contract for the supply of the Materials between Supplier and GEHC. If there is any conflict between this
QA Agreement and a Supply Agreement, if any, or any other contract for the supply of the Materials between Supplier and GEHC regarding
the quality requirements relating to the Material, this QA Agreement shall prevail.

 

		2	TERM 

 

		2.1	This QA Agreement commenced on the Start Date specified in Section C and shall
continue in full force and effect until the Expiry Date.

 

		2.2	If the Expiry Date is calculated by reference to the expiry date specified in Section C on page
1 or in any Renewal Form (defined below), this Agreement may only be renewed by the Parties executing a renewal form in substantially
the form set out in Annex 7 ("Renewal Form"), in absence of which this QA Agreement will automatically expire
on the Expiry Date.

 

		2.3	To avoid doubt, if the Parties have entered into a Supply Agreement, this QA Agreement shall continue
in full force and effect for the term of the Supply Agreement and shall automatically expire upon the expiry or termination of
the Supply Agreement.

 

		3	SCOPE

 

		3.1	The Supplier acknowledges and agrees that this QA Agreement is for the benefit of GEHC and any
GEHC Affiliates that purchase the Material from the Supplier or any of its Affiliates and who are listed in Annex 2 (if any) or
who purchase the Material from the Supplier or any of its Affiliates in accordance with the Supply Agreement, if any. The Supplier
shall not unreasonably refuse to add a GEHC Affiliate to Annex 2.

 

		3.2	Any Supplier Affiliate that supplies Material to GEHC or any of its Affiliates shall be subject
to all of the terms and conditions applicable to the Supplier under this QA Agreement and entitled to all of the rights and protections
afforded to the Supplier under this QA Agreement.

 

		3.3	To avoid doubt, any reference herein to GEHC shall be deemed to include reference
to any GEHC Affiliate placing the purchase order for the Material and any reference to the Supplier shall be deemed to include
reference to the Supplier Affiliate making the supply.

 

		4	CONTRACT MANAGER 

 

		4.1	Each Party has appointed a contract manager who shall act as a contact point
for the purposes of this QA Agreement. Each Party shall promptly notify the other of any change to its nominated contract manager.
As at the Start Date, the contacts for the respective Parties are as set out in Annex 2.

 

		5	MANUFACTURE AND QUALITY CONTROL

 

		5.1	The Supplier is responsible for the purchase, receipt, testing, storage, release and overall quality
of all Raw Materials in accordance with the terms and conditions of this QA Agreement.

 

		5.2	The Supplier shall perform its obligations in this QA Agreement with reasonable skill and care
in accordance with best practice and standards in the Supplier's industry or trade and in accordance with all applicable laws and
regulations.

 

		5.3	The Supplier is responsible for and shall undertake a quality assessment of key vendors of Critical
and Raw Materials. Critical and Raw Materials shall only be sourced from third parties who have been evaluated and approved by
the Supplier in accordance with its written internal requirements.

 

		5.4	The Supplier shall control and release the Raw Materials according to written
test procedures and specifications which the Supplier shall maintain and keep current.

 

		5.5	The Supplier shall ensure that the Material is manufactured, controlled and
supplied in accordance with applicable regulations, standards and guidelines as defined in Annex 3.

 

		5.6	During the manufacture of the Material, Supplier shall perform in-process and release control testing
in accordance with written and internally approved methods and specifications.

 

		5.7	The Supplier shall ensure that no materials from animal origin shall be used
in the manufacture of Material unless certified as TSE (Transmissible Spongiform Encephalopathies) risk free by the appropriate
agency or authority.

 

		5.8	The Supplier shall ensure that all equipment used in or in connection with the manufacture and
testing of the Material is qualified, calibrated and maintained as appropriate in accordance with applicable regulations, standards
and guidelines as defined in Annex 3.

 

		5.9	The Supplier shall ensure that at all times there will be a sufficient number
of personnel engaged in the manufacture of the Material with a suitable level of skill, qualification and experience.

 

		6	SAMPLES, APPROVAL, RELEASE AND CERTIFICATION 

 

		6.1	The Supplier is responsible for the release of all batches of Material for shipment to GEHC following
manufacture. The Supplier shall approve such batches based on a review of the manufacturing and control records and documents and
analytical results (if applicable) relating to each batch in question. Such review shall be performed against the criteria set out in the
AQL, if any.

 

 

    	25

    	 

    

DRAFT SUBJECT TO CONTRACT

 

		6.2	Except as set out in Annex 5, the Supplier shall not be responsible for the sampling of any Material
to be supplied to GEHC.

 

		6.3	If GEHC and the Supplier have agreed an AQL Document, any sampling shall be performed by either
GEHC or the Supplier, as applicable, against the criteria set out in the AQL Document.

 

		6.4	The release for use of the Material or the performance of acceptance testing by GEHC on the Material
if any, including without limitation any acceptance testing performed against the criteria in an AQL Document, shall not imply
any restriction of the Suppliers warranty relating to the Products either under the Supply Agreement, if any, or under any other
contract for the supply of the Materials between Supplier and GEHC, or otherwise remove the Supplier's responsibility for any non-conforming
items where either:

 

		6.4.1	the non-conformity is one that was not apparent on normal visual inspection
(if any is performed); or

 

		6.4.2	the non-conformity is one that was not apparent as result of acceptance testing, if any is performed,
and/or could not reasonably have been expected to be made apparent as a result of such acceptance testing.

 

		6.5	The Parties acknowledge that Clause 6.4 shall not apply where the non-conformity in question is
of a type against which acceptance testing is performed pursuant to the criteria in an AQL Document and the result of such acceptance
testing is within the agreed tolerances in such AQL Document.

 

		6.6	Nothing in this QA Agreement shall place an obligation on GEHC to sample or test the material either
on receipt or prior to its use and in this regard, the provisions of the Supply Agreement, if any, or any other contract for the
supply of the Materials between Supplier and GEHC shall apply; provided however that if the Parties have agreed an AQL Document
in writing, any acceptance testing shall be performed against the criteria in the AQL Document.

 

		6.7	The Supplier shall ensure that the certification specified in Annex 5 shall either accompany all
consignments of the Material or be otherwise sent to GEHC on or before the agreed delivery date for the Material. All such documents
shall be in English and either signed by an authorised person from the Supplier's Quality Assurance department or similarly validated
using an electronic system.

 

		7	LABELLING, PACKAGING AND TRANSPORTATION 

 

		7.1	The Supplier shall ensure that all Material sent to GEHC is labeled to permit, at a minimum, the
following details to be identified:

 

		7.1.1	Supplier name;

 

		7.1.2	Material name/Product code

 

		7.1.3	Supplier's own control number/lot number of the batch supplied

 
		7.1.4	Retest date (where applicable)

 

		7.2	Any specific labeling requirements are set out in Annex 6.

 

		7.3	The Supplier shall ensure that Material sent to GEHC is suitably packaged
to prevent damage during transportation.

 

		7.4	Any specific storage, shipping or packaging requirements are set out in Annex
6.

 

		8	REFERENCE SAMPLES

 

		8.1	The collection and storage of any reference samples of each batch of Material delivered to GEHC
shall be the responsibility of the Supplier.

 

		9	CHANGE CONTROL 

 

		9.1	The Supplier undertakes not to make, and shall procure that any permitted sub-contractor shall
not make any Major Change without the prior written approval of GEHC which may be withheld in GEHC's absolute discretion.

 

		9.2	The Supplier undertakes to follow the Change Control process set out in Annex
3 in respect of any Major Change.

 

		9.3	Except as specified in Annex 3, all Major Changes must be approved by GEHC
in writing before implementation. Any Major Changes agreed upon shall be appropriately verified and implemented in accordance with
any applicable requirements and guidelines and all other applicable laws and regulations.

 

		9.4	At the reasonable request of GEHC at any time, the Supplier shall provide samples of the Materials
manufactured and processed in accordance with the new specification, method, process or using the new Critical Materials or equipment,
as appropriate, for evaluation by GEHC including, without limitation, prior to any delivery of the Material to GEHC.

 

		9.5	If any unusual occurrence or major deviation is observed during or in connection with manufacture
and/or quality control, for example, without limitation, major deviations from the normal course of production and control,
difficulties disclosed by the quality control tests carried out on the Materials or any continued stability testing relating to
the Materials, the Supplier shall fully document this. If any such occurrence or major deviation will or may potentially affect
the quality, safety, performance or regulatory status of the Material or its fitness for purpose, the Supplier must promptly notify
the Quality Assurance Department of GEHC using the contact details provided for this purpose.

 

    	26

    	 

    

DRAFT SUBJECT TO CONTRACT

 

If
the occurrence or major deviation relates to Material that has already been supplied to GEHC, the Supplier shall provide such
notification using a rapid means of communication (fax, telephone, email) which it will then confirmed by a written report.

 

		9.6	Supplier shall continuously monitor applicable regulations,
standards and requirements relevant to the manufacture and supply of the Material and inform GEHC if any changes to Material test
procedures, Specifications and manufacturing practices are required.

 

		10	DOCUMENTATION AND RECORDS

 

		10.1	The Supplier shall maintain a documented quality system in accordance with
the standards referred to in Annex 3.

 

		10.2	The Supplier shall prepare and retain complete and accurate original batch documentation from the
manufacture and quality control of each batch of the Material for GEHC.

 

		10.3	Supplier shall keep a complete and
                                                             up-to-date archive of manufacturing formulas, processing, sampling
                                                             and packaging instructions/documentation, testing procedures, specifications,
                                                             standard operating procedures, change control records and other procedures
                                                             related to the manufacture and quality control of Material (which
                                                             together with the records referred to in Clause 10.2 shall be known
                                                             as the "Records").

 

		10.4	The Supplier shall implement and follow efficient procedures for version control
of the Records.

 

		10.5	The Supplier shall store the Records in a safe and secure manner such that they are easily retrievable
and reasonably protected from loss and damage.

 

		10.6	Copies of the Records shall be made available to GEHC upon reasonable request.

 

		10.7	Supplier shall keep all Records for a period of at least seven (7) years from the date of manufacture
of the Material to which they relate.

 

		11	AUDIT 

 

		11.1	GEHC shall be entitled to carry out and/or procure at its own cost the carrying out of an audit
of premises, equipment, procedures and personnel of the Supplier and any permitted sub-contractor to assess the ability of Supplier to successfully
meet the requirements of this QA Agreement and the Supply Agreement, if any, or any other contract for the supply of the Materials
between Supplier and GEHC.

 

		11.2	Such audit may be carried out not more than once in every twenty-four (24)
months except:

 

		11.2.1	if an audit reveals that the Supplier is non-compliant with the requirements set out in this QA
Agreement, the Supply Agreement, if any, or any other contract for the supply
of the Materials between Supplier and GEHC, GEHC shall be entitled to carry out and/or procure the carrying out of a further audit(s)
until the non-compliance has been resolved to GEHC's satisfaction, acting reasonably; or

 

		11.2.2	if there is a Major Change, in which case GEHC shall be entitled to carry out an additional audit
following such Major Change; or

 

		11.2.3	in the case of what is considered in the reasonable opinion of GEHC to be an emergency; in which
case GEHC shall be entitled to carry out such additional audit(s) as it considers reasonably necessary in the circumstances.

 

		11.3	For the purposes of illustration only, an emergency situation under Clause 11.2.3 may include, without
limitation, a quality investigation being conducted by GEHC or any Competent Authority.

 

		11.4	GEHC agrees to carry out any audit during normal working hours in such manner as to minimise disruption
and inconvenience to the Supplier and its permitted sub-contractors. Except in the case of what is considered to be in the reasonable
opinion of GEHC to be an emergency, the Parties agree that GEHC will give not less than thirty (30) days notice of an audit under
this Clause 11.

 

		11.5	GEHC and its representatives shall observe such site rules and regulations of the Supplier as the
Supplier enforces generally with respect to visitors to the site in question.

 

		11.6	Any anomalies identified that are outside the scope of the audit will be discussed if considered
necessary.

 

		11.7	Supplier shall use all reasonable endeavours to procure that its permitted sub-contractors will
permit the GEHC to exercise its rights under this Clause 11 and that its agreements with such permitted sub-contractors contain
rights of inspection in favour of GEHC in a form similar to those in this Clause 11.

 

		11.8	Without prejudice to GEHC's right of audit in this Clause 11, the Supplier acknowledges and agrees
with GEHC that representatives from any Competent Authority may, in relation to the manufacture of the Material, carry out or procure
the carrying out of an audit of premises, equipment, procedures and personnel of the Supplier and any permitted
sub-contractor if required in connection with their inspection or assessment of GEHC for products where Material supplied from
Supplier is used. Notwithstanding anything to the contrary in the Supply Agreement, if any, or any other contract for the supply
of the Materials between Supplier and GEHC, this QA Agreement will be accessible upon request to any Competent Authority.

 

		11.9	Furthermore, Supplier shall provide GEHC with all reasonable assistance required
in connection with any applications made by GEHC to, and answering relevant questions raised by, any Competent
Authority.

 

    	27

    	 

    

 

DRAFT SUBJECT TO CONTRACT

 

 

		12	COMPLAINTS

 

		12.1	The Parties shall keep each other currently informed about complaints received from third parties
concerning the Material and, in the Supplier's case, the Critical Materials. If such complaint relates to the quality, safety,
performance or regulatory status of the Material and/or Critical Materials or its fitness for purpose or it otherwise requested
by GEHC, the Supplier shall immediately and fully investigate the complaint within the timescales specified in Annex 2 or, in none,
in a timely manner.

 

		12.2	If the complaint relates to the quality, safety, performance or regulatory status of the Material
or its fitness for purpose, the Party originally receiving the complaint shall notify the other Party of its receipt using a rapid
means of communication (fax, telephone, email) followed promptly by written notification. Reports detailing the outcome of any
investigation into the report shall be provided in writing on the Supplier's headed notepaper, signed by the Supplier.

 

		13	CONFIDENTIAL INFORMATION

 

		13.1	During the Term, each party (the "Recipient") may receive or have access to certain information
of the other party (the "Discloser") that is Confidential Information of the Discloser.

 

		13.2	Subject to Clause 13.3, 13.4, 13.5 and 13.6 the Recipient:

 

		13.2.1	shall treat as strictly confidential and use solely for
the purposes contemplated by this QA Agreement, the Supply Agreement, if any, and any other contract for the supply of the Materials
between Supplier and GEHC, any and all Confidential Information obtained or received by it as a result of entering into or performing
its obligations under this QA Agreement, the Supply Agreement (if any) and any other contract for the supply of the Materials
between Supplier and GEHC; and

 

		13.2.2	shall not, except with the prior written consent of the Discloser publish or
otherwise disclose to any person any Confidential Information for any purpose whatsoever

 

		13.3	The undertakings in Clause 13.1 shall not apply to:

 

		13.3.	1 information which at the time of disclosure is published
or otherwise generally available to the public;

 

		13.3.2	information which is published or becomes generally available
to the public, otherwise than through any act or omission on the part of the Recipient or any Authorised Representative (defined
below);

 

		13.3.3	information which the Recipient can show by reasonable written record was in its possession at
the time of disclosure and which was not acquired directly or indirectly from the Discloser;

 

		13.3.4	information rightfully acquired from a third party who did not obtain it under pledge of secrecy
to the Discloser or another; or

 

		13.3.5	Information that is independently developed without use of or reliance on the Discloser's Confidential
Information.

 

		13.4	The Recipient may disclose Confidential Information which would otherwise be
subject to Clause 13.1 if but only to the extent that it can demonstrate that such disclosure is required by law or by any securities
exchange or regulatory or governmental body having jurisdiction over it, wherever situated, and whether or not the requirement
has the force of law, provided that any such disclosure shall not be made without prior consultation, if possible, with the Discloser.

 

		13.5	The Recipient may disclose Confidential Information to those of its officers,
employees, agents and professional advisors who need to know for the purposes of this QA Agreement and the Supply Agreement, if
any, or any other contract for the supply of the Materials between Supplier and GEHC, and who are bound by similar obligations
as to confidentiality (each an "Authorised Representative"). The Recipient shall inform each Authorised Representative
receiving Confidential Information in accordance with this Clause of its confidential nature.

 

		13.6	GEHC may disclose the Confidential Information of the Supplier to any Competent
Authority, provided it has agreed with the Supplier in advance of any disclosure the extent and manner of such disclosure. The
Supplier agrees that it shall not place any unreasonable conditions upon such disclosure.

 

		13.7	Confidential Information shall not be deemed to be in the public domain merely
because any part of said Confidential Information is embodied in general disclosures or because individual features, components
or combinations thereof are known to the public.

 

		13.7.	1 All Confidential Information supplied to or acquired by the Recipient shall
be returned promptly to the Discloser on written request and, in any event, on expiry of this QA Agreement, except that the Recipient
shall be entitled to maintain one (1) copy of such Confidential Information to ensure compliance hereunder.

 

		13.7.2	The restrictions contained in this Clause shall survive the expiry of this
QA Agreement and shall continue for a period of five (5) years after its expiry.

 

    	28

    	 

    

 

DRAFT SUBJECT TO CONTRACT

 

		14	EFFECTS OF EXPIRY

 

		14.1	Expiry of this QA Agreement shall not affect any rights, remedies or obligations
of the parties that have accrued or become due prior to the Expiry Date.

 

		14.2	The provisions of Clause 10, Clause 11.9, Clause 12, Clause 13, Clause 14 and Clause 16 shall survive
the expiry of this QA Agreement and continue in full force and effect, along with any
other Clauses or Annexes necessary to give effect to them. In addition, any other provision of this QA Agreement which by its nature
or implication (including in respect of any accrued rights and liabilities is required to survive the expiry of this QA Agreement)
shall survive expiry as aforesaid.

 

		15	SUB-CONTRACTING AND ASSIGNMENT

 

		15.1	Unless the Supply Agreement provides otherwise, the Supplier may not sub-contract the manufacture
of the Material and/or any of its obligations under this QA Agreement without the prior written consent of GEHC.

 

		15.2	Any permitted sub-contract arrangements with any third party should ensure, without limitation,
that the manufacturing, control and analytical information are made available in the same manner as between Supplier and GEHC.

 

		15.3	Any permitted sub-contractors known at the Start Date of this QA Agreement are as set out either
in Annex 2 or in the Supply Agreement, if any.

 

		15.4	The Supplier shall ensure that none of its sub-contractors, without the prior written consent of
the Supplier and GEHC, sub-contract, assign, transfer or otherwise dispose of the whole or any part of their rights or obligations
under their sub-contracts and that the sub-contracts shall contain provisions to this effect.

 

		15.5	The Supplier shall at all times remain fully liable to GEHC in connection with the manufacture of
this Material and for the performance of this QA Agreement and for the compliance of any third · party to
which it sub-contracts any of its obligations hereunder as though it was its own conduct.

 

		15.6	This QA Agreement is personal to the Parties and, subject to Clause 15.3, no party shall without
the prior written consent of the other party, assign, transfer, mortgage, charge, declare a trust of or deal in any other manner
with this QA Agreement or any part of it, or purport to do any of the same. Any such action shall be declared null and void.

 

		15.7	Notwithstanding Clause 15.2, GEHC may assign its rights and obligations under this QA
                                                                 Agreement without the Supplier's consent: (i) to an Affiliate; or (ii) incidental to the transfer of all or substantially all of its business or that
part to which this QA Agreement relates.

 

		15.8	To avoid doubt, any assignment of the Supply Agreement in accordance with its terms shall be deemed
to include an assignment of this QA Agreement to the same third party assignee.

 

		16	GENERAL 

 

		16.1	The relationship of the Parties hereunder shall be that of independent contractors. Nothing in
this QA Agreement shall be deemed to create a partnership, joint venture, or similar relationship between the Parties, and no party
shall be deemed to be an agent of the other party.

 

		16.2	Except as required by applicable law or regulations, neither Party shall use the name, trademarks, trade names, or other references
from which a Party can be identified in any advertising, publicity, press releases or similar disclosures without the prior written
consent of the other Party.

 

		16.3	Modification shall only be agreed by the Parties in writing and expressly designated
as a modification of this QA Agreement.

 

		16.4	If any provision of this QA Agreement or the application of any such provision to any person or
circumstance shall be invalid under the law of any jurisdiction, the remainder of this QA Agreement or the application of such
provision to persons or circumstances other than those as to which it is invalid shall not be affected thereby.

 

		16.5	The failure of either Party to enforce its rights under this QA Agreement at any time for any period
shall not be construed as a waiver of such rights.

 

		16.6	Except as provided in the Supply Agreement, if any, or any other contract for the supply of the
Materials between Supplier and GEHC and without prejudice to Clause 1.6:

 

		16.6.1	this QA Agreement contains all of the agreements and understandings between the Parties with respect
to the quality requirements and obligations relating to the Material and supersedes and terminates all prior agreements and understandings
between the Parties; and

 

		16.6.2	there are no agreements or understandings, either oral or written, between the Parties regarding
the quality requirements relating to the Material other than as contained in this Agreement.

 

		16.7	The Supplier acknowledges that in entering into this QA Agreement, it has not relied on or been induced to enter into this QA Agreement by any statement, representation, warranty, understanding, assurance, covenant, undertaking or commitment of any nature whatsoever of any person (whether a party to this QA Agreement or not) which is not set out in this QA Agreement.

                                                                                The Supplier agrees that it
shall have no right of action or remedy against GEHC arising out of or in connection with any statement, representation, warranty
or understanding of any person (whether a party to this QA Agreement or not) which is not set out in this QA Agreement. The only
remedy available to the Supplier shall be for breach of
contract.

 

 

    	29

    	 

    

DRAFT SUBJECT TO CONTRACT

 

 

		16.8	Notwithstanding that any term of this QA Agreement may be or become enforceable by a person who is not a party to it, the terms
of this QA Agreement or any of them may be varied, amended or modified or this QA Agreement may be suspended, cancelled or terminated
by agreement in writing between the parties, or this QA Agreement may be rescinded (in each case), without the consent of any such
third party.

 

		16.9	This Agreement shall be governed
by and construed in accordance with either the laws governing the Supply Agreement, if any, or if none, the laws of the country
where GEHC, or the GEHC Affiliate
who places a purchase order for the Material (if applicable), is located.

 

		16.10	The Parties hereby submit to the dispute resolution applicable to the Supply Agreement, if any or, if none, to the
non-exclusive jurisdiction of the courts of the country where GEHC or the GEHC Affiliate who places a purchase order for the Material
(if applicable) is located.

 

		16.11	This QA Agreement may be executed in any number of counterparts, each of which when executed and
delivered shall constitute an original of this QA Agreement, but all the counterparts shall together constitute the same agreement.
No counterpart shall be effective until each Party has executed at least one counterpart.

 

    	30

    	 

    

 

ANNEX
2- CONTACTS

 

 

GEHC
AFFILIATES, SITE ADDRESSES AND CONTACT INFORMATION

 

		1.	GEHC AFFILIATES AND SITE ADDRESSES

 

	GEHC Affiliate:	 
	Address:
	 	 
	Site:
	
        Site Address:

        State Address or if the same as above, state

        "As Above"

 

	GEHC Affiliate:	 
	Address:
	 
	Site:
	
        Site Address:

        State
        Address or if the same as above, state

        "As Above"

 

[Any
GEHC Affiliates who may purchase the Material under the terms of the Supply Agreement.]

 

 

		2.	CONTRACT MANAGERS AND CONTACT INFORMATION

 

	GEHC	SUPPLIER
	Contract Manager	AsbjØrn  Jortveit	Contract Manager	Gary Klee
	Address	
         

         

        Lindesnes Site

        N-5421 Spangereid

        Norway
	Address	
         

        AMRI Rensselaer, Inc.

        33 Riverside Avenue

        Rensselaer, New York 12144

        USA

	Telephone	+47 38 25 82 02	Telephone	518-433-7700 ext 7525
	 	Email	AsbjØrn.Jortveit@ge.com	Email	gary.klee@amriglobal.com
	Fax	+47 38 25 97 50	Fax	518-433-7819

 

GEHC
personnel·

	Quality Assurance	
        Lindy Sorland

        Lindy.Sorland@ge.com
	QA Director
	
        AsbjØrn Jortveit

        AsbjØrn.Jortveit@ge.com
	QA Manager
	Quality Control	
        Monica lren Alvestad

        Monica-lren.Aivestad@ge.com
	QC Manager
	Production and logistic	
        Jorunn Gislefoss

        Jorunn.gislefoss@ge.com
	Operations  Director
	 	
        Roger Halvorsen

        Roaer.Halvorsen@ge.com
	Logistic Manager
	
        Purchasing

         
	
        Bard Reinholdtsen

        Bard.Reinholdtsen@ge.com

         
	Global Sourcing Manager
	Purchasing	
        Bard Reinholdtsen

        Bard.Reinholdtsen@ge.com
	Global Sourcing Manager

 

 

AMRI1
personne:

	Quality Assurance	Karen Matteo	Assistant Director, QA
	Quality Control	Jody Meringlo	
        Senior Research Scientist II, AQS

	Regulatorv	Gary Klee	Director,
    Regulatory Affairs

 

 

 

		3.	PERMITTED SUBCONTRACTORS (CLAUSE [ ])

N/A

 

    	31

    	 

    

ANNEX
3-MANUFACTURING AND QUALITY SYSTEM PRINCIPLES

 

		1.	Quality System Requirements

 

		1.1.	Quality systems

 

The
supplier should establish, document, and implement an effective system for managing quality that involves the active participation
of management and appropriate manufacturing personnel.

 

The
system for managing quality should encompass the organizational structure, procedures, processes and resources, as well as activities
necessary to ensure confidence that the material will meet its intended specifications for quality and purity. All quality related
activities should be defined and documented. Key elements in the quality system are addressed in § 5
to 12 in Annex 1. Besides, the additional requirements below also apply.

 

 

 

		1.2.	Manufacturing

 

The
Supplier agrees not to manufacture, blend mix or store any cytotoxic or highly potent substances (such as antibiotics, cephalosporins,
beta-lactams, cytotoxics, steroids etc.) in equipment and pipin1 used for the manufacture of Material without prior notification
to GEHC. In general the Supplier is obliged to implement and maintain appropriate procedures for equipment cleaning in order to
prevent cross-contamination.

 

 

		2.	Change Control- Major Changes

 

		2.1	For the purposes of this QA Agreement, a Major Change
means [any deviation or change to:

 

		a.	the Specification; or

 

		b.	the Critical Materials and Critical Material Suppliers,
manufacturing process and location, including but not limited to key equipment used in the manufacture of the Material, testing
and analytical procedures for Material, and quality control procedures for Material;

 

		c.	the manufacturing site including, without limitation,
a change to a new manufacturing site location and any change which causes or will cause the equipment used in the manufacture
of the Material to be moved to a new building on the current manufacturing site location.

 

[in each case which will or may potentially
affect the quality or regulatory status of the Material or its fitness for purpose]],

 

		2.2	If the Supplier or any permitted sub-contractor wishes
to implement a Major Change, the Supplier shall submit the change to GEHC in writing (in the form of a document revision which
is to be approved by GEHC), explaining the reason for the changes and providing reasonable detail sufficient for GEHC to evaluate
the change.

 

		2.3	The supplier should provide a brief summary of major
changes to GEHC on annual basis.

 

		3.	Complaints Response

 

	
         

        LEVEL OF COMPLAINT
	
         

        RESPONSE TIMES

	Critical Complaints:	A verbal and initial written reply within 2 days after receipt of samples (if samples available)-maximum duration is 4 weeks for a comprehensive written reply.
	Major Complaints:	
        A verbal and initial written reply within 7 days after
        receipt of samples (if samples available)-

        maximum duration is 4 weeks for a comprehensive written
        reply.

	Corrective Actions;	
        Must be received from Supplier
        once all internal investigations have been completed, a maximum of 4 weeks duration is given for the corrective action to be raised
        and sent to GEHC.

        

 

 

 

    	32

    	 

    

 

ANNEX 4 – MATERIAL SPECIFICATIONS

 

 

Product:
Aminobisamide Hydrochloride

 

 

 

	Issued:	1.01.2010	Supersedes: 1.01.2009

 

	Written by:	Odd. E. Ingvoldstad
	 	 
	Approved by: 	Asbjorn Jortveit

 

 

 

	PROPERTY/TEST	UNIT	SPEFICIATION
	 	 	 
	Appearance	 	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	TLC:	 	 
	Identification	 	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	wt%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	wt%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	UC Spectrum (Identity)	 	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	UV Assay	wt%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	 	 	 
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	wt%	 
	 	 	 
	HPLC:	 	 
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AREA%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AREA%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AREA%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AREA%	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	Colour of Solution	 	 
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AU	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AU	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	AU	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]
	 	 	 
	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]	ppm	[/*CONFIDENTIAL TREATMENT REQUESTED]*/]

 

The supplier accepts that the product, which implies all containers
within each lot shipped to GE Healthcare AS, Lindesnes Site, should meet the above mentioned specifications.

Relevant documentation to confirm compliance (as certificate
of analysis) should accompany each delivery. 1)

Alternative test: Determination of water by Karl Fischer.

 

    	33

    	 

    

ANNEX
5- SAMPLING, RELEASE & CERTIFICATION REQUIREMENTS

 

		1.	Sampling

 

		1.1.	Sampling procedures

 

The
supplier shall sample each manufactured loUbatch according to written procedures. The samples shall be used for analysis and release
of each material batch.

 

		1.2.	Retain samples

 

The
Supplier shall keep retained samples under adequate conditions for six (6) years from the year of manufacture. The retained samples
shall be large enough to perform full retest of the lot on two occasions. The retest shall include all tests specified for release.
GEHC is entitled to receive a sample of retained material on request.

 

 

		2.	Release

 

The
Supplier is responsible for the qualification of the methods, release testing and sampling procedure, to ascertain that the results
on each lot of Material are representative for the whole lot, and to ascertain that the Material is delivered to GEHC within the
specifications agreed upon (Annex 4). Continued long-term use of the methods and acceptable historical results renders the methods
sufficiently qualified to the satisfaction of both parties.

 

Each
shipment of Material delivered to GEHC shall be accompanied by documentation according to Annex 6.

 

 

		3.	Certification

 

		o	Certificate
of Conformance

		o	Certificate
of Sterility

		o	Certificate
of Origin

		þ	Material
Safety Data Sheet

		þ	TSE
Certificate (general, not lot/batch specific)

 

The
Supplier shall for each delivery provide GEHC with Certificate of Analysis for each lot/batch, according to requirements stated
in Annex 4 and 6.

 

    	34

    	 

    

ANNEX
6- LABELLING, SHIPPING, PACKAGING AND TRANSPORTATION REQUIREMENTS

 

Packaging and labeling

 

ABA-HCI shall be packed in suitable containers
with light closure systems to protect the product during storage and transportation.

 

ABA-HCI shall be packed
as follows: Bagged in Coated/Woven Polypropylene Bag. Size of packaging should match with GEHC's needs for making full batches
without splitting bags. Stubs from the Supplier may be collected batch by batch in separate bags to make a full bag size. Quantities
and identification of each batch must be recorded and the documentation must accompany the shipment The parent batches must be
shipped prior to or in the same shipment as the stub bags.

 

The supplier agrees not
to change the above packaging without seeking prior approval of GEHC.

 

The containers of ABA-HCI
delivered to GEHC shall be marked with Product name, quantity, lot number, and relevant safety regulation.

 

 

Documentation requirement

 

Enclosed each delivery:

 

Copy of the packaging
list (which includes the following information):

- Supplier name

- Customers order number

- Quantities (specified
pr. lot/batch)

- Shipment date

 

 

    	35

    	 

    

 

ANNEX 7- SAMPLE RENEWAL FORM

 

 

 

	QUALITY ASSURANCE  AGREEMENT RENEWAL FORM
	GE HEALTHCARE	THE SUPPLIER
	Address	Address
	Each a "Party" and together the "Parties",
	Aqreement
	
         

        The Parties in accordance
        with Clause 2.2 of Annex 1 of the Quality Assurance entered into by and between the Parties with effect from [xxxxxxxxx] (the "Agreement")
        hereby agree to renew the Agreement as follows:

         

        Starting
        Date of Renewal Term:

        [                      ]

        

Expiration Date of Renewal
Term:

[                      ]

 

        All capitalized terms used
        but not defined herein shall have the meaning ascribed to them in the Agreement. All terms and conditions of the Agreement shall
        remain unchanged and continue to apply in full force and effect [except as amended and/or provided hereunder]:

         

        [Insert amendments, if
        any]

	For and on behalf of GEHC	For and on behalf of the SUPPLIER
	
         

        Signature:

        By: (print name)

        Title:
        

        Date:
	
         

        Signature:

        By: (print name)

        Title:
        

        Date:

	 	 	 

 

    	36

    	 

    

 

 

Attachment F – Documentation
requirements

 

Documentation requirement

 

for supply of raw materials to

 

GE Healthcare, Lindesnes Site

 

Before delivery:

 

	The QC department shall receive the following documentation on fax no +47 38 25 82 82:
	 	 	E
	-	Certificate of analysis	F
	-	Packaging list	F
	-	Cleaning certificate (For not dedicated containers or tanks)	E
	 	 	C
	The documents shall contain the following information:	T
	 	 	I
	-	Customers order number	V
	-	Product name and eventual quality term	E
	-	Eventual supplier product number	 
	-	Manufacture	 
	-	Name of product plant	 
	-	Batch numbers, and the amount of each batch	 
	-	Results of analysis (at minimum the parameters in customers specification)	 
	 	 	 
	Enclosed delivery:
	 	 	 
	Copy of the packaging list (which includes the following information)
	 	 	 
	-	Supplier	 
	-	Customer order number	 
	-	Quantities (specified pr. lot/batch)	 
	-	Shipment date	 
	 	 	 

 

    	37

    	 

    

 

 

	Attachment G– Aminobisamide Packaging Specifications
	 	 
	Unit of Issue	At least one bag from each batch must contain [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] Kilograms &/or [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] Kilograms depending on customer requirements.
	 	 
	Outer Container	White Polypropylene Coated Bag,
	 	40 x 41 x 47”  #32000449
	 	 
	Outer Container Closure	One Pull-tight Security Seal
	 	#32000778; Tie Cord Bag Closure
	 	 
	Liner	Not Applicable
	 	 
	Liner Closure	Not Applicable
	 	 
	Labeling	Intermediate
	 	 
	Caution Labelling	Aminobisamide with English &
	 	Norwegian Text
	 	 
	Recommended Storage	Warehouse Ambient
	 	 

 

 

    	38

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