Document:

Exhibit
10.45

 

DATED
August [_8_], 2021

 

STERLING
WISCONSIN, LLC

 

and
BIOSIGHT LTD.

 

MASTER
AGREEMENT

 

    	 

     

    

 

THIS
AGREEMENT dated is made BETWEEN:

 

	(1)	STERLING
    WISCONSIN, LLC a limited liability company organized under the laws of Wisconsin (“the Supplier”); and
	 	 
	(2)	BIOSIGHT
    LTD., a limited liability company organized under the laws of Israel (“the Purchaser”).

 

The
Supplier and the Purchaser are collectively referred to as the “Parties” and each individually as a “Party”.

 

BACKGROUND

 

	(A)	The
    Supplier is in the business of manufacturing and supplying active pharmaceutical ingredients, intermediates and other pharmaceutical
    ingredients.
	 	 
	(B)	The
    Purchaser wishes to appoint the Supplier to Manufacture and supply the Products to the Purchaser under this MA.
	 	 
	(C)	The
    Supplier shall Manufacture and supply the Products on the terms of this MA and on the terms set out in individual Product Orders
    to be executed by the Parties from time to time, the Price List and to the regulatory and compliance standards provided for within
    the Quality Agreement.

 

IT
IS AGREED as follows:

 

	1.	DEFINITIONS
                                            AND INTERPRETATION

 

		1.1	The
                                            definitions and rules of interpretation in this Section 1 apply:

 

	 	“Affiliate”	 	means,
    in relation to either Party, any person, firm, trust, partnership, corporation, company or other entity or combination thereof that
    directly or indirectly Controls such Party, is Controlled by such Party or is under the common Control with such Party (and for the
    purpose of this expression “Control” shall mean in relation to any Party, the beneficial ownership of fifty percent (50%)
    or more (including ownership by trusts with substantially the same beneficial interests) of the issued share capital of, or the legal
    power to direct or cause the direction of the general management of the Party in question or its holding company or parent undertaking;
	 	 	 	 
	 	“Approvals”	 	means
    all registrations with and approvals from the relevant Regulatory Authority necessary to market and sell the relevant Product.
	 	 	 	 
	 	“Background”	 	means,
    with respect to either Party, all rights in Intellectual Property, and embodiments thereof that:

    

 

	 	 	(a)	come
into the ownership or control of or are licensed to that Party on or after the Effective Date other than Foreground; or

    

	 	 	(b)	were
    owned by, controlled by or licensed to that Party prior to the Effective Date;

 

	 	“Business
    Day”	 	means
    a day which is not Friday, Saturday or Sunday or a bank or national holiday in the United States of America or Israel;

 

    	2

     

    

 

	 	“Cancellation
    Fee”	 	has
    the meaning given in Clause 5.2;
	 	 	 	 
	 	“Change
    Order”	 	means
    a document detailing changes, agreed between the Parties, to a Product Order;
	 	 	 	 
	 	“Commercially
    Reasonable Efforts”	 	means,
    with respect to the efforts to be expended by either Party with respect to any objective, such reasonable and diligent efforts as
    such Party would normally use to accomplish a similar objective under similar circumstances as expeditiously as possible, which in
    no event shall be less than the standard of care generally adhered to in the industry of such Party for the providing of such efforts,
    but for the avoidance of doubt, it shall not involve incurring material expense which would not reasonably be expected by the Party
    concerned at the Effective Date and/or material risk which would not reasonably be expected by the Party concerned at the Effective
    Date;
	 	 	 	 
	 	“Confidential
    Information”	 	means
    in relation to each Party, all information of a confidential nature, including data, know-how and trade secrets relating to its business
    which come into the possession of the other Party pursuant to this MA, whether orally, or in documentary, electronic, or other form
    including the existence and terms of this MA;
	 	 	 	 
	 	“Contract
    Year”	 	means
    the period of twelve (12) months from and including the Effective Date and each consecutive period of twelve (12) months thereafter
    except that the last Contract Year of this MA shall be for such shorter period that commences on an anniversary of the Effective
    Date and expires on the expiration or termination of this MA;
	 	 	 	 
	 	“Delivery
    Date”	 	means
    the expected delivery date for each batch of Product as specified in the applicable Product Order;
	 	 	 	 
	 	“Effective
    Date”	 	means
    the date of this MA;
	 	 	 	 
	 	“End-Product”	 	means
    the formulated drug product manufactured by or for the Purchaser, of which the Product forms part;
	 	 	 	 
	 	“Force
    Majeure Event”	 	means
    any circumstances arising from or attributable to acts, events, omissions or accidents beyond the affected Party’s reasonable
    control, including but not limited to: acts of God including adverse weather conditions or , other natural disaster; epidemic, pandemic
    or disease that is required by law to be notified to a government or a public or regulatory authority, war, threat of or preparation
    for war, armed conflict, imposition of sanctions, embargo, import or export controls, breaking off of diplomatic relations or similar
    actions; terrorist attack, civil commotion or riots; nuclear, chemical or biological contamination; compliance with any law; any
    action taken by a government or by a public or regulatory authority; malicious or accidental damage; loss at sea; collapse of building
    structures, failure of plant machinery, machinery, computers or vehicles; any labour dispute, including but not limited to strikes,
    industrial action or lockouts; non-performance by suppliers or subcontractors; shortage of raw materials; and interruption or failure
    of utility service, including but not limited to electric power, gas, water, internet or data services.

 

    	3

     

    

 

	 	“Foreground”	 	means
    Purchaser’s Foreground and Supplier Foreground;
	 	 	 	 
	 	“Good
    Manufacturing Practice” or “GMP”	 	means
    current practices with respect to the Manufacture of the Product being those practices from time to time required by:

    

    

 

	 	 	(a)	the
    International Conference on Harmonisation Guidelines, ICHQ7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients;
    and/or
	 	 	 	 
	 	 	(b)	those
    practices from time to time required by provisions of 21 C.F.R., by the parts 210 and 211 and all applicable rules, regulations,
    orders and guidance published thereunder; and/or

 

	 	 	 	subject
    to prior approval by the Supplier, those practices from time to time required by the regulations applicable to the supply of End-Product
    in such locality as the Purchaser may wish to supply the End-Product provided that such requirements shall in any event be no more
    onerous than the requirements set out in (a) and (b) above;
	 	 	 	 
	 	“Independent
    Laboratory”	 	means
    such laboratory as shall be mutually agreed between the Parties as shall be used for the purpose of Section 8;
	 	 	 	 
	 	“Insolvency
    Event”	 	means
    in relation to a Party, dissolution, liquidation, arrangement for the benefit of creditors, having a receiver appointed, bankruptcy
    or other insolvency or restructuring process (other than in relation to a solvent restructuring), or that Party suspends, or threatens
    to suspend, or ceases or threatens to cease to carry on all or a substantial part of its business;
	 	 	 	 
	 	“Intellectual
    Property” or “Intellectual Property Rights”	 	means
    all and any intellectual property of whatever nature in any part of the world including, without limitation, rights in designs, unregistered
    design right, registered designs, copyright, moral rights, rights in databases, patents, rights to inventions, trademarks, trade
    names and domain names, rights in get-up, rights to goodwill and to sue for passing off and unfair competition, know-how, trade secrets,
    logos, information, data, formulas, technology, techniques rights in confidential information, in each case whether registered or
    unregistered and including any and all applications (and rights to apply) for such rights, any renewals, extensions, divisions, continuations,
    continuations-in-part, additions, registrations, confirmations, re-examinations, supplementary protection certificates, or reissues;
	 	 	 	 
	 	“Losses”	 	means
    all liabilities, claims, demands, damages, losses, costs, expenses or money judgments (including attorney’s fees and investigative
    and production costs) resulting from any actual or threatened third party claim, demand or action;
	 	 	 	 
	 	“Manufacture”
    or “Manufacturing”	 	means
    all steps involved in the production of Product, as set forth in the applicable Product Order, including processing, preparation,
    assembling, testing, labelling, packaging, and storage of Product at the Manufacturing Site;
	 	 	 	 
	 	“Manufacturing
    Licenses”	 	means
    all licenses and/or permits necessary for or required in connection with the Manufacture of the Product at the Manufacturing Site;
	 	“Manufacturing
    Site”	 	means
    the manufacturing facility of the Supplier as specified in the Product Order;

 

    	4

     

    

 

	 	“Materials”	 	means
    the raw materials (including starting materials) and components used in the Manufacture of the Product;
	 	 	 	 
	 	“Minimum
    Lead Time”	 	means
    the period of time between the Product Order and the Delivery Date in relation to the relevant Product, as specified in the relevant
    Product Order;
	 	 	 	 
	 	“MA”	 	means
    this Master Agreement;
	 	 	 	 
	 	“Non-conforming
    Product”	 	as
    defined in Section 8.2;
	 	 	 	 
	 	“PPI
    Index”	 	means
    the Producer Price Index for Pharmaceutical Preparation Manufacturing as published by the U.S. Bureau of Labor Statistics or such
    other index as the Parties may agree in writing;
	 	 	 	 
	 	“Price”	 	means
    the price of the Product as set out in the applicable Product Order and calculated in accordance with the Price List;
	 	 	 	 
	 	“Price
    List”	 	means
    a price list that forms part of this MA and is attached hereto at Appendix 1. Subject to Section 10, the Price List will set out
    the prices for the Products and Supplier’s services at different development stages throughout the Term;
	 	 	 	 
	 	“Product”	 	means
    the product to be Manufactured and supplied as set out in the applicable Product Order;
	 	 	 	 
	 	“Product
    Order”	 	means
    an order that forms part of this MA for each Product order substantially in the form set out in Appendix 2 (Form of Product Order)
    and executed by authorized representatives of the Purchaser and the Supplier;
	 	 	 	 
	 	“Purchaser
    Foreground”	 	means
    any Intellectual Property first created, made, conceived, discovered or reduced to practice as a direct result of the performance
    by the Purchaser of its respective obligations under this MA;
	 	 	 	 
	 	“Purchaser’s
    Intellectual Property “	 	Means:
    (a) Purchaser’s Foreground and (b) all data, information and Intellectual Property first created, made, conceived, discovered
    or reduced to practice as a direct result of the performance by the Supplier of its respective obligations under this MA or related
    to Purchaser’s Confidential Information, Purchaser’s Background, the Purchaser-Supplied Materials, the Product, or the
    End Product other than such data, information or Intellectual Property of a general nature related to Supplier’s business,
    manufacturing processes, quality control, testing and compliance procedures, Supplier’s Background or general microbial production;
	 	 	 	 
	 	“Purchaser
    Supplied Materials”	 	means
    all Materials to be supplied by, or on behalf of, the Purchaser for the performance of the processing activities (if any) as set
    forth in the applicable Product Order;
	 	 	 	 
	 	“Quality
    Agreement”	 	means
    an agreement that forms part of this MA for each Product and executed by authorized representatives of the Purchaser and Supplier,
    setting out the responsibilities of the Parties in relation to quality assurance and control obligations in connection with the production
    and shipment of the Product as required for compliance with GMP;
	 	 	 	 
	 	“Regulatory
    Authority”	 	means
    any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional,
    state or local regulatory agency, department, bureau, commission, council or other governmental authority involved in the granting
    of regulatory or similar approvals for pharmaceutical products;

 

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	 	“Reserved
    Time Slot”	 	means
    the applicable time slots for the Manufacturing as specified in each Product Order;
	 	 	 	 
	 	“Specification(s)”	 	means
    the specification(s) for the Product as set out in the applicable Product Order;
	 	 	 	 
	 	“Supplier
    Foreground”	 	means
    any Intellectual Property first created, made, conceived, discovered or reduced to practice as a direct result of the performance
    by the Supplier of its obligations under this MA, other than Purchaser Intellectual Property;
	 	 	 	 
	 	“Supplier
    Supplied Materials”	 	means
    any Materials that are necessary for the performance of manufacturing and supplying the Products which are not included within the
    definition of the “Purchaser Supplied Materials”;
	 	 	 	 
	 	“Term”	 	means
    the term of this MA specified under Section 26; and
	 	 	 	 
	 	“Wasted
    Conversion Costs”	 	any
                                                         costs (both internal and external) outlined in the Product Order which are reasonably incurred by the Supplier in
                                                         anticipation of Manufacturing Product which cannot be reutilized, cancelled or reallocated (including but not limited to
                                                         Manufacturing costs, the cost of raw materials, packaging and waste costs and transportation and storage costs);

 

    	6

     

    

 

		1.2	For
                                            the purposes of this MA:

 

		1.2.1	the
                                            headings and recitals are for convenience only and they shall not affect its construction
                                            or meaning;

 

		1.2.2	references
                                            to Sections, Recitals, Appendices, Schedules and Paragraphs are to sections of, recitals,
                                            appendices and schedules to and paragraphs of this MA;

 

		1.2.3	the
                                            Schedules and Appendices form part of this MA and the expression “this MA” includes
                                            the Schedules and Appendices;

 

		1.2.4	unless
                                            otherwise expressly stated, references to any statute, statutory instrument, or regulation
                                            shall mean a reference to the current provision as amended from time to time, any successor
                                            legislation thereto and any regulations promulgated thereunder;

 

		1.2.5	unless
                                            the context otherwise requires, words denoting the singular shall include the plural and
                                            vice versa and references to any gender shall include all other genders;

 

		1.2.6	references
                                            to any person (which for the purposes of this MA shall include bodies corporate, unincorporated
                                            associations, partnerships, limited liability partnerships, limited liability companies,
                                            governments, governmental agencies and departments, statutory bodies or other entities, in
                                            each case whether or not having a separate legal personality) shall include the person’s
                                            permitted successors and assigns; and

 

		1.2.7	general
                                            words shall not be given a restrictive interpretation by reason of their being preceded or
                                            followed by words indicating a particular class of acts, matters or things and each reference
                                            throughout this MA to “includes” or “including” shall be construed
                                            without limitation.

 

	2.	FRAMEWORK
                                            AGREEMENT

 

		2.1	This
                                            MA governs the overall relationship of the Parties and together with the Price List, any
                                            relevant Product Orders and Quality Agreement, sets out the terms and conditions which shall
                                            govern the Manufacture and supply by the Supplier of each of the Products and the performance
                                            of activities under this MA.

 

Product
Orders

 

		2.2	This
                                            MA is structured so that a separate Product Order shall be entered into for the development
                                            work, Manufacture and supply of different batches of the Product at different stages of development
                                            throughout the Term (it being understood that a particular Product Order may include an entire
                                            Product family and multiple Products as may be agreed to by the Parties and set forth in
                                            such Product Order).

 

		2.3	Subject
                                            to the provisions of Section 5 below, each Product Order shall be agreed in the following
manner:

 

		2.3.1	the
                                            Purchaser may request that the Supplier develop, Manufacture and supply one or more Products
                                            and provide the Supplier with as much information as the Supplier may reasonably require
                                            in order to prepare a draft Product Order for the Products to be Manufactured and supplied;

 

    	7

     

    

 

		2.3.2	following
                                            receipt of the information requested from the Purchaser, the Supplier shall, as soon as reasonably
                                            practicable, and no later than 10 days as of the receipt of information from the Purchaser,
                                            either:

 

		(a)	inform
                                            the Purchaser that it declines to provide the requested Products; or

 

		(b)	provide
                                            the Purchaser with a draft Product Order which will incorporate any proposal issued by the
                                            Supplier to the Purchaser.

 

		2.3.3	if
                                            the Supplier provides the Purchaser with a draft Product Order pursuant to Section 2.3.2,
                                            the Supplier and the Purchaser shall discuss that draft Product Order; and

 

		2.3.4	both
                                            Parties shall execute the draft Product Order if and when it is agreed upon.

 

		2.4	A
                                            Product Order shall not enter into force, be legally binding or have any other effect unless:

 

		2.4.1	the
                                            Product Order has been executed by authorized representatives of both the Purchaser and the
                                            Supplier; and

 

		2.4.2	as
                                            of the date the Product Order is signed, this MA has not been terminated.

 

		2.5	Each
                                            Product Order forms a separate contract incorporating the terms of this MA.

 

		2.6	Once
                                            a Product Order has been agreed upon and executed in accordance with Section 2.3 and Section
                                            5 below, no amendment shall be made to it except in accordance with Section 6 (Changes to
                                            Product Order), 10 (Prices) or Section 26.3 (Duration and Termination; Rescheduling and Reduction
                                            of Orders).

 

	3.	PURCHASE
                                            AND SUPPLY OF PRODUCT

 

		3.1	The
                                            Supplier shall develop, Manufacture and supply the Product and the Purchaser shall purchase
                                            the Product in accordance with the terms of this MA, the terms of the applicable Product
                                            Order, and the terms of the relevant Quality Agreement.

 

		3.2	The
                                            Supplier shall Manufacture the Product at the Manufacturing Site, in conformance with the
                                            Specification(s), current industry standards, required Approvals, applicable law, and applicable
                                            statutory and regulatory requirements, including but not limited to Good Manufacturing Practice.

 

	4.	THE
                                            PURCHASER’S OBLIGATIONS

 

		4.1	The
                                            Purchaser shall:

 

		4.1.1	reasonably
                                            cooperate with the Supplier in all matters relating to the Manufacture and supply of the
                                            Product;

 

		4.1.2	provide
                                            to the Supplier in a timely manner all documents, information, items and materials in any
                                            form (whether owned by the Purchaser or a third party) required from the Purchaser under
                                            a Product Order or otherwise reasonably required by the Supplier in connection with the Manufacture
                                            and supply of the Product and ensure that to Purchaser’s knowledge they are accurate
                                            and complete in all material respects;

 

		4.1.3	if
                                            specified in any applicable Product Order, supply, or cause to be supplied to the Supplier
                                            at the Manufacturing Site, at no cost to the Supplier, the agreed upon quantity of the Purchaser
                                            Supplied Material, in accordance with the delivery schedule, Purchaser Material Specifications
                                            and any other relevant terms set out in the applicable Product Order; and

 

		4.1.4	comply
                                            with any additional responsibilities of the Purchaser as set out in the applicable Product
                                            Order.

 

    	8

     

    

 

		4.2	Without
                                            prejudice to the application of Section 19, and any other rights and remedies of the Parties
                                            under this MA (express or implied), to the extent and for so long as either Supplier’s
                                            or Purchaser’s, as applicable, performance of its obligations under this MA or a Product
                                            Order is prevented, hindered or delayed by any material act or omission of the other Party,
                                            its agents, subcontractors, consultants or employees, such Party, shall:

 

		(a)	not
                                            be in breach of this MA and shall be discharged from performing its obligations under the
                                            applicable Product Order;

 

		(b)	shall
                                            have no liability for any relevant liquidated damages; and

 

		(c)	the
                                            date for the performance of such Party’s relevant obligations shall be extended, subject
                                            to such Party continuing to perform all other obligations not affected by such delay / failure
                                            of the other Party.

 

	5.	PRODUCT
                                            ORDERS

 

		5.1	Having
                                            due regard to the Minimum Lead Time, the Purchaser shall provide the Supplier preliminary
                                            Product Order drafts that shall include, inter alia, the desired quantities and Specifications
                                            of the Products and the desired dates for development, Manufacturing and delivery of the
                                            Products by Supplier to the Purchaser. The Supplier will respond to each such preliminary
                                            draft Product Order received from the Purchaser with a proposed Product Order draft that
                                            includes all the details required for such Product Order as soon as reasonably practicable
                                            and no later than ten (10) Business Days following receipt. In the event that discussion
                                            is required regarding Prices, the timing of production and delivery, then the relevant planning
                                            personnel from both Parties will endeavor to agree upon and confirm any amendments to the
                                            proposed Product Order prior to it being accepted in writing by the Supplier. Following receipt
                                            of the proposed Product Order draft from the Supplier, the Parties shall use Commercially
                                            Reasonable Efforts to execute the Product Order soon as practicably possible. If the Parties
                                            are unable to agree upon and confirm any amendments to a proposed Product Order, either Party
                                            may require the matter to be resolved in accordance with the dispute resolution procedure
                                            in Section 37.

 

		5.2	Other
                                            than in the event (i) of Supplier’s breach of or non-conformance with the terms of
                                            this MA and/or the applicable Product Order, (ii) that Supplier is unable to meet Purchaser’s
                                            demand as set forth in a Product Order; or (iii) that Supplier terminates this MA and/or
                                            the applicable Product Order other than due to Purchaser’s material breach of the terms
                                            thereof, the Supplier will only accept Purchaser’s cancellation or reduction of Product
                                            Orders and/or a negative adjustment (including any postponement) to the quantity of Products
                                            to be Manufactured under the applicable Product Order upon payment by the Purchaser for all
                                            related work in progress and compensation for any non-cancellable costs in accordance with
                                            this Clause 5.2. In respect of the services which are detailed in Table 1 of Appendix 1,
                                            to reflect the value of non-cancellable costs, the Purchaser will pay the Supplier (other
                                            than in the event of cancellation due to a reason specified in Subsections (i)-(iii) above
                                            of this Section 5.2) a cancellation fee equal to:

 

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		5.2.1	one
                                            hundred percent (100%) of the value of the applicable Wasted Conversion Costs as outlined
                                            in the Product Order (or the value of the relevant portion of the Wasted Conversion Costs
                                            outlined in the Product Order) if there is cancellation or reduction of Product Orders and/or
                                            a negative adjustment (including any postponement) to the quantity of Products to be Manufactured
                                            under the applicable Product Order less than forty five (45) calendar days prior to the Reserved
                                            Time Slot;

 

		5.2.2	fifty
                                            percent (50%) of the value of the applicable Wasted Conversion Costs as outlined in the Product
                                            Order (or the value of the relevant portion of the Wasted Conversion Costs outlined in the
                                            Product Order) if there is cancellation or reduction of Product Orders and/or a negative
                                            adjustment (including any postponement) to the quantity of Products to be Manufactured under
                                            the applicable Product Order more than forty five (45) calendar days but less than ninety
                                            (90) calendar days prior to the Reserved Time Slot; and

 

(each
a “Cancellation Fee”). No Cancellation Fee shall be payable if there is cancellation or reduction of Product Orders
and/or a negative adjustment (including any postponement) to the quantity of Products to be Manufactured under the applicable Product
Order of more than ninety (90) calendar days.

 

		5.2.3	In
                                            respect of the services which are detailed in Table 2 of Appendix 1, to reflect the value
                                            of non-cancellable costs, the Purchaser will pay the Supplier (other than in the event of
                                            cancellation due to a reason specified in Subsections (i)-(iii) above of this Section 5.2)
                                            a cancellation fee detailed in each Product Order or, if no such detail is provided in the
                                            applicable Product Order, a cancellation fee equal to the Cancellation Fee identified in
                                            Section 5.2.1 and 5.2.2 above (“PO Cancellation Fee”)

 

		5.4	5.3
                                            If a Product Order is cancelled or reduced in accordance with Clause 5.2 above and the Supplier
                                            is able to utilize the Manufacturing capacity reserved in anticipation of such cancelled
                                            or reduced Product Order for a third party, the Wasted Conversion Costs shall be reduced
                                            by a sum equal to the fee paid by such third party. All communication between the Parties
                                            pursuant to this Clause 5 shall be by email.

 

		5.5	In
                                            all communications, the Supplier and the Purchaser may employ their standard forms, but nothing
                                            in those forms will be construed to modify or amend the terms of this MA, and, in the case
                                            of any conflict with the terms, the terms and conditions herein will control. Any terms and
                                            conditions set forth in a Order, confirmations or any other correspondence from the Purchaser
                                            that are in addition to, inconsistent with, or in conflict with the terms of this MA or the
                                            Product Order shall have no force or effect unless specifically agreed to in a writing signed
                                            by the Supplier which expressly references such terms.

 

	6.	CHANGES
                                            TO PRODUCT ORDERS

 

		6.1	Either
                                            Party may propose changes to a Product Order. Proposed changes shall be discussed between
                                            the Parties in good faith, but no proposed changes shall come into effect until a relevant
                                            Change Order has been executed by both Parties.

 

		6.2	If
                                            the Parties are unable to agree upon a Change Order to reflect the changes proposed by a
                                            Party to a Product Order, either Party may require the matter to be resolved in accordance
                                            with the dispute resolution procedure in Section 37.

 

	7.	DELIVERY

 

		7.1	The
                                            Supplier shall make delivery of the Product Ex Works (Incoterms 2020) at the Manufacturing
                                            Site, unless otherwise agreed in the applicable Product Order, on the Delivery Date.

 

		7.2	All
                                            Delivery Dates of the Products subject to development services are estimates only, except
                                            the Supplier shall use Commercially Reasonable Efforts to deliver the quantity of Product
                                            on the Delivery Date or as may otherwise be agreed in writing. The Supplier shall promptly
                                            notify Purchaser if the Supplier determines that it will not be able to deliver the Product
                                            by the Delivery Dates. In respect of Delivery Dates of the Products which are subject to
                                            a validated GMP process, a delay of no more fifteen (15) Business Days shall not be deemed
                                            a breach of this MA in the event that Supplier uses all Commercially Reasonable Efforts to
                                            deliver the quantity of Product on the Delivery Date and that the delay was communicated
                                            to the Purchaser in advance as soon as practicable.

 

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		7.3	If
                                            the Supplier delivers the Product on the Delivery Date or as may otherwise be agreed in writing
                                            in an applicable Product Order, and the Purchaser fails to take delivery or to give the Supplier
                                            adequate delivery instructions, the Supplier may charge for any reasonable additional expense
                                            incurred in storage and/or re-delivery.
	 	 	 
	 	7.4	Each
delivery shall be accompanied by the documentation set forth in the applicable Product Order, and a copy of applicable shipping documentation
shall be sent by email not later than the date of delivery.

 

	8.	REJECTION
                                            AND REPLACEMENT OF NON-CONFORMING PRODUCT

 

		8.1	Upon
                                            receipt of each delivery from the Supplier or any third party on its behalf under this MA,
                                            the Purchaser or any third party on its behalf shall examine and test the Products for (a)
                                            defect and non-conformity with any applicable standards that the Products are required to
                                            meet under this MA and/or the applicable Product Order, including GMP if applicable; (b)
                                            in the case of Product manufactured to Specification, the failure of the Product to meet
                                            Specification, and (c) such testing as prescribed in the applicable Product Order; and shall
                                            report any adverse findings to the Supplier pursuant to Section 8.2.

 

		8.2	The
                                            Purchaser may reject any Products delivered to it that do not comply with Section 23.1.1
                                            (Non-conforming Products), provided that:

 

		8.2.1	notice
                                            of rejection is given to the Supplier;

 

		8.2.2	in
                                            the case of a defect that is apparent on normal visual inspection within the earlier of ten
                                            (10) Business Days of the Products’ seal removal by the Purchaser or its designee or
                                            sixty (60) days of the date of actual delivery of the Product to Purchaser;

 

		8.2.3	in
                                            the case of any defect in respect of Non-conforming Products which is not reasonably apparent
                                            on the date of actual delivery to Purchaser or upon the Product’s seal removal, the
                                            Purchaser must provide written notice to the Supplier of the defect within fourteen (14)
                                            Business Days of the date on which the Purchaser became aware of, or ought reasonably to
                                            have become aware of the defect; and

 

		8.2.4	none
                                            of the events listed in Section 8.4 apply.

 

		8.3	If
                                            the Purchaser fails to give notice of rejection in accordance with Section 8.2 within twelve
                                            (12) months of the date of actual delivery to Purchaser of the Product, it shall be deemed
                                            to have accepted these Products and the Product shall be deemed to be in accordance with
                                            the Specification and except as set forth in Sections 8.6 and 8.7 all claims by the Purchaser
                                            concerning non-conformity of such product shall be deemed waived.

 

		8.4	The
                                            Supplier shall not be liable for a Product’s failure to comply with the warranty set
                                            out in Section 23.1.1 in any of the following events:

 

		8.4.1	the
                                            Purchaser makes any further use of those Products after giving notice in accordance with
                                            Section 8.2;

 

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		8.4.2	the
                                            defect arises because the Purchaser failed to follow the Supplier’s reasonable written
                                            instructions for the storage, commissioning, installation, use and maintenance of the Products
                                            or (if there are none) Good Manufacturing Practice;

 

		8.4.3	the
                                            defect arises as a result of the Supplier duly following any drawing, design or Specification
                                            supplied by the Purchaser in writing;

 

		8.4.4	the
                                            Purchaser alters or repairs those Products without the written consent of the Supplier, which
                                            alteration or repair caused the Product to become Non-confirming Product;

 

		8.4.5	the
                                            defect arises as a result of wilful damage, gross negligence, or abnormal storage or working
                                            conditions on the part of the Purchaser; or

 

		8.4.6	the
                                            Products differ from the Specification as a result of changes reasonably made to ensure they
                                            comply with applicable statutory or regulatory requirements, provided that such changes were
                                            approved in advance by the Purchaser in writing.

 

		8.5	If
                                            the Purchaser rejects the Products in accordance with Section 8.2:

 

		8.5.1	the
                                            Parties shall use Commercially Reasonable Efforts as soon as reasonably practicable to agree
                                            upon whether or not the delivery in question constitutes Non- conforming Product; and

 

		8.5.2	the
                                            Purchaser shall store the Product at issue in a secure, clean and dry environment, and the
                                            Supplier shall be entitled at all reasonable times to inspect and/or analyze it.

 

		8.6	The
                                            Parties shall use all Commercially Reasonable Efforts to resolve any dispute that may arise
                                            pursuant to this Section 8.6, but if the Parties fail to resolve such dispute within thirty
                                            (30) days of notification to the Supplier pursuant to Section 8.5, the issue of whether or
                                            not the delivery constitutes Non-conforming Product shall be determined by the Independent
                                            Laboratory or other independent consultant agreed by the Parties (the “IC”)
                                            and the decision of the Independent Laboratory or the IC shall be final and binding on the
                                            Parties, unless there has been a manifest error, in which case, the matter shall be resolved
                                            in accordance with the dispute resolution procedure in Section 37. The decision of the Independent
                                            Laboratory or the IC must be in writing. The Independent Laboratory or the IC shall act as
                                            an expert and not as an arbitrator and (unless the Independent Laboratory or the IC otherwise
                                            determines) its fees shall be borne equally by the Parties, provided, however, that the Party
                                            against whom the IC or the Independent Laboratory’s decision is given must reimburse
                                            the successful Party for its share of the costs.

 

		8.7	If
                                            the Supplier agrees or the Independent Laboratory or the IC finds that any delivery of the
                                            Product is Non-conforming Product, the Supplier will, at the Purchaser’s option:

 

		8.7.1	refund
                                            the Price (or a proportionate part of the Price relating to the Non-conforming Product) to
                                            the extent the same has been paid; or

 

		8.7.2	replace
                                            the Non-conforming Product with Product which complies with the requirements of this MA,
                                            or applicable Product Order such that the Supplier shall supply, at no extra cost, a replacement
                                            delivery to the Purchaser as soon as reasonably practicable. In the event Purchaser requires
                                            Supplier to replace such Product, Supplier shall use its Commercially Reasonable Efforts
                                            to deliver the quantity of Product that it had failed to deliver as soon as possible by means
                                            of expedited means of performance and delivery and shall be responsible for the additional
                                            cost thereof; and

 

		8.7.3	collect
                                            at its own expense any rejected Product from wherever the Purchaser may reasonably direct
                                            or reimburse the Purchaser for any costs reasonably incurred in its disposal of the Non-conforming
                                            Product.

 

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	9.	PASSING
                                            OF TITLE IN PRODUCT

 

		9.1	Risk
                                            in and responsibility for the Product shall pass to the Purchaser in accordance with the
                                            applicable Incoterm as specified in Section 7.1 or in the applicable Product Order.

 

		9.2	Title
                                            to the Product shall pass to the Purchaser upon delivery in accordance with the applicable
                                            Incoterm as specified in Section 7.1 or in the applicable Product Order.

 

	10.	PRICE
                                            OF PRODUCT

 

		10.1	The
                                            Price payable by the Purchaser for the Product shall be set out in the applicable Product
                                            Order in accordance with the Price List.

 

		10.2	Subject
                                            to Section 5.1 or any amendment agreed between the Parties pursuant to Section 28, Table
                                            1 and Table 2 of the Price List at Appendix 1 shall bind the Parties throughout the Term.
                                            Notwithstanding the above, subject to Sections 10.4 and 10.5, once per Contract Year (including
                                            the first Contract Year), or at any time during a Contract Year if the costs of Materials
                                            vary by more than 5% (five per cent) since the Effective Date or since the date of the most
                                            recent price review pursuant to this Section 10.2, the Supplier may vary the Price for any
                                            future Product Order to reflect the increase or decrease, as the case may be, in the costs
                                            of Materials, including, but not limited to increases or decreases relating to currency fluctuations.

 

		10.3	The
                                            Supplier shall act in good faith and endeavour to secure the best price reasonably obtainable
                                            in the circumstances.

 

		10.4	Supplier
                                            shall maintain such records as may be reasonable in the circumstances to verify the calculation
                                            pursuant to Section 10.2. Supplier will, upon Purchaser’s reasonable request and within
                                            one month of the variation pursuant to Section 10.2, provide such records (redacted as the
                                            Supplier may determine in its reasonable discretion) to the Purchaser for the strict purpose
                                            of allowing the Purchaser to verify the calculation. Purchaser shall agree to keep Supplier’s
                                            business information confidential. If, following such verification, it is agreed between
                                            the Parties that an adjustment is required to any payments that have been made by the Purchaser,
                                            such adjustment shall be paid (in the case of an amount due to the Supplier) or credited
                                            (in the case of an amount due to the Purchaser) as an adjustment to the amount due on the
                                            monthly invoice prepared after the date of such agreement.

 

		10.5	Once
                                            per Contract Year, commencing as of the third Contract Year, the Supplier may vary the Price
                                            in the Price List which will apply to any future Product Order to reflect the increase or
                                            decrease, as the case may be, in the Supplier’s non-Materials costs since the Effective
                                            Date or since the date of the most recent price review pursuant to this Section 10.5, as
                                            the case may be. If the Purchaser does not consent to any change in the Price proposed by
                                            the Supplier pursuant to this Section 10.5, the Price shall increase by the lower of 3% (three
                                            per cent) or the percentage increase in the PPI Index since the beginning of the previous
                                            Contract Year.

 

		10.6	The
                                            Price as adjusted in accordance with this Section 10 shall be effective for all future Product
                                            Orders placed by the Purchaser until the next scheduled price review, unless otherwise agreed
                                            in writing.

 

		10.7	Unless
                                            otherwise agreed in an applicable Product Order, the Price and any other amounts payable
                                            pursuant to this MA or an applicable Product Order shall be exclusive of sales or other applicable
                                            taxes (other than taxes on Supplier’s income). Purchaser may withhold any amounts as
                                            required by applicable law from any payments due in connection with this MA.

 

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	11.	INVOICE
                                            AND PAYMENT

 

		11.1	Subject
                                            to Section 11.2, the Supplier shall be entitled to invoice the Purchaser the Price upon the
                                            Supplier’s delivery of the Product in accordance with the applicable Incoterm as specified
                                            in Section 7.1 or in the applicable Product Order, or pursuant to agreed upon payment milestones
                                            specified in the applicable Product Order or Price List.

 

		11.2	Unless
                                            otherwise stated in the applicable Product Order, the Supplier shall be entitled to invoice
                                            the Purchaser:

 

		11.2.1	for
                                            the Supplier Supplied Materials, to the extent that the Purchaser is expressly liable to
                                            pay for the same pursuant to the applicable Product Order upon the Supplier’s delivery
                                            of the Product; and

 

		11.2.2	for
                                            the Cancellation Fee (or PO Cancellation Fee), if applicable in accordance with Section 5.2,
                                            at any time after the date of cancellation or reduction of the relevant Product Order.

 

		11.3	Each
                                            invoice issued by the Supplier hereunder shall specify:

 

		11.3.1	the
                                            Price in respect of the Product in U.S. Dollars;

 

		11.3.2	the
                                            quantity of Product delivered and the applicable Product Order;

 

		11.3.3	the
                                            amount of sales or applicable taxes due (if any) in respect of the Product; and

 

		11.3.4	any
                                            other amounts reimbursable or payable to the Supplier pursuant to this MA or the applicable
                                            Product Order.

 

		11.4	Unless
                                            otherwise stated in the applicable Product Order, all amounts due to the Supplier hereunder
                                            shall be paid by the Purchaser in full and cleared funds in U.S. Dollars to the account designated
                                            by the Supplier in writing, within forty-five (45) calendar days from the end of the calendar
                                            month in which the Purchaser received the relevant invoice, without any set-off or counterclaim
                                            in respect of any liability of the Supplier. Notwithstanding the foregoing, in the event
                                            Purchaser reasonably disputes an invoice and provides Supplier with reasonable written detail
                                            of such dispute (on the grounds that the Product is Non- conforming Product or otherwise),
                                            Purchaser shall pay the undisputed portion of such invoice only. The failure to pay the reasonably
                                            disputed portion of any such invoice shall not be a breach under this MA.

 

		11.5	Without
                                            prejudice to any other right or remedy that the Supplier may have, if the Purchaser fails
                                            to pay the Supplier any undisputed sum due under this MA on the due date, and such undisputed
                                            sum remains outstanding for a period of more than 30 days:

 

		11.5.1	the
                                            Purchaser shall pay interest on the overdue undisputed sum from the due date until payment
                                            of the overdue sum. Interest under this Section 11.5.1 will accrue at
                                            the lower of: (a) two percent (2%) a year above the prime rate published in the Wall
                                            Street Journal on the date of payment, but at two percent (2%) a year for any period
                                            when that prime rate is below zero percent (0%), and (b) the maximum rate permitted by law,
                                            until payment is received; and

 

		11.5.2	the
                                            Supplier may suspend performance of this MA (in whole or in part) or stop the transmission,
                                            of all or any of the Product and work in progress until all outstanding amounts, plus interest
                                            charged by the Supplier in addition thereto, is received in full by the Supplier, and the
                                            costs of the Supplier doing so are for the Purchaser’s account.

 

		11.6	Without
                                            prejudice to any other right or remedy that the Supplier may have, if the Purchaser fails
                                            to pay an undisputed invoice for ninety (90) days after the due date, then the Supplier will
                                            have the right, in its sole discretion, to terminate this MA and the applicable Product Order
                                            without penalty.

 

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	12.	SUPPLY
                                            AND STORAGE OF MATERIALS AND PRODUCT

 

		12.1	The
                                            Supplier shall be solely responsible for ordering the relevant quantities of the Supplier
                                            Supplied Materials for use in the Manufacture of the Product and shall ensure that they comply
                                            with the requirements of Good Manufacturing Practice and the provisions of this MA. Any such
                                            purchase from a supplier shall be on the Supplier’s own behalf and not as an agent
                                            for the Purchaser.

 

		12.2	If
                                            Purchaser requests, the Supplier shall store the Product at the Supplier’s premises
                                            at Germantown for two (2) month free of charge
                                            following release by Purchaser, and thereafter at a daily rate (invoices will include any
                                            applicable taxes) as outlined in the applicable Product Order. The Product shall be deemed
                                            to have been delivered pursuant to Section 7.1 upon it being placed into storage by the Supplier
                                            other than in the event of gross negligence of Supplier in connection with the storage.

 

	13.	PRODUCT
                                            LICENSE

 

The
Purchaser shall be responsible for the registration of the End-Products with all relevant authorities and the Supplier shall, at the
Purchaser’s expense to the extent that costs are reasonably and properly incurred, provide such assistance as the Purchaser may
reasonably request in connection with such matters insofar as such assistance relates to the Manufacture of
the Product and/or performance of this MA by the Supplier.

 

	14.	MANUFACTURING
                                            LICENSES

 

The
Supplier shall obtain and maintain in full force and effect for the duration of this MA the Manufacturing License and all necessary permits,
approvals and authorizations required under applicable laws in the country of Manufacture to enable the Supplier to Manufacture and supply
the Product to the Purchaser.

 

	15.	QUALITY
                                            AGREEMENT

 

	15.1	A
                                            separate Quality Agreement shall be entered into in relation to the quality assurance terms
                                            applicable to the Manufacture of the Product. Subject to Section 34, each Quality Agreement
                                            shall be governed by and incorporated into this MA.

 

		15.2	The
                                            Quality Agreement sets out:

 

		15.2.1	the
                                            mutually agreed quality standards applicable for the Manufacture of any Product in accordance
                                            with the Specification(s) and Good Manufacturing Practice; and

 

		15.2.2	the
                                            roles and responsibilities of each party’s personnel in relation to quality, regulatory
                                            and compliance matters.

 

	16.	PRODUCT
                                            RECALL

 

		16.1	The
                                            Purchaser shall be solely responsible in accordance with applicable laws and regulations
                                            for the reporting to Regulatory Authorities of any complaints and product recalls relating
                                            to the End-Product which arise for any reason. The Supplier shall promptly advise the Purchaser
                                            of any occurrence or information which arises out of the Supplier’s Manufacturing activities
                                            which have or could reasonably be expected to have adverse regulatory compliance and/or reporting
                                            consequences concerning the Product and/or the End-Product and promptly furnish copies of
                                            any related information or reports as requested by Purchaser or as further set forth and
                                            detailed in the Quality Agreement.

 

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		16.2	If
                                            the Purchaser or any Regulatory Authority deems that a recall of any lots of distributed
                                            End-Product is required, the recall process and strategy shall be as set forth in the Quality
                                            Agreement.

 

		16.3	The
                                            costs of any action required by the Purchaser under this Section 16, shall be borne by the
                                            Supplier only in the event and to the extent that upon delivery of Product hereunder such
                                            Product did not conform to the Specification, GMP, or the terms of the Manufacturing Licenses;
                                            the need for the action is the result of a failure on the part of the Supplier to comply
                                            with its obligations under this MA or the Quality Agreement; or is the result of any negligence
                                            on the part of the Supplier; subject always to the Purchaser’s duty to mitigate under
                                            Section 22.7.

 

	17.	INTELLECTUAL
                                            PROPERTY RIGHTS

 

		17.1	This
                                            MA shall not affect the ownership of the respective Background of the Parties and nothing
                                            in this MA shall oblige either Party to maintain any rights that it has, or may have, in
                                            its Background for the benefit of the other Party or otherwise. Except as specifically provided
                                            herein, nothing in this MA shall be construed as granting any right in or license to either
                                            Party under any Background of the other Party.

 

		17.2	Subject
                                            to the provisions of this Section 17, the Purchaser’s Intellectual Property shall belong
                                            to and be the sole legal and beneficial property of the Purchaser. Supplier hereby assigns
                                            to Purchaser
                                            or its
                                            designee and shall
                                            continue
                                            to assign
                                            to Purchaser
                                            or its
                                            designee, all right, title and interest of Supplier in any Purchaser’s Intellectual
                                            Property.

 

		17.3	All
                                            Supplier Foreground shall belong to and be the sole legal and beneficial property of the
                                            Supplier. Purchaser hereby assigns to Supplier or its designee and shall continue to assign
                                            to Supplier or its designee, all right, title and interest of Purchaser in any Supplier Foreground.

 

		17.4	To
                                            the extent that it has come to its notice, each Party shall promptly and fully notify the
                                            other Party of any actual, threatened or suspected:

 

		17.4.1	infringement
                                            of any Intellectual Property of the other Party (to the extent it relates to this MA); and

 

		17.4.2	claim
                                            by any third party that the activities of either Party pursuant to this MA (including the
                                            use, distribution or sale by the Purchaser of products or of any End Product or of any other
                                            product the manufacture of which uses or incorporates the Product), infringe any rights (including
                                            Intellectual Property rights) of any other person.

 

		17.5	Each
                                            Party shall promptly at the request and cost of the other (whether during or after expiration
                                            or termination of this MA) sign and execute all such deeds and documents and do all such
                                            acts and things as the other Party may reasonably require to apply for, obtain and vest and
                                            maintain any Intellectual Property the other Party owns or to which the other Party should
                                            have title in accordance with Section 17.1, 17.2 or 17.3.

 

		17.6	The
                                            Purchaser hereby grants to the Supplier a free, non-exclusive license to use any Background
                                            provided by the Purchaser together with any Purchaser’s Intellectual Property solely
                                            for the purpose of fulfilling the Supplier’s obligations under this MA. This license
                                            terminates automatically on the termination of this MA. Under no circumstances may Supplier
                                            transfer Purchaser Supplied Materials, Purchaser Background, Purchaser’s Intellectual
                                            Property, or Product out of the relevant Manufacturing Site to any Affiliate, subcontractor
                                            and/or any other third party without Purchaser’s prior written consent.

 

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		17.7	The
                                            Supplier hereby grants to the Purchaser a free, non-exclusive, perpetual, sublicensable,
                                            worldwide, license to use any Background provided by the Supplier together with any Supplier
                                            Foreground and Supplier Confidential Information to the extent required to make, have made,
                                            use, distribute, import, sell, or offer to sell End Products or the Products supplied by
                                            Supplier under this MA.

 

		17.8	Except
                                            for the licenses expressly granted in this MA, no rights or licenses are granted by implication,
                                            estoppel or otherwise.

 

	18.	CONFIDENTIALITY

 

		18.1	Each
                                            Party undertakes in relation to the Confidential Information of the other Party:

 

		18.1.1	to
                                            keep all Confidential Information confidential and in a place and manner that ensures such
                                            confidentially (which in any event shall be not less than customary industry standards);

 

		18.1.2	not
                                            to use Confidential Information except as strictly necessary for the purposes of performing
                                            its obligations under this MA (Permitted Purpose) (and in particular not to use Confidential
                                            Information to obtain a commercial, trading or any other advantage);

 

		18.1.3	not,
                                            without
                                            the
                                            other
                                            Party’s prior written
                                            consent,
                                            to disclose
                                            Confidential
                                            Information to any other person except those of its employees, officers, representatives,
                                            consultants and advisers who need to know the Confidential Information in connection with
                                            the Permitted Purpose; and

 

		18.1.4	at
                                            the earlier of: (a) end of the Term, and (b) within seven (7) days following a written request
                                            by the disclosing Party at any time, to return all Confidential Information and all documents
                                            or media containing any such Confidential Information and any and all copies or extracts
                                            thereof or, where return is not possible or at the request of the disclosing Party, to delete,
                                            destroy or render inaccessible such Confidential Information, save for one confidential copy
                                            that may be retained in a Party’s confidential files solely for purposes of monitoring
                                            compliance with the terms hereof and, where applicable, for the purposes of regulatory compliance.
                                            Any Confidential Information retained pursuant to the foregoing sentences shall remain subject
                                            to the confidentiality obligations under this MA until destroyed or no longer deemed Confidential
                                            Information based on Section 18.2 hereinafter.

 

	18.2	Section
                                            18.1 shall not apply to Confidential Information to the extent that it is or was:

 

		18.2.1	already
                                            in the possession of the other free of any obligation of confidentiality on the date of its
                                            disclosure to such other Party;

 

		18.2.2	received
                                            by the other independently from a third party free to lawfully disclose such information;

 

		18.2.3	in
                                            the public domain other than as a result of a breach of this Section 18;

 

		18.2.4	required
                                            to be disclosed:

 

		(a)	pursuant
                                            to applicable law, by any governmental or regulatory body or by a securities exchange of
                                            competent authority; or

 

		(b)	in
                                            connection with proceedings before a court of competent jurisdiction or under any court order
                                            or for the purpose of receiving legal advice, but
only to the extent and for the purpose of that disclosure and provided that, to the extent it is legally permitted to do so, it gives
the other Party as much notice of such disclosure as possible.

 

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	 	18.3	Without
                                            derogating from the foregoing, disclosure of the contents and the existence of this MA by
                                            a party in connection with a due diligence inquiry and subject to confidentiality undertakings
                                            at least as restrictive as those contained in this MA shall not be considered to be a breach
                                            of this MA.

 

	 	18.4	Each
                                            Party acknowledges that Confidential Information is valuable and that damages might not be
                                            an adequate remedy for any breach of Section 18.1, and accordingly, a Party will be entitled,
                                            without proof of special damage, to an injunction and other equitable relief for any actual
                                            or threatened breach of this Section 18.

 

	 	18.5	Except
                                            as provided in Section 17 hereof, no right or license, either express or implied, is granted
                                            under any Intellectual Property right by virtue of disclosure of Confidential Information
                                            under this MA or otherwise.

 

	 	18.6	The
                                            confidentiality
                                            obligations
                                            under this
                                            Section 18 shall
                                            survive
                                            and remain
                                            in full
                                            force
                                            and effect after termination or expiration of this MA for any reason for a period of seven
                                            years or such longer period if trade secret protection shall apply.

 

	19.	FORCE
                                            MAJEURE

 

		19.1	A
                                            Party shall not be in breach of this MA, nor liable for any failure or delay in performance
                                            of any obligations under this MA arising from or attributable to a Force Majeure Event.

 

		19.2	Any
                                            Party that is subject to a Force Majeure Event shall not be in breach of this MA provided
                                            that it promptly notifies the other Parties in writing of the nature and extent of the Force
                                            Majeure Event causing its failure or delay in performance.

 

		19.3	If
                                            the Force Majeure Event prevails for a continuous period of more than six (6) months, any
                                            Party may terminate this MA by giving fourteen (14) days’ written notice to the other
                                            Party. Upon the expiration of this notice period, this MA will terminate.

 

	20.	RECORDS,
                                            INSPECTIONS & AUDITS

 

		20.1	The
                                            Purchaser, its designee and representatives of applicable Regulatory Authorities, shall have
                                            the right from time to time during the Term of this MA at least once per Contract Year during
                                            the hours between 09:00 am to 5:00 pm on a Business Day, and (except in the case of Regulatory
                                            Authorities) upon not less than fifteen (15) Business Days prior written notice to enter
                                            and inspect the Manufacturing Site and any related utilities, any
                                            premise where Records (as defined below) are maintained and/or services used in the
                                            Manufacture of the Product, and Supplier’s equipment, documents and records (including
                                            without limitation any Manufacturing Licenses and Records) for the purpose of determining
                                            compliance with the requirements of this MA or any Product Order and applicable laws or to
                                            the extent required to carry out GMP, quality, environmental and compliance audits of those
                                            parts of the Manufacturing Site involved in or which could have any impact on the Manufacture
                                            of the Product.

 

		20.2	The
                                            Purchaser shall have the right to enter the Manufacturing Site at any time during normal
                                            business hours and upon not less than five (5) Business Days prior written notice to inspect
                                            any Product stored by the Supplier for the purpose of Section 8.1.

 

		20.3	Where
                                            the Supplier is required to undertake an audit by a Regulatory Authority directly related
                                            to the Product, the Supplier shall at the expense of the Purchaser, undertake a pre–audit
                                            review to ensure compliance with the Regulatory Authority’s requirements.

 

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		20.4	At
                                            its own expense, Supplier shall keep and maintain complete and accurate records of its performance
                                            of Manufacturing services pursuant to this MA (“Records”). The Records
                                            shall be prepared, maintained and retained consistent with generally accepted standards (a)
                                            in accordance with, and shall be subject to, the provisions of applicable laws and the procedures
                                            set forth in the Quality Agreement; (b) sufficient to demonstrate that any and all amounts
                                            invoiced to Purchaser under the Product Order are accurate and proper in both kind and amount;
                                            and (c) sufficient to demonstrate the accuracy of any representations or reports submitted
                                            to Purchaser under the MA. Records shall be maintained and stored in secure and readable
                                            formats agreed between the Parties. Purchaser will maintain all of the Records in accordance
                                            with its standard operating procedures. At no additional cost to Purchaser, Supplier will
                                            allow Purchaser to inspect Records upon reasonable notice, and shall deliver a copy to Purchaser
                                            upon its written request. Purchaser shall be further entitled to make use of such Records
                                            in connection with its regulatory activities.

 

	21.	SAFETY
                                            HAZARDS

 

		21.1	The
                                            Parties will inform one another and keep one another informed of all safety hazards and changes
                                            in regulations and guidance (statutory or otherwise) which either Party knows or believes
                                            to impact the use, handling, storage, labelling, transport, treatment and disposal of the
                                            Product and each Party will ensure that the Product is handled by it in accordance with the
                                            special handling procedures required for the Product.

 

		21.2	The
                                            Supplier will ensure that relevant consignments are safe, packaged, labelled so as to prevent
                                            any health risk to persons, property or the environment and properly marked with the appropriate
                                            internationally recognised danger symbols and that prominent hazard warnings appear in English
                                            on all packages and documents.

 

	22.	INDEMNITIES

 

		22.1	Subject
                                            to Section 24, the Purchaser shall indemnify, defend and hold harmless the Supplier from
                                            and against any and all Losses to the extent arising out of or resulting from:

 

		22.1.1	the
                                            material breach of this MA by the Purchaser;

 

		22.1.2	Product
                                            recalls, End Product recalls, personal injury, product liability or property damage arising
                                            from or relating to the Purchaser’s use, handling, design, labelling or sales of the
                                            Product or any End-Product or other product the manufacture of
                                            which uses or incorporates the Product except to the extent the Supplier is obligated
                                            to indemnify the Purchaser under Section 22.2;

 

		22.1.3	any
                                            chemical process, procedure or materials provided by the Purchaser to the Supplier for use
                                            in performing its obligations under this MA except to the extent the Supplier is obligated
                                            to indemnify the Purchaser under Section 22.2; or

 

		22.1.4	any
claims alleging Supplier’s proper use of the Purchaser Supplied Materials, infringes any rights (including, without limitation,
any Intellectual Property rights) vested in any third party,

 

except
to the extent the Supplier is obligated to indemnify the Purchaser under Section 22.2.

 

		22.2	Subject
                                            to Section 24, the Supplier shall indemnify, defend and hold harmless the Purchaser from
                                            and against any and all Losses to the extent arising out of or resulting from:

 

		22.2.1	the
                                            material breach of this MA or a Product Order by the Supplier;

 

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		22.2.2	the
                                            improper administration, use, handling, storage or other disposition of the Purchaser Supplied
                                            Materials in any form;

 

		22.2.3	failure
                                            of Supplier to manufacture the Product according to GMP material non- conformance or material
                                            deviation of any of the required quality, quantity, storage, handling or packaging requirements
                                            as set forth in this MA, the Specifications, the applicable Product Order, the Quality Agreement,
                                            the Manufacturing Licenses or applicable laws;

 

		22.2.4	any
                                            claims alleging that any of Supplier’s acts hereunder (excluding Supplier’s proper
                                            use of Customer Materials) infringes any rights (including without limitation any Intellectual
                                            Property rights) vested in any third party;

 

		22.2.5	gross
                                            negligence,
                                            willful misconduct or
                                            illegality,
                                            on the
                                            part
                                            of Supplier
                                            or its
                                            Affiliates; or.

 

		22.2.6	any
                                            Product recalls, End Product recalls, personal injury, product liability or property damage
                                            relating to or arising from any breach of the Supplier’s warranties hereunder

 

except
to the extent the Purchaser is obligated to indemnify the Supplier under Section 22.1.

 

		22.3	The
                                            Party seeking indemnity hereunder shall notify the indemnifying Party in writing of any fact
                                            or circumstance which gives rise to liability for which the indemnified Party is indemnified
                                            hereunder with reasonable promptness after such fact or circumstance first comes to the attention
                                            of the indemnified Party, further provided, however, that the failure by the indemnified
                                            Party to give such notice shall not relieve the indemnifying Party of its indemnification
                                            obligations unless, and only to the extent that, the failure to give such notice actually
                                            prejudices the rights of the indemnifying Party.

 

		22.4	If
                                            a demand, claim or action arising from any circumstance for which the indemnified Party is
                                            indemnified hereunder is brought by a third party, the indemnifying Party shall diligently
                                            defend such demand, claim or action at its expense with counsel of its choice and shall keep
                                            the indemnified Party informed with respect to such defence and shall take into consideration
                                            the reasonable requests of the indemnified Party with respect to the manner in which such
                                            defence is handled.

 

		22.5	The
                                            indemnifying Party shall not have the right to compromise or settle such claim without written
                                            consent of the indemnified Party, which consent shall not be unreasonably refused or delayed.

 

		22.6	The
                                            indemnified Party shall cooperate with the indemnifying Party in all reasonable ways in defense
                                            of any such demand, claim or action, at the indemnifying Party’s expense.

 

		22.7	Notwithstanding
                                            the indemnities granted under this MA, the Purchaser and the Supplier shall use Commercially
                                            Reasonable Efforts to mitigate any losses which they may respectively incur and in respect
                                            of which they may be entitled to be indemnified by the other Party pursuant to this Section
                                            22.

 

		22.8	The
                                            provisions of this Section 22 shall continue in force after termination or expiration of
                                            this MA.

 

    	20

     

    

 

	23.	WARRANTIES
                                            AND DISCLAIMERS

 

The
Supplier Warranty

 

		23.1	The
                                            Supplier warrants to the Purchaser that:

 

		23.1.1	the
                                            Products shall meet the Specification when delivered and for the period of its shelf life
                                            as confirmed by the stability tests required under the Product Order and shall be Manufactured
                                            by the Supplier in compliance with GMP, the provisions of this MA and the Quality Agreement,
                                            all applicable law and with the appropriate level of skill and care by professional personnel,
                                            qualified to perform the Manufacturing procedures consistent with the technical requirements
                                            set forth in the Product Order;

 

		23.1.2	it
                                            has the right to enter into this MA and Product Order and the execution, delivery and performance
                                            of this MA or a Product Order will not conflict with, violate or breach any agreement to
                                            which the Supplier is a party, nor does the execution, delivery and performance of this MA
                                            by Supplier violate any order, law or regulation of any court, governmental body or administrative
                                            or other agency having authority over it;

 

		23.1.3	it
                                            has the appropriate facilities, skilled personnel, registrations, licenses permits and other
                                            governmental authorizations required to carry out its obligations under this MA;

 

		23.1.4	it
                                            will perform its obligations under this MA in accordance with generally accepted standards
                                            of the industry and reasonable skill and care;

 

		23.1.5	to
                                            its knowledge, it owns its Background and it has the unencumbered right to disclose its Background,
                                            the Supplier Foreground and the Supplier Confidential Information to the Purchaser and to
                                            authorise the Purchaser to use, and license to the Purchaser the use of, the Supplier’s
                                            Background, Foreground and Confidential Information as permitted hereunder. During the Term,
                                            Supplier will not enter into any contract, arrangement or commitment which prohibits the
                                            grant of such license rights;

 

		23.1.6	it
                                            will not knowingly infringe or misuse any rights (including without limitation any Intellectual
                                            Property rights) vested in any third party in its Manufacturing of the Products; and

 

		23.1.7	all
                                            Product delivered hereunder will be transferred free and clear of any liens or encumbrances
                                            of any kind.

 

		23.2	EXCEPT
                                            FOR THE FOREGOING, THE SUPPLIER MAKES NO WARRANTY OR REPRESENTATION OF ANY KIND, EITHER EXPRESS
                                            OR IMPLIED, INCLUDING THE WARRANTIES OF SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE
                                            AND MERCHANTABILITY, AND ANY REPRESENTATION OR ANY WARRANTY THAT THE MANUFACTURE, USE OR
                                            SALE OF PRODUCT WILL NOT INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

 

		23.3	IT
                                            IS ACKNOWLEDGED AND AGREED THAT THIS MA PROVIDES FOR THE CARRYING OUT OF EXPERIMENTAL RESEARCH
                                            AND THE USE OF EXPERIMENTAL MATERIALS WHOSE PROPERTIES AND SAFETY MAY NOT HAVE BEEN ESTABLISHED.
                                            ACCORDINGLY, SPECIFIC RESULTS CANNOT BE GUARANTEED AND ANY RESULTS, MATERIALS, INFORMATION
                                            OR INTELLECTUAL PROPERTY RIGHTS PROVIDED OR DELIVERED UNDER OR IN ACCORDANCE WITH THIS MA.
                                            WITHOUT LIMITING THE FOREGOING, THE SUPPLIER DOES NOT GIVE ANY WARRANTY THAT ANY PATENT APPLICATIONS
                                            MADE OR LICENSED PURSUANT TO THIS MA WILL RESULT IN VALID, GRANTED PATENTS, OR THAT THE PRODUCTS
                                            ULTIMATELY WILL ACHIEVE COMMERCIALLY VIABLE SALES.

 

    	21

     

    

 

The
Purchaser Warranty

 

	23.4	The
                                            Purchaser represents and warrants to the Supplier that:

 

		23.4.1	it
                                            is entering into this MA solely to obtain Product relating to the manufacture by the Purchaser
                                            of drug products;

 

		23.4.2	regulations
                                            relating to its activities under this MA, and its transportation, export, handling, storage,
                                            marketing, sale, distribution or other use by the Purchaser of any Product delivered hereunder
                                            or of any End-Product or other drug product into which any Product is incorporated by or
                                            on behalf of the Purchaser;

 

		23.4.3	without
                                            limiting the foregoing, in no event will the Purchaser sell, market or distribute any Product
                                            or any End-Product or other drug products incorporating the Product to any third party for
                                            human or veterinary consumption prior to the completion of all necessary validation work
                                            required for compliance with Good Manufacturing Practices. For clarity, the validation of
                                            the Products shall be performed by the Supplier in accordance with Purchaser’s written
                                            instructions as shall be set forth in the applicable Product Orders;

 

		23.4.4	to
                                            its knowledge, the Purchaser owns its Background and it has the unencumbered right to disclose
                                            its Background and Confidential Information to the Supplier and to authorise the Supplier
                                            to use, and license to the Supplier the use of, the Purchaser’s Background and Confidential
                                            Information for the purposes of performing the Supplier’s obligations under this MA;

 

		23.4.5	to
                                            its knowledge, proper use of any of the Purchaser’s Background and Confidential Information
                                            by the Supplier as authorized under this MA, including without limitation, for the manufacturing
                                            of the Product by the Supplier and any required intermediate compounds, and the sale to the
                                            Purchaser of the Product by the Supplier contemplated hereunder, will not infringe the Intellectual
                                            Property Rights of any third party;

 

		23.4.6	to
                                            its knowledge, the use, distribution or sale by the Purchaser of Products will not infringe
                                            the Intellectual Property Rights of any third party; and

 

		23.4.7	it
                                            has the right to enter into this MA and Product Order and the execution, delivery and performance
                                            of them does not conflict with, violate or breach any other agreement to which the Purchaser
                                            is a party.

 

	24.	LIMITATIONS
                                            OF LIABILITY

 

		24.1	Sections
                                            24.4 and 24.6 set out the entire liability of the Supplier (including any liability for the
                                            acts or omissions of its officers, employees, agents or subcontractors) to the Purchaser
                                            in respect of:

 

		24.1.1	any
                                            breach by the Supplier of this MA;

 

		24.1.2	non
                                            or incomplete performance or contemplated performance by the Supplier of this MA;

 

		24.1.3	negligence
                                            for which the Supplier is liable;

 

		24.1.4	any
                                            other tortious act or omission or breach of statutory duty on the part of the Supplier or
                                            on the part of any of its employees, agents or subcontractors; and

 

		24.1.5	any
                                            representation or statement arising under or in connection with this MA or by or on behalf
                                            of the Supplier.

 

		24.2	The
                                            Supplier shall in all circumstances have no liability:

 

		24.2.1	Resulting
                                            from or in connection with the Purchaser’s breach of this MA or any Product Order;

 

    	22

     

    

 

		24.2.2	by
                                            the Supplier following any instruction, process or specification provided in writing by the
                                            Purchaser; or

 

		24.2.3	resulting
                                            from or in connection with any act, omission or delay by the Purchaser.

 

		24.3	The
                                            Price of the Product is determined on the basis of the exclusions from and limitations of
                                            liability contained in this MA. Each Party expressly agrees that these exclusions and limitations
                                            are reasonable because of (amongst other matters) the likelihood that the amount of damages
                                            awardable to the other Party for breach of this MA may be disproportionately greater than
                                            the Price of the Product.

 

		24.4	EXCEPT
                                            IN THE EVENT OF A BREACH OF ITS OBLIGATIONS OF CONFIDENTIALITY OR ITS INFRINGEMENT OR MISAPPROPRIATION
                                            OF THE OTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS, IN NO EVENT SHALL ONE PARTY’S
                                            LIABILITY TO THE OTHER PARTY UNDER SECTION 22 OF THIS MA EXCEED THREE (3) TIMES THE PRICE
                                            PAID BY THE PURCHASER TO THE SUPPLIER DURING THE TWELVE MONTHS PRECEDING SUCH CLAIM.

 

		24.5	EXCEPT
                                            IN THE EVENT OF A BREACH OF ITS OBLIGATIONS OF CONFIDENTIALITY OR ITS INFRINGEMENT OR MISAPPROPRIATION
                                            OF THE OTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS AND SUBJECT TO SECTION 24.4, IN NO
                                            EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY UNDER THIS MA EXCEED TWO (2) TIMES
                                            THE PRICE PAID BY THE PURCHASER TO THE SUPPLIER DURING THE TWELVE MONTHS PRECEDING SUCH CLAIM

 

		24.6	IN
                                            NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR LOSS OF PROFIT, LOSS OF REPUTATION,
                                            LOSS OF BUSINESS, REVENUE OR GOODWILL, LOSS OF ANTICIPATED SAVINGS, LOSS OR DAMAGE TO DATA,
                                            OR CONSEQUENTIAL OR INDIRECT LOSS. FOR THE AVOIDANCE OF DOUBT, THIS LIMITATION SHALL NOT
                                            LIMIT THE PURCHASER’S OBLIGATIONS TO PAY FOR THE PRODUCTS PROPERLY RENDERED WHEN DUE.

 

		24.7	Notwithstanding
                                            anything to the contrary herein, neither Party’s liability to the other Party for:

 

		24.7.1	death
                                            or personal injury resulting from the negligence of the Party concerned, its employees, agents
                                            or subcontractors; or

 

		24.7.2	fraud
                                            (including fraudulent misrepresentation),

 

shall
be excluded or limited, nor shall any other liability be excluded or limited to the extent such liability may not be excluded or limited
as a matter of law.

 

	25.	INSURANCE

 

	 	25.1	During
                                            the term of the MA, and for a period of five (5) years after its termination or expiration
                                            for any reason, each Party shall maintain, at its own cost, full and sufficient third party,
                                            public and product liability insurance, and such other types of insurance as are customary
                                            for persons and entities in this line of business, which may be by means of self-insurance,
                                            with sufficient coverage for its actual and potential liabilities hereunder and shall provide
                                            to the other party a certificate of such insurance (or equivalent) upon request. Without
                                            derogating from the above, during the term of the ma, supplier must maintain a comprehensive
                                            general liability insurance performing the services hereunder and an insurance covering any
                                            damage to the materials and the products, with insurance companies and in amounts as supplier
                                            customarily maintains for similar activities.

 

    	23

     

    

 

	26.	DURATION
                                            AND TERMINATION; RESCHEDULING AND REDUCTION OF ORDERS

 

		26.1	This
                                            MA shall be effective as of the Effective Date and shall remain in full force and effect
                                            for a period of five (5) years after which period, subject to earlier termination in accordance
                                            with its terms, it will automatically terminate unless extended by agreement between the
                                            Parties in writing.

 

		26.2	Either
                                            Party may terminate any Product Order by written notice at a date set in such notice in the
                                            event of a material breach of that Product Order, the Quality Agreement or the MA by the
                                            other Party, provided that, if the breach is curable, the breaching Party fails to cure such
                                            breach within twenty (20) calendar days from the date of such notice.

 

		26.3	Purchaser
                                            may cancel any Product Order or reschedule for a later date than the applicable due Manufacturing/delivery
                                            date any Manufacturing/delivery of Products determined pursuant to any Product Order or reduce
                                            the quantity of Products ordered under any Product Order subject to payment of the Cancellation
                                            Fees (or PO Cancellation Fee) specified in Section 5.2 above.

 

		26.4	If
                                            either Party experiences an Insolvency Event, it shall promptly notify the other Party in
                                            writing giving particulars of the circumstances whereupon such other Party may terminate
                                            this MA together with any Product Orders then in effect immediately by a written notice (for
                                            the avoidance of doubt, the MA together with any Product Orders in effect may be terminated
                                            upon the occurrence of an Insolvency Event notwithstanding that the notice may not have been
                                            given as required).

 

		26.5	If,
                                            in the reasonable opinion of the Supplier or the Purchaser, the safety profile of the other
                                            Party deteriorates, or the other Party is associated with unethical behaviour and in the
                                            reasonable opinion of such Party, association with the other Party would bring the reputation
                                            of such Party into disrepute, such Party may terminate the MA and all Product Orders immediately
                                            by written notice.

 

		26.6	Either
                                            the Supplier or the Purchaser may terminate the applicable Product Order if it reasonably
                                            determines that the manufacture of the Product is not feasible in accordance with the Specification
                                            or otherwise, for scientific or technical reasons despite Supplier applying Commercially
                                            Reasonable Efforts, or that a safety hazard of a type described in Section 21 exists that
                                            cannot be safely and appropriately managed by the Supplier. Such issue shall be discussed,
                                            and a sixty (60) day period shall be allowed for good faith discussions and attempts to resolve
                                            such problems (e.g., by modifications of the Product Order). If Supplier is and will remain
                                            unable to resolve the scientific or technical issues, then either Party may terminate the
                                            applicable Product Order by written notice.

 

	26.7	Either
                                            Party may terminate this MA on thirty (30) days written notice to the other Party if there
                                            are no Product Orders then in effect.

 

	27.	CONSEQUENCES
                                            OF TERMINATION

 

		27.1	Upon
                                            termination or expiration of this MA, each Party shall at the request of the other Party,
                                            within five (5) Business Days of such request and at the requesting Party’s cost, return
                                            to Confidential Information of the requesting Party, together with all know-how and/or information
                                            of a technical nature relating to the relevant Product and its manufacture which it has in
                                            its possession and which were provided to it by the requesting Party, together with all copies
                                            thereof (except for one (1) copy, which may be retained for the purposes of complying with
                                            applicable regulatory obligations, or to perform and enforce its surviving obligations under
                                            this MA).

 

		27.2	Upon
                                            termination or expiration of this MA, each Party shall at the request of the other Party,
                                            within thirty (30) Business Days of such request and at the requesting Party’s cost,
                                            return to the requesting Party or otherwise destroy (at the requesting Party’s election)
                                            all of the requesting Party’s property, equipment, materials and inventory, except
                                            to the extent it is required to be retained by law or to comply with such Party’s continuing
                                            obligations hereunder.

 

    	24

     

    

 

		27.3	With
                                            effect from termination or expiration of the MA, neither Party shall make any use for any
                                            purpose whatsoever of any relevant Intellectual Property or Confidential Information which
                                            is the property of the other Party and shall ensure that copies thereof are dealt with in
                                            accordance with Section 18.

 

		27.4	The
                                            Supplier agrees, at the Purchaser’s expense, to provide the Purchaser with reasonable
                                            assistance with respect to any investigation or filing required by any Regulatory Authority
                                            with respect to Manufacture of the Product carried out prior to such termination or expiration
                                            even after the date of such termination or expiration.

 

		27.5	Upon
                                            termination or expiration of this MA or a Product Order, the Supplier shall cease to produce
                                            the relevant Product for the Purchaser, and (except for in the event of termination of a
                                            Product Order pursuant to the provisions of Section 26.3 above) will issue the Purchaser
                                            with an invoice for all work in progress, unused Materials (to the extent Supplier is unable
                                            to use such materials for other products) and outstanding costs incurred by the Supplier
                                            in the Manufacture of the Product as detailed in the applicable Product Order (including
                                            without limitation, the Cancellation Fees (or PO Cancellation Fee) (if any)), unless terminated
                                            by the Purchaser for the Supplier’s material breach under Section 26.2. Such invoice
                                            shall be paid in accordance with the provisions of Section 11.4.

 

		27.6	Any
                                            termination or the expiration of this MA will not affect the coming into force or the continuance
                                            in force of any provision which is intended to come into or continue in force on or after
                                            such termination or expiration.

 

		27.7	Termination
                                            of this MA shall not affect any rights, remedies, obligations or liabilities of the Parties
                                            that have accrued up to the date of termination, including the right to claim damages for
                                            any breach that existed on or before the date of termination.

 

	28.	AMENDMENT

 

No
amendment to this MA shall be effective unless it is in writing and signed by the Parties.

 

	29.	WAIVER

 

		29.1	A
                                            waiver of any right or remedy under this MA or by law is only effective if given in writing
                                            and shall not be deemed a waiver of any subsequent right or remedy.

 

		29.2	A
                                            failure or delay by a Party to exercise any right or remedy provided under this MA or by
                                            law shall not constitute a waiver of that or any other right or remedy, nor shall it prevent
                                            or restrict any further exercise of that or any other right or remedy. No single or partial
                                            exercise
                                            of any
                                            right
                                            or remedy
                                            provided under this
                                            MA or by
                                            law
                                            shall
                                            prevent
                                            or restrict
                                            the further exercise of that or any other right or remedy.

 

	30.	NOTICES

 

		30.1	Any
                                            notice to be given under this MA or any Product Order shall be:

 

		30.1.1	in
                                            writing in the English language;

 

		30.1.2	signed
                                            by or on behalf of the Party giving it; and

 

		30.1.3	addressed
                                            to the other Party at its registered office or such other address as may have been notified
                                            for these purposes, marked for the attention of the CEO of the Purchaser, with a copy to
                                            General Counsel, Sterling Pharma Solutions Limited, Sterling Place, Dudley, Northumberland,
                                            NE23 7QG, United Kingdom1 (in the case of the Supplier), and for the attention of
                                            Purchaser’s counsel, Horn & Co. Law Offices, Amot Investments Tower, 2 Weizmann
                                            St. , 24th Floor, Tel-Aviv 6423902, Israel (in the case of the Purchaser).

 

    	25

     

    

 

		30.2	A
                                            notice shall either be:

 

		30.2.1	delivered
                                            by hand;

 

		30.2.2	sent
                                            by registered or certified United States mail to an address in the United States with return
                                            receipt requested;

 

		30.2.3	sent
                                            by reputable international overnight courier (if notice is to be served by post to an address
                                            outside the country from which it is sent); or

 

		30.2.4	sent
                                            be electronic email or facsimile.

 

		30.3	A
                                            notice shall be deemed to have been received:

 

		30.3.1	if
                                            delivered by hand, upon signature of a delivery receipt;

 

		30.3.2	if
                                            sent by registered or certified United States mail to an address in the United States, at
                                            9.00am on the third (3rd) Business Day after posting;

 

		30.3.3	if
                                            sent by reputable international overnight courier to an address outside the country from
                                            which it is sent, on signature of a delivery receipt;

 

		30.3.4	if
                                            sent be email or facsimile, at 9.00am on the first (1st) Business Day after sending,

 

provided
that a notice delivered or posted, as appropriate, after 5.00pm on any Business Day or on a non-Business Day shall be deemed delivered
or posted, as appropriate, at 9.00am on the next Business Day.

 

	31.	RELATIONSHIP
                                            OF THE PARTIES

 

Nothing
in this MA or any Product Order is intended to, or shall be deemed to, establish any partnership between any of the Parties, or constitute
any Party to this MA the agent, fiduciary or employee of any other Party to this MA. No Party to this MA will have any authority to impose
any obligation to a third party on any other Party to this MA.

 

	32.	ASSIGNMENT
                                            AND SUBCONTRACTING

 

		32.1	Neither
                                            party will assign or transfer any rights or obligations under this MA without the other Party’s
                                            prior written consent (not to be unreasonably withheld); except that either Party may assign
                                            or transfer any rights or obligations under this MA without such consent to an Affiliate
                                            or to its successor in interest by way of merger, acquisition or sale of all or substantially
                                            all of its assets to which this MA relates.

 

		32.2	Subject
                                            to Purchaser’s prior written consent, the Supplier’s Affiliates may, from time
                                            to time, fulfil the Supplier’s obligations under this MA.

 

	33.	ENTIRE
                                            AGREEMENT

 

		33.1	This
                                            MA, the Product Orders, the Price List the Quality Agreements and any documents appended
                                            or expressly incorporated herein or therein constitutes the entire agreement between the
                                            Parties and supersedes and extinguishes all previous agreements, arrangements, promises,
                                            assurances, warranties, representations and understandings between them, whether written
                                            or oral, relating to its subject matter.

 

    	26

     

    

 

		33.2	Each
                                            Party agrees that it does not rely on and will have no remedies in respect of any statement,
                                            representation, assurance or warranty (whether made innocently or negligently) that is not
                                            set out in this MA or the Product Order.

 

	34.	CONFLICT
                                            BETWEEN DOCUMENTS

 

		34.1	If
                                            and to the extent there is a conflict, discrepancy or inconsistency between any of the provisions
                                            of:

 

		34.1.1	the
                                            main body of this MA (including the Price List);

 

		34.1.2	any
                                            Product Order;

 

		34.1.3	any
                                            Quality Agreement; and

 

		34.1.4	any
                                            other document or form used by the Parties,

 

the
earlier listed document shall prevail over the later listed document, except:- i) to the extent that a document expressly and specifically
states an intent to supersede any prevailing document MA on a specific matter; or ii) with respect to quality assurance and quality compliance
matters in connection with the Products supplied by the Supplier, the terms of the Quality Agreement shall have priority over the terms
of MA any document or form used by the Parties.

 

	35.	RIGHTS
                                            AND REMEDIES

 

Unless
expressly stated in relation to any Section of this MA, the rights and remedies given to the Parties in this MA and any Product Orders
are: i) in addition to; ii) without prejudice to; and

 

iii)
not exclusive of; any and all other rights or remedies given to them whether by this MA, the Product Orders, by law or otherwise, and
all such rights and remedies are cumulative.

 

	36.	SEVERABILITY

 

		36.1	Each
                                            provision or sub-provision of this MA and each Product Order is severable and distinct from
                                            the others.

 

		36.2	If
                                            any provision or sub-provision of this MA or any Product Order is or becomes to any extent
                                            invalid, illegal or unenforceable under any regulation or applicable law in any jurisdiction,
                                            but would be valid, legal and enforceable if the provision or sub-provision were modified,
                                            that provision or sub-provision will apply with whatever modification is necessary to make
                                            it valid, legal and enforceable. If such modification is not possible, it will be severed
                                            from the remainder of this MA or the applicable Product Order (as applicable), and in either
                                            case, neither the validity, legality or enforceability of the remaining provisions, nor the
                                            legality, validity or enforceability of such provision or sub-provision under the law of
                                            any other jurisdiction will be affected.

 

	37.	DISPUTE
                                            RESOLUTION

 

		37.1	If
                                            any dispute arises in connection with this MA or any Product Order (a Dispute), either
                                            Party may by written notice (a Referral Notice) to the other Party refer the matter
                                            for resolution.

 

		37.2	Once
                                            a Referral Notice has been served in relation to a Dispute, that Dispute shall be referred
                                            for resolution to the Representatives (who will be senior individuals in each Party as specified
                                            by the respective Parties to this MA at that time). Those Representatives shall meet at the
                                            earliest convenient time and in any event within ten (10) days of the date of service of
                                            the relevant Referral Notice and shall in good faith attempt to resolve the Dispute.

 

    	27

     

    

 

		37.3	If
                                            a Dispute has not been resolved within twenty (20) days of such meeting of the Representatives,
                                            the Parties shall be free to seek for any lawful remedy or file any claim in the Competent
                                            Courts. The “Competent Courts” of London, England, shall have sole and
                                            exclusive jurisdiction to settle any disputes which may arise in connection with this MA
                                            or any other document executed by the Parties.

 

		37.4	Nothing
                                            in this Section 37 will prevent or delay either Party from:

 

		37.4.1	seeking
                                            orders for specific performance, interim or final injunctive relief in any competent court
                                            worldwide (and not necessarily in a Competent Court);

 

		37.4.2	exercising
                                            any rights it has to terminate this MA, Quality Agreement or a Product Order; or

 

		37.4.3	commencing
                                            any proceedings where this is necessary to avoid any loss of claim due to the rules on limitation
                                            of actions.

 

	38.	THIRD
                                            PARTY RIGHTS

 

Except
as expressly stated in this MA or provided under Section 32, no third party, except any permitted successor or assign of any Party to
this MA, has any rights to enforce any term of this MA.

 

	39.	GOVERNING
                                            LAW

 

This
MA and any dispute or claim arising out of or in connection with its subject matter or formation (including non-contractual disputes
or claims) shall be governed by and construed in accordance with the laws of England and Wales.

 

	40.	COUNTERPARTS

 

This
MA and each Product Order may be executed in any number of counterparts by the Parties, each of which when executed and delivered shall
constitute an original, but all of which together shall constitute one and the same agreement. Delivery of the executed Agreement by
electronic means is equally as effective and binding as delivery of an originally-executed Agreement.

 

	41.	ELECTRONIC
                                            SIGNATURE

 

Each
Party agrees to execute this MA by electronic signature (whatever form the electronic signature takes), and that this method of signature
is conclusive of the Parties’ intention to be bound by this MA.

 

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IN
WITNESS WHEREOF, the Parties have entered into this MA as of the Effective Date.

 

	 	SUPPLIER
	 	 
	 	Sterling Wisconsin, LLC
	 	 
	 	By:	/s/
    Andrew Henderson
	 	Name:	Andrew Henderson
	 	Title:	Chief Commercial Officer
	 	 	 
	 	PURCHASER
	 	 
	 	BIOSIGHT LTD.
	 	 
	 	By:	/s/ Ruth
    Ben Yakar__& /s/ Roy Golan
	 	Name:	Ruth Ben Yakar__& Roy Golan _____
	 	Title:	CEO______________EVP & CFO___ 

 

Appendix
1 – Price List

 

Appendix
2 – Sample Product Order

 

Appendix
3 – Template Change Order

 

    	29Exhibit 10.46

 

Separation
Agreement (the “Agreement”) 

 

By
and between Biosight Ltd., with its registered office at 3 Hayarden St., Airport City, Lod, Israel (the “Company”),
and RAM Technologies (RBY 2012) Ltd. (the “CEO”) and Dr. Ruth Ben Yakar (“Dr. Ben Yakar”), dated
this 7th day of October 2021.

 

Whereas,
the, Company and the CEO are parties to a certain Consultancy Agreement, dated December 21, 2014 (as amended, the “Consultancy
Agreement”); and

 

Whereas,
Dr. Ben Yakar has been serving as a member of the Company’s board of directors.

 

Whereas,
on July 1, 2021, the Board of Directors of the Company (the “Board”) approved a certain merger transaction between
the Company, Advaxis Inc. and Advaxis Inc.’s subsidiary (the “Merger”) pursuant to the terms and conditions
set forth in the Agreement and Plan of Merger and Reorganization dated July 4, 2021 (as such agreement may be further amended by the
parties thereto, the “Merger Agreement”); and

 

Whereas,
the parties have reached certain agreements as further detailed herein, which shall enter into force and effect following and subject
to the consummation of the Merger pursuant to the terms set forth below;

 

Therefore,
it is hereby agreed by the parties as follows:

 

	 	1.	Termination of Engagement: Immediately following to
and contingent upon the closing of the Merger (the “Closing”) the CEO and Dr. Ben Yakar personally where applicable,
shall: (i) resign from her Board position and cease to serve as an officer of the Company; and (ii) cease to act as the Company’s
CEO; (iii) support the Company in the handover of responsibilities and perform all tasks assigned to it/her by the Board for a proper
transition of her position to the new Company’s CEO (including without limitation, fully support the Merger) for a period of 12
months following the Closing (as such term is defined in the Merger Agreement) as a consultant of the Company (the “Consultancy
Period”). The engagement of the parties shall automatically terminate upon the end of the Consultancy Period (subject to survival
of provisions of the Consultancy Agreement which survive termination of the Consultancy Agreement, for the period and terms provided
therein). In consideration for her services to the Company during the Consultancy Period, the CEO shall receive; (i) at the end of each
month during the first three months of the Consultancy Period, an amount of NIS 92,400 + VAT; and (ii) at the end of each month during
the remaining nine months of the Consultancy Period, an amount of NIS 5,000 + VAT. Continuing the provision of services under this section
1 by Dr. Ben Yakar (through the CEO) shall not be deemed as “Termination of Employment” for the purposes of Section 10.1
of Company’s 2009 Israeli Share Option Plan.

 

	 	2.	Compensation pursuant to the Consultancy Agreement and Board
Resolutions: Until the Closing, the Company shall continue to pay to the CEO the consideration to which the CEO is entitled pursuant
to the Consultancy Agreement in accordance with the terms of the Consultancy Agreement and to any resolution of the Board, including
without limitation, to the recommendations of the Board’s Compensation Committee and the resolution of the Board with respect to
Dr. Ben Yakar’s annual bonus for 2021 dated March 22, 2021.

 

	 	3.	Merger Bonus: Following to and contingent upon the Closing,
the CEO shall be entitled to a one-time bonus payment in the amount of NIS 550,000 + VAT (the “Merger Bonus”). The
Merger Bonus will be paid within 14 days following the Closing.

 

	 	4.	Options: Immediately following and contingent upon the
Closing the vesting of all the options that were granted to the Dr. Ben Yakar for her services as a member of the Company’s Board
pursuant to the terms of Company’s 2009 Israeli Share Option Plan (the “Plan”) which shall be non-vested on
the date of the Closing shall accelerate, similar to the acceleration of all other Company’s outstanding unvested options in the
framework of the Merger Agreement, such that all such options shall be deemed fully vested as of the date of the Closing. Company undertakes
that the shares purchased by Dr. Ben Yakar as a result of the exercise of her options under the Plan and assumption of such options by
Advaxis Inc. shall not be subject to lock-up following the Merger, unless required by the lead banks and investors of the round of Private
Investment in Public Equity contemplated by the Company. Notwithstanding the above, should such lead banks and investors require a lock
up, the Company shall make its best efforts to avoid it with respect to Dr. Ben Yakar.

 

    	1 

     

    

 

	 	5.	Mutual non-disparagement: The Company, including any
of its officers and board members. will not disparage the CEO (nor Dr. Ben Yakar) or it/her performance or otherwise take any action
or make any comment or statement, whether written or oral, that could reasonably be expected to adversely affect the CEO’s personal
or professional reputation. Similarly, the CEO and Dr. Ben Yakar will not disparage the Company or any of its directors, officers, or
employees or otherwise take any action that could reasonably be expected to adversely affect the personal or professional reputation
of the Company or any of its directors, officers, or employees. Nothing herein is to be construed as attempting to impede either party’s
obligation, as applicable, to respond to inquiries required by law.

 

	 	6.	Continued Obligations: Nothing herein is intended to
derogate from the Company, the CEO’s or Dr. Ben Yakar’s obligations under the Consultancy Agreement or any applicable law,
including with respect to non-competition and/or confidentiality, for the specific periods stated therein, as set forth in the Consultancy
Agreement.

 

	 	7.	D&O Insurance and D&O Indemnification: Dr. Ben
Yakar’s D&O insurance and indemnification agreement dated April 13, 2016 (and entered into effectiveness on May 1, 2016) shall
continue to be in full force and effect following the termination date of the CEO’s and Company’s engagement, according to
the terms provided thereof, but in any case, it shall remain in full force, at least, until such time as it remains in effect for all
former directors and officers of the Company.

 

	 	8.	Mutual Waiver: Other than with respect to the transactions
contemplated herein, this Agreement constitutes a waiver of any claim(s) that either party might have, as of the date hereof, against
the other party.

 

	 	9.	Taxes: The CEO and Dr. Ben Yakar shall be solely responsible
for income tax and other taxes and related payments required by law and applied on it/her in connection with the compensation paid to
the CEO and Dr. Ben Yakar under this Agreement (including the options granted to Dr. ben Yakar under the Plan in accordance with the
terms of the option agreements provided to Dr. Ben Yakar for her services as a member of the Board of Directors, which are subject to
the conditions of Section 102(b)(2) (Capital Gain route) of the Israeli Tax Ordinance) and the Consultancy Agreement (), provided, however,
that the Company may withhold any amounts as required by applicable law for tax purposes from any payments or other forms of compensation
hereunder or in connection with this Agreement and/or the Consultancy Agreement.

 

	 	10.	Further Waiver and Indemnification by the CEO and Dr. Ben
Yakar: Subject to the Company’s fulfillment of its undertakings and declarations under this agreement,
each of the CEO and Dr. Ben Yakar agrees and undertakes that (i) the above payments constitute the full, appropriate, and sole consideration
for any claims or demands it/she might have against the Company with respect to it/her engagement period with the Company; (ii) apart
from the aforesaid, it/she will not be entitled to any additional consideration or compensation in connection with the period of it/her
engagement with the Company, and - (iii) it/she waives all claims, demands or rights against the Company. Each of the CEO and Dr. Ben
Yakar will hold the Company and any of its directors, officers, employees, and service providers harmless of any damage or liability,
relating to any payment or compensation component that a competent court of law may determine in the future CEO was entitled to under
the Consultancy Agreement and/or during its engagement period with the Company. Nothing in this section or the preceding section is intended
to derogate from Dr. Ben Yakar’s rights as an option holder or, as applicable, as a shareholder of the Company.

 

	 	11.	Termination Date for This Agreement: In the event that
the Closing shall not take place until the End Date (as such term was defined in the Merger Agreement), subject to extensions of the
End Date pursuant to the terms of the Merger Agreement, this Agreement shall automatically be terminated and have no force and effect.

 

	 	12.	Governing Law and Jurisdiction: This Agreement shall
be exclusively governed by and construed in accordance with the laws of the State of Israel. Any dispute in connection with this Agreement
or any of the transactions contemplated hereby shall be resolved exclusively in the competent court in Tel Aviv-Jaffa, Israel.

 

	 	13.	Entire Agreement: This Agreement constitutes the entire
understanding of the parties hereto and as such supersedes any oral or written agreement previously executed by the CEO and the Company.

 

    	2 

     

    

 

IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first above-mentioned.

 

	/s/
    Dr. Pini Orbach     	 	/s/
    Dr. Ruth Ben Yakar
	biosight
    Ltd.  	 	Dr.
    Ruth ben yakar 
	 	 	 	 
	By:	Dr.
    Pini Orbach	 	 
	title:	Director	 	/s/
    Dr. Ruth Ben Yakar
	 	 	 	RAM
    TECHNOLOGIES (RBY 
	 	 	 	2012)
    LTD.
	 	 	 	
	 	 	 	By:	D
    R. RUTH BEN YAKAR
	 	 	 	title:	

 

    	3

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