Document:

Document

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Exhibit 10.2
			
	DATE: FEBRUARY 25, 2021
	EXCLUSIVE MANUFACTURING AND SUPPLY AGREEMENT
	
	Between
CONTURA INTERNATIONAL A/S

and
CONTURA LIMITED

	

TABLE OF CONTENTS
									
	1.	Definitions and interpretation	1
	2.	The parties’ obligations	5
	3.	Forecasts	6
	4.	Orders	7
	5.	Delivery	8
	6.	Title and risk in the product	9
	7.	Price	10
	8.	Invoicing and payment	11
	9.	Quality	11
	10.	Changes to Specifications or Packaging	12
	11.	Steering Committee	12
	12.	Intellectual property rights	13
	13.	Indemnity	14
	14.	Warranties	14
	15.	Limitation of liability	15
	16.	Regulatory compliance	15
	17.	Product recalls	16
	18.	Confidential information	16
	19.	Force majeure event	17
	20.	Audits	18
	21.	Term and termination	18
	22.	Consequences of expiry or termination	19
	23.	Survival	19
	24.	Notices	19
	25.	No partnership or agency	20
	26.	Assignment and sub-contracting	20
	27.	Third party rights	20
	28.	Compliance with law	20
	29.	Entire agreement	20
	30.	Severance	21
	31.	Further assurance	21
	32.	Variation	21
	33.	Waiver	21
	34.	Counterparts	21
	35.	Set-off	21
	36.	Dispute resolution procedure	21
	37.	Conflicts within agreement	22
	38.	Governing law and jurisdiction	22
	Schedule 1 Product and Prices	23

									
	Schedule 2 Specifications	24
	Schedule 3 Change Control Procedure	25
	Schedule 4 Regulatory Responsibilities	26

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

THIS AGREEMENT is made on the date on which it has been signed by both parties.
PARTIES:
(1)    Contura International A/S, a company incorporated in Denmark with a principal place of business at Sydmarken 23, DK 2860 Søborg, Denmark (“Manufacturer”); and
(2)    Contura Limited, a company incorporated in England with a principal place of business at 14 Took’s Court, London, EC4A 1LB (“Customer”)
(each of the Manufacturer and the Customer being a “party” and together the Manufacturer and the Customer are the “parties”).
RECITALS:
(A)    The Manufacturer is the manufacturer of Product (as defined below).
(B)    The Customer and/or its Affiliates have on or around the date of this Agreement acquired and/or in-licenced worldwide rights to the Product, including, but not limited to, the Product IP (the “Acquisition”). 
(C)    This Agreement is made wholly in connection with the Acquisition and as an essential part of the Customer and its Affiliates realising the value of the distribution business and the Product IP previously operated by the Manufacturer with a view to maximising the availability of the Products in the Field worldwide.
(D)    The Customer wishes for the Manufacturer to exclusively manufacture and supply the Product to the Customer following the Acquisition, subject to Customer’s right to a technology transfer as provided in clause 22 of this Agreement. The technology transfer right provided in clause 22 is a material part of this Agreement.
(E)    The Manufacturer shall manufacture and supply to the Customer, and the Customer shall purchase, the Product on the terms and conditions of this Agreement.
THE PARTIES AGREE:
1.    DEFINITIONS AND INTERPRETATION
In this Agreement:
“Affiliate” means any entity that directly or indirectly Controls, is Controlled by or is under common Control with, another entity;
“Applicable Laws” means all applicable laws, statutes, directives, rules, regulations, and guidelines, including all applicable standards or guidelines promulgated by any applicable Governmental Entity;
“Acquired IP” means the Intellectual Property Rights relating to the Product assigned to the Customer and/or its Affiliates as part of the Acquisition;
“BUKIT” means a Bulkamid kit, as further set out in the Specifications;
“BU10” means a single 1mL syringe of urethral bulking agent, consisting of [***]% water and [***]% polyacrylamide, as further set out in the Specifications;
“Business Day” means a day other than a Saturday, Sunday or bank or public holiday in Denmark, England or California;

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

“Change Control Procedure” means, unless otherwise provided in this Agreement, the process by which any change to this Agreement including a change to the Product is agreed, as set out in Schedule 3;
“Commencement Date” means the effective date of this Agreement;
“Confidential Information” means:
(a)    information however recorded or communicated, including technical or other information (other than the Know-how licenced under the Know-how Licence Agreement), received or obtained directly or indirectly by a party from the other party in anticipation of or in connection with this Agreement which is identified as being confidential at the time of disclosure or which a reasonable person in the position of the Receiving Party would understand to be confidential due to the nature, type or presentation of the information;
(b)    the Know-how licenced to the Customer under the Know-how Licence Agreement, of which the Customer shall be deemed to be the Disclosing Party but only in relation to use in the Field; 
(c)    any other Know-how of either party relating to the Manufacture of the Product (other than the Know-how licenced to the Customer under the Know-how Licence Agreement); 
(d)    Improvements, of which the owning party shall be deemed to be the Disclosing Party;
(e)    Joint Improvements (as defined in clause 12.2), of which each party shall be deemed to be both the Disclosing Party and the Receiving Party; and
(f)    the terms of this Agreement, of which each party shall be deemed to be both the Disclosing Party and the Receiving Party;
“Contract Year” means a period of 12 consecutive months during the Term commencing on 1 January, provided that: 
(a)    the first Contract Year shall start on the Commencement Date and end on 31 December 2021; and 
(b)    the last Contract Year shall end on the date of termination of this Agreement;
“Control” means:
(a)    the possession, directly or indirectly, of more than 50% of the issued share capital, stock or securities of, or the voting rights in, a person or the right to receive more than 50% of the income, profits or assets of a person; 
(b)    the right or power, directly or indirectly, to appoint or remove the majority of the board of directors or other officers of a person or of those directors or officers who have voting rights in relation to the person’s management; or
(c)    the right or power, directly or indirectly, to direct or cause the direction of the management, policies or affairs of a person, through voting rights, by contract or otherwise;
“Cross-Licence Agreement” means the licence agreement between Contura A/S and Customer signed on or around the Commencement Date under which Contura A/S granted Customer a licence to use certain trade marks relevant to the Products and Customer granted Contura A/S an exclusive licence to certain patents outside the Field;  

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

“Customer Group” means the Customer together with its Affiliates;
“Customer Intellectual Property” means any Intellectual Property Rights that are owned, developed or acquired by, or  licenced (other than by the Manufacturer Group) to, the Customer Group prior to, on or after the Commencement Date, including the Acquired IP.
“Delivery” means delivery of the Product by the Manufacturer in accordance with the requirements of clause 5 and “Deliver” and “Delivered” shall be construed accordingly;
“Disclosing Party” means the party:
(a)    whose, or whose Affiliate’s, Confidential Information is disclosed to or obtained by the other party or its Affiliate, or
(b)    which is so deemed in relation to particular Confidential Information;
“Enforcement against Customer” has the meaning given to it in Schedule 4 section 14.3;
“Enforcement against Manufacturer” has the meaning given to it in Schedule 4 section 14.1;
“Field” means the field of [***]; 
“Force Majeure Event” means any act, event, omission, accident or circumstances beyond the reasonable control of a party, which prevents, delays or hinders it from performing its obligations under this Agreement, including, any of the following: (a) acts of God, flood, earthquake, windstorm or other natural disaster, (b) war (or threat of, or preparation for, war), armed conflict (or threat of, or preparation for, armed conflict), (c) imposition of border controls, sanctions, embargo, breaking off of diplomatic relations or similar actions, (d) terrorist attack, civil war, civil commotion or riot (or the threat of, or preparation for, a terrorist attack, civil war, civil commotion or riot), (e) nuclear, chemical or biological contamination or sonic boom, (f) epidemic or pandemic, (g) fire or explosion (other than, in each case, one caused by breach of contract by, or with the assistance of, the party seeking to rely on it as a Force Majeure Event or by a member of the same group as such party), (h) adverse weather conditions, (i) any labour dispute, including, but not limited to, strikes, industrial action or lockouts,  (j) interruption or failure of utility service, including but not limited to electricity, gas or water, (k) any Applicable Law, and (l) any action taken by a Governmental Entity or public authority, including, but not limited to, a failure to grant a necessary licence or consent or the imposition of an export restriction, import restriction, quota or other restriction or prohibition; but not including any obligation of the Customer to pay the Price to the Manufacturer;
“Forecast” has the meaning given in clause 3.1 and “Forecasted”  shall be construed accordingly;
“Governmental Entity” means any court, administrative body, local authority or other governmental or quasi-governmental entity with competent jurisdiction, any supra-national, national, federal, state, municipal, provincial or local governmental, regulatory or administrative authority, ministry, agency, commission, coordination group, court, tribunal, arbitral body, self-regulated entity, private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority or other governmental entity, including any relevant Regulator; 
“Improvement” means any new or improved process, technique, method, formula, invention or Know-how that relates to the Products or the Manufacture of the Products and is created during the Term of this Agreement;
“Intellectual Property Rights” means copyright, rights related to copyright such as moral rights, patents, rights in inventions, rights in confidential information, Know-how, trade secrets, trade 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

marks, trade names, design rights, rights in get-up, database rights, databases, data exclusivity rights, domain names, rights in computer software, unfair competition and passing off, and all similar rights of whatever nature wherever in the world arising and, in each case:
(a)    whether registered or not,
(b)    including any applications to protect or register such rights,
(c)    including all renewals and extensions of such rights or applications, and
(d)    wherever existing;
 “Know-how” means all industrial, manufacturing, technical and or commercial information and techniques in any form, whether or not confidential, proprietary, patented or patentable, including drawings, designs, data relating to inventions, formulae, methods, processes, trade secrets, performance methodologies, techniques, specifications, technical information, component lists, expertise, test results, reports, research reports, project reports and testing procedures, instruction and training manuals, operating tables of operating conditions, market forecasts and lists and particulars of customers and suppliers;  
“Know-how Licence Agreement” means the licence agreement between the Manufacturer and Contura A/S and Customer signed on or around the Commencement Date, under which the Manufacturer and Contura A/S granted Customer a licence to use certain Know-how relevant to the Manufacture of the Products;
“Latent Defect” means a failure of the Product (a) to conform to the Specifications or (b) to have been Manufactured in accordance with the terms of this Agreement, which failure exists at the time of Delivery of such Product but could not have been discovered by a reasonable visual inspection undertaken by or on behalf of the Customer;
“Licenced Intellectual Property” means the Intellectual Property Rights licenced to Customer under the Cross-Licence Agreement and the Know-how Licence Agreement;
 “Losses” means all losses, claims, liabilities, costs, awards, fines, penalties, expenses (including reasonable legal fees and other professional expenses) and damages of any nature whatsoever and whether or not reasonably foreseeable or avoidable;
“Manufacture” means planning, purchasing of materials for manufacturing, manufacture, processing, compounding, assembly, storage, filling, packaging, labelling, leafleting, testing, waste disposal, quality assurance and control, despatch, sample retention and, to the extent required by Applicable Laws, stability testing, verification and validation testing, and release of finished Products, and “Manufactured”  and “Manufacturing”  shall be construed accordingly; 
“Manufacturer Group” means the Manufacturer together with its Affiliates;
“Manufacturer Intellectual Property” means any Intellectual Property Rights that are owned, developed or acquired by, or  licenced (other than from the Customer Group) to, the Manufacturer Group prior to, on or after the Commencement Date, excluding, for the avoidance of doubt, the Acquired IP which after the effective date of the Acquisition are owned by Customer Group;
“Manufacturing Site” means the manufacturing site operated by the Manufacturer at  Sydmarken 23, DK 2860 Søborg, Denmark, and any replacement manufacturing site pursuant to clause 2.7; 
“Notified Body” means a conformity assessment body designated as a notified body in accordance with the European Union medical devices directive 93/42/EEC (or “EU MDD”), the European Union medical devices regulation 2017/745/EU (or “EU MDR”) and/or the United 

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Kingdom Medical Devices Regulations 2002 or any subsequent regulation or laws amending, supplementing or replacing any of the foregoing;
“Official Product Recall Notice” has the meaning given in clause 17.1;
“Order” has the meaning given in clause 4.1;
“Price” means the price of the Products, as set out in, or calculated or determined in accordance with, Schedule 1 and clause 7;
“Product” means BUKITs or BU10s, as applicable, and any modification and/or variations of each agreed by the parties under this Agreement for use in the Field;
“Product IP” means the Acquired IP and the Licenced Intellectual Property;   
“Quality Agreement” means the agreement allocating regulatory responsibilities and tasks in relation to the Products, to be entered into by the parties without undue delay after the Commencement Date, but no later than 15 Business Days after the Commencement Date, to be negotiated in good faith among the parties immediately after the Commencement Date, as amended from time to time;
“Receiving Party” means the party:
(a)    to whom, or to whose Affiliate, Confidential Information of the other party or its Affiliate is disclosed; or
(b)    which is so deemed in relation to particular Confidential Information;
 “Regulator” means any relevant authority which regulates any aspect of the development, Manufacture, supply, promotion and/or use of the Product and/or which has competence for market surveillance in respect of the Product; 
“Rest of World” means any jurisdiction in which the Products are investigated, Manufactured, placed on the market, promoted, supplied and/or used outside of the European Union (or “EU”), the United Kingdom (or “UK”) or the United States of America (or “USA”);
“SKU” means Stock Keeping Unit and shall comprise, in respect of Product, separable lines of Product by reference to their packaging, labeling, instruction for use or other contents (for example a BUKIT for the EU market will be a different SKU to a BUKIT for the US market, due to their different labeling and release requirements);
“Specifications” means the technical specifications for the required quality and characteristics of each Product as attached to this Agreement at Schedule 2;
“Steering Committee” has the meaning given in clause 11.1;
“Sub-contract” means any contract between the Manufacturer and a Third Party pursuant to which the Manufacturer agrees to source the performance of services or the supply of goods (or any of them) from that Third Party; 
“Sub-contractor” means those persons with whom the Manufacturer enters into a Sub-contract including its or their employees, officers, sub-contractors or agents;
“Term” means the term of this Agreement, as set out in clause 21.1;
“Third Party” means any person other than the parties and their Affiliates;
“Third Party Claim” has the meaning given in clause 13.3;

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

“UK Approved Body” has the meaning given to the term “approved body” in the United Kingdom Medical Devices Regulations 2002;
“UK Responsible Person” has the meaning(s) given to the term “UK Responsible Person” in the United Kingdom Medical Devices Regulations 2002;
“VAT” means value added tax or other sales tax chargeable under Applicable Laws; and
“Working Hours” means 8:00am to 4:00pm on a Business Day.
1.1    In this Agreement:
1.1.1    a reference to this Agreement includes its Schedules, appendices and annexes (if any);
1.1.2    a reference to a party includes that party’s personal representatives, successors and permitted assigns;
1.1.3    a reference to a ‘person’ includes a natural person, corporate or unincorporated body (in each case whether or not having separate legal personality) and that person’s personal representatives, successors and permitted assigns;
1.1.4    words in the singular include the plural and vice versa;
1.1.5    any words that follow ‘include’, ‘includes’, ‘including’, ‘in particular’ or any similar words and expressions shall be construed as illustrative only and shall not limit the sense of any word, phrase, term, definition or description preceding those words;
1.1.6    ‘writing’ or ‘written’ includes any method of reproducing words in a legible and non-transitory form, including email; 
1.1.7    the table of contents, background section and any clause, Schedule or other headings in this Agreement are included for convenience only and shall have no effect on the interpretation of this Agreement;
1.1.8    a reference to legislation includes all subordinate legislation made from time to time under that legislation and is a reference to that legislation as amended, extended, re-enacted, incorporated, transposed, converted or consolidated from time to time;
1.1.9    a reference to a particular time shall be that time in the time zone applicable to the Manufacturing Site; and
1.1.10    a reference to any English action, remedy, method of judicial proceeding, court, official, legal document, legal status, legal doctrine, legal concept or thing shall, in respect of any jurisdiction other than England, be deemed to include a reference to that which most nearly approximates to the English equivalent in that jurisdiction.
2.    THE PARTIES’ OBLIGATIONS
2.1    Subject to clause 2.6, the Manufacturer shall Manufacture and supply to the Customer such quantities of the Product as ordered by the Customer in accordance with clause 4 using due care and skill and in accordance with:
2.1.1    the terms of this Agreement; 
2.1.2    the Specifications; 
2.1.3    the Quality Agreement; and
2.1.4    all Applicable Laws.

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2.2    The Manufacturer shall, in performing its obligations under this Agreement, comply with all Applicable Laws relevant to the Manufacture of the Product and the sale and supply of the Product under this Agreement.
2.3    Each party shall cooperate with the other party to enable the other party to carry out its obligations in accordance with this Agreement. In particular, the Customer shall provide such assistance, information or cooperation as the Manufacturer may reasonably request in connection with its regulatory obligations relating to this Agreement. The Manufacturer shall not be liable under this Agreement for any failure to perform its regulatory obligations to the extent such failure results from the acts or omissions of the Customer. 
2.4    The Manufacturer agrees to Manufacture and supply the Product exclusively in the Field for the Customer and its Affiliates during the Term. The Customer agrees to procure all of its, and its Affiliates’, demand for Products exclusively from the Manufacturer during the Term, provided however, that this exclusivity shall terminate upon the exercising by Customer of the technology transfer option set forth in clause 22, but in no event prior to the date set forth in clause 22.1.3. 
2.5    The Manufacturer shall be entitled to suspend the Manufacture and supply of the Product to the Customer if (a) the Customer becomes subject to any of the events listed in clause 21.2.3; (b) the Customer is in material breach of any of its obligations under this Agreement and that breach is capable of remedy but the Customer has failed to remedy that breach within [***] days after receiving written notice identifying the alleged material breach and requiring it to remedy that breach; or (c) the Customer fails to pay any amount due under this Agreement on the due date for payment and does not pay such amount within [***] days of a notice to the Customer in writing requesting it to do so, except to the extent such amount is disputed in good faith. The Manufacturer shall promptly resume the Manufacture and supply of the Product to the Customer once the relevant issue has been resolved to the Manufacturer’s reasonable satisfaction. 
2.6    The Manufacturer shall obtain the Customer’s written consent (such consent not to be unreasonably withheld, delayed or conditioned) prior to:
2.6.1    changing the Manufacturing Site; 
2.6.2    effecting any change that constitutes or requires a change to the Specifications; or
2.6.3    changing any part of the manufacturing process for the Products, including but not limited to substituting, changing the terms of or Specifications in relation to any Sub-contractors or suppliers.
2.7    Except as otherwise provided in this Agreement, in relation to any costs, expenses or similar amounts that may be payable in connection with this Agreement: 
2.7.1    each party will bear its own internal costs in relation to its compliance with, and performance of, this Agreement; and
2.7.2    each party will bear any Third Party costs incurred in relation to matters for which that party is responsible under Schedule 4, including as set out in the funding provisions of such Schedule, or otherwise in this Agreement; provided that to the extent that one party assists the other party to perform that other party’s responsibilities and wishes to instruct a Third Party in connection with such assistance, the first party shall not instruct such Third Party without the prior written consent of the other party, which will not be unreasonably withheld, delayed or conditioned. 

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3.    FORECASTS
3.1    The Customer shall provide to the Manufacturer rolling forecasts of the Customer’s volume requirements by SKU for the Product for at least a one year period starting 180 days after the date of the forecast (the “Forecast”). The Forecast shall include the Customer’s monthly volume requirements for the Product for the period of the Forecast. The first such Forecast shall be provided by the Customer to the Manufacturer within 10 Business Days of the Commencement Date (the “Initial Forecast”). For the period starting on the Commencement Date and ending 6 months thereafter (the “Initial Period”), a Forecast shall not be required and Manufacturer shall during the Initial Period have sufficient resources available to be able to Deliver up to [***] BUKITs to the Customer, including up to [***] BUKITs in each month of the Initial Period within [***] Business Days following an Order by Customer. The Manufacturer shall not be liable to deliver more than [***] BUKITs in the Initial Period.
3.2    The Customer shall update and provide the Forecast to the Manufacturer once every three months following the Initial Forecast during the Term. The Customer shall use its commercially reasonable endeavours to ensure that the Forecast is accurate, complete and a reasonable estimate of its anticipated requirements at the date of its preparation. 
3.3    The Manufacturer shall notify the Customer in writing as soon as practicable following receipt of the Forecast if it anticipates that it shall not be able to meet the Customer’s Forecast requirements. In such circumstances the Customer may at its option agree to alternative dates of Delivery of the Products. 
3.4    The parties agree that the Product volumes detailed in the first six-months of the Forecast shall constitute a firm Order by the Customer for such Product for the purposes of clause 4.1.  The remaining period of the Forecast are estimates of the Customer’s future requirements for the Product and shall not comprise a binding commitment by the Customer to purchase such Product. The Manufacturer shall use its commercially reasonably endeavours to have available the capacities for Manufacturing the Products in the quantity as indicated by the Forecast. 
3.5    In each updated Forecast, the Customer may change its volume requirements for the Product. The Manufacturer shall not be obliged to accept any changes to the Forecast that exceed a 25% change in volume for the relevant period from the previous Forecast. Subject to clause 4.6, the Manufacturer shall use commercially reasonable endeavours to accept Orders which exceed a 25% increase in the volume for the applicable period in the previous Forecast, but shall not be bound to supply such excess volumes. 
4.    ORDERS
4.1    The Customer may place orders for the Product from time to time during the Term (each, an “Order”). The Customer will submit a firm Order every three months that will, subject to clause 4.3, be binding on both Customer and Manufacturer.
4.2    The Customer shall issue Orders either in writing or electronically (or by any other means agreed by the parties) to the Manufacturer at least 180 days in advance of the required Delivery date, except for the Initial Period, in which the Customer shall be entitled to issue Orders at any time with 20 Business Days in advance of the required Delivery date to the extent in accordance with the volumes set forth in Section 3.1. Each Order shall be treated as a separate offer by the Customer to purchase the Product on and subject to the terms and conditions of this Agreement. 
4.3    The Manufacturer shall confirm each Order in writing or electronically (or by any other means agreed by the Parties) within 10 Business Days of receipt, provided however, that the 

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Manufacturer may decline an Order within the same 10 Business Days period: (a) to the extent it relates to volumes of Product in excess of the volumes permitted under clause 3.5, and the Manufacturer can demonstrate that using reasonable endeavours it is unable to supply these incremental volumes and provided that Manufacturer complies with clause 4.5; or (b) to the extent it falls outside the maximum order quantities in clause 4.6; or (c) if the Manufacturer has suspended Manufacture and supply of the Product pursuant to clause 2.6.
4.4    Any Order may be amended or cancelled only by written agreement of both parties.
4.5    Where the volume of the Product to be delivered pursuant to an Order exceeds the preceding Forecast by more than 25%, the Manufacturer may suggest amendments to the timing or quantities for Delivery of the excess volumes of Product, in which case the parties shall use reasonable endeavours to agree such amendments, and in the event of such agreement, the Manufacturer shall promptly confirm to the Customer its acceptance of the exceeding portion of the Order, including the agreed quantity of the Product and the date for Delivery. For the avoidance of doubt, the Manufacturer shall not be entitled to decline an Order which is within a range of 25% (less or more) than the relevant preceding Forecast. 
4.6    The Customer shall have no obligation to purchase any minimum quantities of Products during the Term.  Manufacturer shall have no obligation to Manufacture or supply the Product, or use reasonable endeavours to do so (notwithstanding clause 3.5), in volumes that exceed the maximum order quantities set out below:
						
	Contract Year	Maximum order quantity
	Contract Year 1	[***] BUKITs (where for the purpose of this maximum, 2 BU10s shall be treated as equivalent to 1 BUKIT)
	Contract Year 2	[***] BUKITs (where for the purpose of this maximum, 2 BU10s shall be treated as equivalent to 1 BUKIT)
	Contract Year 3	[***] BUKITs (where for the purpose of this maximum, 2 BU10s shall be treated as equivalent to 1 BUKIT)
	Contract Year 4 and each subsequent Contract Year	As agreed pursuant to clause 4.8

4.7    As Contract Year 1 will be less than a full calendar year, the maximum order quantity for Contract Year 1 will be reduced on a pro-rata basis.
4.8    For Contract Year 4 and each subsequent Contract Year, the parties shall discuss the maximum order quantity in the Steering Committee and shall use reasonable endeavours to agree to maximum order quantities within 30 days of a written request from either party to agree to such maximum order quantities; provided, however, that if the parties are unable to agree to such maximum order quantity, the maximum order quantity for Contract Year 4 shall be no lower than 120% of the maximum order quantity for Contract Year 3, with subsequent Contract Years following this model based on the Product quantities for the preceding Contract Year.
5.    DELIVERY
5.1    The Manufacturer shall Deliver the Product DAP (Incoterms 2020) to a location in the Netherlands designated by Customer in the relevant Order (or such other location agreed in 

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writing by the parties) and shall promptly notify the Customer in writing that the Product has been delivered.  The cost of shipping the Product to Customer’s designated location and the risk of loss during such shipment shall be the responsibility of Manufacturer.
5.2    The Manufacturer shall not be liable for any delay in delivering an Order to the extent that delay is due to the Customer’s failure to comply with its obligations under this Agreement.
6.    TITLE AND RISK IN THE PRODUCT
6.1    Risk in the Product shall pass to the Customer on Delivery.
6.2    Title to the Product shall pass to the Customer on Delivery.
6.3    If, at any time before title to the Product has passed to the Customer, the Customer has become subject to any of the events specified in clause 21.2.3, the Manufacturer may require the Customer at the Customer’s expense to return to the Manufacturer all Products for which the Customer has not yet paid the Manufacturer. If the Customer fails to do so within a reasonable period, the Manufacturer may enter any premises where the Products for which the Manufacturer has not yet been paid are stored and repossess them.
7.    PRICE
7.1    The Prices of the Product are set out in Schedule 1 as may be adjusted from time to time pursuant to this clause 7 and the Change Control Procedure in relation to Specification changes set out in clause 10. 
7.2    The Prices are inclusive of the costs of packaging, shipping, and insurance, but exclude applicable taxes and duties. 
7.3    The Prices are exclusive of VAT. The Customer shall pay such VAT upon presentation by the Manufacturer of a valid VAT invoice.
7.4    For Contract Year 4 and each subsequent Contract Year, the Prices shall be the Prices for the preceding Contract Year adjusted up or down in line with the Producer and Import Price Index for Commodities, as published by Statistics Denmark and notified by the Manufacturer to the Customer in writing in the first month of such Contract Year. 
7.5    If the volume of Product Delivered to the Customer in Contract Year 4 or any subsequent Contract Year is in excess of the volumes set out in the table below for that Contract Year, the Manufacturer shall apply the corresponding volume discount to all volumes of Products Delivered to the Customer for such Product in the remainder of that Contract Year. Such discounts shall be calculated on the then-current Price and applied to the relevant invoice for the Product.
						
	Product purchase volume	Discount
	[***] BUKITs per Contract Year	[***]% discount on the Price of all BUKITs retroactive to the first unit ordered in such Contract Year
	[***] BUKITs per Contract Year	[***]% discount on the Price of all BUKITs retroactive to the first unit ordered in such Contract Year

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	[***] BUKITs per Contract Year	[***]% discount on the Price of all BUKITs retroactive to the first unit ordered in such Contract Year

8.    INVOICING AND PAYMENT
8.1    The Customer shall pay the applicable Prices for the Product supplied under this Agreement in accordance with this clause 8.
8.2    The Manufacturer shall invoice the Customer upon Delivery of the Product. Each invoice shall specify: 
8.2.1    the Price in respect of the Product Delivered;
8.2.2    the quantity of the Product Delivered and the corresponding Order reference number; 
8.2.3    the amount of VAT (if any) due in respect of the Product Delivered; and
8.2.4    any other amounts payable to the Manufacturer pursuant to this Agreement.
8.3    The Customer shall pay all amounts invoiced by the Manufacturer in Euros (€) within 45 days after the date of the invoice to the account nominated in writing by the Manufacturer.
8.4    The Manufacturer may charge interest at a rate of four per cent (4%) per annum above the base rate of the Bank of England from time to time on amounts not paid by the Customer in accordance with clause 8.3 until payment is received in full. The Customer shall pay any such accrued interest required by the Manufacturer pursuant to this clause 8.4 together with the overdue amount. 
9.    QUALITY
9.1    The Manufacturer shall ensure that the Product supplied to the Customer pursuant to this Agreement at the date of Delivery:
9.1.1    conforms to the Specifications; 
9.1.2    conforms to the requirements of the Quality Agreement; and
9.1.3    complies with all Applicable Laws that relate to the Products and the Manufacture of the Products.
9.2    The Customer shall inspect the Products without undue delay following Delivery with respect to any discrepancies in volume, transport damage or any non-conformity that can be identified through a visual, external inspection of the packaged Products Delivered. The Customer may reject any Product Delivered to it which does not meet the requirements of clause 9.1, provided that written notice of rejection is given to the Manufacturer no later than 5:00pm on the thirtieth day following the date of Delivery or, in the case of a Latent Defect, no later than 5:00pm on the tenth Business Day following the date of discovery of the Latent Defect. Such right to reject the Product shall cease to the extent:
9.2.1    the Customer uses the Product, or provides it to any Third Party for use, in any way after giving a notice of rejection;
9.2.2    the defect is due to the Manufacturer having followed the Customer’s instruction or Specifications; or

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9.2.3    the defect is due to repair, repackaging, alteration, misuse, neglect, damage in transit, storage conditions, or operating conditions caused after Delivery, or results from fair wear and tear. 
9.3    If the Customer rejects the Product pursuant to clause 9.2, the Manufacturer shall, at Customer’s choice, repair or replace the Product or repay the price for the rejected Product in full upon return of such Product to Manufacturer. Any available remedies under this Agreement or Applicable Laws shall remain unaffected. If the Customer fails to reject defective Product within the time allowed by clause 9.2 it shall be deemed to have accepted the Product. 
9.4    If the Manufacturer disagrees that any Product is defective, or considers that the defect has arisen as a result of any of the matters set out in clause 9.2, either party may require that the alleged defective Product be delivered to an independent testing laboratory (the identity of which shall be agreed by the parties or, in the absence of agreement, as determined by the Chief Executive of the Association of British HealthTech Industries) for evaluation.  Except in case of manifest error, the decision of the laboratory as to whether the Product is defective, and the cause of the defect, shall be final and binding on the parties.  If the laboratory determines that the Product is defective for reasons not attributable to the acts or omissions of the Customer, the Manufacturer shall pay the laboratory's fees, but otherwise the Customer shall pay the laboratory's fees and shall accept the allegedly defective batch. 
9.5    This clause 9 shall not affect the parties’ obligations in relation to Product complaints and vigilance, which shall be covered in Schedule 4.
10.    CHANGES TO SPECIFICATIONS OR PACKAGING
10.1    Each party shall notify the other party in writing of any changes it requires to the Specifications. The receiving party shall be entitled, acting reasonably, to reject any request to change the Specifications except that it shall not reject a request to change where the change is required by Applicable Laws or a Government Entity.
10.2    All changes to the Specifications, and the basis on which the Manufacturer is to be compensated for its costs of implementing the change, shall be agreed in writing between the parties and implemented in accordance with the Change Control Procedure.
10.3    Without prejudice to the general provisions above, if either party wishes to vary the Product packaging, it shall give written notice to the other party stating fully and accurately the details of the variation (the “Packaging Change”) it requires and the reason for such request.
10.4    The Manufacturer shall within 20 Business Days of receipt of the relevant request from the Customer for a Packaging Change, or at the same time as its request for a Packaging Change, give notice to the Customer stating whether it considers that such Packaging Change will result in, and giving details of, any increases in the lead time for Delivery of the Product and in the Price. The parties shall agree to any variation in the Price or lead times. If the parties do not agree to such variation in writing within three months following the Manufacturer’s receipt of notice under clause 10.3, the parties may resolve the issue under clause 37.  
11.    STEERING COMMITTEE
11.1    In order to monitor the performance of the parties under this Agreement and areas for improvement, the parties shall establish a steering committee (the “Steering Committee”). 
11.2    The Steering Committee shall comprise up to three representatives of each party and a Steering Committee meeting shall be deemed quorate if one member from each party is present.  Each 

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member of the Steering Committee may appoint and notify the other members of an alternate in case he or she is unavailable. 
11.3    Each member shall have sufficient seniority, technical expertise and familiarity with the subject matter of this Agreement and be able to contribute to the Steering Committee on behalf of their party. Each party may appoint new members by providing written notice to the other party of the names and contact details of such new members and shall have the right to remove any members they have appointed.  
11.4    Each Steering Committee meeting may be held in person (if reasonable to do so), or by telephone or by video conference.  The parties will produce and circulate to all Steering Committee members minutes of each meeting.
11.5    The Steering Committee shall use reasonable endeavours to meet within 30 days of the Commencement Date and after that at least once every quarter (or more frequently if the parties agree (acting reasonably) that more frequent meetings are necessary) during the Term.
11.6    Decisions of the Steering Committee shall be taken by way of consensus, with each party having one vote. In the event of deadlock, the party making the proposal under consideration shall, within 10 days, submit a revised proposal to the Steering Committee.  Within 5 Business Days of the revised proposal being submitted, the Steering Committee shall meet and take a decision on the revised proposal. If that does not resolve the deadlock, either party may refer the matter for resolution pursuant to clause 37.  
12.    INTELLECTUAL PROPERTY RIGHTS
12.1    Except as expressly set out in this clause 12, no Intellectual Property Rights of either party are transferred or  licenced as a result of this Agreement. The Manufacturer Intellectual Property is and shall remain the exclusive property of the Manufacturer (or, where applicable, the Third Party licensor from whom the Manufacturer derives the right to use them), and the Customer Intellectual Property, including the Acquired IP, is and shall remain the exclusive property of the Customer (or, where applicable, the Third Party licensor from whom the Customer derives the right to use them).
12.2    The Customer will own all Improvements, and all Intellectual Property Rights in all Improvements, that are invented, developed and/or created solely by the Customer (the “Customer Improvements”). The Manufacturer will own all Improvements, and all Intellectual Property Rights in all Improvements, that are invented, developed and/or created solely by the Manufacturer (the “Manufacturer Improvements”). The Customer and the Manufacturer will jointly own all Improvements, and all Intellectual Property Rights in all Improvements, that are invented, developed and/or created jointly by the Customer and the Manufacturer (the “Joint Improvements”). 
12.3    The Manufacturer agrees that it will execute any and all documents deemed necessary by the Customer and will otherwise cooperate with the Customer to perfect its Intellectual Property Rights in the Customer Improvements and Joint Improvements, including without limitation, by providing reasonable assistance to the Customer (at the Customer’s cost) in the preparation and prosecution of patent applications, and by executing any necessary assignments of patents and other Intellectual Property Rights to the Customer. The Customer agrees that it will execute any and all documents deemed necessary by the Manufacturer and will otherwise cooperate with the Manufacturer to perfect its Intellectual Property Rights in the Manufacturer Improvements and Joint Improvements, including without limitation, by providing reasonable assistance to the 

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Manufacturer (at the Manufacturer’s cost) in the preparation and prosecution of patent applications, and by executing any necessary assignments of patents and other Intellectual Property Rights to the Manufacturer.  
12.4    The Manufacturer hereby grants to the Customer a perpetual, irrevocable, limited, exclusive, royalty-free, fully paid-up, transferrable licence to use the Manufacturer Improvements and Joint Improvements solely in the Field. For the avoidance of doubt, the Customer shall not be licenced, and shall not have the right, to use any of the Manufacturer Improvements or Joint Improvements outside the Field for any purpose or for any reason. The Customer may grant sublicences through multiple tiers under the licence granted in this clause 12.4 without the prior written consent of the Manufacturer, subject to such sublicences (i) not purporting to grant any right under such Manufacturer Improvements or Joint Improvements that is broader than the rights granted in this clause 12.4 and (ii) containing restrictions on the sublicensee no less onerous than those set out in this Agreement. The Customer shall ensure that each sublicensee fully complies with the terms of its sublicence, and Customer shall be fully responsible, and shall bear all liability for, any sublicensee’s failure to do so.
12.5    The Customer hereby grants to the Manufacturer a perpetual, irrevocable, limited, exclusive, royalty-free, fully paid-up, transferrable licence to use the Customer Improvements and Joint Improvements solely outside the Field. For the avoidance of doubt, and except as provided in clause 12.6 below, the Manufacturer shall not be licenced, and shall not have the right, to use any of the Customer Improvements or Joint Improvements in the Field for any purpose or for any reason. The Manufacturer may grant sublicences through multiple tiers under the licence granted in this clause 12.5 without the prior written consent of the Customer, subject to such sublicences (i) not purporting to grant any right under such Customer Improvements or Joint Improvements that is broader than the rights granted in this clause 12.5 and (ii) containing restrictions on the sublicensee no less onerous than those set out in this Agreement. The Manufacturer shall ensure that each sublicensee fully complies with the terms of its sublicence, and Manufacturer shall be fully responsible, and shall bear all liability for, any sublicensee’s failure to do so.
12.6    The Customer hereby grants (and shall procure that each of its Affiliates grants) to the Manufacturer and its Affiliates, for the sole purposes of, and to the extent necessary to, Manufacture the Product for the Customer and otherwise perform its obligations and exercise its rights under this Agreement a limited, non-exclusive, royalty-free, fully paid-up licence (including the right to grant sub-licences in multiple tiers to Sub-contractors) to use the Product IP, Customer Improvements and other Customer Intellectual Property relating to the Product or its Manufacture during the Term. For the avoidance of doubt, except as expressly provided herein or any other agreement with the Customer or the Customer Group, the Manufacturer shall not be licenced to use any of the Product IP, Customer Improvements or other Customer Intellectual Property to Manufacture the Products in the Field for any person or entity other than the Customer or the Customer Group.
12.7    The Parties recognize that the Manufacturer and Chempilots A/S have entered into a Master Development Service Agreement effective as of 2 February 2021, and amended on 11 February 2021, and agree that the Manufacturer shall not, except with the prior written consent of Customer, provide written consent or a waiver of provision 5.1.2 of such Master Development Service Agreement in relation to any product within the Field, or do or undertake to do any other action which may have a similar effect.

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13.    INDEMNITY
13.1    To the fullest extent permitted by Applicable Law, the Customer shall indemnify, hold harmless and keep the Manufacturer and its Affiliates held harmless from and against any Losses incurred by the Manufacturer and its Affiliates as a result of or in connection with any Enforcement against Manufacturer, action, demand or claim that:
13.1.1    results from Product claims, information or activities that are in violation of Applicable Laws relating to any of:
(a)    the marketing or promotion of the Product after the Commencement Date;
(b)    the training developed or modified after the Commencement Date (or where Customer has failed after the Commencement Date to update such training to reflect changes to Applicable Laws after the Commencement Date) for and delivered to healthcare professionals in relation to the Product;
(c)    information developed or modified after the Commencement Date (or where Customer has failed after the Commencement Date to update such information to reflect changes to Applicable Laws after the Commencement Date) and released for patients concerning the Product, 
except to the extent that any of the above arise from negligence or wilful misconduct of the Manufacturer or was caused prior to the Commencement Date; or
13.1.2    the Manufacturer has failed to comply with any of its regulatory responsibilities relating to the Product, to the extent this is due to the acts, default or omissions of the Customer or to Manufacturer’s reliance on information provided to it by Customer.
13.2    To the fullest extent permitted by Applicable Law, the Manufacturer shall indemnify, hold harmless and keep the Customer and its Affiliates held harmless from and against any Losses incurred by the Customer and its Affiliates as a result of or in connection with any Enforcement against Customer, action, demand or claim that:
13.2.1    relates to a Product supplied by the Manufacturer, to the extent such Product did not comply with the Specification at the time such Product was supplied to the Customer and such non-compliance could not have been identified by the Customer upon reasonable inspection;
13.2.2    arises from a breach by Manufacturer of the warranties in clause 14.1 of this Agreement;  
13.2.3    the Customer has failed to comply with any of its regulatory responsibilities relating to the Product, where this is due to the acts, default or omissions of the Manufacturer or to Customer’s reliance on information provided to it by the Manufacturer.
13.3    If any claim covered by clauses 13.1 or 13.2 is made or is reasonably likely to be made against the applicable indemnified party or any of its Affiliates (the “Indemnitees”), the other party (the “Indemnifying Party”) shall:
13.3.1    as soon as reasonably practicable after the applicable Indemnitee receives notice of any Third Party claim qualifying for an indemnity (“Third Party Claim”), give written notice to the Indemnifying Party specifying reasonable details of the Third Party Claim and permit the Indemnifying Party to assume the conduct, defence and settlement of the Third Party Claim (provided that the Indemnifying Party shall not agree to any settlement that includes any sort of injunction or other non-monetary remedy being 

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granted against any of the Indemnitees without the prior written consent of the relevant Indemnitee, such consent not to be unreasonably withheld, delayed or conditioned);
13.3.2    provide to the Indemnifying Party reasonable assistance relating to any Third Party Claim at the Indemnifying Party’s request and cost; and 
13.3.3    not make any admissions or agreements in relation to any Third Party Claim without the Indemnifying Party’s prior written consent. 
13.4    If any indemnity payment under clauses 13.1 or 13.2 is subject, in the Indemnitee’s hands, to any applicable taxes, the amount required to be paid by the Indemnifying Party shall be increased so as to ensure that the Indemnitee receives (after any applicable taxes have been paid) the same amount as it would have received had no such taxes been levied.
14.    WARRANTIES
14.1    The Manufacturer warrants that:
14.1.1    the Product shall:
(a)    subject to the Customer complying with its obligations in accordance with clause 16, be Manufactured in accordance with Applicable Laws that relate to the Manufacture of the Product; and
(b)    on Delivery comply with the Specifications; and
14.1.2    it has full capacity and authority to enter into this Agreement and to perform its obligations under this Agreement;
14.1.3    it has as of the Commencement Date and will maintain in full force and effect for the duration of this Agreement all necessary permits, licences, approvals and authorisations required under Applicable Laws to enable the Manufacturer to Manufacture and supply the Product in accordance with this Agreement;
14.1.4    as of the Commencement Date, the Intellectual Property Rights subsisting in the Manufacturer’s manufacturing processes or methods employed or to be employed at any facility used to Manufacture Products, are owned by the Manufacturer or the Manufacturer is otherwise entitled to use them for the purposes of this Agreement;
14.1.5    the facilities and all equipment, tooling and molds utilized in the Manufacture, storage and supply of Product hereunder by the Manufacturer shall, during the Term of this Agreement, be maintained in good operating condition;
14.1.6    the Manufacturer has and will maintain for the Term of the Agreement the skilled personnel and equipment to supply the Product in accordance with the respective Orders and this Agreement;
14.1.7    subject to clause 6.2, unencumbered title to Product will be conveyed to Customer upon Delivery; and
14.1.8    the Manufacturer will not make available the Customer Intellectual Property, the Customer Improvements or the Product IP to any Third Party in the Field, or for use in the Field, without Customer’s prior written consent, except to the extent in accordance with this Agreement, the Cross-Licence Agreement or any other agreement entered into between Manufacturer and the Customer.

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14.2    Save as set out expressly in this Agreement, all warranties, conditions and other terms, including the terms implied by sections 13 to 15 of the Sale of Goods Act 1979, are to the fullest extent permitted by law excluded from this Agreement.
14.3    The Customer warrants and represents that it has full capacity and authority to enter into this Agreement. 
15.    LIMITATION OF LIABILITY
15.1    The entire liability of the parties to each other (including liability for the acts or omissions of their respective employees, agents and Sub-contractors) under or in connection with this Agreement (regardless of whether such liability arises in tort, contract or in any other way and whether or not caused by negligence or misrepresentation) shall be as set out in this clause 15.
15.2    Neither party limits nor excludes its liability for:
15.2.1    death or personal injury caused by its negligence;
15.2.2    fraud or fraudulent misrepresentation; or
15.2.3    any other liability that cannot be excluded under Applicable Laws.
15.3    Subject to clause 15.2, for any Losses caused in the first three (3) Contract Years, either Party’s total aggregate liability in respect of all Losses, whether arising from contract, tort (including negligence) or otherwise under or in connection with this Agreement shall in no event exceed the greater of the aggregate Price paid by the Customer to the Manufacturer for all Products supplied under this Agreement or EUR 5,000,000. For any Losses caused as from the beginning of  Contract Year four (4), subject to clause 15.2, either Party’s total aggregate liability in respect of all Losses, whether arising from contract, tort (including negligence) or otherwise under or in connection with this Agreement shall in no event exceed the aggregate Price paid by the Customer to the Manufacturer for all Products supplied under this Agreement in the preceding three (3) years. 
15.4    Subject to clause 15.2, neither party shall be liable to the other party for: 
15.4.1    any breach of this Agreement or the Quality Agreement by the first party to the extent due to the (a) acts, default or omissions of the other party or (b) first party’s reliance on information provided to it by the other party, whether pursuant to this Agreement or otherwise; 
15.4.2    any indirect, special or consequential loss or damage;
15.4.3    loss of profit;
15.4.4    loss of or corruption to data;
15.4.5    loss of use;
15.4.6    loss of production;
15.4.7    loss of contract;
15.4.8    loss of opportunity;
15.4.9    loss of savings, discount or rebate (whether actual or anticipated); or
15.4.10    harm to reputation or loss of goodwill.

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16.    REGULATORY COMPLIANCE
16.1    Each party shall comply with its regulatory responsibilities set out in Schedule 4.  
16.2    The Customer shall give reasonable advance notification to the Manufacturer during the Term of any proposed change to Applicable Laws which may impact the Products and/or constitute or require a change to Specifications. The parties shall agree on any required change to the Manufacture and/or the Specifications as required by clause 10. 
16.3    The Customer shall promptly send copies of any documents received from the Regulator related to the Product to the Manufacturer as soon as reasonably possible. The parties shall work together to agree on any necessary changes notified to the Customer by the Manufacturer in accordance with clause 16.2 in accordance with the Change Control Procedure including changes to the Price necessary to compensate the Manufacturer for the increased costs and expenses incurred in connection with the change.
16.4    The Manufacturer shall (at the Manufacturer’s cost and expense):
16.4.1    permit and handle inspections of the Manufacturing Site as may be requested by any Regulator, Notified Body, UK Approved Body or other certification body;
16.4.2    if any such inspections are required by any Regulatory, Notified Body, UK Approved Body or other certification body and Customer receives the first notice of such inspection, the Manufacturer shall notify the Customer a reasonable time in advance of any such inspection and notify the Customer in writing of the findings of such inspections.
16.5    The Manufacturer shall (at the Manufacturer’s cost and expense) respond to any questions of a regulatory nature relating to the Product or its Manufacture raised by any Regulator, Notified Body, UK Approved Body or other certification body.
16.6    The parties agree to cooperate with respect to data from clinical trials, other clinical data, including safety reporting, obtained by either party in relation in the Field or outside the Field and discuss and negotiate in good faith on a case-by-case how the respective other party may participate in such data, including the obtaining of and any licenses to such data, subject to regulatory compliance and the Applicable Laws in each individual case. The parties agree to cooperate and share data relating to the safety of the Product and each party grants the other party a limited, non-exclusive, irrevocable, fully paid-up licence under such data controlled by it, solely to the extent necessary for the other party to comply with its regulatory obligations relating to its products in the Field (in the case of the Customer’s products) or outside the Field (in the case of the Manufacturer’s products). Nothing in this clause shall oblige either party to share data where doing so would breach any Applicable Laws.
16.7    The parties undertake to enter into a Quality Agreement without undue delay after the Commencement Date, but no later than 15 Business Days after the Commencement Date, to be negotiated and agreed in good faith among the parties immediately after the Commencement Date. 
17.    PRODUCT RECALLS
17.1    In the event that either the Customer or the Manufacturer receives a court order or other notice from a Governmental Entity to withdraw, recall or take any other preventive or corrective action in connection with a Product in the market (“Official Product Recall Notice”), that party shall notify the other party immediately and shall enclose a copy of such Official Product Recall Notice.

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17.2    The Manufacturer shall have in place and agreed with Customer within 3 months after the Commencement Date SOPs for Product recalls. Subject to the requirements of Schedule 4 section 13 the Customer shall undertake, implement or facilitate any Product recall, withdrawal or preventive or corrective action as expressly required by the Official Product Recall Notice. The Customer is responsible for authorizing and initiating a Product recall, unless to the extent required by an Official Recall Notice. In the event of a recall (other than due to an Official Product Recall Notice), the Customer shall notify the Manufacturer which Product, batch and/or lot is affected. The Manufacturer shall promptly follow its SOPs for such Product recalls. The Manufacturer shall provide and maintain emergency contacts and phone numbers to enable the Customer to contact the Manufacturer at any time on any day. Customer shall bear responsibility to manage and coordinate any recall or corrective actions with the Manufacturer’s full support.  The Manufacturer shall be responsible for the costs of any Recall to the extent it arises from the Manufacturer’s breach of its obligations under this Agreement or breach of warranties in this Agreement.
18.    CONFIDENTIAL INFORMATION
18.1    General obligations
At all times during the Term and for a period of five years thereafter, each party (“Receiving Party” ) shall, and shall cause its officers, directors, employees, agents, and Affiliates to, keep confidential and not publish or otherwise disclose and not use, directly or indirectly, for any purpose any Confidential Information of the other party (“Disclosing Party” ), except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is reasonably necessary for the performance of this Agreement.
18.2    Permitted disclosures
Each party may disclose Confidential Information to the extent that such disclosure is:
18.2.1    made in response to a valid order of a court of competent jurisdiction or other competent authority; provided, however, that the Receiving Party shall first have given to the Disclosing Party (unless legally prohibited from doing so) a reasonable opportunity to challenge the order or obtain a protective order limiting disclosure and use of the Confidential Information and documents that are the subject of the order; and provided further that if the order is not dismissed or a protective order is not obtained, the Confidential Information disclosed in response to the order shall be limited to the information that is legally required to be disclosed in response to the order; or
18.2.2    otherwise required by law; provided that the Receiving Party shall (i) provide the Disclosing Party (unless legally prohibited from doing so) with reasonable advance notice of and an opportunity to comment on any such required disclosure, (ii) if requested by the Disclosing Party, seek confidential treatment with respect to any such disclosure to the extent available, and (iii) use all reasonable endeavours to incorporate the comments of the Disclosing Party in any such disclosure or request for confidential treatment.
18.3    Exclusions
Confidential Information shall not include any information that:
18.3.1    is or becomes part of the public domain or generally known to the public through no wrongful act or fault of the Receiving Party;

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18.3.2    can be demonstrated by written evidence to have been in the Receiving Party’s or its Affiliate’s possession prior to disclosure by the Disclosing Party;
18.3.3    is subsequently received by the Receiving Party or its Affiliate from a Third Party who is not bound by any obligation of confidentiality with respect to that information;
18.3.4    is generally made available to Third Parties by the Disclosing Party without restriction on disclosure or use; or
18.3.5    is independently developed by or for the Receiving Party or its Affiliate without reference to the Confidential Information.
18.4    Where Confidential Information consists of a combination of individual elements or the principle of combining those individual elements, which combination or principle is not part of the public domain and is not in the possession of the Receiving Party, that Confidential Information shall not be treated as being part of the public domain or in the possession of the Receiving Party merely because one or more of the individual elements is part of the public domain or in the possession of the Receiving Party.
18.5    Use of name
Neither party shall mention or otherwise use any name, trade mark or trade name of the other party or its Affiliates or Sublicensees in any publication, press release, promotional material or other form of publicity without the prior written consent of the other party.
19.    FORCE MAJEURE EVENT
19.1    A party shall not be liable if delayed, hindered or prevented from performing its obligations under this Agreement due to a Force Majeure Event, provided that it:
19.1.1    promptly notifies the other of the Force Majeure Event and its expected duration; and
19.1.2    uses reasonable endeavours to minimise the effects of that event.
19.2    If, due to a Force Majeure Event, a party is delayed in or prevented from performing its obligations under this Agreement for a continuous period of more than six months, the other party may terminate this Agreement on not less than four weeks’ written notice.
19.3    If one Party’s performance of its obligation is hindered, delayed or prevented due to an Force Majeure Event, the other Party’s corresponding obligations shall be equally suspended.
20.    AUDITS
20.1    The Customer shall have the right, upon not less than 30 Business Days’ prior notice, at its own cost and expense, to conduct an audit during Working Hours (and no more than once in any period of 12 months), of the Manufacturing Site and the Manufacturer’s quality and environmental, health and safety procedures and systems to ensure such procedures and systems are those reasonably required for the Manufacturer to Manufacture the Product in accordance with this Agreement. 
20.2    The Manufacturer shall have the right, upon not less than 30 Business Days’ prior notice, at its own cost and expense, to conduct an audit during Working Hours (and no more than once in any period of 12 months), of the Customer’s post-market surveillance system and procedures and its compliance with the Quality Agreement to ensure such procedures and systems are those reasonably required for the Customer to carry out appropriate post-market surveillance in relation to the Product in accordance with this Agreement.

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21.    TERM AND TERMINATION
21.1    This Agreement shall continue from the Commencement Date for eight Contract Years, after which time it may be renewed by mutual written agreement of the parties (“Term”) unless terminated earlier: 
21.1.1    by the Customer for convenience on not less than six months’ prior written notice to the Manufacturer; or
21.1.2    in accordance with clause 19.2 or 21.2.
21.2    Either party may, without prejudice to its other rights and remedies, by notice in writing to the other party immediately terminate this Agreement if that other party:
21.2.1    is in material breach of any of its obligations under this Agreement and that breach is not capable of remedy;
21.2.2    is in material breach of any of its obligations under this Agreement and that breach is capable of remedy but the party in breach has failed to remedy that breach within 90  days after receiving written notice identifying the alleged breach and requiring it to remedy that breach; or
21.2.3    is unable to pay its debts (within the meaning of section 123 of the Insolvency Act 1986) or becomes insolvent or an order is made or a resolution passed for the administration, winding-up or dissolution (otherwise than for the purposes of a solvent amalgamation or reconstruction) or an administrative or other receiver, manager, liquidator, administrator, trustee or similar officer is appointed over all or any substantial part of its assets, or any analogous event occurs in any applicable jurisdiction.
22.    TECHNOLOGY TRANSFER OPTION
22.1    Subject to clause 22.1.3, at any time after Commencement Date but before the end of the Term, the Customer may exercise, by giving notice in writing to the Manufacturer, a technology transfer option, pursuant to which the Manufacturer will transfer and assist the Customer in the transfer of all Manufacturing Know-how owned by the Manufacturer and necessary to enable the Customer to Manufacture the Product for use in the Field itself or have it Manufactured by a Third Party, subject to the Customer:
22.1.1    [***]; 
22.1.2    Accepting the transfer of all regulatory responsibilities (including the CE mark and other similar registrations) associated with the Product with effect from the date of the exercise of the option under clause 22.1, or as soon afterwards as is possible.  The Customer and the Manufacturer shall cooperate in good faith and use commercially reasonable best efforts to enable such transfer, including signing documents, providing information and liaising with Governmental Entities as requested by the Manufacturer; and
22.1.3    Not exercising the technology transfer option before June 30, 2022.
Notwithstanding the foregoing provisions of this clause 22.1, and at the cost of the Customer as set out in clause 22.1.1, Manufacturer agrees to provide Customer with the Know-how needed for Customer to Manufacture Product with effect from Commencement Date, except to the extent 

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that providing such Know-how would require a significant investment of time from Manufacturer. For avoidance of doubt, this Know-how will include but not be limited to: (a) design history files, drawings, copies of technical reports and other documentation related to the Manufacturing process, standard operating procedures, regulatory filings, complaints, work instructions, any recovery steps established, process validation, product identity assays, in-process-control assays, formulas, and manufacturing settings relating to the Manufacturing process for the Products, and (b) allowing Customer or a Third Party designated by Customer to have access to the Manufacturing Site and observe Product Manufacturing in progress. Manufacturer will have provided the documentation identified in this paragraph within thirty (45) days of the Commencement Date and will have granted access to the Manufacturing Site within ninety (90) days of the Commencement Date.
22.2    Upon exercise of the technology transfer option and subject to the provisions of this clause 22, Manufacturer shall: 
22.2.1    promptly transfer to Customer and/or a Third Party designated by Customer, in a format and medium reasonably requested by Customer, all data and information necessary to transfer the Manufacturing process, as further developed by Manufacturer (e.g. in-process control assays, standard operating procedures, etc.), to the extent not already provided to Customer pursuant to clause 22.1, and  
22.2.2    (i) promptly furnish to Customer and/or a Third Party designated by Customer all reasonable assistance and personnel and answer all questions regarding the transfer of the Manufacturing process (including, but not limited to, regular check-in meetings, initial in-person training for Customer’s personnel at the Manufacturing Site concerning the use and operation of the manufacturing process, additional in-person training at Customer’s chosen manufacturing site, etc.), and (ii) continue to provide such assistance to Customer for a period of six (6) months after the commencement of the transfer; in each case, in order to allow Customer or a Third Party designated by Customer to replicate and implement the Manufacturing process and to take over the Manufacturing of the Product. Without limiting the foregoing, Manufacturer will provide Customer and/or a Third Party designated by Customer with all technical reports and all other documents that are relevant for the Manufacture of the Product using the Manufacturing process as performed by Manufacturer at such time (including, but not limited to, any recovery steps established, process validation, product identity assays, in-process control assays, relevant standard operating procedures, etc.), to the extent not already provided to Customer pursuant to clause 22.1, and 
22.2.3    provided Customer gives Manufacturer at least ten (10) Business Days’ notice, (i) allow Customer to access, review and copy all records in Manufacturer’s possession, custody or control that relate to the Manufacture of the Products and (ii) cooperate in good faith with Customer to determine a mutually agreeable process to access, review and copy such records, and
22.2.4    provided Customer gives Manufacturer at least twenty (20) business days’ notice, (i) allow Customer to visit the Manufacturing Site to view and inspect the equipment used to Manufacture the Products and participate in test Product Manufacturing runs with Manufacturer’s personnel, and (ii) cooperate in good faith with Customer to determine a mutually agreeable schedule and agenda for such visit, and
22.2.5    transfer any and all documentation and Know-how necessary to assume regulatory responsibility for the Products and the Manufacture of the Products and/or to transfer 

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regulatory responsibility and obligations, including (but not limited to) regulatory processes, certifications, SOPs and/or Product related regulatory approvals or permits. 
The Parties shall agree in good faith on a schedule and plan for effecting the technology transfer. Any transfers of data, information or Know-how under this clause to a Third Party will be subject to such Third Party first entering into a customary written agreement with the Manufacturer to ensure the confidential treatment of such data, information or Know-how and limit its use to the Field, to the extent required for Manufacturer to protect any owned trade secrets or Intellectual Property Rights. 
22.3    Following the transfer of manufacturing Know-how to the Customer or its chosen Third Party supplier under this clause 22 and Customer’s assumption of all related regulatory responsibilities in a relevant jurisdiction for the Product, the Manufacturer shall have no further regulatory or product liability in relation to the Product in that jurisdiction, save for Product Manufactured by Manufacturer. For the avoidance of doubt, Manufacturer shall remain responsible for all Products it has Manufactured and Delivered to Customer. 
22.4    Following the completion of the technology transfer option to the Customer or its chosen Third Party supplier under this clause 22 Manufacturer shall not make available to any Third Party any Know-how related to the Manufacturing of the Product in the Field, except as may be required under this Agreement. To the extent that Manufacturer makes available to a Third Party the Know-how relating to the Manufacturing of any products outside the Field, Manufacturer shall procure that such third party is contractually obliged not to use the Know-how for the Manufacturing of any product in the Field. 
22.5    The technology transfer referred to in this clause shall be restricted to Customer’s rights to manufacture Product for use within the Field.  Customer shall only use such technology and Know-how to manufacture the Product for use in the Field. This restriction shall survive expiry or termination of this Agreement for any reason.
22.6    The Parties acknowledge and agree that the technology transfer right provided in this clause 22 form a material part of this Agreement and is considered by Customer a consideration to enter into this Agreement. Under the technology transfer as set forth in this clause 22, the Manufacturer shall transfer to the Customer Know-how and technology which is material to the Customer. Subject to the technology transfer option being exercised by Customer, the Manufacturer hereby undertakes during the Term and for a period of ten (10) years thereafter, that the Manufacturer will not Manufacture for itself, for the Manufacturer Group or for any Third Party, (i) any Product in the Field, or (ii) any other product in the Field which includes or incorporates any polyacrylamide hydrogel that is proprietary to the Customer or its Affiliates.
23.    CONSEQUENCES OF EXPIRY OR TERMINATION
23.1    Upon expiry or termination of this Agreement for any reason:
23.1.1    the Manufacturer shall notify the Customer of and may at its option require the Customer to purchase all stock of the Product and work in progress and raw materials specific to the Manufacture of Product reasonably held by the Manufacturer (considering in particular Customer’s Forecasts) at the date of termination of this Agreement. The Customer shall pay the Manufacturer the Price for such Product and in the case of work in progress and raw materials, the landed cost of such items, not later than 45 days following the date of termination of the Agreement and the Delivery of such Product, work in progress and raw materials. 

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23.1.2    for the avoidance of doubt, the terms of this Agreement shall apply to any Product completed and/or Delivered pursuant to this Agreement and clause 23.1.1;
23.1.3    each party shall return to the other party (or, at the other party’s option, destroy) all equipment, materials, Confidential Information and property belonging to the other party that the other party has supplied to it in connection with this Agreement; 
23.1.4    except to the extent necessary to comply with clause 23.1.1 and with the exception of the licences granted under clauses 12.4 and 12.5, any licences granted by either party to the other in respect of Intellectual Property Rights shall automatically terminate;
23.1.5    at any time after (i) completion of the Term or (ii) earlier termination in accordance with clause 21, and subject to the Manufacturer having offered to Customer to assume against reasonable remuneration the following rights and positions, the Manufacturer may discontinue, surrender or abandon the CE mark (or any equivalent Product registration) relating to the Product, and the Customer shall continue to carry out its post-market surveillance and other obligations relating to the Product after such discontinuance, surrender or abandonment in accordance with sections 11 through 15 of Schedule 4 of this Agreement, provided, however  that the Customer may, except in the event of a termination due to a material breach by the Customer, request to be transferred any and all documentation, correspondence with Notified Bodies or other certification bodies or authorities held by the Manufacturer regarding the Product; and
23.1.6    the Customer shall, at any time following expiry or termination, without delay forward to the Manufacturer any complaints received by the Customer or its Affiliates, correspondence from Governmental Entities received by the Customer or its Affiliates or other information requested by the Manufacturer, in each case in relation to any Product which has been CE marked by the Manufacturer or carries an equivalent mark from the Manufacturer. 
24.    SURVIVAL
Provisions of this Agreement which are expressed to survive its expiration or termination, or from the nature or context of which it is contemplated that they are to survive, shall remain in full force and effect notwithstanding such expiry or termination.
25.    NOTICES
25.1    Notices under this Agreement shall be in writing and sent to a party’s address as set out on the first page of this Agreement (or to the email address set out below). Notices may be given, and shall be deemed received: 
25.1.1    by airmail: 5 Business Days after posting;
25.1.2    by hand: on delivery; and
25.1.3    by email to[***] in the case of the Manufacturer and by email to [***], with a copy to [***] in the case of the Customer: on delivery, subject to clause 25.3 and provided the email is sent between 9am and 5pm in Denmark (for a notice to Manufactuer) or in California, US (for a notice to Customer) on a Business Day.
25.2    This clause does not apply to notices given in legal proceedings or arbitration.

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25.3    A notice given under this Agreement by email is not validly served if (i) an out-of-office or other automatic “undelivered message” reply is received and (ii) it is not followed by a hard copy sent by airmail or courier in accordance with this clause.
26.    NO PARTNERSHIP OR AGENCY
Nothing in this Agreement constitutes, or shall be deemed to constitute, a partnership between the parties nor make any party the agent of another party.
27.    ASSIGNMENT AND SUB-CONTRACTING
27.1    Subject to clauses 27.2 and 27.3, neither Party shall assign, transfer, mortgage, charge or deal in any other manner with any or all of its rights and obligations under this Agreement without the prior written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.
27.2    The Customer may assign or transfer all of its rights under this Agreement to an Affiliate or to any person to which it transfers all or substantially all of the Product IP, provided that the assignee undertakes in writing to Manufacturer to be bound by Customer’s obligations under this Agreement.
27.3    The Customer or its parent company(ies) may, without having given prior written notice to the Manufacturer, sell or transfer all or substantially all of its business or assets to a third party.
27.4    The Manufacturer may perform any of its obligations and exercise any of its rights granted under this Agreement through any Affiliate or Sub-contractor only with the Customer’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned. The Manufacturer acknowledges and agrees that any act or omission of its Affiliates or Sub-contractors in relation to the Manufacturer’s rights or obligations under this Agreement shall be deemed to be an act or omission of the Manufacturer itself.
28.    THIRD PARTY RIGHTS
Except as expressly provided in this Agreement, a person who is not a party to this Agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the provisions of this Agreement.
29.    COMPLIANCE WITH LAW
The parties shall each comply with all Applicable Laws, provided that a party shall not be liable for any breach of this clause 29 to the extent that such breach is directly caused or contributed to by the other party or any of its officers, directors, members or partners, and any of its employees, consultants, agents, representatives or professional advisers.
30.    ENTIRE AGREEMENT
30.1    This Agreement, together with the Acquisition, the IP Assignment Agreement, the Cross-License Agreement, the Know-How License Agreement and the Quality Agreement, and any agreements contemplated therein, constitutes the entire agreement between the parties relating to its subject matter and supersedes all prior agreements, arrangements and understanding between them relating to that subject matter. 

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30.2    The Parties confirm that they have not entered into this Agreement on the basis of any representations that are not expressly incorporated in this Agreement.  The provisions of this clause 30.2 shall not apply to a fraudulent misrepresentation.
31.    SEVERANCE
If any provision of this Agreement (or part of any provision) is or becomes illegal, invalid or unenforceable, the legality, validity and enforceability of any other provision of this Agreement shall not be affected.
32.    FURTHER ASSURANCE
Each party shall at the request of the other, and at the cost of the requesting party, do all acts and execute all documents which are necessary to give full effect to this Agreement.
33.    VARIATION
No variation of this Agreement shall be valid or effective unless it is in writing, refers to this Agreement and is duly signed or executed by, or on behalf of, each party.
34.    WAIVER
No failure, delay or omission by either party in exercising any right, power or remedy provided by law or under this Agreement shall operate as a waiver of that right, power or remedy, nor shall it preclude or restrict any future exercise of that or any other right, power or remedy. No single or partial exercise of any right, power or remedy provided by law or under this Agreement shall prevent any future exercise of it or the exercise of any other right, power or remedy.
35.    COUNTERPARTS
35.1    This Agreement may be signed in any number of separate counterparts, each of which when signed and dated shall be an original, and such counterparts taken together shall constitute one and the same Agreement.
35.2    Each party may evidence their execution of this Agreement by transmitting by email a signed signature page of this Agreement in PDF format together with the final version of this Agreement in PDF or Word format, which shall constitute an original signed counterpart of this Agreement. Each party adopting this method of signing will, following circulation by email, provide the original, hard copy signed signature page to the other parties as soon as reasonably practicable.
36.    SET-OFF
Any amount that either Party owes to the other Party under this Agreement, whether now or at any time in the future, whether it is liquidated or not and whether it is actual or contingent, may be set off by such Party from any amount due to the other Party from such Party under this Agreement. Any exercise by any Party of its rights under this clause 36 shall not prejudice any other right or remedy available to it under this Agreement or otherwise.
37.    DISPUTE RESOLUTION PROCEDURE
37.1    If any dispute arises between the parties out of or in connection with this Agreement, the matter shall be referred to senior representatives of each party who shall use their reasonable endeavours to resolve it.

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37.2    If the dispute is not resolved within 30 days of the referral being made under clause, the parties shall  resolve the matter through mediation in accordance with the London Court of International Arbitration Mediation Rules.
37.3    Until the parties have completed the step referred to in clause 37.1, and have failed to resolve the dispute, neither party shall commence mediation except that either party may at any time seek urgent interim relief.
38.    CONFLICTS WITHIN AGREEMENT
38.1    In the event of any conflict or inconsistency between different parts of this Agreement, the following descending order of priority applies:
38.1.1    Schedule 4;
38.1.2    the Quality Agreement;
38.1.3    the terms and conditions in the main body of this Agreement; and
38.1.4    Schedules 1, 2 and 3. 
38.2    Subject to the above order of priority between documents, later versions of documents shall prevail over earlier ones if there is any conflict or inconsistency between them.
39.    GOVERNING LAW AND JURISDICTION
39.1    This Agreement and any dispute or claim arising out of, or in connection with, it, its subject matter or formation (including non-contractual disputes or claims) shall be governed by, and construed in accordance with, the laws of England.
39.2    The parties irrevocably agree that the courts of England shall have exclusive jurisdiction to settle any dispute or claim arising out of, or in connection with, this Agreement, its subject matter or formation (including non-contractual disputes or claims).

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THIS AGREEMENT has been executed and delivered on the dates written below. 

						
	Signed by Patrick Banks, Director	/s/ Patrick Banks.................................
	for and on behalf of	Authorised signatory
	Contura International A/S	
	Date: February 25, 2021	
	Signed by Rakesh Tailor, Director	/s/ Rakesh Tailor.................................
	for and on behalf of	Authorised signatory
	Contura International A/S	
	Date: February 25, 2021	

and    
						
	Signed by Patrick Banks, Director	/s/ Patrick Banks.................................
	for and on behalf of	Authorised signatory
	Contura Limited	
	Date: February 25, 2021	
	Signed by Rakesh Tailor, Director	/s/ Rakesh Tailor.................................
	for and on behalf of	Authorised signatory
	Contura Limited	
	Date: February 25, 2021	

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SCHEDULE 1
PRICES
Price
						
	Price per BUKIT (€)	Price per BU10 (€)
	[***]	[***]

The above mentioned Price shall be subject, during the Term, to the Price adjustment mechanisms set out in clauses 7.4 and 7.5  and as otherwise provided in the Agreement.

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SCHEDULE 2
SPECIFICATIONS
[***]

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BUKIT
[***]

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SCHEDULE 3
CHANGE CONTROL PROCEDURE
    
Either party may submit a written request for change to the other party in accordance with this Schedule, but no change will come into effect until a written record of the change agreed by the parties pursuant to the Change Control Procedure (a “Change Control Note”) has been signed by the authorised representatives of each party.
1.    If the Customer requests a change:
(a)    the Customer will submit a written request to the Manufacturer containing as much information as is necessary to enable the Manufacturer to prepare a draft Change Control Note; and
(b)    within 30 Business Days of receipt of a request, the Manufacturer will, unless otherwise agreed, send to the Customer a draft Change Control Note.
2.    If the Manufacturer requests a Change, it will send to the Customer a draft Change Control Note.
3.     A Change Control Note must contain sufficient information to enable the Customer to assess the proposed change, including as a minimum:
(a)    the title of the change;
(b)    the party that requested the change and date of request;
(c)    description of the change;
(d)    details of the effect of the proposed change on:
i.    the Products;
ii.    the Price; 
iii.    the regulatory implications; and
iv.    any other term of this Agreement;
(e)    the date of expiry of validity of the Change Control Note; and
(f)    provision for signature by the Customer and Manufacturer.
4.    If, following the Customer's receipt of a draft Change Control Note pursuant to sections 2 or 3 above:
(a)    the parties agree the terms of the relevant Change Control Note, they will sign it and that change Control Note will amend this Agreement; or
(b)    either party does not agree to any term of the Change Control Note, then the other party may refer the disagreement to be dealt with in accordance with the dispute resolution procedure in clause 37.
 5.     Each party will bear its own costs in relation to compliance with the Change Control Procedure.

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SCHEDULE 4
REGULATORY RESPONSIBILITIES
Each party shall comply with its regulatory responsibilities set out in this Schedule 4. Any regulatory responsibilities not allocated to the Manufacturer in this Schedule 4 or not otherwise dealt with in the Quality Agreement shall be the responsibility of the Customer.  Costs of compliance shall be allocated as set out in clause 2.7 of the Agreement. 
MANUFACTURER
Manufacturer shall perform such tasks as are necessary for day to day regulatory compliance associated with maintaining Product registrations in the US, UK, EU and Rest of World as set out below.  Customer shall fully collaborate and cooperate with Manufacturer as set out below to ensure Manufacturer is enabled to achieve and/or maintain compliance as the manufacturer and/or Product registration holder. 
1.    VALIDATION TESTING. 
1.1    Manufacturer shall design and conduct, or procure the design and conduct of all validation testing of Manufacturing equipment and/or procedures where this is required for the sole purpose and necessity of maintaining Product registrations in the US, the UK, the EU and Rest of World. For the avoidance of doubt, this shall include additional validation work related to the Manufacturing equipment and/or Manufacturing procedures required for any necessary upgrading of Product dossiers to meet UKCA Mark and/or EU MDR and/or US Food and Drug Administration (“FDA”) requirements or other changes in applicable regulatory requirements in these jurisdictions or in the Rest of World.  
1.2    Funding. All validation testing shall be funded by the Manufacturer, including payment of fees of Third-Party service providers and/or of certification bodies or Regulators.  Customer shall reimburse Manufacturer the costs of all such validation testing where: 
1.2.1    validation testing of Manufacturing equipment and/or procedures is required for the sole purpose and necessity of obtaining Product registrations in Rest of World; or
1.2.2    validation testing of Manufacturing equipment and/or procedures is required for the sole purpose and necessity of modifying Product registrations in existence at the date of this Agreement where such modification is not required due to adverse safety data or any change in Applicable Laws.
2.    QMS OR PRODUCT AUDITS OR REVIEWS, CERTIFICATION OR REGISTRATION RENEWALS, REMEDIAL ACTIONS TO AUDIT FINDINGS 
2.1    Where this is required for obtaining and/or maintaining Product registrations in the US, the UK, the EU and Rest of World, Manufacturer shall establish and maintain appropriate quality management systems (“QMSs”) and Product certification including undergoing periodic external audit by relevant certification bodies and shall perform remedial actions where necessary.  This shall include:
2.1.1    Preparing for and undergoing regulatory QMS and Product audits, such as Notified Body, FDA and/or UK Approved Body QMS and/or Product certification audits or reviews; 
2.1.2    Addressing any adverse findings emerging from such audits via remedial actions and undergoing re-audit where required; and 

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2.1.3    From time to time applying for renewal of Product certifications, registrations and/or re-audits on a timely basis. 
2.2    Customer shall provide Manufacturer on a timely basis with all sales, post-market surveillance, clinical, and pre-clinical or other data concerning the Products, their instructions for use (“IFU”) and/or healthcare professional training, including for the avoidance of doubt any data or information concerning PMA P170023, which may be required to support any QMS or Product audits and/or to address adverse findings arising therefrom. 
2.3    Funding. For all Product registrations existing as at the date of this Agreement, all QMS or Product audits or reviews, certification or registration renewals and/or remedial actions responding to adverse findings from these shall be funded by the Manufacturer, including payment of fees of Third Party service providers and/or of certification bodies or Regulators.  For all Product registrations varied, modified and/or first obtained after the date of this Agreement, all QMS or Product audits or reviews, certification or registration renewals and/or remedial actions responding to adverse findings from these shall be funded by Customer, including payment of fees of Third Party service providers and/or of certification bodies or Regulators.  
3.    CHANGE OF NOTIFIED BODY, UK APPROVED BODY OR OTHER CERTIFICATION BODY   
3.1    Manufacturer shall be entitled to change any Notified Body, UK Approved Body or other certification body at its own discretion and to select an appropriately qualified alternative body.  In the event Manufacturer is required under Applicable Laws to appoint a new Notified Body, UK Approved Body or other certification body Manufacturer shall determine the choice of such new body at its sole discretion.  In all cases Customer shall provide Manufacturer on a timely basis with all sales, post-market surveillance, clinical, pre-clinical or other data concerning the Products, including for the avoidance of doubt any data or information concerning PMA P170023, which may be required to support any change in or appointment of any such new body.
3.2    Funding.  Customer shall fund all costs arising from the selection and appointment of any new Notified Body, UK Approved Body or other certification body including all costs incurred by Manufacturer in selecting and appointing such new body unless any change is solely due to Manufacturer’s own volition in which case Manufacturer shall bear all such costs.
4.    SUPPLIER DUE DILIGENCE AND AUDITS  
4.1    Manufacturer shall perform appropriate supplier due diligence and qualification for suppliers of raw materials for Manufacturing the Products and for any Third Party suppliers of components and/or contract manufacturing organisations employed to Manufacture the Products.
4.2    Funding. Manufacturer shall fund supplier due diligence, qualification and fees for such Third Party suppliers.
5.    CONTACT WITH COMPETENT AUTHORITIES 
5.1    With the exception of all contact which under Applicable Laws is the responsibility of the Customer and/or its Affiliates as the holder of PMA P170023 Manufacturer shall conduct, or procure via appropriate Third Party service providers, all day-to-day liaison with relevant Regulators for purposes of obtaining and/or maintaining Product registrations in the US, UK, EU and Rest of World.  This shall include the effecting and maintenance of all database registrations of the Products and of the Manufacturer where required by law or Regulators, e.g. Eudamed registrations though the parties acknowledge and agree that Customer shall enter and maintain 

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details of any importers or other economic operators which may be required for Product registrations. 
5.2    Where Product registrations require specified human resource for manufacturers (e.g. Person Responsible for Regulatory Compliance in the EU) Manufacturer shall ensure that such human resource is available to the extent required. 
5.3    Where Regulators request information or documentation regarding the conformity of the Products, the training materials employed for healthcare professional training, patient information and/or or marketing and/or access to Product samples Manufacturer shall respond to all such requests unless samples are requested from the field, in which case Customer shall procure Manufacturer access to such field samples for provision to Regulators. Customer shall provide Manufacturer on a timely basis with all relevant data or documentation including healthcare professional training, patient information and/or or marketing materials, sales, complaints, post-market surveillance or other data concerning the Products or with field samples which may be required to respond to Regulator inquiries or requests.
5.4    Funding. Except for tasks and activities performed by Customer in accordance with this Agreement to fulfil the responsibility under Applicable Laws of the holder of PMA P170023, all day-to-day liaison and human resource shall be funded by Manufacturer, including payment of fees of Third Party service providers and/or of Regulators where the sole purpose and necessity of this is to maintain the Product registrations existing as at the date of this Agreement.  All other contact with relevant Regulators concerning the Product registrations in the US, UK, the EU and Rest of World shall be conducted by Manufacturer or its agents but funded by Customer, including payment of fees of Third Party service providers and/or of Regulators.
6.    LABELLING, INCLUDING UDI 
6.1    Manufacturer shall utilise and/or develop and approve all Product labelling, IFU and packaging based on Manufacturer’s materials and versions currently in use for the Product registrations existing at the date of this Agreement. Manufacturer shall amend Product labelling, IFU and packaging as required in response to complaints from end-users, or in the event of adverse safety information, regulatory enforcement and/or changes in labelling requirements under Applicable Laws in order to maintain Product registrations.  This shall include meeting all applicable requirements for UDI for labelling Products.  Customer may, subject to necessary regulatory compliance and approval (including by Manufacturer), require Manufacturer to develop and/or approve alternative or modified Product labelling, instructions for use (“IFU”) and/or packaging.
6.2    Funding. All labelling, IFU and packaging approval and UDI which is based on Manufacturer’s materials and versions currently in use for the Product registrations existing at the date of this Agreement shall be funded by Manufacturer, including payment of fees of any Third Party providers or Regulators where the sole purpose and necessity of this is to maintain the Product registrations existing at the date of this Agreement.  All incremental costs and/or wastage resulting from the development, approval and production of any alternative labelling, IFU or packaging for the Product registrations existing at the date of this Agreement or for any modified or new Product registrations shall be borne by Customer.  Such incremental costs shall include approvals with relevant Notified Bodies, UK approved bodies and/or Regulators and the costs of any wasted labelling, IFU or packaging materials as well as payment of fees of Third Party service providers and/or of Regulators.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

7.    UK RESPONSIBLE PERSON 
7.1    Manufacturer shall continue to designate Contura Limited, or such other UK party as is designated by Customer from time to time, as its UK Responsible Person for the Products via a UK Responsible Person agreement. 
7.2    Funding.  Each party shall meet its own costs of compliance with its respective obligations under the applicable UK Responsible Person agreement.

CUSTOMER
Customer shall perform such tasks as are necessary for regulatory compliance associated with obtaining and/or maintaining Product registrations in the US, UK, EU and Rest of World as set out below, including for the avoidance of doubt in its capacity as the holder of PMA P170023.  Customer shall fully collaborate and cooperate with Manufacturer as set out below to ensure Manufacturer is enabled to achieve and/or maintain compliance as the manufacturer and/or Product registration holder.  
8.    CLINICAL TRIALS. 
8.1    Customer shall design, conduct and be the regulatory sponsor of any and all clinical investigations or clinical trials, studies or other non-clinical Product testing (“study” or “studies”) where the purpose and necessity of the study is in order to obtain and/or maintain Product registrations (including modified or varied registrations) in the US, the UK the EU and Rest of World, including where the study is required to generate clinical, pre-clinical or non-clinical data to upgrade Product dossiers to meet UKCA mark and/or EU MDR requirements and/or US FDA requirements or other changes in applicable regulatory requirements in these jurisdictions or in the Rest of World.  Customer shall promptly provide Manufacturer with access to the raw study data, all study adverse event reports and to all study reports for all studies made for purposes of sentence 1 of this clause 8.1, provided that such data may not be used for any other purposes than outlined in sentence 1 of this clause 8.1 and in order to fulfil Manufacturer’s obligations as regards post-market surveillance and vigilance and its obligations to continually assess the benefit-risk profile of any of its products when used outside the Field.
8.2    Funding. Customer shall fund the design, conduct, sponsoring and reporting of all studies including payment of fees of Third Party service providers and/or of certification bodies and/or Regulators. 
9.    MARKETING MATERIALS. 
9.1    Customer shall develop all Product marketing materials for Products for use in any of the US, the UK, the EU and Rest of World.  Manufacturer shall have the right to receive all Product marketing materials to the extent required to ensure their compliance with regulatory requirements though Customer shall be responsible for such compliance as concerns all marketing materials for Products.  Where necessary, Customer and Manufacturer shall work together to respond to complaints from end users or regulatory agencies and/or changes in legislation or regulatory guidance to ensure ongoing compliance of all Product marketing materials.
9.2    Funding. All development, re-development or amendment of Product marketing materials shall be at the sole cost of the Customer.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

10.    HCP EDUCATION AND TRAINING ON THE SAFE AND EFFECTIVE USE OF THE PRODUCTS 
10.1    Customer shall design, approve and deliver (or shall procure the same of) all healthcare professional education materials and/or training programmes required in the US, the UK, the EU and Rest of World to facilitate safe and effective use of the Products.  Manufacturer shall have the right to receive all healthcare professional education materials and/or training programmes to ensure their ongoing compliance with relevant regulatory requirements from time to time.
10.2    Funding. Customer shall fund the design and approval and delivery of all healthcare professional education and training materials and the delivery of all training, including payment of fees of any Third Party service providers, including any changes required by Manufacturer and/or any Regulator.
11.    POST-MARKET SURVEILLANCE AND VIGILANCE REPORTING 
11.1    Manufacturer and Customer shall enter into a Quality Agreement setting out, inter alia, their respective post-market surveillance and vigilance obligations.  Pursuant to the terms of the Quality Agreement both Manufacturer and Customer shall establish, maintain and operate appropriate post-market surveillance and vigilance reporting systems and procedures in respect of all Products in the US, the UK, the EU and Rest of World.  Where Product registrations require specified human resource for manufacturers, Manufacturer shall ensure that such human resource is available to the extent required under Applicable Laws.  
11.2    Funding.  Manufacturer shall bear its own internal costs of establishing, maintaining and operating its own post-market surveillance and vigilance reporting systems and procedures in compliance with Manufacturer’s obligations in the Quality Agreement. All post-market surveillance and vigilance reporting systems and procedures and human resource required under Applicable Laws shall be funded by Customer, including payment of fees of Third Party service providers where the purpose and necessity of this is to obtain and/or maintain the Product registrations.  
12.    US PMA
12.1    Customer shall perform its respective activities under this Agreement as holder of the US PMA P170023 in accordance with the applicable provisions of the U.S. Federal Food, Drug, and Cosmetic Act and the implementing U.S. Food and Drug Administration (“FDA”) regulations (“FDA Laws”) including, without limitation, all provisions of the FDA Laws that are applicable to the holder of a Premarket Approval application approved pursuant to 21 U.S.C. § 360e, which may or may not be specifically identified in this Agreement.  Without limiting the generality of the foregoing, Customer shall perform all obligations specifically identified in this Agreement in accordance with the applicable FDA Laws. 
12.2    Funding: Save as otherwise delegated to the Manufacturer under this Agreement or the Quality Agreement, Customer shall bear its own costs of performing its respective activities as holder of US PMA P170023 in compliance with all applicable FDA regulations and FDA Laws.
13.    RESPONDING TO ADVERSE SAFETY DATA AND PREVENTIVE AND CORRECTIVE ACTIONS 
13.1    Manufacturer shall evaluate all adverse safety data in relation to the Products as identified by Manufacturer or reported to Manufacturer by Customer in the course of the parties’ post-market surveillance and/or vigilance activity in accordance with the Quality Agreement.  Manufacturer 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

shall determine the reportability (or not) to Regulators of any incident or corrective or preventive action and shall report as required to Regulators and, where the Customer is the holder of any local marketing authorizations and contact for Regulators, cooperate and coordinate with the Customer such reporting.   
13.2    Customer shall provide Manufacturer on a timely basis with all post-market surveillance or other data concerning the Products, their IFU and/or healthcare professional training which may be required to support any post-market surveillance and/or vigilance activity and/or to address any inquiries or requirements of Regulators pursuant to the terms of the Quality Agreement. The parties accept and agree that Manufacturer shall be significantly reliant upon Customer in order to meet its obligations under Applicable Laws.
13.3    Manufacturer shall perform the necessary investigations and analysis (e.g. root cause analysis) in respect of any incident and shall direct Customer as to any investigation or inquiry in the field which may be desirable in order to evaluate any incident or to respond to questions from Regulators.  Customer shall carry out all appropriate investigations in respect of any incident and promptly update Manufacturer with the results of such investigations.
13.4    Manufacturer shall be responsible for making any modifications to the design or Manufacture of, and/or IFU, labelling or packaging for, the Products that may be required to maintain conformity with applicable requirements in light of the results of the post-market surveillance and which is solely and necessarily for the maintenance of the Product registrations in the US, the UK, the EU and Rest of World. For the avoidance of doubt all such modifications shall only be performed by Manufacturer on the instruction of Customer or its PMA holder Affiliate in relation to Products to be supplied in the US.   In the event Manufacturer determines that any incident is due to, and/or preventive or corrective action is required as a result of, any healthcare professional training, marketing activity or marketing materials utilised by Customer it shall inform Customer of its determination and Customer shall promptly cease, withdraw, recall and/or remediate the materials and/or activity in question.
13.5    Manufacturer shall determine what, if any, preventive or corrective actions may be required to eliminate, or if that is not possible, mitigate the risks posed by Products and the scope and timing of such actions and, where the Customer is the holder of any local marketing authorizations coordinate and cooperate with Customer in this respect.  The Parties accept and agree that Manufacturer shall be significantly reliant upon Customer carrying out such preventive or corrective actions on behalf of Manufacturer, including monitoring the progress of these and communicating all relevant information promptly back to Manufacturer pursuant to the terms of the Quality Agreement.  Customer shall accordingly promptly implement all such preventive or corrective actions which may be appropriate and shall monitor and record the progress of these and communicate all relevant information promptly back to Manufacturer.
13.6    Funding. Manufacturer shall bear the costs of its own investigations and determinations into root causes in relation to any incident, including the cost of any Third Party service providers as well as the cost of reporting to Regulators where relevant.  Manufacturer shall also bear the cost of any corrective and preventive action (“CAPA”) where this relates to the design and/or Manufacture of the Products including the labelling, IFU and/or packaging for Product registrations (where the latter relate to the versions existing at the date of this Agreement). Customer shall bear the costs of its own investigations and of the implementation of any Product withdrawal, recall or other preventing or corrective action instituted.  Customer shall also bear the cost of any CAPA resulting from any labelling, IFU and/or packaging for modified or new Product registrations. 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

14.    PRODUCT WITHDRAWALS, RECALLS OR OTHER PREVENTIVE OR CORRECTIVE ACTIONS ORDERED, REQUESTED OR SUGGESTED BY COMPETENT AUTHORITIES 
14.1    Manufacturer and Customer shall cooperate with each other and with Governmental Entities and/or Regulators in relation to Official Product Recall Notices issued by them and /or Product recalls or other preventive or corrective actions requested or suggested by them.  Except where this is the responsibility of the holder of PMA P170023 under Applicable Laws Manufacturer shall have final approval for the implementation of these.  Customer shall promptly carry out all such cooperative actions in the field on behalf of Manufacturer and shall monitor and record the progress of these and communicate all relevant information promptly back to Manufacturer.  The parties accept and agree that Manufacturer shall be significantly reliant upon Customer in order to meet its obligations under Applicable Laws.
14.2    Funding. Manufacturer and Customer shall each be responsible for their own costs of fulfilling their obligations under the Quality Agreement which arise in connection with Official Product Recall Notices issued by Governmental Entities and/or Regulators and/or Product withdrawals, recalls or other preventive or corrective actions requested or suggested by them. 
15.    ENFORCEMENT ACTION BY COMPETENT AUTHORITIES OR EU NOTIFIED BODY, UK APPROVED BODY OR OTHER CERTIFICATION BODY  
15.1    Manufacturer shall respond to any inquiry, investigation, prosecution or administrative or other enforcement action initiated or threatened by any Governmental Entity, Regulator or Notified Body, UK Approved Body or other certification body into (i) Manufacturer or (ii) the compliance of the Products irrespective of whether this is directed at Manufacturer or at the Products themselves (“Enforcement against Manufacturer”).  Manufacturer shall promptly inform Customer of any such Enforcement or threat in writing. 
15.2    Manufacturer shall perform the necessary investigations and analysis in respect of any Enforcement against Manufacturer by Regulators and shall direct Customer as to any investigation or inquiry in the field which may be desirable in Manufacturer’s view in order to establish the facts underlying any actual or threatened Enforcement against Manufacturer and/or to respond to questions from Regulators or to prepare for interviews or the submission of any defence and/or evidence in any proceedings or other process comprised in the Enforcement against Manufacturer.  Customer shall promptly carry out all appropriate and requested investigations into the circumstances underlying any Enforcement against Manufacturer including into any healthcare professional training, marketing activity in the field and/or the conformity, performance and/or safety of the Products in the field on behalf of Manufacturer.  Customer shall communicate all relevant information promptly to Manufacturer.  The parties accept and agree that Manufacturer shall be reliant upon Customer in order to respond to any Enforcement against Manufacturer.
15.3    Customer shall respond to any inquiry, investigation, prosecution or administrative or other enforcement action initiated or threatened by any Governmental Entity, Regulators or EU notified body, UK Approved Body or other certification body into (i) Customer; (ii) the compliance of the Products with PMA P170023; or (iii) Customer’s marketing and/or healthcare professional training in relation to the Products irrespective of whether this is directed at Customer or at the Products themselves (“Enforcement against Customer”).  Customer shall promptly inform Manufacturer of any such Enforcement against Customer or threat in writing. 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

15.4    Funding by Manufacturer.  Manufacturer shall bear the costs of defending any Enforcement against Manufacturer, which shall include all internal, legal and expert costs, arising from any breaches by Manufacturer of, or non-conformities of the Products with, Applicable Laws unless and to the extent Manufacturer’s alleged breach or any alleged non-conformity of the Products giving rise to the Enforcement against Manufacturer is due directly or indirectly to the act or default of Customer or its agents or representatives or to reliance on information given to Manufacturer by Customer, its agents or representatives, in which case Customer shall bear such costs.
15.5    Funding by Customer.  Customer shall bear the costs of defending any Enforcement against Customer, which shall include all internal, legal and expert costs, arising from any breaches by Customer of, or non-conformities of the Products with, Applicable Laws unless and to the extent Customer’s alleged breach or any alleged non-conformity of the Products giving rise to the Enforcement against Customer is due directly or indirectly to the act or default of Manufacturer or its agents or representatives or to reliance on information given to Customer by Manufacturer, its agents or representatives, in which case Manufacturer shall bear such costs.
16.    RETENTION OF DOCUMENTS 
16.1    Customer shall keep available for Regulators in the US, the UK, the EU and Rest of World copies of all regulatory documentation required to be kept available for the requisite time period after the last Product has been placed on the market.  Customer shall notify Manufacturer of the last date of placing on the market any Product in any of the US, the UK, the EU and Rest of World.
16.2    Funding.  All document retention shall be funded by Customer, including payment of fees of Third Party service providers where the purpose and necessity of this is to comply with the requirements of Product registrations.
17.    HEALTH TECHNOLOGY APPRAISAL / REIMBURSEMENT 
17.1    Customer shall generate and provide all information, data and documentation concerning the cost-effectiveness, safety, performance and/or clinical effectiveness of the Products to support Health Technology Appraisal (“HTA”) / reimbursement applications made, and/or participation, by Customer in relation to any Product registration in the US, the UK, the EU or Rest of World, e.g. NICE clinical guideline development or updates.
17.2    Funding.  All HTA/reimbursement applications made shall be at the sole cost of Customer.Document

LOAN AND SECURITY AGREEMENT
This LOAN AND SECURITY AGREEMENT (this “Agreement”) dated as of February 25, 2021 (the “Effective Date”) by and among (a) SILICON VALLEY BANK, a California corporation (“SVB”), in its capacity as administrative agent and collateral agent (“Agent”), (b) SVB, as a lender, (c) SVB INNOVATION CREDIT FUND VIII, L.P., a Delaware limited partnership (“SVB Capital”), as a lender (SVB and SVB Capital and each of the other “Lenders” from time to time a party hereto are referred to herein collectively as the “Lenders” and each individually as a “Lender”), and (d) AXONICS MODULATION TECHNOLOGIES, INC., a Delaware corporation (“Borrower”), provides the terms on which Agent and the Lenders shall lend to Borrower and Borrower shall repay Agent and the Lenders.  The parties agree as follows:
1    ACCOUNTING AND OTHER TERMS
Accounting terms not defined in this Agreement shall be construed following GAAP.  Calculations and determinations must be made following GAAP.  Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 14 of this Agreement.  All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.
2    LOAN AND TERMS OF PAYMENT
2.1    Promise to Pay.  Borrower hereby unconditionally promises to pay to Agent, for the ratable benefit of each Lender, the outstanding principal amount of all Credit Extensions advanced to Borrower by such Lender and accrued and unpaid interest thereon, together with any fees as and when due in accordance with this Agreement.
2.1.1    Term Loan Advance
(a)    Availability.  Subject to the terms and conditions of this Agreement, on the Effective Date, or as soon thereafter as all conditions precedent to the making thereof have been met, the Lenders, severally and not jointly, shall make one (1) term loan advance to Borrower in an original principal amount equal to Seventy-Five Million Dollars ($75,000,000) according to each Lender’s Term Loan Advance Commitment as set forth on Schedule 1.1 hereto (the “Term Loan Advance”).  After repayment, the Term Loan Advance (or any portion thereof) may not be reborrowed.
(b)    Interest Payments.  Commencing on the first (1st) Payment Date of the month following the month in which the Funding Date of the Term Loan Advance occurs, and continuing on the Payment Date of each month thereafter, Borrower shall make monthly payments of interest to Agent, for the account of the Lenders, in arrears, on the principal amount of the Term Loan Advance, at the rate set forth in Section 2.2(a).
(c)    Repayment of Principal.  Commencing on September 1, 2022, and continuing on each Payment Date thereafter, Borrower shall repay the aggregate outstanding Term Loan Advance to Agent, for the account of the Lenders, in (i) eighteen (18) consecutive equal monthly installments of principal, plus (ii) monthly payments of accrued interest at the rate set forth in Section 2.2(a).  All outstanding principal and accrued and unpaid interest with respect to the Term Loan Advance, the Final Payment, and all other outstanding Obligations under the Term Loan Advance, are due and payable in full on the Term Loan Maturity Date.
(d)    Permitted Prepayment.  Borrower shall have the option to prepay all, but not less than all, of the Term Loan Advance advanced by the Lenders under this Agreement, provided Borrower (i) provides written notice to Agent of its election to prepay the Term Loan Advance at least five (5) days prior to such prepayment, and (ii) pays to Agent, for the account of the Lenders in accordance with its respective Pro Rata Share, on the date of such prepayment (A) all outstanding principal plus accrued and unpaid interest, (B) the Prepayment Premium, (C) the Final Payment and (D) all other sums, if any, that shall have become due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

(e)    Mandatory Prepayment Upon an Acceleration.  If the Term Loan Advance is accelerated by Agent, following the occurrence and during the continuance of an Event of Default, Borrower shall immediately pay to Agent, for the account of the Lenders in accordance with its respective Pro Rata Share, an amount equal to the sum of (i) all outstanding principal plus accrued and unpaid interest with respect to the Term Loan Advance, (ii) the Prepayment Premium, (iii) the Final Payment and (iv) all other sums, if any, that shall have become due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.
2.2    Payment of Interest on the Credit Extensions.
(a)    Interest Rate.  Subject to Section 2.2(b), the principal amount outstanding under the Term Loan Advance shall accrue interest at a floating per annum rate equal to the greater of (A) nine percentage points (9.00%) and (B) five and three quarters percentage points (5.75%) above the Prime Rate, which interest, in each case, shall be payable monthly in accordance with Section 2.2(d) below.
(b)    Default Rate.  At Agent’s option, upon the occurrence and during the continuance of an Event of Default, Obligations shall bear interest at a rate per annum which is five percentage points (5.00%) above the rate that is otherwise applicable thereto (the “Default Rate”).  Fees and expenses which are required to be paid by Borrower pursuant to the Loan Documents (including, without limitation, Lenders’ Expenses) but are not paid when due shall bear interest until paid at a rate equal to the highest rate applicable to the Obligations (but no higher than the Default Rate).  Payment or acceptance of the increased interest rate provided in this Section 2.2(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Agent or any Lender.
(c)    Adjustment to Interest Rate.  Changes to the interest rate of any Credit Extension based on changes to the Prime Rate shall be effective on the effective date of any change to the Prime Rate and to the extent of any such change. 
(d)    Payment; Interest Computation.  Interest is payable monthly on the Payment Date and shall be computed on the basis of a three-hundred-sixty (360) day year for the actual number of days elapsed.  In computing interest, (i) all payments received after 12:00 p.m. Eastern time on any day shall be deemed received at the opening of business on the next Business Day, and (ii) the date of the making of any Credit Extension shall be included and the date of payment shall be excluded; provided, however, that if any Credit Extension is repaid on the same day on which it is made, such day shall be included in computing interest on such Credit Extension.
2.3    Fees.  Borrower shall pay to Agent:  
(a)    Final Payment.  The Final Payment, when due hereunder, to be shared between the Lenders pursuant to their respective Term Loan Commitment Percentages;
(b)    Prepayment Premium.  The Prepayment Premium, if and when due hereunder, to be shared between the Lenders pursuant to their respective Term Loan Commitment Percentages; and
(c)    Lenders’ Expenses.  All Lenders’ Expenses (including reasonable attorneys’ fees and expenses for documentation and negotiation of this Agreement) incurred through and after the Effective Date, when due (or, if no stated due date, upon demand by Agent).
Unless otherwise provided in this Agreement or in a separate writing by Agent, Borrower shall not be entitled to any credit, rebate, or repayment of any fees earned by Agent or any Lender pursuant to this Agreement notwithstanding any termination of this Agreement or the suspension or termination of any Lender’s obligation to make loans and advances hereunder.  Agent may deduct amounts owing by Borrower under the clauses of this Section 2.3 pursuant to the terms of Section 2.4(e).  Agent shall provide Borrower written notice of deductions made from the Designated Deposit Account pursuant to the terms of the clauses of this Section 2.3.

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2.4    Payments; Pro Rata Treatment; Application of Payments; Debit of Accounts.  
(a)    All payments (including prepayments) to be made by Borrower under any Loan Document shall be made to Agent for the account of Lenders, in immediately available funds in Dollars, without setoff or counterclaim, before 12:00 p.m. Eastern time on the date when due.  Agent shall distribute such payments to Lenders in like funds as set forth in Section 2.5.  Payments of principal and/or interest received after 12:00 p.m. Eastern time are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment shall be due the next Business Day, and additional fees or interest, as applicable, shall continue to accrue until paid.
(b)    Each borrowing by Borrower from Lenders hereunder shall be made according to the respective Term Loan Commitment Percentages of the relevant Lenders.
(c)    Except as otherwise provided herein, each payment (including each prepayment) by Borrower on account of principal or interest on the Term Loan Advance shall be applied according to each Lender’s Pro Rata Share of the outstanding principal amount of the Term Loan Advance.  The amount of each principal prepayment of the Term Loan Advance shall be applied to reduce the then remaining installments of the Term Loan Advance based upon each Pro Rata Share of Term Loan Advance.
(d)    Subject to Section 9.4 of this Agreement, Agent has the right to determine in its good faith business judgment (with consideration of Borrower’s requests) the order and manner in which all payments with respect to the Obligations may be applied.  Borrower shall have no right to specify the order or the accounts to which Agent shall allocate or apply any payments required to be made by Borrower to Agent or otherwise received by Agent or any Lender under this Agreement when any such allocation or application is not specified elsewhere in this Agreement.
(e)    Agent may debit any of Borrower’s deposit accounts, including the Designated Deposit Account, for principal and interest payments or any other amounts Borrower owes Agent or any Lender when due. These debits shall not constitute a set-off.
(f)    Unless Agent shall have been notified in writing by Borrower prior to the date of any payment due to be made by Borrower hereunder that Borrower will not make such payment to Agent, Agent may assume that Borrower is making such payment, and Agent may, but shall not be required to, in reliance upon such assumption, make available to Lenders their respective Pro Rata Share of a corresponding payment amount.  If such payment is not made to Agent by Borrower within three (3) Business Days after such due date, Agent shall be entitled to recover, on demand, from each Lender to which any amount which was made available pursuant to the preceding sentence, such amount with interest thereon at the rate per annum equal to the daily average Federal Funds Effective Rate.  Nothing herein shall be deemed to limit the rights of Agent or any Lender against Borrower.
2.5    Settlement Procedures.  If Agent receives any payment for the account of Lenders on or prior to 12:00 p.m. (Eastern time) on any Business Day, Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such payment on such Business Day. If Agent receives any payment for the account of Lenders after 12:00 p.m. (Eastern time) on any Business Day, Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such payment on the next Business Day.  
2.6    Withholding by Borrower.  Payments received by Agent from Borrower under this Agreement will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any Governmental Authority (including any interest, additions to tax or penalties applicable thereto).  Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to Agent, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, Agent receives a net sum equal to the sum which it would have received had no withholding or deduction been required, and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority.  Borrower will, upon request, furnish Agent with proof reasonably satisfactory to Agent indicating that Borrower has 
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made such withholding payment; provided, however, that Borrower need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Borrower.  The agreements and obligations of Borrower contained in this Section 2.6 shall survive the termination of this Agreement.

3    CONDITIONS OF LOANS
3.1    Conditions Precedent to Initial Credit Extension.  Each Lender’s obligation to make the initial Credit Extension hereunder is subject to the condition precedent that Agent shall have received, in form and substance satisfactory to Agent and the Lenders, such documents, and completion of such other matters, as Agent may reasonably deem necessary or appropriate, including, without limitation:
(a)    duly executed signatures to the Loan Documents;
(b)    the Operating Documents and long-form good standing certificates of Borrower certified by the Secretary of State (or equivalent agency) of Borrower’s jurisdiction of organization or formation and each jurisdiction in which Borrower is qualified to conduct business and has a material presence or conducts a material portion of its business, each as of a date no earlier than thirty (30) days prior to the Effective Date;
(c)    a secretary’s certificate of Borrower with respect to such Borrower’s Operating Documents, incumbency, specimen signatures and resolutions authorizing the execution and delivery of this Agreement and the other Loan Documents to which it is a party;
(d)    duly executed signatures to the completed Borrowing Resolutions for Borrower;
(e)    certified copies, dated as of a recent date, of Lien searches (including without limitation, UCC searches), as Agent may request, accompanied by written evidence (including any UCC termination statements and other Lien releases) that the Liens indicated in any such financing statements or other filings either constitute Permitted Liens or have been or, in connection with the initial Credit Extension hereunder, will be terminated or released;
(f)    a final execution version of the Contura Sale and Purchase Agreement and any other documents entered into by Borrower or Axonics UK in connection therewith;
(g)    the Perfection Certificate of Borrower, together with the duly executed signatures thereto;
(h)    a legal opinion (authority and enforceability) of Borrower’s counsel dated as of the Effective Date, together with the duly executed signature thereto; and
(i)    payment of the fees and Lenders’ Expenses then due as specified in Section 2.3 hereof.
3.2    Conditions Precedent to all Credit Extensions.  Each Lender’s obligation to make each Credit Extension, including the initial Credit Extension, is subject to the following conditions precedent:
(a)    timely receipt by the Lenders of (i) an executed Disbursement Letter and (ii) an executed Payment/Advance Form;  
(b)    the representations and warranties in this Agreement shall be true, accurate, and complete in all material respects on the date of the Disbursement Letter (and the Payment/Advance Form) and on the Funding Date of each Credit Extension; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension.  Each Credit Extension is Borrower’s representation and warranty on that date that 
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the representations and warranties in this Agreement remain true, accurate, and complete in all material respects; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date; and
(c)    Agent and each Lender determine to its satisfaction that there has not been any material impairment in the general affairs, management, results of operation, financial condition or the prospect of repayment of the Obligations, nor any material adverse deviation by Borrower from the most recent business plan of Borrower presented to and accepted by Agent and the Lenders.
3.3    Covenant to Deliver.  Except as set forth in Section 6.13, Borrower agrees to deliver to Agent and each Lender each item required to be delivered to Agent and each Lender under this Agreement as a condition precedent to any Credit Extension.  Borrower expressly agrees that a Credit Extension made prior to the receipt by Agent and each Lender of any such item shall not constitute a waiver by Agent or Lenders of Borrower’s obligation to deliver such item, and the making of any Credit Extension in the absence of a required item shall be in each Lender’s sole discretion.
3.4    Procedures for Borrowing.  
(a)    Term Loan Advance.  Subject to the prior satisfaction of all other applicable conditions to the making of a Credit Extension set forth in this Agreement, to obtain a Credit Extension, Borrower shall notify Agent (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 12:00 p.m. Eastern time at least three (3) Business Days before the proposed Funding Date of such Credit Extension.  Together with any such electronic or facsimile notification, Borrower shall deliver to Agent by electronic mail or facsimile a completed Disbursement Letter (and Payment/Advance Form) executed by an Authorized Signer.  Agent may rely on any telephone notice given by a person whom Agent believes is an Authorized Signer.  On the Funding Date, Agent shall credit the Credit Extensions to the Designated Deposit Account.  Agent may make Credit Extensions under this Agreement based on instructions from an Authorized Signer or without instructions if the Credit Extensions are necessary to meet Obligations which have become due.
(b)    Funding.  In determining compliance with any condition hereunder to the making of a Credit Extension that, by its terms, must be fulfilled to the satisfaction of a Lender, Agent may presume that such condition is satisfactory to such Lender unless Agent shall have received notice to the contrary from such Lender prior to the making of such Credit Extension.  Unless Agent shall have been notified in writing by any Lender prior to the date of any Credit Extension, that such Lender will not make the amount that would constitute its share of such borrowing available to Agent, Agent may assume that such Lender is making such amount available to Agent, and Agent may, in reliance upon such assumption, make available to Borrower a corresponding amount.  If such amount is not made available to Agent by the required time on the Funding Date therefor, such Lender shall pay to Agent, on demand, such amount with interest thereon, at a rate equal to the greater of (i) the Federal Funds Effective Rate or (ii) a rate determined by Agent in accordance with banking industry rules on interbank compensation, for the period until such Lender makes such amount immediately available to Agent.  If such Lender’s share of such Credit Extension is not made available to Agent by such Lender within three (3) Business Days after such Funding Date, Agent shall also be entitled to recover such amount with interest thereon at the rate per annum applicable to the Term Loan Advance, on demand, from Borrower.
4    CREATION OF SECURITY INTEREST
4.1    Grant of Security Interest.  Borrower hereby grants Agent, for the ratable benefit of the Lenders, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Agent, for the ratable benefit of the Lenders, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof.  For clarity, any reference to “Agent’s Lien” or any granting of collateral to Agent in this Agreement or any Loan Document means the Lien granted to Agent for the ratable benefit of the Lenders.

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Borrower acknowledges that it previously has entered, and/or may in the future enter, into Bank Services Agreements with SVB.  Regardless of the terms of any Bank Services Agreement, Borrower agrees that any amounts Borrower owes SVB thereunder shall be deemed to be Obligations hereunder and that it is the intent of Borrower and SVB to have all such Obligations secured by the first priority perfected security interest in the Collateral granted herein (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Agent’s Lien in this Agreement), and by any and all other security agreements, mortgages or other collateral granted to Agent by Borrower as security for the Obligations, now or in the future.
If this Agreement is terminated, Agent’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash.  Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as the Lenders’ obligation to make Credit Extensions has terminated, Agent shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower.  In the event (x) all Obligations (other than inchoate indemnity obligations), except for Bank Services, are satisfied in full, and (y) this Agreement is terminated, Agent shall terminate the security interest granted herein upon Borrower providing to SVB cash collateral acceptable to SVB in its good faith business judgment for Bank Services, if any. In the event such Bank Services consist of outstanding Letters of Credit, Borrower shall provide to SVB cash collateral in an amount equal to (x) if such Letters of Credit are denominated in Dollars, then at least one hundred five percent (105.0%); and (y) if such Letters of Credit are denominated in a Foreign Currency, then at least one hundred ten percent (110.0%), of the Dollar Equivalent of the face amount of all such Letters of Credit plus, in each case, all interest, fees, and costs due or to become due in connection therewith (as estimated by SVB in its business judgment), to secure all of the Obligations relating to such Letters of Credit.
4.2    Priority of Security Interest.  Borrower represents, warrants, and covenants that the security interests granted herein are and shall at all times continue to be a first priority perfected security interests in the Collateral (subject only to Permitted Liens).  If Borrower shall acquire a commercial tort claim, Borrower shall promptly notify Agent in a writing signed by Borrower of the general details thereof and grant to Agent, for the ratable benefit of the Lenders, in such writing a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Agent.
4.3    Authorization to File Financing Statements.  Borrower hereby authorizes Agent, on behalf of the Lenders, to file financing statements and other similar forms, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Agent’s and Lenders’ interest or rights hereunder, including a notice that any disposition of the Collateral, by Borrower or any other Person, shall be deemed to violate the rights of Agent under the Code.  Such financing statements and other similar forms may indicate the Collateral as “all assets of the Debtor” or words of similar effect, or as being of an equal or lesser scope, or with greater detail, all in Agent’s discretion.
5    REPRESENTATIONS AND WARRANTIES
Borrower represents and warrants as follows: 
5.1    Due Organization, Authorization; Power and Authority.  Borrower is duly organized, validly existing and in good standing as a Registered Organization in its jurisdiction of formation and is qualified and licensed to do business and is in good standing in any other jurisdiction in which the conduct of its business or its ownership of property and other assets or business which it is engaged in requires that it be qualified except where the failure to do so could not reasonably be expected to have a material adverse effect on Borrower’s business. In connection with this Agreement, Borrower has delivered to Agent and each Lender a completed certificate signed by Borrower, entitled “Perfection Certificate” (collectively, the “Perfection Certificate”).  Borrower represents and warrants to Agent and each Lender that: (a) Borrower’s exact legal name is that indicated on the Perfection Certificate and on the signature page hereof; (b) Borrower is an organization of the type and is organized or is incorporated in the jurisdiction set forth in the Perfection Certificate; (c) the Perfection Certificate accurately sets forth Borrower’s organizational identification number or accurately states that Borrower has none; (d) the Perfection Certificate accurately sets forth Borrower’s place of business, or, if more than one, its chief executive office as well as Borrower’s mailing address (if different than its chief executive office); (e) except as indicated on the Perfection Certificate, Borrower (and each of its predecessors) has not, in the past five (5) years, changed its jurisdiction of formation, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all 
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other information set forth on the Perfection Certificate pertaining to Borrower and each of its Subsidiaries is accurate and complete (it being understood and agreed that Borrower may from time to time update certain information in the Perfection Certificate after the Effective Date to the extent permitted by one or more specific provisions in this Agreement).
The execution, delivery and performance by Borrower of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s Operating Documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or any of its Subsidiaries or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect), filings and registrations contemplated by this Agreement, or (v) conflict with, contravene, constitute a default or breach under, or result in or permit the termination or acceleration of, any material agreement by which Borrower is bound.  Borrower is not in default under any agreement to which it is a party or by which it is bound in which the default could reasonably be expected to have a material adverse effect on Borrower’s business.  
5.2    Collateral.  Borrower has good title to, rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien under this Agreement and other Loan Documents, free and clear of any and all Liens except Permitted Liens.  Borrower has no Collateral Accounts at or with any bank or financial institution other than SVB or SVB’s Affiliates except for the Collateral Accounts described in the Perfection Certificate delivered to Agent and each Lender in connection herewith and which Borrower has given Agent notice and taken such actions as are necessary to give Agent, for the ratable benefit of the Lenders, a perfected security interest therein, pursuant to the terms of Section 6.6(c).  The Accounts are bona fide, existing obligations of the Account Debtors.  
The Collateral is not in the possession of any third party bailee (such as a warehouse) except as otherwise provided in the Perfection Certificate.  None of the components of the Collateral shall be maintained at locations other than as provided in the Perfection Certificate or as permitted pursuant to Section 7.2.
All Inventory is in all material respects of good and marketable quality, free from material defects.
Except as set forth in the Perfection Certificate, Borrower is the sole owner of the Intellectual Property which it owns or purports to own except for (a) non-exclusive licenses granted to its customers in the ordinary course of business, (b) over-the-counter software that is commercially available to the public, and (c) material Intellectual Property licensed to Borrower and noted on the Perfection Certificate.  Each Patent which it owns or purports to own and which is material to Borrower’s business is valid and enforceable, and no part of the Intellectual Property which Borrower owns or purports to own and which is material to Borrower’s business has been judged invalid or unenforceable, in whole or in part.  To the best of Borrower’s knowledge, no claim has been made that any part of the Intellectual Property violates the rights of any third party except to the extent such claim would not reasonably be expected to have a material adverse effect on Borrower’s business. Except as noted on the Perfection Certificate, Borrower is not a party to, nor is it bound by, any Restricted License.
5.3    Litigation.  Except as set forth in the Perfection Certificate delivered by Borrower to Agent on or prior to the Effective Date, there are no actions or proceedings pending or, to the knowledge of Borrower, threatened in writing by or against Borrower or any of its Subsidiaries reasonably expected to result in liability or costs to Borrower in excess of One Million Dollars ($1,000,000) individually or in the aggregate.  
5.4    Financial Statements; Financial Condition.  All consolidated financial statements for Borrower and any of its Subsidiaries delivered to Agent and the Lenders by submission to the Financial Statement Repository or otherwise submitted to Agent and the Lenders fairly present in all material respects Borrower’s consolidated financial condition and Borrower’s consolidated results of operations.  There has not been any material deterioration in Borrower’s consolidated financial condition since the date of the most recent financial statements submitted to Agent and the Lenders the Financial Statement Repository or otherwise submitted to Agent and the Lenders.

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5.5    Solvency.  The fair salable value of Borrower’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of Borrower’s liabilities; Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts (including trade debts) as they mature.
5.6    Regulatory Compliance.  Borrower is not an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended.  Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors).  Borrower (a) has complied in all material respects with all Requirements of Law, and (b) has not violated any Requirements of Law the violation of which could reasonably be expected to have a material adverse effect on its business.  None of Borrower’s or any of its Subsidiaries’ properties or assets has been used by Borrower or any Subsidiary or, to the best of Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than legally.  Borrower and each of its Subsidiaries have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.
5.7    Subsidiaries; Investments.  Borrower does not own any stock, partnership, or other ownership interest or other equity securities except for Permitted Investments.  
5.8    Tax Returns and Payments; Pension Contributions.  Borrower has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except (a) to the extent such taxes are being contested in good faith by appropriate proceedings promptly instituted and diligently conducted, so long as such reserve or other appropriate provision, if any, as shall be required in conformity with GAAP shall have been made therefor, or (b) if such taxes, assessments, deposits and contributions do not, individually or in the aggregate, exceed Two Hundred Fifty Thousand Dollars ($250,000).  
To the extent Borrower defers payment of any contested taxes, Borrower shall (i) notify Agent in writing of the commencement of, and any material development in, the proceedings and (ii) post bonds or take any other steps required to prevent the Governmental Authority levying such contested taxes from obtaining a Lien upon any of the Collateral that is other than a “Permitted Lien.”  Borrower is unaware of any claims or adjustments proposed for any of Borrower’s prior tax years which could result in additional taxes becoming due and payable by Borrower in excess of Fifty Thousand Dollars ($50,000).  Borrower has paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and Borrower has not withdrawn from participation in, and has not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.
5.9    Use of Proceeds.  Borrower shall use the proceeds of the Credit Extensions as working capital and to fund its general business requirements and not for personal, family, household or agricultural purposes.
5.10    Full Disclosure.  To the best of Borrower’s knowledge, no written representation, warranty or other statement of Borrower in any report, certificate, or written statement submitted to the Financial Statement Repository or otherwise submitted to Agent or any Lender in connection with the Loan Documents, or the transactions contemplated thereby, as of the date such representation, warranty, or other statement was made, taken together with all such written reports, written certificates and written statements submitted to the Financial Statement Repository or otherwise submitted to Agent or any Lender, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the reports, certificates, or written statements not misleading (it being recognized by Agent and each Lender that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

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5.11    Definition of “Knowledge.”  For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of any Responsible Officer.
6    AFFIRMATIVE COVENANTS
Borrower shall do all of the following:
6.1    Government Compliance.  
(a)    Maintain its and all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of formation and maintain qualification in each jurisdiction in which the failure to so qualify would reasonably be expected to have a material adverse effect on Borrower’s business or operations.  Borrower shall comply, and have each Subsidiary comply, in all material respects, with all laws, ordinances and regulations to which it is subject.
(b)    Obtain all of the Governmental Approvals necessary for the performance by Borrower of its obligations under the Loan Documents to which it is a party and the grant of a security interest to Agent, for the ratable benefit of the Lenders, in all of its property.  Borrower shall promptly provide copies of any such obtained Governmental Approvals to Agent.
6.2    Financial Statements, Reports.  Provide Agent and each Lender with the following by submitting to the Financial Statement Repository or otherwise submitting to Agent and each Lender:
(a)    Quarterly Financial Statements.  As soon as available, but no later than forty-five (45) days after the last day of each calendar quarter, a company prepared consolidated and consolidating balance sheet, cash flow statement, and income statement covering Borrower’s and each of its Subsidiary’s operations for such calendar quarter in a form consistent with Borrower’s public filings (the “Quarterly Financial Statements”); provided, however, notwithstanding the foregoing, the Quarterly Financial Statements for the fourth (4th) calendar quarter of each year, shall be due no later than ninety (90) days after the last day of such calendar quarter;
(b)    Quarterly Compliance Statement.  Within forty-five (45) days after the last day of each calendar quarter and together with the Quarterly Financial Statements, a completed Compliance Statement confirming that as of the end of such calendar quarter, Borrower was in full compliance with all of the terms and conditions of this Agreement, and setting forth calculations showing compliance with the financial covenant(s) (if any) set forth in this Agreement and such other information as Agent or the Lenders may reasonably request; 
(c)    Annual Operating Budget and Financial Projections.  Within thirty (30) days after the last day of each fiscal year of Borrower, and within seven (7) days of any updates or amendments thereto, (i) annual operating budgets (including income statements, balance sheets and cash flow statements, by month) for the then-current fiscal year of Borrower, and (ii) annual financial projections for the then-current fiscal year (on a quarterly basis) as approved by the Board, together with any related business forecasts used in the preparation of such annual financial projections;
(d)    Annual Audited Financial Statements.  As soon as available, and in any event within one hundred eighty (180) days after the last day of Borrower’s fiscal year, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified public accounting firm;
(e)    Other Statements.  Within five (5) days of delivery, copies of all statements and reports made available to Borrower’s security holders or to any holders of Subordinated Debt;

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(f)    Monthly Asset Management Account Statements.  Within thirty (30) days after the last day of each month, copies of, or real-time access to, Borrower’s asset management account statements for each of Borrower’s accounts maintained outside of SVB;
(g)    SEC Filings.  Within five (5) days of filing, copies of all periodic and other reports, proxy statements and other materials filed by Borrower and/or any Guarantor with the SEC, any Governmental Authority succeeding to any or all of the functions of the SEC or with any national securities exchange, or distributed to its shareholders, as the case may be.  Documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the internet at Borrower’s website address;
(h)    Legal Action Notice.  A prompt report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could reasonably be expected to result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, One Million Dollars ($1,000,000) or more;
(i)    Additional Reporting Requirement. At any time that Borrower is not a public company or an issuer of securities that are registered with the SEC under Section 12 of the Exchange Act (or that is required to file reports under Section 15(d) of the Exchange Act), written notice of any changes to the beneficial ownership information set out in Section 14 of the Perfection Certificate.  Borrower understands and acknowledges that each Lender relies on such true, accurate and up-to-date beneficial ownership information to meet such Lender’s regulatory obligations to obtain, verify and record information about the beneficial owners of its legal entity customers; and
(j)    Other Financial Information.  Other financial information reasonably requested by Agent or any Lender.
Any submission by Borrower of a Compliance Statement, or any other financial statement submitted to the Financial Statement Repository pursuant to this Section 6.2 or otherwise submitted to Agent and Lenders shall be deemed to be a representation by Borrower that (a) as of the date of such Compliance Statement, or other financial statement, the information and calculations set forth therein are true, accurate and correct, (b) as of the end of the compliance period set forth in such submission, Borrower is in complete compliance with all required covenants except as noted in such Compliance Statement, or other financial statement, as applicable; (c) as of the date of such submission, no Events of Default have occurred or are continuing; (d) all representations and warranties other than any representations or warranties that are made as of a specific date in Article 5 remain true and correct in all material respects as of the date of such submission except as noted in such Compliance Statement, or other financial statement, as applicable; (e) as of the date of such submission, Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except as otherwise permitted pursuant to the terms of Section 5.9; and (f) as of the date of such submission, no Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Agent and Lenders.
6.3    Taxes; Pensions. Timely file, and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely pay, all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower and each of its Subsidiaries, except for deferred payment of any taxes contested pursuant to the terms of Section 5.8 hereof, and shall deliver to Agent, on demand, appropriate certificates attesting to such payments, and pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms.

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6.4    Inventory; Returns.  Keep all Inventory in good and marketable condition in all material respects, free from material defects.  Returns and allowances between Borrower and its Account Debtors shall follow Borrower’s customary practices as they exist at the Effective Date.  Borrower must promptly notify Agent and the Lenders of all returns, recoveries, disputes and claims that involve more than One Million Dollars ($1,000,000).
6.5    Insurance.  
(a)    Keep its business and the Collateral insured for risks and in amounts standard for companies in Borrower’s industry and location and as Agent may reasonably request.  Insurance policies shall be in a form, with financially sound and reputable insurance companies that are not Affiliates of Borrower, and in amounts that are satisfactory to Agent.  All property policies shall have a lender’s loss payable endorsement showing Agent as the sole lender loss payee.  All liability policies shall show, or have endorsements showing, Agent as an additional insured.  Agent shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral. 
(b)    Ensure that proceeds payable under any property policy are, at Agent’s option, payable to Agent for the ratable benefit of the Lenders on account of the Obligations. 
(c)    At Agent’s request, Borrower shall deliver certified copies of insurance policies and evidence of all premium payments.  Each provider of any such insurance required under this Section 6.5 shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to Agent, that it will give Agent thirty (30) days prior written notice before any such policy or policies shall be materially altered or canceled.  If Borrower fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons and Agent, Agent may make all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Agent deems prudent. 
6.6    Operating Accounts.
(a)    Maintain at least one (1) depository or securities account with SVB or SVB’s Affiliates.  In addition, during the Control Agreement Transition Period and at all times thereafter until Control Agreements for all Collateral Accounts outside Bank have been delivered to Agent, Borrower shall maintain at least Seventy-Five Million Dollars ($75,000,000) in unrestricted cash and Cash Equivalents in its account(s) held with SVB.
(b)    In addition, Borrower and all of its Domestic Subsidiaries shall obtain any business credit cards and Letters of Credit exclusively from SVB provided that such products and services are available from SVB on commercially reasonable terms. 
(c)    In addition to and without limiting the restrictions in (a), Borrower shall provide Agent five (5) days prior written notice before establishing any Collateral Account at or with any bank or financial institution other than SVB or SVB’s Affiliates.  For each Collateral Account that Borrower at any time maintains, Borrower shall cause the applicable bank or financial institution (other than SVB) at or with which any Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Agent’s Lien in such Collateral Account in accordance with the terms hereunder, which Control Agreement may not be terminated without the prior written consent of the Lenders.  The provisions of the previous sentence shall not apply to deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s employees and identified to Agent and the Lenders by Borrower as such.
6.7    Minimum Revenue.  For any calendar quarter during which Borrower’s Liquidity falls below One Hundred Fifty Million Dollars ($150,000,000) at any time during such quarter, Borrower shall achieve Revenue (measured on a trailing three (3) month basis) of not less than the amount set forth in the table below for the corresponding measuring period:

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	Measuring Period Ending	Minimum Trailing-3 Month Revenue
	March 31, 2021	$20,000,000
	June 30, 2021	$30,000,000
	September 30, 2021
	$34,000,000
	December 31, 2021
	$44,000,000
	Each calendar quarter thereafter through the Term Loan Maturity Date
	115% of Borrower’s actual Revenue for the same quarterly measuring period in the prior calendar year

6.8    Protection of Intellectual Property Rights.
(a)    (i) Protect, defend and maintain the validity and enforceability of any Intellectual Property that has any material value as determined by the Board; (ii) promptly advise Agent in writing of material infringements or any other event that could reasonably be expected to materially and adversely affect the value of its Intellectual Property; and (iii) not allow any Intellectual Property material to Borrower’s business to be abandoned, forfeited or dedicated to the public without Agent’s written consent.  
(b)    Provide written notice to Agent within ten (10) days of entering or becoming bound by any Restricted License (other than over-the-counter software that is commercially available to the public).  Borrower shall take such commercially reasonable steps as Agent requests to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for (i) any Restricted License to be deemed “Collateral” and for Agent to have a security interest in it that might otherwise be restricted or prohibited by law or by the terms of any such Restricted License, whether now existing or entered into in the future, and (ii) Agent to have the ability in the event of a liquidation of any Collateral to dispose of such Collateral in accordance with Agent’s and the Lenders’ rights and remedies under this Agreement and the other Loan Documents.
6.9    Litigation Cooperation.  From the date hereof and continuing through the termination of this Agreement, make available to Agent, without expense to Agent or any Lender, Borrower and its officers, employees and agents and Borrower’s books and records, to the extent that Agent and/or the Lenders may deem them reasonably necessary to prosecute or defend any third-party suit or proceeding instituted by or against Agent and/or any Lender with respect to any Collateral or relating to Borrower.
6.10    Access to Collateral; Books and Records.  Allow Agent or its agents, at reasonable times, on five (5) Business Days’ notice (provided no notice is required if an Event of Default has occurred and is continuing), to inspect the Collateral and audit and copy Borrower’s Books.  Such inspections or audits shall be conducted no more often than once every twelve (12) months unless an Event of Default has occurred and is continuing in which case such inspections and audits shall occur as often as Agent shall determine is necessary.  The foregoing inspections and audits shall be at Borrower’s expense and the charge therefor shall be One Thousand Dollars ($1,000) per person per day (or such higher amount as shall represent Agent’s then-current standard charge for the same), plus reasonable out-of-pocket expenses.  In the event Borrower and Agent schedule an audit more than eight (8) days in advance, and Borrower cancels or reschedules the audit with less than eight (8) days written notice to Agent, then (without limiting any of Agent’s or any Lender’s rights or remedies) Borrower shall pay Agent a fee of Two Thousand Dollars ($2,000) plus any out-of-pocket expenses incurred by Agent to compensate Agent for the anticipated costs and expenses of the cancellation or rescheduling.
6.11    Formation or Acquisition of Subsidiaries.  Notwithstanding and without limiting the negative covenants contained in Sections 7.3 and 7.7 hereof, at the time that (i) Borrower or any Guarantor forms any direct or indirect Material Subsidiary or acquires any direct or indirect Material Subsidiary after the Effective Date 
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(including, without limitation, pursuant to a Division), or (ii) any existing Subsidiary of Borrower becomes a Material Subsidiary, Borrower and such Guarantor shall (a) cause such Material Subsidiary to either (I) provide to Lenders a joinder to this Agreement to become a co-borrower hereunder or a Guaranty to become a Guarantor hereunder, together with such appropriate financing statements and/or Control Agreements, or (II) guarantee the Obligations of Borrower under the Loan Documents and, in each case, grant a continuing pledge and security interest in and to the assets of such Subsidiary (substantially as described on Exhibit A hereto), all in form and substance satisfactory to Agent and Lenders (including being sufficient to grant Lenders a first priority Lien (subject to Permitted Liens) in and to the assets of such newly formed or acquired Material Subsidiary), (b) provide to Lenders appropriate certificates and powers and financing statements, pledging all of the direct or beneficial ownership interest in such Material Subsidiary, in form and substance satisfactory to Agent and Lenders; and (c) provide to Lenders all other documentation in form and substance satisfactory to Agent and Lenders, including one or more opinions of counsel satisfactory to Lenders, which in its opinion is appropriate with respect to the execution and delivery of the applicable documentation referred to above; provided, however, that no Foreign Subsidiary shall be required to become a co-borrower or Guarantor hereunder so long as the Borrower is in compliance with Section 7.11 hereof.  Any document, agreement, or instrument executed or issued pursuant to this Section 6.11 shall be a Loan Document.
6.12    Further Assurances.  Execute any further instruments and take further action as Agent and the Lenders reasonably request to perfect or continue Agent’s Lien in the Collateral or to effect the purposes of this Agreement.  Deliver to Agent and the Lenders, within five (5) days after the same are sent or received, copies of all correspondence, reports, documents and other filings with any Governmental Authority regarding compliance with or maintenance of Governmental Approvals or Requirements of Law or that could reasonably be expected to have a material effect on any of the Governmental Approvals which are material to the business of Borrower or otherwise on the operations of Borrower or any of its Subsidiaries.  
6.13    Post-Closing Conditions.  
(a)    No later than thirty (30) days after the Effective Date (the period of time from the Effective Date through such date, the “Control Agreement Transition Period”), Borrower shall deliver to Agent a Securities Account Control Agreement covering Borrower’s account no. XXX-03021 at Merrill Lynch in favor of Agent.
(b)    As soon as possible, and no later than forty-five (45) after the Effective Date, Borrower shall deliver to Agent evidence, satisfactory to Agent, that the insurance policies and endorsements required by Section 6.5 hereof are in full force and effect with respect to Borrower, together with appropriate evidence showing lender loss payable and/or additional insured clauses or endorsements in favor of Agent.
7    NEGATIVE COVENANTS
Borrower shall not do any of the following without the prior written consent of the Lenders:
7.1    Dispositions.  Convey, sell, lease, transfer, assign, or otherwise dispose of (including, without limitation, pursuant to a Division) (collectively a “Transfer”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) of Inventory in the ordinary course of business; (b) of worn-out or obsolete Equipment that is, in the reasonable judgment of Borrower, no longer economically practicable to maintain or useful in the ordinary course of business of Borrower; (c) consisting of Permitted Liens and Permitted Investments; (d) consisting of the sale or issuance of any stock of Borrower permitted under Section 7.2 of this Agreement; (e) consisting of Borrower’s use or transfer of money or Cash Equivalents in a manner that is not prohibited by the terms of this Agreement or the other Loan Documents; and (f) of non-exclusive licenses for the use of the property of Borrower or its Subsidiaries in the ordinary course of business and licenses that could not result in a legal transfer of title of the licensed property but that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discreet geographical areas outside of the United States.
7.2    Changes in Business, Management, Control, or Business Locations.  (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses currently engaged in by Borrower and such Subsidiary, as applicable, or reasonably related thereto and reasonable extension thereof; (b) liquidate or 
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dissolve;  (c) fail to provide notice to Agent and Lenders of any Key Person departing from or ceasing to be employed by Borrower within ten (10) Business Days after such Key Person’s departure from Borrower; or (d) permit or suffer any Change in Control.  
Borrower shall not, without at least thirty (30) days prior written notice to Agent: (1) add any new offices or business locations, including warehouses (unless such new offices or business locations contain less than Two Hundred Fifty Thousand Dollars ($250,000) in Borrower’s assets or property) or deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Two Hundred Fifty Thousand Dollars ($250,000) to a bailee at a location other than to a bailee and at a location already disclosed in the Perfection Certificate, (2) change its jurisdiction of organization, (3) change its organizational structure or type, (4) change its legal name, or (5) change any organizational number (if any) assigned by its jurisdiction of organization.  If Borrower intends to add any new offices or business locations, including warehouses, containing in excess of Two Hundred Fifty Thousand Dollars ($250,000) of Borrower’s assets or property, then Borrower will first cause the landlord of any such new offices or business locations, including warehouses, to execute and deliver a landlord consent in form and substance reasonably satisfactory to Agent.  If Borrower intends to deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Two Hundred Fifty Thousand Dollars ($250,000) to a bailee, and Agent and such bailee are not already parties to a bailee agreement governing both the Collateral and the location to which Borrower intends to deliver the Collateral, then Borrower will first cause such bailee to execute and deliver a bailee agreement in form and substance reasonably satisfactory to Agent.
7.3    Mergers or Acquisitions.  Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person (including, without limitation, by the formation of any Subsidiary or pursuant to a Division).  A Subsidiary may merge or consolidate into another Subsidiary or into Borrower.  Notwithstanding the foregoing, Axonics UK may consummate the Contura Acquisition.
7.4    Indebtedness.  Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.
7.5    Encumbrance.  Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, permit any Collateral not to be subject to the first priority security interest granted herein, or enter into any agreement, document, instrument or other arrangement (except with or in favor of Agent, for the ratable benefit of the Lenders) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower or any Subsidiary from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or any Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of “Permitted Liens” herein.
7.6    Maintenance of Collateral Accounts.  Maintain any Collateral Account except pursuant to the terms of Section 6.6(c) hereof.
7.7    Distributions; Investments.  (a) Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock; or (b) directly or indirectly make any Investment (including, without limitation, by the formation of any Subsidiary) other than Permitted Investments, or permit any of its Subsidiaries to do so.
7.8    Transactions with Affiliates.  Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower, except for transactions that are in the ordinary course of Borrower’s business or consistent with past practice, upon fair and reasonable terms that are no less favorable to Borrower than would be obtained in an arm’s length transaction with a non-affiliated Person.
7.9    Subordinated Debt.  (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof, provide for earlier or greater principal, interest, or other payments thereon, or adversely affect the subordination thereof to Obligations owed to Agent and the Lenders.
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7.10    Compliance.  Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to (a) meet the minimum funding requirements of ERISA, (b) prevent a Reportable Event or Prohibited Transaction, as defined in ERISA, from occurring, or (c) comply with the Federal Fair Labor Standards Act, or violate any other law or regulation, if the violation could reasonably be expected to have a material adverse effect on Borrower’s business, or permit any of its Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.
7.11    Assets in Foreign Subsidiaries. Permit its Foreign Subsidiaries to hold or maintain, at any time, assets (other than Intellectual Property and other intangible assets) with an aggregate value in excess of Ten Million Dollars ($10,000,000).  
8    EVENTS OF DEFAULT
Any one of the following shall constitute an event of default (an “Event of Default”) under this Agreement:
8.1    Payment Default.  Borrower fails to (a) make any payment of principal or interest on any Credit Extension when due, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day cure period shall not apply to payments due on the Term Loan Maturity Date).  During the cure period, the failure to make or pay any payment specified under clause 8.2(b) hereunder is not an Event of Default (but no Credit Extension will be made during the cure period);
8.2    Covenant Default.  
(a) Borrower fails or neglects to perform any obligation in Sections 6.2, 6.3, 6.5, 6.6, 6.7, 6.9, 6.10, 6.11, 6.12, or 6.13 or violates any covenant in Section 7; or
(b) Borrower fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period).  Cure periods provided under this section shall not apply, among other things, to financial covenants or any other covenants set forth in clause (a) above;
8.3    Material Adverse Change.  A Material Adverse Change occurs;
8.4    Attachment; Levy; Restraint on Business.  
(a)    (i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or of any entity under the control of Borrower (including a Subsidiary) in excess of Two Hundred Fifty Thousand Dollars ($250,000), or (ii) a notice of lien or levy is filed against any of Borrower’s assets in excess of Two Hundred Fifty Thousand Dollars ($250,000) by any Governmental Authority, and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; or 

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(b)     (i) any material portion of Borrower’s assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower from conducting all or any material part of its business;
8.5    Insolvency.  (a) Borrower or any of its Subsidiaries is unable to pay its debts (including trade debts) as they become due or otherwise becomes insolvent; (b) Borrower or any of its Subsidiaries begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower or any of its Subsidiaries and is not dismissed or stayed within thirty (30) days (but no Credit Extensions shall be made while any of the conditions described in clause (a) exist and/or until any Insolvency Proceeding is dismissed);
8.6    Other Agreements.  There is, under any agreement to which Borrower or any Guarantor is a party with a third party or parties, (a) any default resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount individually or in the aggregate in excess of Two Million Dollars ($2,000,000); or (b) any breach or default by Borrower or Guarantor, the result of which could reasonably be expected to have a material adverse effect on Borrower’s or any Guarantor’s business;
8.7    Judgments; Penalties.  One or more fines, penalties, or final judgments, orders or decrees for the payment of money in an amount, individually or in the aggregate, of at least Two Million Dollars ($2,000,000) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower by any Governmental Authority, and the same are not, within thirty (30) days after the entry, assessment or issuance thereof, discharged, satisfied, or paid, or after execution thereof, stayed or bonded pending appeal, or such judgments are not discharged prior to the expiration of any such stay (provided that no Credit Extensions will be made prior to the satisfaction, payment, discharge, stay, or bonding of such fine, penalty, judgment, order or decree);
8.8    Misrepresentations.  Borrower or any Person acting for Borrower makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Agent or any Lender or to induce Agent or any Lender to enter this Agreement or any Loan Document (other than the Lender Intercreditor Agreement), and such representation, warranty, or other statement is incorrect in any material respect when made;
8.9    Subordinated Debt.  Any document, instrument, or agreement evidencing the subordination of any Subordinated Debt shall for any reason be revoked or invalidated or otherwise cease to be in full force and effect, any Person shall be in breach thereof or contest in any manner the validity or enforceability thereof or deny that it has any further liability or obligation thereunder, or the Obligations shall for any reason be subordinated or shall not have the priority contemplated by this Agreement or any applicable subordination or intercreditor agreement;
8.10    Guaranty.  (a) Any guaranty of any Obligations terminates or ceases for any reason to be in full force and effect; (b) any Guarantor does not perform any obligation or covenant under any guaranty of the Obligations and such failure is not cured ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by such Guarantor be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then such Guarantor shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period); (c) any circumstance described in Sections 8.3, 8.4, 8.5, 8.6, 8.7, or 8.8 of this Agreement occurs with respect to any Guarantor, (d) the death, liquidation, winding up, or termination of existence of any Guarantor; or (e) a material impairment in the perfection or priority of Agent’s Lien in the collateral provided by Guarantor or in the value of such collateral; or
8.11    Governmental Approvals.  Any Governmental Approval (other than with respect to Governmental Approvals related to Borrower’s products in the ordinary course of business) shall have been (a) revoked, rescinded, suspended, modified in an adverse manner or not renewed in the ordinary course for a full term or (b) subject to any decision by a Governmental Authority that designates a hearing with respect to any applications for renewal of any of such Governmental Approval or that could result in the Governmental Authority taking any of the actions described in clause (a) above, and such decision or such revocation, rescission, suspension, 
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modification or non-renewal (i) causes, or could reasonably be expected to cause, a Material Adverse Change, or (ii)  adversely affects the legal qualifications of Borrower or any of its Subsidiaries to hold such Governmental Approval in any applicable jurisdiction and such revocation, rescission, suspension, modification or non-renewal could reasonably be expected to materially and adversely affect the status of or legal qualifications of Borrower or any of its Subsidiaries to hold any Governmental Approval in any other jurisdiction.
9    RIGHTS AND REMEDIES
9.1    Rights and Remedies.  Upon the occurrence and during the continuance of an Event of Default, Agent, as directed by Lenders in accordance with the Lender Intercreditor Agreement or, if such rights and remedies are not addressed in the Lender Intercreditor Agreement, as directed by Lenders having a majority of the Obligations, may, without notice or demand, do any or all of the following:
(a)    declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations are immediately due and payable without any action by Agent or any Lender);
(b)    stop advancing money or extending credit for Borrower’s benefit under this Agreement or under any other agreement among Borrower, Agent and/or any Lenders;
(c)    demand that Borrower (i) deposit cash with SVB in an amount equal to at least (x) one hundred five percent (105.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in Dollars remaining undrawn, and (y) one hundred ten percent (110.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in a Foreign Currency remaining undrawn (plus, in each case, all interest, fees, and costs due or to become due in connection therewith (as estimated by SVB in its good faith business judgment)), to secure all of the Obligations relating to such Letters of Credit, as collateral security for the repayment of any future drawings under such Letters of Credit, and Borrower shall forthwith deposit and pay such amounts, and (ii) pay in advance all letter of credit fees scheduled to be paid or payable over the remaining term of any Letters of Credit;
(d)    terminate any FX Contracts;
(e)    verify the amount of, demand payment of and performance under, and collect any Accounts and General Intangibles, settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Agent and/or the Lenders consider advisable, and notify any Person owing Borrower money of Agent’s security interest in such funds. Borrower shall collect all payments in trust for Lenders and, if requested by Agent, immediately deliver the payments to Lenders in the form received from the Account Debtor, with proper endorsements for deposit;
(f)    make any payments and do any acts Agent or any Lender considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral.  Borrower shall assemble the Collateral if Agent requests and make it available as Agent designates.  Agent may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest or charges and pay all expenses incurred. Borrower grants Agent a license to enter and occupy any of its premises, without charge, to exercise any of Agent’s rights or remedies;
(g)    apply to the Obligations (i) any balances and deposits of Borrower it holds, or (ii) any amount held by Agent owing to or for the credit or the account of Borrower;
(h)    ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral.  Agent, for the benefit of the Lenders, is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s labels, Patents, Copyrights, mask works, rights of use of any name, trade secrets, trade names, Trademarks, and advertising matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with 
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Agent’s exercise of its rights under this Section 9.1, Borrower’s rights under all licenses and all franchise agreements inure to Agent, for the ratable benefit of the Lenders;
(i)    place a “hold” on any account maintained with Agent or Lenders and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;
(j)    demand and receive possession of Borrower’s Books; and
(k)    exercise all rights and remedies available to Agent and the Lenders under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).
9.2    Power of Attorney.  Borrower hereby irrevocably appoints Agent, for the benefit of the Lenders, as its lawful attorney-in-fact, exercisable following the occurrence and during the continuation of an Event of Default, to: (a) endorse Borrower’s name on any checks, payment instruments, or other forms of payment or security; (b) sign Borrower’s name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) demand, collect, sue, and give releases to any Account Debtor for monies due, settle and adjust disputes and claims about the Accounts directly with Account Debtors, and compromise, prosecute, or defend any action, claim, case, or proceeding about any Collateral (including filing a claim or voting a claim in any bankruptcy case in Agent’s or Borrower’s name, as Agent chooses) for amounts and on terms Agent determines reasonable; (d) make, settle, and adjust all claims under Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Agent or a third party as the Code permits. Borrower hereby appoints Agent as its lawful attorney-in-fact to sign Borrower’s name on any documents necessary to perfect or continue the perfection of Agent’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations have been satisfied in full and the Loan Documents (other than the Lender Intercreditor Agreement) have been terminated. Agent’s foregoing appointment as Borrower’s attorney in fact, and all of Agent’s rights and powers, coupled with an interest, are irrevocable until all Obligations have been fully repaid and performed and the Loan Documents (other than the Lender Intercreditor Agreement) have been terminated.
9.3    Protective Payments.  If Borrower fails to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower is obligated to pay under this Agreement or any other Loan Document or which may be required to preserve the Collateral, Agent may obtain such insurance or make such payment, and all amounts so paid by Agent are Lenders’ Expenses and immediately due and payable, bearing interest at the then highest rate applicable to the Obligations, and secured by the Collateral. Agent will make reasonable efforts to provide Borrower with notice of Agent obtaining such insurance at the time it is obtained or within a reasonable time thereafter. No payments by Agent are deemed an agreement to make similar payments in the future or Agent’s or and Lenders’ waiver of any Event of Default.
9.4    Application of Payments and Proceeds.  Agent shall have the right to apply in any order any funds in its possession, whether from Borrower account balances, payments, proceeds realized as the result of any collection of Accounts or other disposition of the Collateral, or otherwise, to the Obligations. Agent shall pay any surplus to Borrower by credit to the Designated Deposit Account or to other Persons legally entitled thereto; Borrower shall remain liable to Agent and the Lenders for any deficiency. If Agent, directly or indirectly, enters into a deferred payment or other credit transaction with any purchaser at any sale of Collateral, Agent shall have the option, exercisable at any time, of either reducing the Obligations by the principal amount of the purchase price or deferring the reduction of the Obligations until the actual receipt by Agent of cash therefor.
9.5    Liability for Collateral.  So long as Agent and Lenders comply with reasonable banking practices regarding the safekeeping of the Collateral in their possession or under the control of Agent and/or Lenders, Agent and Lenders shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Borrower bears all risk of loss, damage or destruction of the Collateral.
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9.6    No Waiver; Remedies Cumulative.  Agent’s and any Lender’s failure, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Agent or any Lender thereafter to demand strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by the party granting the waiver and then is only effective for the specific instance and purpose for which it is given. Agent’s and each Lender’s rights and remedies under this Agreement and the other Loan Documents are cumulative. Agent and each Lender have all rights and remedies provided under the Code, by law, or in equity. Agent’s or any Lender’s exercise of one right or remedy is not an election and shall not preclude Agent or any Lender from exercising any other remedy under this Agreement or any other Loan Document or other remedy available at law or in equity, and Agent’s or any Lender’s waiver of any Event of Default is not a continuing waiver. Agent’s or any Lender’s delay in exercising any remedy is not a waiver, election, or acquiescence.  
9.7    Demand Waiver.  Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Agent on which Borrower is liable.
10    AGENT 
10.1    Appointment and Authority.
(a)    Each Lender hereby irrevocably appoints SVB to act on its behalf as Agent hereunder and under the other Loan Documents and authorizes Agent to take such actions on its behalf and to exercise such powers as are delegated to Agent by the terms hereof or thereof, together with such actions and powers as are reasonably incidental thereto.
(b)    The provisions of this Section 10 are solely for the benefit of Agent and Lenders, and Borrower shall not have rights as a third party beneficiary of any of such provisions.  Notwithstanding any provision to the contrary elsewhere in this Agreement, Agent shall not have any duties or responsibilities to any Lender or any other Person, except those expressly set forth herein, or any fiduciary relationship with any Lender, and no implied covenants, functions, responsibilities, duties, obligations or liabilities shall be read into this Agreement or any other Loan Document or otherwise exist against Agent.
10.2    Delegation of Duties.  Agent may perform any and all of its duties and exercise its rights and powers hereunder or under any other Loan Document by or through any one or more sub-agents appointed by Agent.  Agent and any such sub-agent may perform any and all of its duties and exercise its rights and powers by or through their respective Indemnified Persons.  The exculpatory provisions of this Section 10.2 shall apply to any such sub-agent and to the Indemnified Persons of Agent and any such sub-agent, and shall apply to their respective activities in connection with the syndication of the credit facilities provided for herein as well as activities as Agent.
10.3      Exculpatory Provisions.  Agent shall have no duties or obligations except those expressly set forth herein and in the other Loan Documents.  Without limiting the generality of the foregoing, Agent shall not:
(a)    be subject to any fiduciary, trust, agency or other similar duties, regardless of whether any Event of Default has occurred and is continuing;
(b)    have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and powers expressly contemplated hereby or by the other Loan Documents that Agent is required to exercise as directed in writing by the Lenders, as applicable; provided that Agent shall not be required to take any action that, in its opinion or the opinion of its counsel, may expose Agent to liability or that is contrary to any Loan Document or applicable law; and
(c)    except as expressly set forth herein and in the other Loan Documents, have any duty to disclose, and Agent shall not be liable for the failure to disclose, any information relating to Borrower or any of its Affiliates that is communicated to or obtained by any Person serving as Agent or any of its Affiliates in any capacity.
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Agent shall not be liable for any action taken or not taken by it (i) with the consent or at the request of the Lenders (or as Agent shall believe in good faith shall be necessary, under the circumstances as provided in Section 13.7) or (ii) in the absence of its own gross negligence or willful misconduct.
Agent shall not be responsible for or have any duty to ascertain or inquire into (i) any statement, warranty or representation made in or in connection with this Agreement or any other Loan Document, (ii) the contents of any certificate, report or other document delivered hereunder or thereunder or in connection herewith or therewith, (iii) the performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the occurrence of any Event of Default, (iv) the validity, enforceability, effectiveness or genuineness of this Agreement, any other Loan Document or any other agreement, instrument or document or (v) the satisfaction of any condition set forth in Section 3 or elsewhere herein, other than to confirm receipt of items expressly required to be delivered to Agent.

10.4     Reliance by Agent.  Agent shall be entitled to rely upon, and shall not incur any liability for relying upon, any notice, request, certificate, consent, statement, instrument, document or other writing (including any electronic message, internet or intranet website posting or other distribution) believed by it to be genuine and to have been signed, sent or otherwise authenticated by the proper Person.  Agent also may rely upon any statement made to it orally or by telephone and believed by it to have been made by the proper Person, and shall not incur any liability for relying thereon.  Agent may consult with legal counsel (who may be counsel for Borrower), independent accountants and other experts selected by it, and shall not be liable for any action taken or not taken by it in accordance with the advice of any such counsel, accountants or experts.  In determining compliance with any condition hereunder to the making of a Credit Extension that, by its terms, must be fulfilled to the satisfaction of a Lender, Agent may presume that such condition is satisfactory to such Lender unless Agent shall have received notice to the contrary from such Lender prior to the making of such Credit Extension.  Agent shall in all cases be fully protected in acting, or in refraining from acting, under this Agreement and the other Loan Documents in accordance with a request of the Lenders, and such request and any action taken or failure to act pursuant thereto shall be binding upon Lenders and all future holders of the Credit Extensions.
10.5     Notice of Default.  Agent shall not be deemed to have knowledge or notice of the occurrence of any Event of Default (except with respect to defaults in the payment of principal, interest or fees required to be paid to Agent for the account of Lenders), unless Agent has received notice from a Lender or Borrower referring to this Agreement, describing such Event of Default and stating that such notice is a “notice of default”.  In the event that Agent receives such a notice, Agent shall give notice thereof to Lenders.  Agent shall take such action with respect to such Event of Default as shall be reasonably directed by the Lenders.
10.6     Non-Reliance on Agent and Other Lenders.  Each Lender expressly acknowledges that neither Agent nor any of its officers, directors, employees, agents, attorneys in fact or affiliates has made any representations or warranties to it and that no act by Agent hereafter taken, including any review of the affairs of a Group Member or any Affiliate of a Group Member, shall be deemed to constitute any representation or warranty by Agent to any Lender.  Each Lender represents to Agent that it has, independently and without reliance upon Agent or any other Lender, and based on such documents and information as it has deemed appropriate, made its own appraisal of, and investigation into, the business, operations, property, financial and other condition and creditworthiness of the Group Members and their Affiliates and made its own decision to make its Credit Extensions hereunder and enter into this Agreement.  Each Lender also represents that it will, independently and without reliance upon Agent or any other Lender, and based on such documents and information as it shall deem appropriate at the time, continue to make its own credit analysis, appraisals and decisions in taking or not taking action under this Agreement and the other Loan Documents, and to make such investigation as it deems necessary to inform itself as to the business, operations, property, financial and other condition and creditworthiness of the Group Members and their Affiliates.  Except for notices, reports and other documents expressly required to be furnished to Lenders by Agent hereunder, Agent shall have no duty or responsibility to provide any Lender with any credit or other information concerning the business, operations, property, condition (financial or otherwise), prospects or creditworthiness of any Group Member or any Affiliate of a Group Member that may come into the possession of Agent or any of its officers, directors, employees, agents, attorneys in fact or Affiliates.
10.7    Indemnification.  Each Lender agrees to indemnify Agent in its capacity as such (to the extent not reimbursed by Borrower and without limiting the obligation of Borrower to do so in accordance with the terms 
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hereof), according to its Term Loan Commitment Percentage in effect on the date on which indemnification is sought under this Section 10.7 (or, if indemnification is sought after the date upon which the Commitments shall have terminated and the Obligations shall have been paid in full, in accordance with its Term Loan Commitment Percentage immediately prior to such date), from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements of any kind whatsoever that may at any time (whether before or after the payment of the Credit Extensions) be imposed on, incurred by or asserted against Agent in any way relating to or arising out of, the Commitments, this Agreement, any of the other Loan Documents or any documents contemplated by or referred to herein or therein or the transactions contemplated hereby or thereby or any action taken or omitted by Agent under or in connection with any of the foregoing; provided that no Lender shall be liable for the payment of any portion of such liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements that are found by a final and nonappealable decision of a court of competent jurisdiction to have resulted primarily from Agent’s gross negligence or willful misconduct.  The agreements in this Section shall survive the payment of the Credit Extensions and all other amounts payable hereunder.
10.8    Agent in Its Individual Capacity.  The Person serving as Agent hereunder shall have the same rights and powers in its capacity as a Lender as any other Lender and may exercise the same as though it were not Agent and the term “Lender” or “Lenders” shall, unless otherwise expressly indicated or unless the context otherwise requires, include each such Person serving as Agent hereunder in its individual capacity.  Such Person and its Affiliates may accept deposits from, lend money to, act as the financial advisor or in any other advisory capacity for and generally engage in any kind of business with Borrower, any Guarantor or any Subsidiary or other Affiliate thereof as if such Person were not Agent hereunder and without any duty to account therefor to Lenders.
10.9      Successor Agent.  Agent may at any time give notice of its resignation to Lenders and Borrower, which resignation shall not be effective until the time at which the majority of the Lenders have delivered to Agent their written consent to such resignation.  Upon receipt of any such notice of resignation, the Lenders shall have the right, in consultation with Borrower, to appoint a successor, which shall be a financial institution with an office in the State of California, or an Affiliate of any such bank with an office in the State of California.  If no such successor shall have been so appointed by the Lenders and shall have accepted such appointment within thirty (30) days after the retiring Agent has received the written consent of the majority of the Lenders to such resignation, then the retiring Agent may on behalf of Lenders, appoint a successor Agent meeting the qualifications set forth above; provided that in no event shall any such successor Agent be a Defaulting Lender and provided further that if the retiring Agent shall notify Borrower and Lenders that no qualifying Person has accepted such appointment, then such resignation shall nonetheless become effective in accordance with such notice and (1) the retiring Agent shall be discharged from its duties and obligations hereunder and under the other Loan Documents (except that in the case of any collateral security held by Agent on behalf of the Lenders under any of the Loan Documents, the retiring Agent shall continue to hold such collateral security until such time as a successor Agent is appointed and such collateral security is assigned to such successor Agent) and (2) all payments, communications and determinations provided to be made by, to or through Agent shall instead be made by or to each Lender directly, until such time as the Lenders appoint a successor Agent as provided for above in this Section 10.9.  Upon the acceptance of a successor’s appointment as Agent hereunder, such successor shall succeed to and become vested with all of the rights, powers, privileges and duties of the retiring (or retired) Agent, and the retiring Agent shall be discharged from all of its duties and obligations hereunder or under the other Loan Documents (if not already discharged therefrom as provided above in this Section 10.9).  The fees payable by Borrower to a successor Agent shall be the same as those payable to its predecessor unless otherwise agreed between Borrower and such successor.  After the retiring Agent’s resignation hereunder and under the other Loan Documents, the provisions of this Section 10 shall continue in effect for the benefit of such retiring Agent, its sub-agents and their respective Indemnified Persons in respect of any actions taken or omitted to be taken by any of them while the retiring Agent was acting as Agent.
10.10    Defaulting Lender.  
(a)    Defaulting Lender Adjustments.  Notwithstanding anything to the contrary contained in this Agreement, if any Lender becomes a Defaulting Lender, then, until such time as such Lender is no longer a Defaulting Lender, to the extent permitted by applicable law:
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(i)    Waivers and Amendments.  Such Defaulting Lender’s right to approve or disapprove any amendment, waiver or consent with respect to this Agreement shall be restricted as long as said Lender is a Defaulting Lender.
(ii)    Defaulting Lender Waterfall.  Any payment of principal, interest, fees or other amounts received by the Agent for the account of such Defaulting Lender (whether voluntary or mandatory, at maturity, pursuant to Section 8 or otherwise, and including any amounts made available to the Agent by such Defaulting Lender pursuant to Section 13.10), shall be applied at such time or times as may be determined by the Agent as follows: first, to the payment of any amounts owing by such Defaulting Lender to the Agent hereunder; second, as Borrower may request (so long as no Event of Default exists), to the funding of any Term Loan Advance in respect of which such Defaulting Lender has failed to fund its portion thereof as required by this Agreement, as determined by the Agent; third, if so determined by the Agent and Borrower, to be held in a Deposit Account and released pro rata to satisfy such Defaulting Lender’s potential future funding obligations with respect to Term Loan Advance under this Agreement; fourth, so long as no Event of Default has occurred and is continuing, to the payment of any amounts owing to Borrower as a result of any judgment of a court of competent jurisdiction obtained by Borrower against such Defaulting Lender as a result of such Defaulting Lender’s breach of its obligations under this Agreement; and fifth, to such Defaulting Lender or as otherwise directed by a court of competent jurisdiction; provided that if (A) such payment is a payment of the principal amount of any Term Loan Advance in respect of which such Defaulting Lender has not fully funded its appropriate share and (B) such Term Loan Advance was made at a time when the conditions set forth in Section 3.1 were satisfied or waived, such payment shall be applied solely to pay the Term Loan Advance of all non-Defaulting Lenders on a pro rata basis prior to being applied to the payment of any Term Loan Advance of such Defaulting Lender until such time as the Term Loan Advance is held by the Lenders pro rata in accordance with the Term Loan Commitments under this Agreement.  Any payments, prepayments or other amounts paid or payable to a Defaulting Lender that are applied (or held) to pay amounts owed by a Defaulting Lender pursuant to this Section 10.10(a)(ii) shall be deemed paid to and redirected by such Defaulting Lender, and each Lender irrevocably consents hereto.
(iii)    Certain Fees.  No Defaulting Lender shall be entitled to receive any fee pursuant to Section 2.3(b) or Section 2.3(c) for any period during which such Lender is a Defaulting Lender (and Borrower shall not be required to pay any such fee that otherwise would have been required to have been paid to such Defaulting Lender).  
(b)    Defaulting Lender Cure.  If Borrower and Agent agree in writing that a Lender is no longer a Defaulting Lender, Agent will so notify the parties hereto, whereupon as of the effective date specified in such notice and subject to any conditions set forth therein, such Lender will, to the extent applicable, purchase at par that portion of outstanding Term Loan Advance of the other Lenders or take such other actions as Agent may determine to be necessary to cause the Term Loan Advance to be held on a pro rata basis by the Lenders in accordance with their respective Term Loan Commitment Percentages, whereupon such Lender will cease to be a Defaulting Lender; provided that no adjustments will be made retroactively with respect to fees accrued or payments made by or on behalf of Borrower while such Lender was a Defaulting Lender; and provided further that, except to the extent otherwise expressly agreed by the affected parties, no change hereunder from Defaulting Lender to Lender will constitute a waiver or release of any claim of any party hereunder arising from such Lender having been a Defaulting Lender. 
(c)    Termination of Defaulting Lender.  Borrower may terminate the unused amount of the Term Loan Commitment of any Lender that is a Defaulting Lender upon not less than ten (10) Business Days’ prior notice to Agent (which shall promptly notify the Lenders thereof), and in such event the provisions of Section 10.10(a)(ii) will apply to all amounts thereafter paid by Borrower for the account of such Defaulting Lender under this Agreement (whether on account of principal, interest, fees, indemnity or other amounts); provided that (i) no Event of Default shall have occurred and be continuing, and (ii) such termination shall not be deemed to be a waiver or release of any claim Borrower, Agent or any Lender may have against such Defaulting Lender.

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(d)    If the Person serving as Agent is a Defaulting Lender pursuant to clause (d) of the definition thereof, the non-Defaulting Lenders may, to the extent permitted by applicable law, by notice in writing to Borrower and such Person, remove such Person as Agent and, in consultation with Borrower, appoint a successor.  If no such successor shall have been so appointed by the non-Defaulting Lenders and shall have accepted such appointment within thirty (30) days (or such earlier day as shall be agreed by the non-Defaulting Lenders) (the “Removal Effective Date”), then such removal shall nonetheless become effective in accordance with such notice on the Removal Effective Date.
11    NOTICES
All notices, consents, requests, approvals, demands, or other communication by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by electronic mail; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, or email address indicated below. Agent or Borrower may change its mailing or electronic mail address by giving the other party written notice thereof in accordance with the terms of this Section 11. 
									
	If to Borrower:	Axonics Modulation Technologies, Inc.
26 Technology Drive
Irvine, CA 92618
Attn:     Raymond Cohen, Chief Executive Officer

			
	If to Agent or SVB:	Silicon Valley Bank 
4370 La Jolla Village Drive, Suite 1050, 
San Diego, CA 92122
Attn:    Milo Bissin, Director

			
	with a copy to:	DLA Piper LLP (US)401 B Street, Suite 1700
San Diego, CA 92101
Attn:  Matt Schwartz

			
	If to SVB Capital:
	SVB Innovation Credit Fund VIII, L.P.
c/o SVB Capital
2770 Sand Hill Road
Menlo Park, CA 94025
Attn: SVB Capital Finance and Operations

        
12    CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER AND JUDICIAL REFERENCE
Except as otherwise expressly provided in any of the Loan Documents, California law governs the Loan Documents without regard to principles of conflicts of law.  Except to the extent otherwise set forth in the Loan Documents, Borrower, Agent and Lenders each submit to the exclusive jurisdiction of the State and Federal courts in Santa Clara County, California; provided, however, that nothing in this Agreement shall be deemed to operate to 
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preclude Agent or Lenders from bringing suit or taking other legal action in any other jurisdiction to realize on the Collateral or any other security for the Obligations, or to enforce a judgment or other court order in favor of Agent or any Lender.  Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any such court, and Borrower hereby waives any objection that it may have based upon lack of personal jurisdiction, improper venue, or forum non conveniens and hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court.  Borrower hereby waives personal service of the summons, complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 11 of this Agreement and that service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or three (3) days after deposit in the U.S. mails, proper postage prepaid.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER, AGENT AND EACH LENDER EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR ALL PARTIES TO ENTER INTO THIS AGREEMENT.  EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.
WITHOUT INTENDING IN ANY WAY TO LIMIT THE PARTIES’ AGREEMENT TO WAIVE THEIR RESPECTIVE RIGHT TO A TRIAL BY JURY, if the above waiver of the right to a trial by jury is not enforceable, the parties hereto agree that any and all disputes or controversies of any nature between them arising at any time shall be decided by a reference to a private judge, mutually selected by the parties (or, if they cannot agree, by the Presiding Judge of the Santa Clara County, California Superior Court) appointed in accordance with California Code of Civil Procedure Section 638 (or pursuant to comparable provisions of federal law if the dispute falls within the exclusive jurisdiction of the federal courts), sitting without a jury, in Santa Clara County, California; and the parties hereby submit to the jurisdiction of such court.  The reference proceedings shall be conducted pursuant to and in accordance with the provisions of California Code of Civil Procedure Sections 638 through 645.1, inclusive.  The private judge shall have the power, among others, to grant provisional relief, including without limitation, entering temporary restraining orders, issuing preliminary and permanent injunctions and appointing receivers.  All such proceedings shall be closed to the public and confidential and all records relating thereto shall be permanently sealed.  If during the course of any dispute, a party desires to seek provisional relief, but a judge has not been appointed at that point pursuant to the judicial reference procedures, then such party may apply to the Santa Clara County, California Superior Court for such relief.  The proceeding before the private judge shall be conducted in the same manner as it would be before a court under the rules of evidence applicable to judicial proceedings.  The parties shall be entitled to discovery which shall be conducted in the same manner as it would be before a court under the rules of discovery applicable to judicial proceedings.  The private judge shall oversee discovery and may enforce all discovery rules and orders applicable to judicial proceedings in the same manner as a trial court judge.  The parties agree that the selected or appointed private judge shall have the power to decide all issues in the action or proceeding, whether of fact or of law, and shall report a statement of decision thereon pursuant to California Code of Civil Procedure Section 644(a).  Nothing in this paragraph shall limit the right of any party at any time to exercise self-help remedies, foreclose against collateral, or obtain provisional remedies.  The private judge shall also determine all issues relating to the applicability, interpretation, and enforceability of this paragraph.
This Section 12 shall survive the termination of this Agreement.
13    GENERAL PROVISIONS
13.1    Termination Prior to Term Loan Maturity Date; Survival.  All covenants, representations and warranties made in this Agreement continue in full force until this Agreement has terminated pursuant to its terms and all Obligations have been satisfied.  So long as Borrower has satisfied the Obligations (other than inchoate indemnity obligations, any other obligations which, by their terms, are to survive the termination of this Agreement, and any Obligations under Bank Services Agreements that are cash collateralized in accordance with Section 4.1 of this Agreement), this Agreement may be terminated prior to the Term Loan Maturity Date by Borrower, effective 
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upon written notice of termination is given to Agent.  Those obligations that are expressly specified in this Agreement as surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s termination.  No termination of this Agreement shall in any way affect or impair any right or remedy of Agent or any Lender, nor shall any such termination relieve Borrower of any Obligation to any Lender, until all of the Obligations have been paid and performed in full. Those Obligations that are expressly specified in this Agreement as surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s termination and payment in full of the Obligations then outstanding. 
13.2    Successors and Assigns.  This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not assign this Agreement or any rights or obligations under it without Agent and Lenders’ prior written consent (which may be granted or withheld in Agent’s and Lenders’ sole discretion). Agent and each Lender has the right, without the consent of or notice to Borrower, to sell, transfer, assign, negotiate, or grant participation in all or any part of, or any interest in, such Lender’s obligations, rights, and benefits under this Agreement and the other Loan Documents.
13.3    Indemnification.  Borrower agrees to indemnify, defend and hold Agent, each Lender and their respective directors, officers, employees, agents, attorneys, or any other Person affiliated with or representing Agent or any Lender (each, an “Indemnified Person”) harmless against: (i) all obligations, demands, claims, and liabilities (collectively, “Claims”) claimed or asserted by any other party in connection with the transactions contemplated by the Loan Documents (other than the Lender Intercreditor Agreement); and (ii) all losses or expenses (including Lenders’ Expenses) in any way suffered, incurred, or paid by such Indemnified Person as a result of, following from, consequential to, or arising from transactions between Agent, Lenders and Borrower (including reasonable attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct.  This Section 13.3 shall survive until all statutes of limitation with respect to the Claims, losses, and expenses for which indemnity is given shall have run.
13.4    Time of Essence.  Time is of the essence for the performance of all Obligations in this Agreement.
13.5    Severability of Provisions.  Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.
13.6    Correction of Loan Documents.  Agent may correct patent errors and fill in any blanks in the Loan Documents consistent with the agreement of the parties.
13.7    Amendments in Writing; Waiver; Integration.  No purported amendment or modification of any Loan Document, or waiver, discharge or termination of any obligation under any Loan Document, or release, or subordinate Lenders’ security interest in, or consent to the transfer of, any Collateral shall be enforceable or admissible unless, and only to the extent, expressly set forth in a writing signed by Agent, with the consent of the Lenders in accordance with the Lender Intercreditor Agreement or, if such item is not addressed in the Lender Intercreditor Agreement, as consented to by Lenders holding a majority of the Term Loan, and Borrower.  Without limiting the generality of the foregoing, no oral promise or statement, nor any action, inaction, delay, failure to require performance or course of conduct shall operate as, or evidence, an amendment, supplement or waiver or have any other effect on any Loan Document.  Any waiver granted shall be limited to the specific circumstance expressly described in it, and shall not apply to any subsequent or other circumstance, whether similar or dissimilar, or give rise to, or evidence, any obligation or commitment to grant any further waiver.  The Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements.  All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of the Loan Documents merge into the Loan Documents.  In the event any provision of any other Loan Document is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall exclusively control.
13.8    Counterparts.  This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

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13.9    Confidentiality.  Agent and each Lender agrees to maintain the confidentiality of Information (as defined below), except that Information may be disclosed (a) to Agent and/or any Lender’s subsidiaries or Affiliates, and their respective employees, directors, investors, potential investors, agents, attorneys, accountants and other professional advisors (collectively, “Representatives” and, together with Agent and the Lenders, collectively, “Lender Entities”); (b) to prospective transferees, assignees, credit providers or purchasers of any of Agent’s or Lenders’ interests under or in connection with this Agreement and their Representatives (provided, however, Agent and the Lenders shall use their best efforts to obtain any such prospective transferee’s, assignee’s, credit provider’s, or purchaser’s or their Representatives’ agreement to the terms of this provision); (c) as required by law, regulation, subpoena, or other order; (d) to Agent’s or any Lender’s regulators or as otherwise required in connection with Agent’s or any Lender’s examination or audit; (e) as Agent or any Lender considers appropriate in exercising remedies under the Loan Documents; and (f) to third-party service providers of Agent and/or any Lender so long as such service providers have executed a confidentiality agreement with Agent or the Lenders, as applicable, with terms no less restrictive than those contained herein.  The term “Information” means all information received from Borrower regarding Borrower or its business, in each case other than information that is either: (i) in the public domain or in Agent’s or any Lender’s possession when disclosed to Agent or such Lender, or becomes part of the public domain (other than as a result of its disclosure by Agent or a Lender in violation of this Agreement) after disclosure to Agent and/or the Lenders; or (ii) disclosed to Agent and/or a Lender by a third party, if Agent or such Lender, as applicable, does not know that the third party is prohibited from disclosing the information.
13.10    Attorneys’ Fees, Costs and Expenses.  In any action or proceeding among Borrower, Lender, and/or Agent arising out of or relating to the Loan Documents, the prevailing party shall be entitled to recover its reasonable attorneys’ fees and other costs and expenses incurred, in addition to any other relief to which it may be entitled.
13.11    Right of Setoff.   Borrower hereby grants to Agent, for the ratable benefit of the Lenders, a Lien, security interest, and a right of setoff as security for all Obligations to Agent and the Lenders, whether now existing or hereafter arising upon and against all deposits, credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Agent or any entity under the control of Agent (including a subsidiary of Agent) or in transit to any of them.  At any time after the occurrence and during the continuance of an Event of Default, without demand or notice, Agent or any Lender may setoff the same or any part thereof and apply the same to any Obligation of Borrower then due regardless of the adequacy of any other collateral securing the Obligations.  ANY AND ALL RIGHTS TO REQUIRE AGENT OR ANY LENDER TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER, ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED.
13.12    Electronic Execution of Documents.  The words “execution,” “signed,” “signature” and words of like import in any Loan Document shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which shall be of the same legal effect, validity and enforceability as a manually executed signature or the use of a paper-based recordkeeping systems, as the case may be, to the extent and as provided for in any applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act.
13.13    Captions.  The headings used in this Agreement are for convenience only and shall not affect the interpretation of this Agreement.
13.14    Construction of Agreement.  The parties mutually acknowledge that they and their attorneys have participated in the preparation and negotiation of this Agreement.  In cases of uncertainty this Agreement shall be construed without regard to which of the parties caused the uncertainty to exist.
13.15    Relationship.  The relationship of the parties to this Agreement is determined solely by the provisions of this Agreement.  The parties do not intend to create any agency, partnership, joint venture, trust, fiduciary or other relationship with duties or incidents different from those of parties to an arm’s-length contract.
13.16    Third Parties.  Nothing in this Agreement, whether express or implied, is intended to: (a) confer any benefits, rights or remedies under or by reason of this Agreement on any persons other than the express parties 
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to it and their respective permitted successors and assigns; (b) relieve or discharge the obligation or liability of any person not an express party to this Agreement; or (c) give any person not an express party to this Agreement any right of subrogation or action against any party to this Agreement.
13.17    Patriot Act.  Each Lender hereby notifies Borrower that pursuant to the requirements of the USA PATRIOT Act, it is required to obtain, verify and record information that identifies Borrower and each of its Subsidiaries, which information includes the names and addresses of Borrower and each of its Subsidiaries and other information that will allow Lender, as applicable, to identify Borrower and each of its Subsidiaries in accordance with the USA PATRIOT Act.
14    DEFINITIONS
14.1    Definitions.  As used in the Loan Documents, the word “shall” is mandatory, the word “may” is permissive, the word “or” is not exclusive, the words “includes” and “including” are not limiting, the singular includes the plural, and numbers denoting amounts that are set off in brackets are negative.  As used in this Agreement, the following capitalized terms have the following meanings:
“Account” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.
“Account Debtor” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made.
“Affiliate” is, with respect to any Person, each other Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person’s managers and members.
“Agent” is defined in the preamble hereof. 
“Agreement” is defined in the preamble hereof.
“Authorized Signer” is any individual listed in Borrower’s Borrowing Resolution who is authorized to execute the Loan Documents to which Borrower is party, including any Credit Extension request, on behalf of Borrower.
“Axonics UK” is Axonics Modulation Technologies, UK Limited, a company incorporated in England and Wales with registered number 10166891 whose registered office is at 14 Took's Court, London, England, EC4A 1LB and a wholly owned Subsidiary of Borrower.
“Bank Services”  are any products, credit services, and/or financial accommodations previously, now, or hereafter provided to Borrower or any of its Subsidiaries by SVB or any SVB Affiliate, including, without limitation, any Letters of Credit, cash management services (including, without limitation, merchant services, direct deposit of payroll, business credit cards, and check cashing services), interest rate swap arrangements, and foreign exchange services as any such products or services may be identified in SVB’s various agreements related thereto (each, a “Bank Services Agreement”).
“Bank Services Agreement” is defined in the definition of Bank Services.
“Board” means Borrower’s board of directors.
“Borrower” is defined in the preamble hereof.

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“Borrower’s Books” are all Borrower’s books and records including ledgers, federal and state tax returns, records regarding Borrower’s assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.
“Borrowing Resolutions” are, with respect to any Person, those resolutions adopted by such Person’s board of directors (and, if required under the terms of such Person’s Operating Documents, stockholders) and delivered by such Person to Agent approving the Loan Documents to which such Person is a party and the transactions contemplated thereby, together with a certificate executed by its secretary on behalf of such Person certifying (a) such Person has the authority to execute, deliver, and perform its obligations under each of the Loan Documents to which it is a party, (b) that set forth as a part of or attached as an exhibit to such certificate is a true, correct, and complete copy of the resolutions then in full force and effect authorizing and ratifying the execution, delivery, and performance by such Person of the Loan Documents to which it is a party, (c) the name(s) of the Person(s) authorized to execute the Loan Documents, including any Credit Extension request, on behalf of such Person, together with a sample of the true signature(s) of such Person(s), and (d) that Agent and Lenders may conclusively rely on such certificate unless and until such Person shall have delivered to Agent and Lenders a further certificate canceling or amending such prior certificate.
“Business Day” is any day that is not a Saturday, Sunday or a day on which Agent is closed.
“Cash Equivalents” means (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc.; (c) SVB’s certificates of deposit issued maturing no more than one (1) year after issue; and (d) money market funds at least ninety-five percent (95%) of the assets of which constitute Cash Equivalents of the kinds described in clauses (a) through (c) of this definition.
“Change in Control” means (a) at any time, any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Exchange Act), shall become, or obtain rights (whether by means of warrants, options or otherwise) to become, the “beneficial owner” (as defined in Rules 13(d)-3 and 13(d)5 under the Exchange Act), directly or indirectly, of forty-nine percent (49%) or more of the ordinary voting power for the election of directors of Borrower (determined on a fully diluted basis) other than by the sale of Borrower’s equity securities in a public offering or to venture capital or private equity investors so long as Borrower identifies to the Agent and the Lenders the venture capital or private equity investors at least seven (7) Business Days prior to the closing of the transaction and provides to Agent and the Lenders a description of the material terms of the transaction; (b) during any period of twelve (12) consecutive months, a majority of the members of the board of directors or other equivalent governing body of Borrower cease to be composed of individuals (i) who were members of that board or equivalent governing body on the first day of such period, (ii) whose election or nomination to that board or equivalent governing body was approved by individuals referred to in clause (i) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body or (iii) whose election or nomination to that board or other equivalent governing body was approved by individuals referred to in clauses (i) and (ii) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body; provided, that such clause (b) shall not be triggered by the change in persons appointed to the board of directors by an entity with the right to appoint a designee to the board of directors; or (c) at any time, Borrower shall cease to own and control, of record and beneficially, directly or indirectly, one hundred percent (100.0%) of each class of outstanding capital stock of each Subsidiary of Borrower free and clear of all Liens (except Liens created by this Agreement).
“Claims” is defined in Section 13.3.
“Code” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the State of California; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Agent’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of California, the term “Code” shall mean the Uniform Commercial Code as enacted and in effect in such other 
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jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.
“Collateral” is any and all properties, rights and assets of Borrower described on Exhibit A.
“Collateral Account” is any Deposit Account, Securities Account, or Commodity Account.
“Commitment” and “Commitments” means the Term Loan Commitment(s).
“Commodity Account” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made.
“Compliance Statement” is that certain statement in the form attached hereto as Exhibit B.
“Contingent Obligation” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation, in each case, directly or indirectly guaranteed, endorsed, comade, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn Letters of Credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business.  The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.
“Control Agreement” is any control agreement entered into among the depository institution at which Borrower maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower maintains a Securities Account or a Commodity Account, Borrower, and Agent pursuant to which Agent obtains control (within the meaning of the Code) for the benefit of the Lenders over such Deposit Account, Securities Account, or Commodity Account.
“Control Agreement Transition Period” is defined in Section 6.13(a).
“Contura Acquisition” means the acquisition by Axonics UK of the whole of the issued share capital of Contura Limited as fully set forth in the Contura Sale and Purchase Agreement.
“Contura Limited” means CONTURA LIMITED, a company incorporated in England and Wales with registered number 10166891 whose registered office is at 14 Took's Court, London, England, EC4A 1LB.
“Contura Sale and Purchase Agreement” means that certain Agreement relating to the sale and purchase of the whole of the issued share capital of Contura Limited dated as of February 25, 2021 by and among Axonics UK, Borrower and Contura Holdings Limited, a company incorporated in England and Wales.
“Copyrights” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.
“Credit Extension” is any Term Loan Advance, Letter of Credit, FX Contract, amount utilized for cash management services or any other extension of credit by any Lender for Borrower’s benefit.
“Default Rate” is defined in Section 2.2(b).
“Defaulting Lender” is, subject to Section 10.10(b), any Lender that (a) has failed to (i) fund all or any portion of its Term Loan Advance within two (2) Business Days of the date such Term Loan Advance was required 
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to be funded hereunder unless such Lender notifies Agent and Borrower in writing that such failure is the result of such Lender’s reasonable determination that one or more conditions precedent to funding (each of which conditions precedent, together with any applicable default, shall be specifically identified in such writing) has not been satisfied, or (ii) pay to Agent or any other Lender any other amount required to be paid by it hereunder within two (2) Business Days of the date when due, (b) has notified Borrower or Agent in writing that it does not intend to comply with its funding obligations hereunder, or has made a public statement to that effect (unless such writing or public statement relates to such Lender’s obligation to fund a Term Loan Advance hereunder and states that such position is based on such Lender’s reasonable determination that a condition precedent to funding (which condition precedent, together with any applicable default, shall be specifically identified in such writing or public statement) cannot be satisfied), (c) has failed, within three (3) Business Days after written request by Agent or Borrower, to confirm in writing to Agent and Borrower that it will comply with its prospective funding obligations hereunder (provided that such Lender shall cease to be a Defaulting Lender pursuant to this clause (c) upon receipt of such written confirmation by Agent and Borrower), or (d) has, or has a direct or indirect parent company that has, (i) become the subject of an Insolvency Proceeding, or (ii) had appointed for it a receiver, custodian, conservator, trustee, administrator, assignee for the benefit of creditors or similar Person charged with reorganization or liquidation of its business or assets, including the Federal Deposit Insurance Corporation or any other state or federal regulatory authority acting in such a capacity; provided that a Lender shall not be a Defaulting Lender solely by virtue of the ownership or acquisition of any equity interest in that Lender or any direct or indirect parent company thereof by a Governmental Authority so long as such ownership interest does not result in or provide such Lender with immunity from the jurisdiction of courts within the United States or from the enforcement of judgments or writs of attachment on its assets or permit such Lender (or such Governmental Authority) to reject, repudiate, disavow or disaffirm any contracts or agreements made with such Lender.  Any determination by Agent that a Lender is a Defaulting Lender under any one or more of clauses (a) through (d) above shall be conclusive and binding absent manifest error, and such Lender shall be deemed to be a Defaulting Lender (subject to Section 10.10(b)) upon delivery of written notice of such determination to Borrower and each Lender.
“Deposit Account” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.
“Designated Deposit Account” is the multicurrency account denominated in Dollars, account number xxx-xxxx-020, maintained by Borrower with SVB.
“Disbursement Letter” is that certain form attached hereto as Exhibit D. 
“Division” means, in reference to any Person which is an entity, the division of such Person into two (2) or more separate Persons, with the dividing Person either continuing or terminating its existence as part of such division, including, without limitation, as contemplated under Section 18 217 of the Delaware Limited Liability Company Act for limited liability companies formed under Delaware law, or any analogous action taken pursuant to any other applicable law with respect to any corporation, limited liability company, partnership or other entity.
“Dollar Equivalent” is, at any time, (a) with respect to any amount denominated in Dollars, such amount, and (b) with respect to any amount denominated in a Foreign Currency, the equivalent amount therefor in Dollars as determined by Agent at such time on the basis of the then-prevailing rate of exchange in San Francisco, California, for sales of the Foreign Currency for transfer to the country issuing such Foreign Currency.
“Dollars,” “dollars” or use of the sign “$” means only lawful money of the United States and not any other currency, regardless of whether that currency uses the “$” sign to denote its currency or may be readily converted into lawful money of the United States.
“Domestic Subsidiary” means a Subsidiary organized under the laws of the United States or any state or territory thereof or the District of Columbia.
“Effective Date” is defined in the preamble hereof.

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“Equipment” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.
“ERISA” is the Employee Retirement Income Security Act of 1974, and its regulations.
“Event of Default” is defined in Section 8.
“Exchange Act” is the Securities Exchange Act of 1934, as amended.
“Federal Funds Effective Rate” means, for any day, the weighted average of the rates on overnight federal funds transactions with members of the Federal Reserve System arranged by federal funds brokers, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such rate is not so published for any day that is a Business Day, the average of the quotations for the day of such transactions received by SVB from three federal funds brokers of recognized standing selected by it.
“Final Payment” is a payment (in addition to and not in substitution for the regular monthly payments of principal plus accrued interest) equal to the original principal amount of the Term Loan Advance extended by the Lenders to Borrower hereunder multiplied by six percent (6.00%), due on the earliest to occur of (a) the Term Loan Maturity Date, (b) the payment in full of the Term Loan Advance, (c) as required by Section 2.1.1(d) or 2.1.1(e), or (d) the termination of this Agreement.
“Financial Statement Repository” is SWLSReporting@svb.com or such other means of collecting information approved and designated by Agent or a Lender after providing notice thereof to Borrower from time to time.
“Foreign Currency” means lawful money of a country other than the United States.
“Foreign Subsidiary” means any Subsidiary which is not a Domestic Subsidiary.
“Funding Date” is any date on which a Credit Extension is made to or for the account of Borrower which shall be a Business Day.
“FX Contract” is any foreign exchange contract by and between Borrower and SVB under which Borrower commits to purchase from or sell to SVB a specific amount of Foreign Currency on a specified date.
“GAAP” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other Person as may be approved by a significant segment of the accounting profession, which are applicable to the circumstances as of the date of determination.
“General Intangibles” is all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all Intellectual Property, claims, income and other tax refunds, security and other deposits, payment intangibles, contract rights, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.
“Governmental Approval” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.
“Governmental Authority” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, 
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legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.
“Group Member” means Borrower and its Subsidiaries.
“Guarantor” is any Person providing a Guaranty in favor of Lenders.
“Guaranty” is any guarantee of all or any part of the Obligations, as the same may from time to time be amended, restated, modified or otherwise supplemented.
“Indebtedness” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and Letters of Credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.
“Indemnified Person” is defined in Section 13.3.
“Information” is defined in Section 13.9.
“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
“Intellectual Property” means, with respect to any Person, all of such Person’s right, title, and interest in and to the following:
(a)    its Copyrights, Trademarks and Patents; 
(b)    any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know-how and operating manuals;
(c)    any and all source code;
(d)    any and all design rights which may be available to such Person;
(e)    any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and
(f)    all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.
“Inventory” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of Borrower’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.
“Investment” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance or capital contribution to any Person.
“Key Person” is each of Borrower’s (a) Chief Executive Officer, who is Raymond Cohen as of the Effective Date, and (b) President and Chief Financial Officer, who is Dan Dearen as of the Effective Date.
“Lender” and “Lenders” is defined in the preamble.

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“Lender Entities” is defined in Section 13.9. 
“Lender Intercreditor Agreement” is, collectively, any and all intercreditor agreement, master arrangement agreement or similar agreement by and between SVB Capital (f/k/a Westriver Innovation Lending Fund VIII, L.P.) and SVB, as each may be amended from time to time in accordance with the provisions thereof.
“Lenders’ Expenses” are all of Agent’s and the Lenders’ reasonable, documented, out-of-pocket, audit fees and expenses, costs, and expenses (including reasonable attorneys’ fees and expenses) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (other than the Lender Intercreditor Agreement, but including, without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred with respect to Borrower.
“Letter of Credit” is a standby or commercial letter of credit issued by SVB upon request of Borrower based upon an application, guarantee, indemnity, or similar agreement.
“Lien” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.
“Liquidity” is, at any time, the sum of (a) the aggregate amount of unrestricted cash and Cash Equivalents maintained by Borrower at SVB and in other accounts where SVB has a perfected security interest (via a Control Agreement or other similar agreement) in the cash/Cash Equivalents in such accounts, plus (b) Borrower’s net Accounts receivable.
“Loan Documents” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this Agreement, the Perfection Certificate, each Disbursement Letter, the Lender Intercreditor Agreement, any Bank Services Agreement, any Control Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower or any Guarantor, and any other present or future agreement by Borrower and/or any Guarantor with or for the benefit of Agent and the Lenders in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.
“Material Adverse Change” is: (a) a material impairment in the perfection or priority of Agent’s, for the ratable benefit of the Lenders, Lien in the Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations, or condition (financial or otherwise) of Borrower; or (c) a material impairment of the prospect of repayment of any portion of the Obligations.
“Material Subsidiary” is any Subsidiary of Borrower whose (a) revenues for the most recently ended four (4) quarter period for which financial statements are available exceed One Million Dollars ($1,000,000) or (b) whose Cash and other liquid assets exceed Five Hundred Thousand Dollars ($500,000).
“Obligations” are Borrower’s obligations to pay when due any debts, principal, interest, fees, Lenders’ Expenses, the Final Payment, the Prepayment Premium, and other amounts Borrower owes Agent or any Lender now or later, whether under this Agreement, the other Loan Documents to which it is a party, or otherwise, including, without limitation, all obligations relating to Bank Services, if any, and including interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Agent and/or the Lenders, and to perform Borrower’s duties under the Loan Documents.
“Operating Documents” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form, (b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto.
“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.
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“Payment/Advance Form” is that certain form attached hereto as Exhibit C.
“Payment Date” is the first (1st) calendar day of each month.
“Perfection Certificate” is defined in Section 5.1.
“Permitted Indebtedness” is:
(a)    Borrower’s Indebtedness to Agent and the Lenders under this Agreement, and the other Loan Documents;
(b)    Indebtedness existing on the Effective Date which is shown on the Perfection Certificate;
(c)    Subordinated Debt;
(d)    unsecured Indebtedness to trade creditors incurred in the ordinary course of business; 
(e)    Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;
(f)    Indebtedness secured by Liens permitted under clauses (a) and (c) of the definition of “Permitted Liens” hereunder;
(g)    unsecured Indebtedness of Foreign Subsidiaries incurred on business credit cards in an amount not to exceed  One Hundred Thousand Dollars ($100,000) at any time;
(h)    Indebtedness between Borrower, any co-Borrower and any Guarantor;
(i)    Indebtedness between Borrower and any Foreign Subsidiary that is not a co-Borrower or Guarantor; provided that the amount of such Indebtedness shall not exceed One Million Dollars ($1,000,000) in the aggregate at any one time;
(j)    Indebtedness between Foreign Subsidiaries that are not co-Borrowers or Guarantors; 
(k)    a one (1) time loan by Borrower to Axonics UK not to exceed One Hundred Forty-One Million Two Hundred Fifty Thousand Dollars ($141,250,000) to be used to consummate the Contura Acquisition;  and
(l)    extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (b) above; provided that the principal amount thereof is not increased or the terms thereof are not modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be.
“Permitted Investments” are:
(a)    Investments (including, without limitation, Subsidiaries) existing on the Effective Date which are shown on the Perfection Certificate or Subsidiaries formed after the Effective Date for which Agent has provided consent pursuant to Section 7.7; 
(b)    Investments consisting of Cash Equivalents;
(c)    Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of Borrower;

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(d)    Investments consisting of deposit accounts, Securities Accounts or Commodity Accounts in which Agent, for the benefit of the Lenders, after the date set forth in Section 6.13(b), has a perfected security interest;
(e)    Investments accepted in connection with Transfers permitted by Section 7.1;
(f)    Investments consisting of the creation of a Subsidiary for the purpose of consummating a merger transaction permitted by Section 7.3 of this Agreement, which is otherwise a Permitted Investment;
(g)    Investments (i) by Borrower, any co-Borrower or any Guarantor in Foreign Subsidiaries which are not co-Borrowers or Guarantors not to exceed One Million Dollars ($1,000,000) in the aggregate in any fiscal year, (ii) by Subsidiaries that are not co-Borrowers or Guarantors hereunder in other Subsidiaries that are not co-Borrower or Guarantors hereunder or in Borrower, and (iii) by Borrower, any co-Borrower or any Guarantor in any co-Borrower or Guarantor;
(h)    a one (1) time Investment by Borrower in Axonics UK not to exceed One Hundred Forty-One Million Two Hundred Fifty Thousand Dollars ($141,250,000) to be used to consummate the Contura Acquisition;
(i)    Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by the Board;
(j)    Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business; and
(k)    Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; provided that this paragraph (j) shall not apply to Investments of Borrower in any Subsidiary.
“Permitted Liens” are:
(a)    Liens existing on the Effective Date which are shown on the Perfection Certificate or arising under this Agreement and the other Loan Documents;
(b)    Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on Borrower’s Books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;
(c)    purchase money Liens (i) on Equipment acquired or held by Borrower incurred for financing the acquisition of the Equipment securing no more than One Million Dollars ($1,000,000) in the aggregate amount outstanding, or (ii) existing on Equipment when acquired, if the Lien is confined to the property and improvements and the proceeds of the Equipment; 
(d)    Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed One Million Dollars ($1,000,000) and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

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(e)    Liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);
(f)    Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;
(g)    leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non-exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Agent a security interest therein;
(h)    non-exclusive licenses of Intellectual Property granted to third parties in the ordinary course of business;
(i)    Liens arising from attachments or judgments, orders, or decrees in circumstances not constituting an Event of Default under Sections 8.4 and 8.7; and
(j)    Liens in favor of other financial institutions arising in connection with Borrower’s deposit and/or securities accounts held at such institutions, provided that Agent has a first-priority perfected security interest in the amounts held in such deposit and/or securities accounts.
“Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.
“Prepayment Premium” shall be an additional fee, payable to Agent, for the ratable benefit of the Lenders based on their Pro Rata Share, with respect to the Term Loan Advance, in an amount equal to:
(a)    for a prepayment of the Term Loan Advance made on or prior to the first (1st) anniversary of the Effective Date, two percent (2.00%) of the then outstanding principal amount of the Term Loan Advance immediately prior to the date of such prepayment; 
(b)    for a prepayment of the Term Loan Advance made after the first (1st) anniversary of the Effective Date, but prior to the Term Loan Maturity Date, one percent (1.00%) of the then outstanding principal amount of the Term Loan Advance immediately prior to the date of such prepayment.
“Prime Rate” is the rate of interest per annum from time to time published in the money rates section of The Wall Street Journal or any successor publication thereto as the “prime rate” then in effect; provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement; and provided further that if such rate of interest, as set forth from time to time in the money rates section of The Wall Street Journal, becomes unavailable for any reason as determined by Agent, the “Prime Rate” shall mean the rate of interest per annum announced by SVB as its prime rate in effect at its principal office in the State of California (such SVB announced Prime Rate not being intended to be the lowest rate of interest charged by SVB in connection with extensions of credit to debtors); provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement.
“Pro Rata Share” is, as of any date of determination, with respect to each Lender, a percentage (expressed as a decimal, rounded to the ninth decimal place) determined by dividing the outstanding principal amount of the Term Loan Advance held by such Lender by the aggregate outstanding principal amount of the Term Loan Advance.
“Quarterly Financial Statements” is defined in Section 6.2(a).

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“Registered Organization” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made.
“Removal Effective Date” is defined in Section 10.10(d).
“Representatives” is defined in Section 13.9.
“Requirement of Law” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.
“Responsible Officer” is any of the Chief Executive Officer, President and Chief Financial Officer of Borrower.  
“Restricted License” is any material license or other agreement with respect to which Borrower is the licensee (a) that prohibits or otherwise restricts Borrower from granting a security interest in, or a fixed or floating charge over, Borrower’s interest in such license or agreement or any other property, or (b) for which a default under or termination of could interfere with the Agent’s right to sell any Collateral.
“Revenue” means revenue (determined in accordance with GAAP) of Borrower, but specifically excluding any revenue earned from any Subsidiary of Borrower (including but not limited to Contura Limited or any of its Subsidiaries). 
“SEC” shall mean the Securities and Exchange Commission, any successor thereto, and any analogous Governmental Authority.
“Securities Account” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made.
“Subordinated Debt” is indebtedness incurred by Borrower subordinated to all of Borrower’s now or hereafter indebtedness to Agent and the Lenders (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Agent and the Lenders, entered into between Agent, the Lenders and the other creditor), on terms acceptable to Agent and the Lenders.
“Subsidiary” is, as to any Person, a corporation, partnership, limited liability company or other entity of which shares of stock or other ownership interests having ordinary voting power (other than stock or such other ownership interests having such power only by reason of the happening of a contingency) to elect a majority of the board of directors or other managers of such corporation, partnership or other entity are at the time owned, or the management of which is otherwise controlled, directly or indirectly through one or more intermediaries, or both, by such Person.  Unless the context otherwise requires, each reference to a Subsidiary herein shall be a reference to a Subsidiary of Borrower.
“SVB” is defined in the preamble hereof.
“SVB Capital” is defined in the preamble hereof.
“Term Loan Advance” is defined in Section 2.1.1(a).
“Term Loan Commitment” means, for any Lender, the obligation of such Lender to make a Term Loan Advance as and when available, up to the principal amount shown on Schedule 1.  “Term Loan Commitments” means the aggregate amount of such commitments of all Lenders.
“Term Loan Commitment Percentage” means, as to any Lender at any time, the percentage (carried out to the fourth decimal place) of the Term Loan Commitments represented by such Lender’s Term Loan Commitment 
-37-

at such time.  The initial Term Loan Commitment Percentage of each Lender is set forth opposite the name of such Lender on Schedule 1.
“Term Loan Maturity Date” is February 1, 2024.
“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.
“Transfer” is defined in Section 7.1. 
[Signature page follows.]
-38-

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the Effective Date.
BORROWER:
AXONICS MODULATION TECHNOLOGIES, INC.

By:_/s/ Raymond Cohen________________________

Name: Raymond Cohen

Title: Chief Executive Officer
AGENT:
SILICON VALLEY BANK, as Agent

By:_/s/ Milo Bissin____________________________

Name: Milo Bissin

Title: Director
LENDERS:
SILICON VALLEY BANK, as Lender

By: _/s/ Milo Bissin___________________________

Name: Milo Bissin

Title: Director

SVB INNOVATION CREDIT FUND VIII, L.P., as Lender
By: SVB Innovation Credit Partners VIII, LLC, a
Delaware limited liability company, its General
Partner

By:_/s/ Ryan Grammer_________________________

Name: Ryan Grammer

Title:Senior Managing Director

[Signature Page to Loan and Security Agreement]

SCHEDULE 1

LENDERS AND COMMITMENTS

									
	Lender	Term Advance 
Commitment
	Term Loan Advance Commitment Percentage
	Silicon Valley Bank	$37,500,000	50.0000%
	SVB Innovation Credit Fund VIII, L.P.	$37,500,000	50.0000%
	

TOTAL
	

$75,000,000
	

100.0000%

    
    

EXHIBIT A

COLLATERAL DESCRIPTION

The Collateral consists of all of Borrower’s right, title and interest in and to the following personal property:
All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (except as provided below), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts, certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and 
All Borrower’s Books relating to the foregoing and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.
Notwithstanding the foregoing, the Collateral does not include (a) any Intellectual Property; provided, however, the Collateral shall include all Accounts and all proceeds of Intellectual Property.  If a judicial authority (including a U.S. Bankruptcy Court) would hold that a security interest in the underlying Intellectual Property is necessary to have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Collateral shall automatically, and effective as of the Effective Date, include the Intellectual Property to the extent necessary to permit perfection of Agent’s, for the ratable benefit of the Lenders, security interest in such Accounts and such other property of Borrower that are proceeds of the Intellectual Property, (b) more than sixty-five (65%) of the presently existing and hereafter arising issued and outstanding shares of capital stock owned by Borrower of any Foreign Subsidiary (excluding any Foreign Subsidiary that is a Material Subsidiary) which shares entitle the holder thereof to vote for directors or any other matter, and (c) any interest of Borrower as a lessee or sublessee under a real property lease or an Equipment lease if Borrower is prohibited by the terms of such lease from granting a security interest in such lease or under which such an assignment or Lien would cause a default to occur under such lease (but only to the extent that such prohibition is enforceable under all applicable laws including, without limitation, the Code); provided, however, that upon termination of such prohibition, such interest shall immediately become Collateral without any action by Borrower or the Lenders. 
Pursuant to the terms of a certain negative pledge arrangement with Agent and the Lenders, Borrower has agreed not to encumber any of its Intellectual Property without Agent and the Lenders’ prior written consent.

EXHIBIT B
COMPLIANCE STATEMENT
Date:                  

TO:    SILICON VALLEY BANK (“SVB”), as Agent, SVB, and SVB INNOVATION CREDIT FUND VIII, L.P., as Lender    
FROM:  AXONICS MODULATION TECHNOLOGIES, INC.
Under the terms and conditions of the Loan and Security Agreement among Borrower, Agent, and Lenders (the “Agreement”) (1) Borrower is in complete compliance for the period ending _______________ with all required covenants except as noted below. Attached are the required documents evidencing such compliance, setting forth calculations prepared in accordance with GAAP consistently applied from one period to the next except as explained in an accompanying letter or footnotes.  Capitalized terms used but not otherwise defined herein shall have the meanings given them in the Agreement.
									
	Please indicate compliance status by circling Yes/No under “Complies” column.
	
	Reporting Covenants	Required	Complies
			
	Quarterly Financial Statements with 
Compliance Statement	Quarterly within 45 days (within 90 days for the 4th calendar quarter of each year)	Yes   No
	Annual financial statement (CPA Audited)	FYE within 180 days	Yes   No
	10Q, 10K and 8-K	Within 5 days after filing with SEC	Yes   No
	Board Projections	Annually within 30 days of FYE, and as amended/updated by Board approval	Yes   No
	Monthly Asset Management Account Statements	Monthly within 30 days	Yes   No

												
	Financial Covenant
	Required
	Actual
	Complies
				
	Minimum Revenue*
(measured on a trailing 3-month basis)
	See Schedule 1	$____________	Yes   No
	*For any calendar quarter during which Borrower’s Liquidity falls below One Hundred Fifty Million Dollars ($150,000,000) at any time during such quarter, Borrower shall achieve Revenue (measured on a trailing three (3) month basis) of not less than the amount set forth in the table below for the corresponding measuring period.

Other Matters

									
	Have there been any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries?  If yes, provide copies of any such amendments or changes with this Compliance Statement.	Yes	No

The following financial covenant analysis and information set forth in Schedule 1 attached hereto are true and accurate as of the date of this Compliance Statement.

1

The following are the exceptions with respect to the statements above: (If no exceptions exist, state “No exceptns to note.”)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2

Schedule 1 to Compliance Statement

Financial Covenants of Borrower

    In the event of a conflict between this Schedule and the Loan Agreement, the terms of the Loan Agreement shall govern.

Dated:    ____________________

I.    Minimum Revenue (Section 6.7)
Borrower shall achieve Revenue (measured on a trailing three (3) month basis), tested quarterly as of the last day of each calendar quarter, of at least the following amounts for the corresponding measuring periods:
						
	Measuring Period Ending	Minimum Trailing-3 Month Revenue
	March 31, 2021	$20,000,000
	June 30, 2021	$30,000,000
	September 30, 2021
	$34,000,000
	December 31, 2021
	$44,000,000
	Each calendar quarter thereafter through the Term Loan Maturity Date
	115% of Borrower’s actual Revenue for the same quarterly measuring period in the prior calendar year

Actual:
Did Borrower achieve Revenue (measured on a trailing three (3) month basis) of at least the amount set forth in the chart above for the corresponding measuring period?
_______ No, not in compliance            _______ Yes, in compliance

EXHIBIT C
LOAN PAYMENT/ADVANCE REQUEST FORM

Fax To:      Date: _____________________

Loan Payment:    AXONICS MODULATION TECHNOLOGIES, INC.

From Account #________________________________    To Account #__________________________________________
(Deposit Account #)                        (Loan Account #)
Principal $____________________________________    and/or Interest $________________________________________

Authorized Signature:        Phone Number:     
Print Name/Title:     

Loan Advance:

Complete Outgoing Wire Request section below if all or a portion of the funds from this loan advance are for an outgoing wire.

From Account #________________________________    To Account #__________________________________________
(Loan Account #)                        (Deposit Account #)

Amount of Term Loan Advance $                                                                       

All Borrower’s representations and warranties in the Loan and Security Agreement are true, correct and complete in all material respects on the date of the request for an advance:

Authorized Signature:        Phone Number:     
Print Name/Title:     

Outgoing Wire Request:
Complete only if all or a portion of funds from the loan advance above is to be wired.
Deadline for same day processing is noon, Eastern Time 

Beneficiary Name: _____________________________    Amount of Wire: $    
Beneficiary Bank: ______________________________    Account Number:     
City and State:     

Beneficiary Bank Transit (ABA) #:         Beneficiary Bank Code (Swift, Sort, Chip, etc.):     
(For International Wire Only)

Intermediary Bank:         Transit (ABA) #:     
For Further Credit to:     

Special Instruction:     

By signing below, I (we) acknowledge and agree that my (our) funds transfer request shall be processed in accordance with and subject to the terms and conditions set forth in the agreements(s) covering funds transfer service(s), which agreements(s) were previously received and executed by me (us).

Authorized Signature: ___________________________    2nd Signature (if required): _______________________________
Print Name/Title: ______________________________    Print Name/Title: ______________________________________
Telephone #:                     Telephone #: _____________________________

EXHIBIT D
Form of Disbursement Letter
[see attached]

DISBURSEMENT LETTER 

[DATE]
The undersigned, being an Authorized Signer of AXONICS MODULATION TECHNOLOGIES, INC., a Delaware corporation (“Borrower”), does hereby certify to (a) SILICON VALLEY BANK, a California corporation (“SVB”), in its capacity as administrative agent and collateral agent (“Agent”), (b) SVB, as a lender, (c) SVB INNOVATION CREDIT FUND VIII, L.P., a Delaware limited partnership (“SVB Capital”), as a lender (SVB and SVB Capital and each of the other “Lenders” from time to time a party hereto are referred to herein collectively as the “Lenders” and each individually as a “Lender”) in connection with that certain Loan and Security Agreement dated as of February 25, 2021, by and among Borrower, Agent and the Lenders from time to time party thereto (the “Loan Agreement”; with other capitalized terms used below having the meanings ascribed thereto in the Loan Agreement) that:
1.    The representations and warranties made by Borrower in Section 5 of the Loan Agreement and in the other Loan Documents are true and correct in all material respects as of the date hereof.
2.    No event or condition has occurred that would constitute an Event of Default under the Loan Agreement or any other Loan Document.
3.    Borrower is in compliance with the covenants and requirements contained in Sections 4, 6 and 7 of the Loan Agreement in all material respects.
4.    All conditions referred to in Section 3 of the Loan Agreement to the making of a Credit Extension to be made on or about the date hereof have been satisfied or waived by Agent.
5.    There has not been any material impairment in the general affairs, management, results of operation, financial condition or the prospect of repayment of the Obligations, nor any material adverse deviation by Borrower from the most recent business plan of Borrower presented to and accepted by Agent and the Lenders.
6.    The undersigned is an Authorized Signer.

[Balance of Page Intentionally Left Blank]
1

7A.    The proceeds of the Term Loan Advance shall be disbursed as follows:
												
	Disbursement from SVB:		
	Loan Amount	$_______________	
	Plus:
		
	Deposit Received	$__________	
	Less:
		
	Commitment Fee	($_________)	
	[--Existing Debt Payoff to 
[PAYOFF BANK]	($_________)]	
	[Interim Interest]	($_________)	
	Lenders’ Legal Fees	($_________)*	
		
	Net Proceeds due from SVB:	$_______________	
			
	Disbursement from SVB Capital:		
	Loan Amount	$_______________	
	Plus:
		
	Deposit Received	$__________	
	Less:
		
	Commitment Fee	($_________)	
	[Interim Interest]	($_________)	
			
	Net Proceeds due from SVB Capital:	$_______________	

						
	TOTAL TERM LOAN ADVANCE
NET PROCEEDS FROM LENDERS
	$_______________

7B.    Funds from Borrower’s Designated Deposit Account shall be disbursed as follows:
												
	SVB:		
	Term Loan Fees	$_______________	
	Lenders’ Legal Fees	$_______________	
	SVB Capital:  Designated Deposit Account: xxx-xxx-020
	
	Term Loan Fees	$_______________
	

Funds due from Borrower (“Total Funds”)
	$_______________
		

[Balance of Page Intentionally Left Blank]

8A.    The aggregate net proceeds of the Term Loan Advance shall be transferred to the Borrower’s Designated Deposit Account as follows:
						
	Account Name:	Axonics Modulation Technologies, Inc.
	Bank Name:	Silicon Valley Bank
	Bank Address:	3003 Tasman Drive
Santa Clara, California 95054
	Account Number:	xxx-xxxx-020
	ABA Number:	121140399

8B.    Borrower authorized SVB to debit the Total Funds from the Borrower’s Designated Deposit Account set forth below:
						
	Account Name:	Axonics Modulation Technologies, Inc.
	Bank Name:	Silicon Valley Bank
	Bank Address:	3003 Tasman Drive
Santa Clara, California 95054
	Account Number:	xxx-xxxx-020
	ABA Number:	121140399

[Balance of Page Intentionally Left Blank]

Dated as of the date first set forth above.
			
	BORROWER:
	AXONICS MODULATION TECHNOLOGIES, INC.
	
	By:____________________________________
	Name:__________________________________
	Title:___________________________________
	
	AGENT:
	SILICON VALLEY BANK
	
	By:____________________________________
	Name:__________________________________
	Title:___________________________________
	
	LENDER:
	SILICON VALLEY BANK
	
	By:____________________________________
	Name:__________________________________
	Title:___________________________________
	
	LENDER:

	SVB INNOVATION CREDIT FUND VIII, L.P., as Lender
By: SVB Innovation Credit Partners VIII, LLC, a
Delaware limited liability company, its General
Partner

	
	By:____________________________________
	Name:__________________________________
	Title:___________________________________

[Signature Page to Disbursement Letter]

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