UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2025

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 001-42437

Anteris Technologies Global Corp.

(Exact name of Registrant as specified in its Charter)


Delaware		99-1407174
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)


Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD Australia		4066
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: +61 7 3152 3200

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0001 per share	AVR	The Nasdaq Global Market

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

YES ☒ NO ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). YES ☒ NO☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

YES ☐ NO ☒

The number of shares outstanding of the registrant’s Common Stock as of November 12, 2025 was 41,197,570.

ANTERIS TECHNOLOGIES GLOBAL CORP.

FORM 10-Q

For the quarterly period ended September 30, 2025

TABLE OF CONTENTS


			Page

PART I FINANCIAL INFORMATION			1

	Item 1. Financial Statements (Unaudited)		1

		Condensed Consolidated Statements of Operations	1

		Condensed Consolidated Statements of Comprehensive Loss	2

		Condensed Consolidated Balance Sheets	3

		Condensed Consolidated Statements of Stockholders’ Equity	4

		Condensed Consolidated Statements of Cash Flows	6

		Notes to the Condensed Consolidated Financial Statements	7

	Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations		17

	Item 3. Quantitative and Qualitative Disclosures About Market Risk		24

	Item 4. Controls and Procedures		24

PART II OTHER INFORMATION			24

	Item 1. Legal Proceedings		24

	Item 1A. Risk Factors.		25

	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		25

	Item 3. Defaults Upon Senior Securities		25

	Item 4. Mine Safety Disclosures		25

	Item 5. Other Information		25

	Item 6. Exhibits		26

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

All statements in this Form 10-Q, other than statements of historical facts, including statements regarding our future results of operations and financial position, business strategy, product development, and plans and objectives of management for future operations, are forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements, which are subject to risks, include, but are not limited to, statements about:

●

sufficiency of our capital resources;

●

our ability to raise additional funding when needed;

●

our current and future research and development (“R&D”) activities, including clinical testing and manufacturing and related costs and timing;

●

our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products in our markets;

●

our ability to commercialize products and generate product revenues;

●

any statements concerning anticipated regulatory activities, including our ability to obtain regulatory clearances;

●

our R&D expenses; and

●

risks facing our operations and intellectual property.

We have based the forward-looking statements contained in this Form 10-Q largely on our current expectations, estimates, forecasts and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and amended on April 29, 2025 (as amended, the “Annual Report”), as such risks and uncertainties may be amended, supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K we file with the SEC, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.

The forward-looking statements made in this Form 10-Q relate only to events as of the date on which the statements are made. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make within this Form 10-Q.

You should read this Form 10-Q and the documents that we reference in this Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Form 10-Q by these cautionary statements.

This Form 10-Q contains certain data and information that we obtained from various publications. Statistical data in these publications also include projections based on a number of assumptions.

All references in this Form 10-Q to our common stock, par value $0.0001 per share (“Common Stock”) shall include the shares represented by CHESS Depository Interests (“CDIs”), each of which represents one underlying share of Common Stock, unless the context suggests otherwise. In addition, the nature of the medical technology industry results in significant uncertainties for any projections or estimates relating to the growth prospects or future condition of our industry. Furthermore, if any one or more of the assumptions underlying the market data are later found to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements.

Part I. Financial Information

Item 1.

Financial Statements

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands of U.S. dollars, except per share information; unaudited)


		Three months ended September 30,					Nine months ended September 30,
	Note		2025 $		2024 $			2025 $		2024 $
Net sales			429		769			1,603		2,167
Costs and expenses:
Cost of products sold			(123	)	(443	)		(478	)	(1,229	)
Research and development expense			(16,810	)	(13,946	)		(49,606	)	(38,135	)
Selling, general and administrative expense			(5,761	)	(6,977	)		(16,448	)	(19,656	)
Operating loss			(22,265	)	(20,597	)		(64,929	)	(56,853	)
Other non-operating income, net			147		123			386		637
Interest and amortization of debt discount and expense			(15	)	(11	)		(63	)	(39	)
Net foreign exchange (losses)/gains			(83	)	(1,290	)		(611	)	(457	)
Fair value movement of derivatives			7		(19	)		15		(54	)
Loss before income taxes from continuing operations			(22,209	)	(21,794	)		(65,202	)	(56,766	)
Income tax (expense)/benefit			-		-			-		-
Loss after income tax			(22,209	)	(21,794	)		(65,202	)	(56,766	)

Total (loss)/gain is attributable to:
Non-controlling interests			35		64			(260	)	149
Stockholders of the Company			(22,244	)	(21,858	)		(64,942	)	(56,915	)
			(22,209	)	(21,794	)		(65,202	)	(56,766	)

Share information
Basic and diluted loss per share ($ per share)	7		(0.62	)	(1.07	)		(1.80	)	(2.97	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands of U.S. dollars; unaudited)


	Three months ended September 30,					Nine months ended September 30,
		2025 $		2024 $			2025 $		2024 $
Loss after income tax		(22,209	)	(21,794	)		(65,202	)	(56,766	)
Other comprehensive income/(loss), net of tax:
Foreign currency translation adjustments		31		1,468			644		602
Other comprehensive income/(loss) for the period, net of tax		31		1,468			644		602
Total comprehensive loss		(22,178	)	(20,326	)		(64,558	)	(56,164	)

Total comprehensive loss is attributable to:
Non-controlling interests		35		64			(260	)	149
Stockholders of the Company		(22,213	)	(20,390	)		(64,298	)	(56,313	)
		(22,178	)	(20,326	)		(64,558	)	(56,164	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands of U.S. dollars, except share quantities; unaudited)


	Note	September 30, 2025 $		December 31, 2024 $
ASSETS
Current Assets
Cash, cash equivalents and restricted cash		9,119		70,458
Accounts receivable from customers, net of allowances		234		208
Inventories		436		513
Prepaid expenses		880		640
Other current assets		555		2,832
Total Current Assets		11,224		74,651
Non-Current Assets
Plant and equipment, net		5,295		4,774
Operating lease right-of-use assets, net		1,971		1,085
Intangible assets, net		70		189
Other assets		514		-
Total Non-Current Assets		7,850		6,048
TOTAL ASSETS		19,074		80,699
LIABILITIES
Current Liabilities
Accounts payable		4,276		5,889
Accrued and other liabilities	5	8,435		9,921
Current portion of operating lease liabilities		624		747
Current portion of debt obligations		96		3
Total Current Liabilities		13,431		16,560
Non-Current Liabilities
Operating lease liabilities		1,605		645
Long-term debt obligations		26		-
Other liabilities	5	653		812
Total Non-Current Liabilities		2,284		1,457
TOTAL LIABILITIES		15,715		18,017
COMMITMENTS AND CONTINGENCIES	10
STOCKHOLDERS’ EQUITY
Common stock, $0.0001 par value, 400,000,000 shares authorized, 36,062,370 and 35,939,816 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively	6	4		4
Preferred stock, $0.0001 par value, 40,000,000 shares authorized, no shares outstanding		-		-
Additional paid in capital		355,271		350,036
Accumulated other comprehensive loss		(10,247	)	(10,891	)
Accumulated deficit		(341,330	)	(276,388	)
TOTAL STOCKHOLDERS’ EQUITY		3,698		62,761
Non-controlling interests	9	(339	)	(79	)
TOTAL EQUITY		3,359		62,682
TOTAL LIABILITIES AND EQUITY		19,074		80,699

The accompanying notes are an integral part of these condensed consolidated financial statements.

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands of U.S. dollars, except share quantities; unaudited)








	Common stock		Additional Paid in Capital $	Accumulated Other Comprehensive Loss $		Accumulated Deficit $		Total Stockholders’ Equity $		Non-controlling interests $		Total Equity $
	Shares Quantity	Par Value $	Additional Paid in Capital $	Accumulated Other Comprehensive Loss $		Accumulated Deficit $		Total Stockholders’ Equity $		Non-controlling interests $		Total Equity $
Balance at December 31, 2024	35,939,816	4	350,036	(10,891	)	(276,388	)	62,761		(79	)	62,682
(Loss)/Gain after income tax	-	-	-	-		(21,864	)	(21,864	)	(67	)	(21,931	)
Other comprehensive gain	-	-	-	174		-		174		-		174
Common stock issued	122,271	-	485	-		-		485		-		485
Stock-based compensation	-	-	1,703	-		-		1,703		-		1,703
Balance at March 31, 2025	36,062,087	4	352,224	(10,717	)	(298,252	)	43,259		(146	)	43,113
(Loss)/Gain after income tax	-	-	-	-		(20,834	)	(20,834	)	(228	)	(21,062	)
Other comprehensive gain	-	-	-	439		-		439		-		439
Common stock issued	283	-	1	-		-		1		-		1
Stock-based compensation	-	-	1,541	-		-		1,541		-		1,541
Balance at June 30, 2025	36,062,370	4	353,766	(10,278	)	(319,086	)	24,406		(374	)	24,032
(Loss)/Gain after income tax	-	-	-	-		(22,244	)	(22,244	)	35		(22,209	)
Other comprehensive gain	-	-	-	31		-		31		-		31
Stock-based compensation	-	-	1,505	-		-		1,505		-		1,505
Balance at September 30, 2025	36,062,370	4	355,271	(10,247	)	(341,330	)	3,698		(339	)	3,359

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands of U.S. dollars, except share quantities; unaudited)







	Common stock		Additional Paid in Capital $	Accumulated Other Comprehensive Loss $		Accumulated Deficit $		Total Stockholders’ Equity $		Non-controlling interests $		Total Equity $
	Shares Quantity	Par Value $	Additional Paid in Capital $	Accumulated Other Comprehensive Loss $		Accumulated Deficit $		Total Stockholders’ Equity $		Non-controlling interests $		Total Equity $
Balance at December 31, 2023	17,820,149	2	228,951	(9,555	)	(200,097	)	19,301		(403	)	18,898
(Loss)/Gain after income tax	-	-	-	-		(16,350	)	(16,350	)	197		(16,153	)
Other comprehensive loss	-	-	-	(1,561	)	-		(1,561	)	-		(1,561	)
Common stock issued	275,167	-	1,711	-		-		1,711		-		1,711
Stock-based compensation	-	-	1,500	-		-		1,500		-		1,500
Balance at March 31, 2024	18,095,316	2	232,162	(11,116	)	(216,447	)	4,601		(206	)	4,395
(Loss)/Gain after income tax	-	-	-	-		(18,707	)	(18,707	)	(112	)	(18,819	)
Other comprehensive gain	-	-	-	695		-		695		-		695
Common stock issued	1,127,000	-	14,584	-		-		14,584		-		14,584
Stock-based compensation	-	-	1,695	-		-		1,695		-		1,695
Balance at June 30, 2024	19,222,316	2	248,441	(10,421	)	(235,154	)	2,868		(318	)	2,550
(Loss)/Gain after income tax	-	-	-	-		(21,858	)	(21,858	)	64		(21,794	)
Other comprehensive gain	-	-	-	1,468		-		1,468		-		1,468
Common stock issued	1,917,500	-	18,868	-		-		18,868		-		18,868
Stock-based compensation	-	-	1,804	-		-		1,804		-		1,804
Balance at September 30, 2024	21,139,816	2	269,113	(8,953	)	(257,012	)	3,150		(254	)	2,896

The accompanying notes are an integral part of these condensed consolidated financial statements.

ANTERIS TECHNOLOGIES GLOBAL CORP.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands of U.S. dollars; unaudited)


		Nine months ended September 30,
	Note		2025 $		2024 $
CASH FLOWS FROM OPERATING ACTIVITIES
Loss after income tax			(65,202	)	(56,766	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense			1,238		1,103
Equity-settled stock-based compensation			4,749		5,214
Net foreign exchange losses/(gains)			611		457
Other items			(21	)	55
Change in operating assets and liabilities:
Accounts receivable, prepayments and other assets			379		(757	)
Inventories			77		(17	)
Accounts payable, accrued and other liabilities			(1,107	)	7,708
NET CASH USED IN OPERATING ACTIVITIES			(59,276	)	(43,003	)
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of plant and equipment			(1,557	)	(1,903	)
Acquisition of intangible assets			-		(13	)
Deferred proceeds from sale of distribution rights			1,358		-
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES			(199	)	(1,916	)
CASH FLOWS FROM FINANCING ACTIVITIES
Net proceeds from share issues	6		619		37,060
Share issue transaction costs	6		(1,195	)	(2,112	)
Tax withholding paid on stock option exercises			(97	)	-
Repayment of debt			(1,145	)	(508	)
Principal payments on finance lease obligations			(9	)	(8	)
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES			(1,827	)	34,432
Effect of exchange rate movements on cash, cash equivalents and restricted cash			(37	)	16
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Net change during the period			(61,339	)	(10,471	)
Balance at beginning of period			70,458		21,089
Balance at end of period			9,119		10,618

SUPPLEMENTAL CASH FLOW INFORMATION
Cash received for research and development tax incentive			594		-
Operating cash flows relating to operating leases			738		608
Non-cash additions to right-of-use assets and lease liabilities			1,663		294
Shares of common stock issued to consultants for services provided			-		430

The accompanying notes are an integral part of these condensed consolidated financial statements.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

DESCRIPTION OF BUSINESS

Anteris Technologies Global Corp. (“ATGC,” “Anteris,” “Company,” “we,” “us,” or “our”) was incorporated in Delaware on January 29, 2024. ATGC was formed for the purpose of reorganizing the operations of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), an Australian public company originally registered in Western Australia, Australia and listed on the Australian Securities Exchange (“ASX”), into a structure whereby the ultimate parent company would be a Delaware corporation (the “reverse recapitalization”).

On December 16, 2024, the Company received all the issued and outstanding shares of ATPL pursuant to a scheme of arrangement under Australian law between ATPL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act 2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATPL cancelled all existing options it had outstanding in exchange for ATGC issuing replacement options to acquire shares of ATGC’s common stock, par value $0.0001 per share (“Common Stock”) pursuant to a scheme of arrangement between ATPL and its option holders (the “Option Scheme”) under Part 5.1 of the Corporations Act.

Prior to completion of the reverse recapitalization, ATGC had no business or operations and following completion of the reverse recapitalization, the business and operations of ATGC consist solely of the business and operations of ATPL and its subsidiaries. As a result of the reverse recapitalization, ATGC became the parent company of ATPL and, for financial reporting purposes, the historical financial statements of ATPL became the historical financial statements of ATGC as a continuation of the predecessor.

On December 16, 2024, the Company completed the reverse recapitalization and an initial public offering (“IPO”) of 14,800,000 shares of Common Stock.

ATGC’s principal activities consist of:

●

Continued research and development (“R&D”) of the DurAVR^® Transcatheter Heart Valve (“THV”) System consisting of a single-piece biomimetic valve made with our proprietary ADAPT^® tissue-enhancing technology and deployed with our balloon expandable ComASUR^® Delivery System, to address unmet medical needs in the treatment of aortic stenosis. The DurAVR^® THV, with its single piece, native-shaped biomimetic design is built to mimic the performance of a healthy aortic valve and to restore normal laminar blood flow. This new class of technology can be used to treat new aortic stenosis patients and to treat aortic stenosis patients where their current bioprosthetic aortic valve is failing (“valve-in-valve”).

●

Conducting the randomized global pivotal study (the “PARADIGM Trial”), designed to generate the clinical evidence required to support a Premarket Approval (“PMA”) application in the United States and a parallel CE Mark approval in Europe.

●

The co-development with v2vmedtech, inc. (“v2v”), of an innovative heart valve repair device for the minimally invasive treatment of mitral and tricuspid valve regurgitation (also known as a leaky valve).

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). These policies have been consistently applied to all the periods presented, unless otherwise stated. The accompanying condensed consolidated financial statements of the Company are unaudited. In the opinion of management, all adjustments necessary for a fair statement of results of operations, cash flows, and financial position have been made. The results of operations for the three and nine months ended September 30, 2025 and 2024 are not necessarily indicative of results that may be expected for the full year or any other subsequent interim period.

Unless noted otherwise, all dollar amounts are in thousands of United States dollars (“U.S. dollars” or “$”). Some amounts may not reconcile due to rounding.

For the three and nine months ended September 30, 2024, the condensed consolidated financial statements reflect the consolidated results of operations, comprehensive loss, cash flows, and changes in equity of ATPL and its wholly-owned subsidiaries. The Condensed Consolidated Balance Sheet as of December 31, 2024 presents the financial condition of the Company and its consolidated subsidiaries.

In accordance with ASC 805, Business Combinations, ATPL’s historical equity has been retrospectively restated for all periods up to December 16, 2024, the closing date of the reverse recapitalization (the “Closing Date”), to reflect the number of shares of Common Stock issued to legacy ATPL shareholders in connection with the reverse recapitalization. Additionally, the par value of Common Stock has been restated to align with the post-transaction capital structure.

The Company is an emerging growth company (“EGC”), as defined in Section 2(a) of the Securities Act of 1933, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), which permits the Company to utilize an extended transition period to comply with new or revised accounting standards applicable to public companies.

The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations of future events that management believe to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

The accounting policies adopted in the preparation of the condensed consolidated financial statements are consistent with those adopted and disclosed in the Group’s (defined below) financial statements for the year ended December 31, 2024, and therefore these condensed consolidated financial statements do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes for the year ended December 31, 2024 as included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and amended on April 29, 2025 (as amended, the “Annual Report”).

There have been no material changes to the Company's significant accounting policies from those described in the consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

(a)

Principles of consolidation

The condensed consolidated financial statements include the accounts of ATGC, its wholly-owned subsidiaries, entities for which the Company has a controlling financial interest, as well as any variable interest entities (“VIEs”) for which ATGC has been determined to be the primary beneficiary. ATGC and its subsidiaries together are referred to in these financial statements as the “Group.”

Subsidiaries are all those entities over which the Group has control. Control is the power to govern the financial and operating policies of an entity. All subsidiaries of ATGC have a reporting year end of December 31.

Intercompany transactions, balances and unrealized gains or losses on transactions between entities in the Group are eliminated.

(b)

Recently Adopted Accounting Standards

In June 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2022-03, Fair Value Measurement (Topic 820) Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. ASU 2022-03 clarifies guidance for fair value measurement of an equity security subject to a contractual sale restriction and establishes new disclosure requirements for such equity securities. This ASU was effective January 1, 2025 for smaller reporting companies. The Company has assessed the impact of adopting this accounting guidance and has determined that it does not impact the fair value measurement of our existing equity securities. Nevertheless, the Company will apply the guidance and incorporate the new required disclosures in future filings as needed.

(c)

New Accounting Standards Not Yet Adopted

The FASB has issued several new accounting pronouncements during the first nine months of 2025 which the Company has reviewed. Based on this assessment, the Company has determined that there are no new accounting pronouncements issued but not yet adopted that would have a material impact on the Company's financial position, results of operations, or cash flows.

For further details on new accounting pronouncements issued in prior years but not yet adopted, refer to Note 2(aa) in the consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

GOING CONCERN

The condensed consolidated financial statements have been prepared on the going concern basis, which contemplates continuity of normal business activities and realization of assets and discharges of liabilities in the ordinary course of business. As disclosed in the financial statements, the Group incurred loss after income tax of $65.2 million and had net cash outflows from operating activities of $59.3 million for the nine months ended September 30, 2025. As of September 30, 2025, the Group had a cash balance of $9.1 million.

The Group has been primarily investing in research and development activities associated with the continuing development and proposed commercialization of the DurAVR^® THV System. During the nine months ended September 30, 2025, amounts invested in research and development activities and general operations exceeded cash inflows associated with sales of ADAPT^® tissue products plus research and development tax incentives from the Australian government.

The Group anticipates that additional funds will need to be generated in order to achieve the Group’s long-term goals and complete the research and development of current products. The Group does not expect to generate significant revenue until after regulatory approvals to commercially sell the DurAVR^® THV System have been obtained and sales have commenced. The Group therefore expects to continue incurring losses in the near future.

To become and remain profitable, the Group has commenced conducting the global pivotal PARADIGM Trial and will seek to obtain regulatory approvals with the aim of commercializing, manufacturing and supplying products, including the DurAVR^® THV System, that generate significant revenue. For medtech devices, including the DurAVR^® THV System, this will require the Group to successfully complete product clinical trials, develop and expand quality management systems, obtain regulatory approval post completion of clinical trials, expand manufacturing and distribution capabilities and comply with ongoing post-market regulatory requirements.

Prior to achieving commercialization, the Group will periodically require capital infusion through the issuance of shares of Common Stock, debt instruments, or other securities that can be converted into Common Stock. The future success of the Company is dependent on its ability to attract additional capital and ultimately, upon its ability to develop future profitable operations. There can be no assurance that the Company will be successful in obtaining such financing, or that it will attain positive cash flow from operations. If the Group is unable to obtain adequate capital resources to fund operations, it may be necessary to delay, scale back or eliminate some or all of its operations, which may have a material adverse effect on the business, results of operations and its ability to operate as a going concern. However, the Group has established a track record of successfully raising new capital and entering into debt facilities. This includes completing an IPO in the fourth quarter of 2024 of 14,800,000 shares of Common Stock for gross proceeds of $88.8 million before underwriting discounts, commissions and other transaction costs, as well as entering into binding subscription agreements and confirmation letters in October 2025 for a private placement totaling gross proceeds of $25.2 million, comprised of Common Stock and CHESS Depositary Interests (“CDIs”), both with accompanying warrants. Refer to Note 12 Subsequent Events for details.

The above conditions give rise to substantial doubt as to whether the Group will be able to continue as a going concern for one year from the issuance date of these financial statements.

The Company’s board of directors (the “Board”) and management believe that the going concern basis of preparation is appropriate for the reasons outlined above.

Should the Group be unable to continue as a going concern, it may be required to realize its assets and extinguish its liabilities other than in the ordinary course of business, and at amounts that differ from those stated in the financial statements. These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts or classification of liabilities and appropriate disclosures that may be necessary should the Group be unable to continue as a going concern.

INCOME TAX

The Company’s provision for interim periods is determined using an estimate of the annual effective tax rate, adjusted for discrete items arising in that period. The Company’s effective tax rate differs from the U.S. statutory tax rate primarily due to valuation allowances on its deferred tax assets as it is more likely than not that some, or all, of the Company’s deferred tax assets will not be realized. There was no income tax benefit for the nine months ended September 30, 2025 and September 30, 2024.

Deferred tax assets and liabilities are determined based upon the differences between the unaudited condensed consolidated financial statements carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company has provided a full valuation allowance against the net deferred tax assets as the Company has determined that it was more likely than not that the Company would not realize the benefits of net deferred tax assets.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

ACCRUED AND OTHER LIABILITIES


(in thousands)	September 30, 2025 $	December 31, 2024 $
Current
Accrued liabilities	4,264	4,490
Employee compensation and withholdings	3,946	3,989
Estimated legal contingency liability	-	1,440
Cash-settled stock-based payment provision	225	2
	8,435	9,921
Non-current
Employee compensation and retirement benefits	110	84
Lease asset retirement obligation	503	452
Cash-settled stock-based payment provision	-	222
Other variable liabilities	40	54
	653	812

EQUITY

Share Capital

For information on the pertinent rights and privileges of the Company’s outstanding shares, refer to Note 14 Equity in the audited consolidated financial statements for the year ended December 31, 2024 as included in the Annual Report.

The following details issuance of Common Stock in the nine months ended September 30, 2025:

●

In January 2025, in connection with the IPO which initially closed on December 16, 2024, TD Cowen, Barclays and Cantor (in their capacity as the underwriters’ representatives in the IPO) partially exercised the over-allotment option granted by the Company, pursuant to which the Company issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share for incremental gross proceeds of $0.5 million.

●

During the three months ended March 31, 2025, 831 unlisted options issued under the Employee Incentive Plan were exercised. These options had a weighted average exercise price of $3.99 per share.

●

In March 2025, the following directors exercised options:

–

Mr. John Seaberg exercised 40,000 options with an exercise price $7.13 per option and as a result was issued 3,852 shares of Common Stock. The intrinsic value of the 40,000 options represented the consideration for the issuance of the 3,852 shares.

–

Mr. Wayne Paterson exercised 233,000 options with an exercise price $7.13 per option and as a result was issued 12,607 shares of Common Stock. The net intrinsic value of the 233,000 options (after deduction of taxes and withholdings) represented the consideration for the issuance of the 12,607 shares.

–

Mr. Stephen Denaro exercised 16,500 options with an exercise price of $6.96 per share (AUD $11.20) raising $114,833.

●

During the three months ended March 31, 2025, external investors exercised 10,000 options for $6.22 per share (AUD $10.00), for gross proceeds of $0.1 million.

●

During the three months ended June 30, 2025, 283 unlisted options issued under the Employee Incentive Plan were exercised. These options had a weighted average exercise price of $2.39 per share.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

EQUITY (continued)

For the comparable nine-month period ended September 30, 2024, ATPL issued the following ordinary shares:

●

In January 2024, 667 unlisted options issued under the Employee Incentive Plan were exercised. These options had an exercise price of $5.67 equivalent per share (AUD $8.60).

●

In January 2024, external investors exercised 12,500 unlisted options for $6.70 equivalent per share (AUD $10.00) for gross proceeds of $0.1 million.

●

In March 2024, external investors exercised 262,000 unlisted options for $6.59 equivalent per share (AUD $10.00) for gross proceeds of $1.7 million.

●

In April 2024, 1,000,000 new shares were issued to various sophisticated and professional investors at $14.74 equivalent per share (AUD $23.00) for total consideration of $14.7 million.

●

In May 2024, external investors exercised 12,000 unlisted options for $6.60 equivalent per share (AUD $10.00) for gross proceeds of $0.1 million.

●

In July 2024, 1,875,000 new shares were issued to various sophisticated and professional investors at $10.49 equivalent per share (AUD $16.00) for total consideration of $19,668,000.

●

In July 2024, 41,000 new shares were issued to a consultant for services provided. The equivalent price per share was $10.49 (AUD $16.00).

●

In September 2024, external investors exercised 1,500 unlisted options for $6.84 equivalent per share (AUD $10.00) for gross proceeds of $10,300.

LOSS PER SHARE

The below table presents the computation of basic and diluted loss per share:


		Three months ended September 30,					Nine months ended September 30,
			2025		2024			2025		2024
Loss for the period, attributable to the owners of the Company	$’000		(22,244	)	(21,858	)		(64,942	)	(56,915	)
Weighted average number of shares outstanding: used in the denominator in calculating basic and diluted loss per share	Number		36,062,370		20,513,631			36,045,858		19,144,910
Basic and diluted loss per share	$		(0.62	)	(1.07	)		(1.80	)	(2.97	)
Securities excluded as their inclusion would be anti-dilutive	Number		3,890,493		6,168,195			3,890,493		6,168,195

Subsequent to the end of the reporting period, the Company issued (i) 2,346,936 shares of Common Stock, (ii) warrants to purchase 2,346,936 shares of Common Stock, (iii) 2,788,064 CDIs and (iv) warrants to purchase 3,038,064 CDIs. Refer to Note 12 Subsequent Events for details. The issuance of the additional shares of Common Stock has a material impact on the Company’s loss per share calculations. After the issuance, the basic and diluted loss per share for the three months ended September 30, 2025 would have been a loss of $0.54 per share, reflecting a change of $0.08 per share. The basic and diluted loss per share for the nine months ended September 30, 2025 would have been $1.58 per share, reflecting a change of $0.22 per share.

The financial statements for the period ended September 30, 2025 do not reflect the effects of this issuance, which will be included in the financial statements for the subsequent period.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

STOCK-BASED COMPENSATION

(a)

Stock-based compensation expense

The following table presents the components and classification of stock-based compensation expense recognized for stock options, cash-settled stock-based payments rights (“SPPs”), restricted stock units (“RSUs”) and shares of Common Stock issued to employees, directors and consultants:


	Three months ended September 30,				Nine months ended September 30,
(in thousands)		2025 $	2024 $			2025 $	2024 $
Equity-settled stock-based payments (including stock options and RSUs)		1,505	1,804			4,749	4,999
Cash-settled stock-based payments (SPP rights)		98	(474	)		-	(249	)
Shares of Common Stock issued as compensation to consultants		-	215			-	215
Total stock-based compensation expense		1,603	1,545			4,749	4,965
Classification of stock-based compensation expense
Cost of products sold		11	1			24	3
Research and development expense		879	(58	)		2,422	761
Selling, general and administrative expense		713	1,602			2,303	4,201
Total stock-based compensation expense		1,603	1,545			4,749	4,965
Stock-based compensation capitalized to equity (transaction cost)		-	215			-	215
Total stock-based compensation		1,603	1,760			4,749	5,180

As of September 30, 2025, there was $5.6 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements granted. That cost is expected to be recognized over a weighted-average period of 1.4 years.

(b)

Stock-based awards activity

Director options

No options were issued to directors during the three or nine months ended September 30, 2025.

In March 2025, 289,500 director options were exercised, resulting in the issuance of 32,959 shares of Common Stock. Refer to Note 6 Equity.

On June 19, 2024, following approval by ATPL shareholders at the Annual General Meeting on May 29, 2024, ATPL issued options to purchase an aggregate of shares with an exercise price of $15.34 equivalent (AUD $23.00) per share to the following directors:

John Seaberg (Chair) – 75,000 options

Wayne Paterson (CEO and Managing Director) – 300,000 options

Stephen Denaro (Non-Executive Director and Company Secretary) – 50,000 options

Dr Wenyi Gu (Non-Executive Director) – 50,000 options

The above director share options expire after 5 years and vest in three tranches on the completion of at least 12, 24 and 36 months of service from the date of issue. These options were awarded as part of the existing Employee Incentive Plan.

Following Dr W. Gu’s resignation on June 6, 2025, 50,000 unvested options were forfeited in accordance with the original terms of the awards.

Director RSUs

On August 19, 2025, in accordance with the Company’s Non-Employee Director Compensation Policy, the Company contingently granted RSUs with a grant date fair value of $250,000 to each of the Company’s new directors, Greg Moss and David Roberts. Each grant is subject to stockholder approval in accordance with the rules of the ASX. Each grant of RSU will vest in three tranches on the completion of at least 12, 24 and 36 months of service from the date of contingent grant.

As of September 30, 2025, no stock-based compensation expense has been recognized for these RSUs, as the grant date has not been established under ASC 718.

Employee stock options

During the three and nine months ended September 30, 2025, 21,500 employee stock options were issued. During the same periods, 69,166 and 92,166 employee stock options were cancelled due to expiration or forfeiture, respectively.

During the three and nine months ended September 30, 2024, the Company issued 9,450 and 167,950 employee stock options, respectively. During the same periods, 1,000 and 1,584 employee stock options were cancelled due to expiration or forfeiture, respectively.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

STOCK-BASED COMPENSATION (continued)

Consultant options and share grants

No options or shares were issued to consultants during the three or nine months ended September 30, 2025. In February 2025, 500,000 stock options held by consultants expired unexercised. An additional 500,000 consultant-held options expired unexercised in September 2025.

During the three and nine months ended September 30, 2024, 41,000 ordinary shares were issued to a consultant as compensation for services received.

RSUs

The number of RSUs granted to employees under the Company’s Equity Incentive Plan during the three and nine months ended September 30, 2025 were 19,500 and 546,550, respectively. These RSUs generally vest over a service period of three years, subject to continued employment, and are settled in shares of Common Stock upon vesting.

A total of 44,350 and 83,650 RSUs were forfeited upon cessation of employment during the three and nine months ended September 30, 2025, respectively.

No RSUs were granted during the three or nine months ended September 30, 2024.

SPP rights

No SPP rights were issued during the three or nine months ended September 30, 2025 or 2024. The carrying amount of the SPP liabilities was $0.2 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively.

On September 13, 2025, 283,332 SPP rights were forfeited and cancelled as the share price on the vesting date was less than the base price.

(c)

Fair Value Disclosures

Director options

The following table provides the fair value of the stock-based payments options granted to directors during the periods indicated and the inputs used in the Black-Scholes model.


	Three months ended September 30,			Nine months ended September 30,
		2025	2024		2025	2024
Quantity issued during the period		-	-		-	475,000
Weighted average fair value per option at grant date		-	-		-	$4.87
Assumptions used:
Share price at grant date		-	-		-	$12.62
Exercise price		-	-		-	$15.29
Expected volatility range		-	-		-	52.5% - 60.0%
Expected life range		-	-		-	3 - 4 years
Expected dividends		-	-		-	Nil
Risk-free interest rate range		-	-		-	4.07% - 4.08%

Employee options

The following table provides the weighted average fair value of options granted to employees during the periods indicated and the related weighted average inputs (based on number of options granted) used in the Black-Scholes model.


	Three months ended September 30,			Nine months ended September 30,
		2025	2024		2025	2024
Quantity issued during the period		21,500	9,450		21,500	167,950
Weighted average fair value per option at grant date		$2.48	$4.78		$2.48	$7.50
Assumptions used:
Share price at grant date range		$3.80	$11.31		$3.80	$11.31 - $15.39
Exercise price range		$3.80	$11.63		$3.80	$10.87 - $13.02
Expected volatility range		67.5% - 72.5%	52.5% - 60.0%		67.5% - 72.5%	52.5% - 65.0%
Expected life range		5.5 - 6.5 years	3 - 4 years		5.5 - 6.5 years	3 - 4 years
Expected dividends		Nil	Nil		Nil	Nil
Risk-free interest rate range		3.88% - 3.99%	4.04% - 4.06%		3.88% - 3.99%	3.63% - 4.06%

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

STOCK-BASED COMPENSATION (continued)

RSUs

The weighted-average grant date fair value of RSUs granted during the three and nine months ended September 30, 2025 was $3.80 and $3.46 per RSU, respectively. The fair value of the RSUs was determined based on the market value of the Common Stock on the grant date, which represents the fair value of the underlying shares.

SPP rights

The inputs used in the measurement of the fair values at reporting date of the SPP rights were as follows:


Service based SPP		September 30, 2025			December 31, 2024
Weighted average fair value per right	$	0.13		$	0.12
Share price at measurement date	$	4.50		$	5.58
Base price	$	15.28		$	15.28
Expected volatility (weighted average)		76.0	%		51.3	%
Expected life (weighted average)		1.0 years			1.2 years
Risk-free interest rate (based on government bonds)		3.68	%		4.21	%


Service and performance based SPP		September 30, 2025			December 31, 2024
Weighted average fair value per right	$	0.42		$	0.71
Share price at measurement date	$	4.50		$	5.58
Base price	$	15.28		$	15.28
Expected volatility (weighted average)		70.0	%		57.5	%
Expected life (weighted average)		2.0 years			2.7 years
Risk-free interest rate (based on government bonds)		3.60	%		4.27	%

VARIABLE INTEREST ENTITY

At each reporting period, the Company reassesses whether it remains the primary beneficiary for VIEs consolidated under the VIE model. Pursuant to the guidance under ASC 810, the Company determined that v2vmedtech, inc. (“v2v”) is a VIE and that the Company is the primary beneficiary of v2v. This determination is based on the Company having both power over the most significant activities of v2v, primarily through appointing and holding a majority of v2v’s board of directors and certain benefits through equity ownership. Therefore, the Company consolidated v2v from the acquisition date of its equity interest.

The following table presents the assets and liabilities for VIEs:


	AS OF
(in thousands)		September 30, 2025 $		December 31, 2024 $
Assets
Other current assets		21		28
Total assets		21		28
Liabilities
Other current liabilities		466		86
Non-current liabilities		39		54
Total liabilities		505		140
Net (liabilities)/assets		(484	)	(112	)

Included in other current liabilities is a loan to v2v from v2v’s parent entity amounting to $20,100 as of September 30, 2025 and $20,800 as of December 31, 2024. This loan has been provided to support v2v’s working capital needs. It is unsecured and repayable on demand. This balance is eliminated in the condensed consolidated financial statements. v2v is wholly financed by the Group. The Group contributed $1.0 million and $1.7 million to v2v to finance its operations during the three months and nine months ended September 30, 2025.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

VARIABLE INTEREST ENTITY (continued)

Non-controlling Interests

The Company recognizes non-controlling interests related to v2v and provides a roll forward of the non-controlling interests balance, as follows:


(in thousands)	2025 $		2024 $
Balance as of December 31 prior year	(79	)	(403	)
Net (loss)/gain attributable to non-controlling interests	(67	)	197

Balance as of March 31			(146	)			(206	)
Net (loss) attributable to non-controlling interests			(228	)			(112	)

Balance as of June 30	(374	)	(318	)
Net gain attributable to non-controlling interests	35		64
Balance as of September 30	(339	)	(254	)

10.

COMMITMENTS AND CONTINGENCIES

As of September 30, 2025, the Group had commitments to purchase $0.3 million of plant and equipment, as compared to $0.3 million at December 31, 2024.

The Company is involved in various ongoing proceedings arising in the normal course of business, including proceedings related to product, labor, intellectual property and other matters.

Contingent liabilities

The Group has evaluated its contingent liabilities and determined that there are no material contingent liabilities requiring disclosure as of September 30, 2025.

11.

SEGMENT REPORTING

(a)

Description of segments

Segment information is presented using a management approach, meaning that segment information is provided on the same basis as information is used for internal reporting purposes by the chief operating decision maker (“CODM”) which is the Company’s Vice Chairman and CEO, who makes key strategic decisions. The CODM is responsible for the allocation of resources and assessing the performance of the Group. Management has determined that the activities of the business as reviewed by the CODM are one segment, being the development and commercialization of the ADAPT^® anti-calcification tissue. This is focused on the DurAVR^® THV System.

(b)

Segment information

The revenue and cost information relating to all of the ADAPT^® products including both the DurAVR^® THV System and regenerative tissue products are regularly reviewed by the CODM on an aggregate basis.

The CODM assesses performance and allocates resources based on the Company’s Condensed Consolidated Statements of Operations and key components and processes of the Company’s operations are managed centrally. Segment asset information is not used by the CODM to allocate resources. As a single reportable segment entity, the Company’s segment performance measure is net income or loss.



	Three months ended September 30,				Nine months ended September 30,
(in thousands)	2025 $		2024 $			2025 $		2024 $
Net sales from external customers	429		769			1,603		2,167
Depreciation & amortization	(417	)	(381	)		(1,238	)	(1,103	)
Interest income	147		105			629		371
Interest expense	(15	)	(12	)		(63	)	(39	)
Other segment items	(22,353	)	(22,275	)		(66,133	)	(58,162	)
Segment net loss	(22,209	)	(21,794	)		(65,202	)	(56,766	)

No detailed asset information by reportable segment has been reported given that the single segment’s information is already presented in the Condensed Consolidated Balance Sheets. Refer to the Condensed Consolidated Statements of Cash Flows for significant non-cash items and total expenditure for additions of long-lived assets.

ANTERIS TECHNOLOGIES GLOBAL CORP.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025

11.

SEGMENT REPORTING (continued)

(c)

Geographic information

Segment revenues (net sales) have been based on the geographic location of the customers taking possession of the products.


	Three months ended September 30,			Nine months ended September 30,
(in thousands)		2025 $	2024 $		2025 $	2024 $
United States		420	444		1,306	1,558
Australia		9	6		25	13
Germany		-	319		272	596
		429	769		1,603	2,167

(d)

Major customers

The following table summarizes revenues from major customers that individually accounted for 10% or more of the Company's total revenues.


	Three months ended September 30,			Nine months ended September 30,
(in thousands)		2025 $	2024 $		2025 $	2024 $
Customer A		-	347		272	1,008
Customer B		420	416		1,306	1,146

The total amounts outstanding from these customers was $0.2 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively.

12.

SUBSEQUENT EVENTS

Management has evaluated the impact of subsequent events through November 12, 2025.

Capital Raising Activities

On or about October 23, 2025, the Company entered into (i) subscription agreements (the “Subscription Agreements”) with certain investors, pursuant to which the Company issued and sold an aggregate of 2,346,936 shares of Common Stock (the “Shares”), each with an accompanying warrant (a “Common Stock Warrant”) to purchase one share of Common Stock, at a price of US$4.90 per share of Common Stock and accompanying Common Stock Warrant (the “Common Stock Offering”), and (ii) confirmation letters (the “Confirmation Letters”) with certain investors, pursuant to which the Company issued and sold 2,788,064 CDIs, each with an accompanying warrant to purchase one CDI (a “CDI Warrant”), at a price of A$7.50 per CDI and accompanying CDI Warrant (the “CDI Offering,” and together with the Common Stock Offering, the “Private Placement”). The Private Placement generated gross proceeds totaling approximately $25.2 million, which have been received. The Common Stock Offering closed on October 27, 2025 and the CDI Offering closed on November 5, 2025. The Company also issued 250,000 CDI Warrants to the lead manager of the Private Placement.

The issuance and sale of the Shares, Common Stock Warrants, CDIs and CDI Warrants pursuant to the Subscription Agreements and Confirmation Letters were not, and the issuance of the Common Stock Warrant Shares and CDI Warrant Shares will not be, registered under the Securities Act and were and will be issued and sold in reliance on the exemption provided by Section 4(a)(2) of the Securities Act, including under Rule 506 of Regulation D promulgated thereunder, with respect to the Shares, the Common Stock Warrants and the Common Stock Warrant Shares, and Regulation S with respect to the CDIs, CDI Shares, CDI Warrants, and CDI Warrant Shares.

Each of the Common Stock Warrants and the CDI Warrants is exercisable commencing six months after issuance and expires five years from issuance.

The Private Placement closed after the balance sheet date and will be reflected in the next reporting period.

European Regulatory Clearance

Following receipt of the first European regulatory clearance from the Danish Medicines Agency in October 2025, the first patients were enrolled and treated in the PARADIGM Trial.

FDA IDE Approval

In early November 2025, the Company announced U.S. Food and Drug Administration (“FDA”) approval to initiate the PARADIGM Trial, which is designed to evaluate the DurAVR^® THV in patients with severe calcific aortic stenosis and to support a future Premarket Approval application submission.

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and amended on April 29, 2025 (as amended, the “Annual Report”). Except for historical information, the matters discussed in this MD&A contain various forward-looking statements that involve risks and uncertainties and are based upon judgments concerning various factors beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements. Please also see the section of this Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.”

Overview

Anteris is a structural heart company dedicated to revolutionizing cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Our lead product, the DurAVR^® THV System, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis— a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. Our DurAVR^® THV System consists of a single-piece, biomimetic valve made with our proprietary ADAPT^® tissue-enhancing technology and deployed with our balloon expandable ComASUR^® Delivery System. ADAPT^® is our proprietary anti-calcification tissue shaping technology that is designed to reengineer xenograft tissue into a pure, single-piece collagen bioscaffold. Our patented ADAPT^® tissue has been clinically demonstrated to be calcium free for up to 10 years post-procedure, according to Performance of the ADAPT-Treated CardioCel^® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, published by William Neethling et. al., and has been distributed for use in over 55,000 patients globally in other indications. Our balloon expandable ComASUR^® Delivery System, which was developed in consultation with physicians, is designed to provide precise alignment with the heart’s native commissures to achieve accurate placement of the DurAVR^® THV. As of September 2025, a total of 130 patients have been treated with the DurAVR^®THV worldwide.

On December 12, 2024, our Registration Statement relating to our initial public offering (the “IPO”) became effective pursuant to which we issued and sold 14,800,000 shares of our Common Stock at a public offering price of $6.00 per share. On January 14, 2025, TD Cowen, Barclays and Cantor (the underwriters’ representatives) partially exercised the over-allotment option granted by the Company, pursuant to which we issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share. We received net proceeds of $80.0 million for the IPO and subsequent over-allotment option, after deducting the underwriting discounts, commissions and offering expenses.

During the third quarter of 2025, we advanced regulatory activities in parts of Europe, with the goal of securing clearance to commence the PARADIGM Trial in those countries. In October 2025, we secured the first European regulatory clearance in Denmark and subsequently enrolled and treated the first patients marking the formal initiation of the PARADIGM Trial. We continued to engage with the U.S. Food and Drug Administration (the “FDA”) during the quarter, to advance the Investigational Device Exemption (“IDE”) for the PARADIGM Trial, which FDA approval was received for in the fourth quarter of 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (“IRB”) approval.

The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR^® THV or TAVR using a commercially available and approved THV in an “All Comers Randomized Cohort.” The primary end point of the PARADIGM Trial is a composite of all-cause mortality, all stroke and cardiovascular hospitalization at 1-year post-procedure. The endpoint will be evaluated as a non-inferiority analysis. We anticipate that the subjects will include a broad array of risk profiles. Subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry.

It is anticipated that the design of the PARADIGM Trial will provide the primary clinical evidence on which the FDA could base a decision for the Premarket Approval (“PMA”) that is required for commercialization of the DurAVR^®THV System in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.

We continued strengthening our operational infrastructure during the third quarter of 2025, advancing quality management system (“QMS”) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR^® THV demand.

Financial Overview

As a development-stage company, we have incurred losses since our inception. We anticipate that we will continue to incur losses for the foreseeable future and there can be no assurance that we will ever achieve or maintain profitability.

We expect expenses for our research, clinical validation, development, design, manufacturing and marketing will increase and, as a result, we will need additional capital to fund our operations. Any future funding could involve a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.

Any failure to raise capital or enter into such other arrangements as and when needed could have a negative impact on our financial condition and our ability to market our products.

During October and November 2025, we completed a private placement of Common Stock and CDIs, each with accompanying warrants, generating gross proceeds of approximately $25.2 million. The transaction closed after the balance sheet date and will be reflected in the next reporting period.

Principles of Consolidation and Operating Segments

The condensed consolidated financial statements include the accounts for our company, our wholly-owned subsidiaries, and entities for which we have a controlling financial interest, and, for periods prior to the series of reorganization transactions we completed prior to our IPO (the “Reorganization”), the accounts of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), its wholly-owned subsidiaries, and entities for which ATPL had a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.

Our management has determined that the activities of the business as reviewed by our Company’s Vice Chairman and CEO, who also serves as the Company’s chief operating decision maker, are one segment, being the development and commercialization of the ADAPT^® anti-calcification tissue. This is focused on the DurAVR^® THV System.

Components of Results of Operations

Revenue and Other Income

We currently derive revenue from the sale of regenerative tissue products. Such sales have historically been made principally to 4C Medical Technologies, Inc. (“4C”) and to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold the distribution rights for CardioCel™ and VascuCel™ in 2019 in order to focus on development of our proprietary ADAPT^® tissue for the DurAVR^® THV System. Concurrent with such sale, we entered into a Transition Services Agreement pursuant to which we manufactured and sold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025 and we do not expect to receive any ongoing revenues from LeMaitre associated therewith. The Supply and License Agreement with 4C, which had an initial seven-year term that ended on June 1, 2025, and was automatically renewed for a one-year term in accordance with its renewal provisions. Successive one-year terms automatically renew under the Transition Services Agreement absent prior indication to the contrary. Either we or 4C may terminate the 4C Agreement upon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent, files a petition for bankruptcy or upon the occurrence of similar events.

We earn other income primarily from tax incentive payments under the Australian Government’s R&D Tax Incentive Plan for research and development (“R&D”) activities conducted in Australia that meet specified regulatory criteria. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than AUD $20.0 million. Eligible companies can receive a refundable tax offset for a percentage of their R&D spending.

Expenses

Our most significant expenses are R&D and selling, general and administrative expenses.

Cost of products sold reflects the manufacturing cost from the sale of regenerative tissue products to 4C and to LeMaitre. These expenditures include raw materials and consumables, plus other costs attributable to the manufacturing of these products.

R&D Expense

R&D has been a significant focus for us with investments in the DurAVR^® THV System, including the DurAVR^® THV, the ComASUR^® delivery system, a disposable crimper, and an expandable access sheath, as we aim for commercialization. These components are collectively managed as part of the overall DurAVR^® THV System rather than as separate projects. Since late 2021, when our DurAVR^® THV was first used in human trials in Tbilisi, Georgia, R&D efforts have focused on incorporating feedback from the clinical trials and progressing towards commercialization. These costs have included, among others, preclinical and clinical studies, design iterations, lab services, clinical data monitoring, project and site management, travel, data management and safety of the study.

During the nine months ended September 30, 2025, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR^® THV, ComASUR^® Delivery System, crimper, E-sheath) is being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity relative to 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT^® tissue for the DurAVR^® THV will be sourced from both the United States and Australia moving forward to help mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success.

Going Concern

Our ability to continue as a going concern is dependent upon securing additional funds. Our ability to access capital may be impacted by various factors including economic conditions, a decline in investor confidence and sub-optimal preclinical or clinical outcomes from trials and studies. Limited access to capital may delay the development of our product portfolio, extend the timeline to commercialization, or lead to other operational impacts.

We believe that we have the ability to raise additional funds. Notwithstanding the above factors, our future success is dependent on our ability to attract additional capital and, ultimately, on our ability to develop future profitable operations. If we do not receive sufficient cash inflows, there is substantial doubt as to whether we will be able to continue as a going concern.

In October and November 2025, we completed a private placement of our Common Stock, CDIs and accompanying warrants that generated approximately $25.2 million in gross proceeds, which have been received.

The audit report covering the December 31, 2024 and 2023 consolidated financial statements contains a paragraph that states that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. See Note 3 Going Concern to the consolidated financial statements included in our Annual Report and Note 3 Going Concern to the condensed consolidated financial statements included in this Quarterly Report.

Initial Public Offering and Reorganization

On December 12, 2024, our registration statement on Form S-1 (File No. 333-283414) (the “Registration Statement”) relating to our IPO became effective pursuant to which we issued and sold 14,878,481 shares of Common Stock at a public offering price of $6.00 per share. We received net proceeds of $80.0 million, after deducting the underwriting discounts, commissions and offering expenses and giving effect to the exercise of the underwriters’ option to purchase additional shares. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates.

Prior to the consummation of the IPO, we completed the Reorganization pursuant to which we received all of the issued and outstanding shares of ATPL, which was formerly an Australian public company originally registered in Western Australia, Australia and listed on the ASX, pursuant to a scheme of arrangement under Australian law between ATPL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act 2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATPL also cancelled all existing options it had on issue in exchange for our company issuing replacement options to acquire Common Stock pursuant to a scheme of arrangement between ATPL and its optionholders (the “Option Scheme”) under Part 5.1 of the Corporations Act. The Scheme was approved by ATPL’s shareholders at a general meeting of shareholders, which was held on December 3, 2024. The Option Scheme was approved by ATPL’s optionholders at a general meeting of optionholders held on the same day. ATPL obtained approval of the Scheme and the Option Scheme by the Supreme Court of Queensland on December 4, 2024. As a result of the Reorganization, ATPL became a wholly owned subsidiary of our company and the shareholders of ATPL immediately prior to the consummation of the IPO became holders of either one share of Common Stock for every ordinary share of ATPL or one CDI for every one ordinary share of ATPL for each share held as of the record date.

In connection with the Reorganization, on December 16, 2024, we issued (i) 21,139,816 shares of Common Stock to shareholders of ATPL, 20,360,496 of which were represented by CDIs, pursuant to the Scheme and (ii) 6,118,807 options to purchase shares of Common Stock pursuant to the Option Scheme. The foregoing issuances were made pursuant to an exemption from registration under Section 3(a)(10) of the Securities Act. Each option is exercisable into one share of Common Stock, including as represented by a CDI, upon the payment of the relevant exercise price.

Results of Operations

The following tables set forth our results of operations (in thousands, except percentages).


	Three Months Ended September 30,										Nine Months Ended September 30,
	2025				2024				% Change		2025				2024				% Change
Net sales		$	429			$	769		(44	)%		$	1,603			$	2,167		(26	)%
Costs and expenses:
Cost of products sold			(123	)			(443	)	(72	)%			(478	)			(1,229	)	(61	)%
Research and development expense			(16,810	)			(13,946	)	21	%			(49,606	)			(38,135	)	30	%
Selling, general and administrative expense			(5,761	)			(6,977	)	(17	)%			(16,448	)			(19,656	)	(16	)%
Operating loss			(22,265	)			(20,597	)	8	%			(64,929	)			(56,853	)	14	%
Other non-operating income, net			147				123		20	%			386				637		(39	)%
Interest and amortization of debt discount and expense			(15	)			(11	)	36	%			(63	)			(39	)	62	%
Net foreign exchange (losses)/gains			(83	)			(1,290	)	(94	)%			(611	)			(457	)	34	%
Fair value movement of derivatives			7				(19	)	(137	)%			15				(54	)	(128	)%
Loss before income taxes from continuing operations			(22,209	)			(21,794	)	2	%			(65,202	)			(56,766	)	15	%
Income tax (expense)/benefit			-				-		-				-				-		-
Loss after income tax			(22,209	)			(21,794	)	2	%			(65,202	)			(56,766	)	15	%
Total (loss)/gain is attributable to:
Non-controlling interests			35				64		(45	)%			(260	)			149		(274	)%
Stockholders of the Company		$	(22,244	)		$	(21,858	)	2	%		$	(64,942	)		$	(56,915	)	14	%

Net Sales

Net sales during the three months ended September 30, 2025 was $0.4 million, compared to $0.8 million for the same period in the prior year. Net sales during the nine months ended September 30, 2025 was $1.6 million, compared to $2.2 million for the same period in the prior year. The movements in each period are primarily due to the Transition Services Agreement with LeMaitre, which included sales of CardioCel™ and VascuCel™ products, expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.

Cost of Products Sold

Cost of products sold during the three months ended September 30, 2025 was $0.1 million, a decrease of $0.3 million (72%), compared to $0.4 million for the same period in the prior year. Cost of products sold during the nine months ended September 30, 2025 was $0.5 million, a decrease of $0.8 million (61%), compared to $1.2 million for the same period in the prior year. The movements in each period are primarily due to the change in net sales following the LeMaitre Transition Services Agreement expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.

R&D Expense

R&D expenses during the three months ended September 30, 2025 were $16.8 million, an increase of $2.9 million (21%), compared to $13.9 million for the same period in the prior year. This is primarily due to an increase of $5.8 million relating to the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, a further $1.0 million related to preparatory activities linked to the PARADIGM Trial, including the scaling of our field based clinical team and $0.3 million related to an increase in v2vmedtech development activities. These variances were partly offset by reduced DurAVR^® product research costs of $4.6 million in the second quarter of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.

R&D expenses during the nine months ended September 30, 2025 were $49.6 million, an increase of $11.5 million (30%), compared to $38.1 million for the same period in the prior year. This is primarily due to an increase of $14.9 million relating to the upscaling of manufacturing and quality capabilities including process design and validation activities and the expansion of headcount, a further $3.4 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team and $0.5 million related to an expansion of our medical affairs activities. These variances were partly offset by lower DurAVR^® product research costs of $7.7 million in the nine months ended September 30, 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.

Selling, General and Administrative Expense

Selling, general and administrative expenses during the three months ended September 30, 2025 were $5.8 million, a decrease of $1.2 million (17%) compared to $7.0 million for the same period in the prior year, primarily due to a reduction of $0.9 million in share-based payment expenses associated with directors and executive management, $0.2 million lower travel and entertainment spend and a $0.1 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements, capital raising activities and other operational matters in 2025, and in 2024 included costs related to our re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO.

Selling, general and administrative expenses during the nine months ended September 30, 2025 were $16.4 million, a decrease of $3.2 million (16%) compared to $19.7 million for the same period in the prior year, primarily due to a $1.9 million decline in share-based payment expenses associated with directors and executive management, $0.5 million lower marketing spend, a $0.5 million reduction in travel and entertainment costs and a $0.4 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements, capital raising activities and other operational matters in 2025, and in 2024 included costs related to re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO.

Net Foreign Exchange (Losses)/Gains

Net foreign exchange losses during the three months ended September 30, 2025 were $0.1 million compared to $1.3 million of net foreign exchange losses for the same period in the prior year, a decrease of $1.2 million (94%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the third quarter of 2025, the United States dollar depreciated by 1% relative to the Australian dollar. In the third quarter of 2024, the United States dollar depreciated by 5% relative to the Australian dollar.

Net foreign exchange losses during the nine months ended September 30, 2025 were $0.6 million compared to $0.5 million of net foreign exchange losses for the same period in the prior year, a change of $0.2 million (34%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the nine months ended September 30, 2025, the United States dollar depreciated by 6% relative to the Australian dollar. In the nine months ended September 30, 2024, the United States dollar depreciated by 1% relative to the Australian dollar.

Liquidity and Capital Resources

Capital Requirements and Sources of Liquidity

We have experienced recurring operating losses and cash outflows from operating activities since inception. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $341.3 million and $276.4 million, respectively.

In recent years, our operations have mainly been financed through the issuance of capital stock, including through our IPO on the Nasdaq Global Market, the Private Placement, debt financing, convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. Additional funding has been derived from interest earned from cash deposits. As of September 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $9.1 million and $70.5 million, respectively. As of September 30, 2025 and December 31, 2024, we had capital commitments relating to the lease of properties of $2.2 million and $1.4 million, respectively. We did not have any other material capital expenditure commitments or contingent liabilities as of September 30, 2025 or December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following September 30, 2025. Even with the proceeds from the Private Placement, we will need additional capital to fund our operations. However, our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary materially.

We anticipate that we will require additional funds in order to achieve our long-term goals including completing the R&D of our current products and commercialization thereof. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur losses in the near future. In order to address our short-term capital needs, we intend to raise funds through the issuance of our capital stock or other securities.

Our future capital requirements are difficult to forecast and will depend on many factors, including:

●

the scope, results and timing of clinical trials;

●

the costs of preparing and completing the PARADIGM Trial of our DurAVR^® THV System;

●

the costs and time required to obtain pre-market approval from the FDA for our DurAVR^® THV System; and

●

the costs of establishing marketing, sales and distribution capabilities.

We may seek to raise any necessary capital through a combination of public or private equity offerings or debt financings. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we decide to raise capital by issuing equity securities, the issuance of such equity securities may result in dilution to our existing stockholders. We cannot give any assurance that we will be successful in completing any financings or that any such equity or debt financing will be available to us if and when required or on satisfactory terms.

Cash Flows

The following table summarizes our primary sources and uses of cash for the periods presented (in thousands, except percentages):


	Nine Months Ended September 30,
	2025				2024				% Change
Net Cash provided by (used in):
Operating activities		$	(59,276	)		$	(43,003	)	38	%
Investing activities			(199	)			(1,916	)	(90	)%
Financing activities			(1,827	)			34,432		(105	)%
Effect of exchange rate movements on cash, cash equivalents and restricted cash			(37	)			16		(331	)%
Net change in cash, cash equivalents and restricted cash		$	(61,339	)		$	(10,471	)	486	%

Operating Activities

Net cash used in operating activities during the nine months ended September 30, 2025 was $59.3 million, an increase of $16.3 million (38%), compared to $43.0 million in the same period in the prior year, primarily due to an increase in R&D expenses relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and an increase in salaries and wages linked to growth in headcount. This increase was partly offset by a reduction in selling, general and administrative expenses relating to lower marketing spending, a decline in travel and entertainment costs and a decrease in legal, tax and compliance costs linked to a reduction in costs from 2024, which included our re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO, relative to 2025, which included additional costs related to compliance with dual listing requirements and other operational matters. Additionally, $0.6 million of proceeds relating to the Australian R&D Tax Incentive were received in the nine months ended September 30, 2025. In 2024, this corresponding inflow was received in the fourth quarter.

Investing Activities

Net cash used in investing activities during the nine months ended September 30, 2025 was $0.2 million, compared to cash outflows of $1.9 million in the same period in the prior year, a decrease of $1.7 million (90%). This decrease primarily reflects the receipt of $1.4 million deferred proceeds from LeMaitre relating to the 2019 sale of distribution rights, for which there was no corresponding inflow in 2024. Additionally, investing cash outflows for plant and equipment were $0.3 million lower than in the same period in 2024.

Financing Activities

Net cash used in financing activities during the nine months ended September 30, 2025 was $1.8 million, compared to net cash inflows of $34.4 million in the same period of the prior year, a decrease of $36.3 million (105%). For the nine months ended September 30, 2025, we received net cash proceeds of $0.6 million from the issuance of shares of Common Stock, partially offset by $1.2 million in transaction costs related to our IPO, completed in December 2024, which were paid during the period. Additionally, $1.1 million of cash outflows were associated with supplier financing arrangements to fund our annual insurance premiums, an increase of $0.6 million on the same period in the prior year. For the nine months ended September 30, 2024, net cash provided by financing activities was $34.4 million, primarily reflecting proceeds from share issuances including the exercise of options for new shares in ATPL of $37.1 million, partly offset by $2.1 million in related transaction costs.

Contractual Obligations and Commitments

Leases

We lease laboratory and manufacturing facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between April 2026 and April 2030 and some include options to extend. At September 30, 2025, we had contractual commitments (on an undiscounted basis) for property leases of $2.8 million, which were recognized on a discounted basis at $2.2 million.

The locations and uses of our material properties are as follows:


Location of Facility	Lease expiry date	Extension options
11600-11628 96th Avenue North, Maple Grove, MN 55369 (1)	April 30, 2030	1 period of two years
26 Harris Road, Malaga WA 6090, Australia	July 31, 2026	-

(1) Predominantly used for R&D, manufacturing of the DurAVR^® valve and regulatory compliance teams. On April 30, 2025, we cancelled our sublease of the building without incurring a termination fee and entered into a new 5-year lease agreement directly with the landlord. As a result, we recognized a right-of-use asset and a corresponding lease liability of $1.6 million on the lease commencement date. This change provides longer-term access to the premises.

Commitments

At September 30, 2025, we had commitments to purchase $0.3 million of plant and equipment.

Off-Balance Sheet Arrangements

We currently do not have, and did not have during the periods presented, any off-balance sheet arrangements.

Critical Accounting Policies and Estimates

We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.

Our significant accounting policies are discussed in Note 2 Basis of Preparation and Summary of Significant Accounting Policies in our Annual Report. There were no significant changes to these policies during the nine months ended September 30, 2025.

Consolidation of VIEs

We consolidate a VIE when the reporting entity (a) has an economic interest in another legal entity (known as a “variable interest”) that conveys more than insignificant exposure to potential losses of or benefits from the other legal entity; and (b) has power over the most significant economic activities of the legal entity. There is significant judgment over the analysis to determine whether an entity is a VIE, to determine whether we have a variable interest and to determine whether we are the primary beneficiary of a VIE.

We determined that v2vmedtech, inc. (“v2v”) is a VIE and that we are the primary beneficiary of v2v. This determination is based on our having both power over the most significant activities of v2v, primarily through holding a majority of the positions on v2v’s board of directors (although v2v’s non-Anteris shareholder representative on the v2v board of directors presently maintains certain veto rights), controlling the appointment of the chief executive officer and chief financial officer roles, being the exclusive partner to develop v2v’s products, and benefits through equity ownership.

New Accounting Standards Not Yet Adopted

See Note 2 to our condensed financial statements included in Item 1 of this Quarterly Report on Form 10-Q for more information.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period for any new or revised accounting standards during the period in which we remain an emerging growth company.

As a result, the information that we provide to our investors may be different than what you might receive from other public reporting companies. However, we may adopt certain new or revised accounting standards early.

We are also a “smaller reporting company,” as defined in the Securities and Exchange Act of 1934, as amended (the “Exchange Act”). We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies. As a smaller reporting company, we will present only two years of audited annual financial statements, plus any required unaudited interim condensed financial statements, and related management’s discussion and analysis of financial condition and results of operations.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company, as defined by Rule 12b-2 under the Exchange Act, as amended and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.

Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As of September 30, 2025, management, with the participation and supervision of our Chief Executive Officer and our Chief Financial Officer, have evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, solely as a result of the material weaknesses in our internal control over financial reporting described below, as of September 30, 2025, our disclosure controls and procedures were not effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There are no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control financial reporting.

Previously Reported Material Weakness

In connection with the preparation of our financial statements for the years ended December 31, 2024 and 2023, management and our independent auditors identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting, which remained unremediated as of September 30, 2025. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

The material weaknesses identified by our management and our independent auditors related to (i) a lack of appropriately designed, implemented and documented procedures and controls, and (ii) deficiencies in the segregation of duties.

To remediate these material weaknesses, management has initiated a remediation plan, which includes formally documenting policies, processes, risks, and controls, and reviewing the design and operating effectiveness of key and non-key controls. Testing of operating effectiveness has commenced. Remediation actions are progressing as planned. Segregation of duties has been enhanced across the control environment and financial reporting systems through system automation, strengthened month-end controls, and strengthened month-end review procedures.

While we believe that these efforts will improve our internal control over financial reporting, the design and implementation of our remediation is ongoing and will require validation and testing of the design and operating effectiveness of our internal controls over a sustained period of financial reporting cycles. The actions that we are taking are subject to ongoing senior management review, as well as oversight by the Company’s Audit and Risk Committee. We will not be able to conclude whether the steps we are taking will fully remediate the material weaknesses in our internal control over financial reporting until we have completed our remediation efforts and subsequent evaluation of their effectiveness.

PART II. Other Information

Item 1.

Legal Proceedings

In the ordinary course of our operations, and from time-to-time, we are party to various claims and lawsuits.

We are not party to any material legal proceedings, and no such proceedings are, to management’s knowledge, threatened against us.

Item 1A. Risk Factors

We face a number of risks that could materially and adversely affect our business, results of operations, cash flow, liquidity, or financial condition. Please refer to the factors discussed in Part I, Item 1A. “Risk Factors” in the Annual Report. Other than the supplemental risk factor provided below, there have been no material changes or additions to our risk factors discussed in such report that could materially impact our business, results of operations, cash flow, liquidity, or financial condition.

Although we have received regulatory approvals to begin the PARADIGM Trial, there can be no guarantee that the study will be successful or that we will receive PMA from the FDA as a result.

Although we have received approval from the FDA to proceed with the PARADIGM Trial under the IDE, the current approval from the FDA to proceed could be revoked, the study could be unsuccessful, and PMA from the FDA may not be obtained or could be revoked. Even if we obtain PMA for our DurAVR^® THV System, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls. Any delay in, or failure to receive or maintain, clearance or approval for our DurAVR^® THV System could prevent us from generating revenue or achieving profitability. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products and adversely affect our reputation and the perceived safety and efficacy of our products.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

(a)

Recent Sales of Unregistered Securities

None.

(b)

Use of Proceeds

On December 12, 2024, our registration statement on Form S-1 (File No. 333-283414) (the “Registration Statement”) relating to our initial public offering became effective pursuant to which we issued and sold 14,878,481 shares of our Common Stock at a public offering price of $6.00 per share. The underwriters for the initial public offering were TD Securities (USA) LLC, Barclays Capital Inc., Cantor Fitzgerald & Co. and Lake Street Capital Markets, LLC. We received net proceeds of $80.0 million, after deducting the underwriting discounts, commissions and offering expenses and giving effect to the exercise of the underwriters’ option to purchase additional shares. None of the expenses associated with the initial public offering were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates. The use of proceeds from our initial public offering, as of September 30, 2025, was as follows:

●

$52.7 million for the ongoing development of DurAVR^® THV and the preparation and enrollment of the PARADIGM Trial of DurAVR^® THV for treating severe aortic stenosis; and

●

$18.3 million net, comprising the repayment of $7.0 million of debt (including the Obsidian convertible notes and options), net working capital, v2v expenditures and other general corporate purposes, offset by receipts from tax incentives.

(c)

Issuer Purchases of Equity Securities

None.

Item 3.

Defaults Upon Senior Securities.

Not applicable.

Item 4.

Mine Safety Disclosures.

Not applicable.

Item 5.

Other Information

Trading Plans - Directors and Officers

During the three months ended September 30, 2025, none of the Company's directors or officers adopted or terminated (i) any contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or (ii) any non-Rule 10b5-1 trading arrangement.

Item 6.

Exhibits

The exhibits listed in the Exhibit Index below are filed, furnished, or incorporated by reference as part of this report on Form 10-Q.

Exhibit Index


Exhibit Number	Description	Incorporated by Reference			Filed
Exhibit Number	Description	Form	Date	Number	Herewith
2.1†	Scheme Implementation Deed, dated August 13, 2024, by and between Anteris Technologies Global Corp. and Anteris Technologies Ltd	S-1	11/22/2024	2.1
3.1	Second Amended and Restated Certificate of Incorporation of Anteris Technologies Global Corp.	8-K	12/16/2024	3.1
3.2	Amended and Restated Bylaws of Anteris Technologies Global Corp.	8-K	12/16/2024	3.2
4.1	Reference is made to Exhibits 3.1 through 3.2
4.2	Form of Common Stock Warrant				X
4.3	Form of Confirmation Letter (containing the terms of the CDI Warrants)				X
10.1^†	First Amended and Restated Master Services Agreement, dated July 31, 2025, by and between Switchback Medical, LLC and Anteris Technologies Corporation				X
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
32.1*	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002				X
101.INS	XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.				X
101.SCH	XBRL Taxonomy Extension Schema Document.				X
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.				X
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.				X
101.LAB	XBRL Taxonomy Extension Label Linkbase Document.				X
101.PRE	XBRL Taxonomy Extension Presentation Linkbase.				X
104	Cover Page Interactive Data File (embedded within the Inline XBRL Document and contained in Exhibit 101)				X

This certification attached as Exhibit 32.1 that accompanies this Form 10-Q, is deemed furnished and not filed with the U.S. Securities and Exchange Commission (the “SEC”) and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.

†

Certain information in this exhibit has been redacted pursuant to Item 601(a)(6) of Regulation S-K.

Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. Anteris Technologies Global Corp. agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized, in the City of Eagan, State of Minnesota, on the 12th day of November, 2025.


Anteris Technologies Global Corp.

By:	/s/ Wayne Paterson
	Name:	Wayne Paterson
	Title:	Vice Chairman and Chief Executive Officer (Principal Executive Officer)


By:	/s/ Matthew McDonnell
	Name:	Matthew McDonnell
	Title:	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

Exhibit 4.2

THIS SECURITY REPRESENTED HEREBY HAS NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT UNDER ANY CIRCUMSTANCES BE OFFERED, TRANSFERRED, SOLD OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE FEDERAL, STATE AND FOREIGN SECURITIES LAWS.

COMMON STOCK PURCHASE WARRANT

ANTERIS TECHNOLOGIES GLOBAL CORP.

Warrant Shares: _______________

Issuance Date: October 27, 2025

THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, ____________________ or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after April 27, 2026 (the “Initial Exercise Date”) and on or prior to 5:00 p.m. (New York City time) on October 27, 2030, but not thereafter, to subscribe for and purchase from Anteris Technologies Global Corp., a Delaware corporation (the “Company”), up to _______________ shares (as subject to adjustment hereunder, the “Warrant Shares”) of common stock, par value $0.0001 per share (“Common Stock”) of the Company. The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b). This Warrant was issued pursuant to that certain Subscription Agreement, dated as of October 23, 2025, by and between the Company and the Holder (as may be amended, amended and restated, supplemented or otherwise modified from time to time in accordance with its terms, the “Subscription Agreement”).

Section 1. Definitions. In addition to the terms defined elsewhere in this Warrant, the following terms have the meanings indicated in this Section 1:

“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

“Bid Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

“Board of Directors” means the board of directors of the Company.

“Commission” means the United States Securities and Exchange Commission.

“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.

“Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

“Subsidiary” means any subsidiary of the Company and shall, where applicable, also include any direct or indirect subsidiary of the Company formed or acquired after the date hereof.

“Trading Day” means a day on which the Common Stock is traded on a Trading Market.

“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange, QTCQB or QTCQX (or any successors to any of the foregoing).

“Transfer Agent” means Computershare Investor Services, the current transfer agent of the Company and any successor transfer agent of the Company.

“VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

“Warrants” means this Warrant and other Common Stock Purchase Warrants issued by the Company pursuant to Other Subscription Agreements (as defined in the Subscription Agreement).

Section 2. Exercise.

a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date by delivery to the Company of a duly executed PDF copy submitted by e-mail (or e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined in Section 2(c)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required by the Company. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Trading Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

For the avoidance of doubt, there is no circumstance that would require the Company to net cash settle the Warrants.

b) Exercise Price. The exercise price per share of Common Stock under this Warrant shall be $7.50, subject to adjustment hereunder (the “Exercise Price”).

c) Mechanics of Exercise.

i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) the Warrant Shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144, and otherwise by crediting the account of the Holder in the DRS book entry system maintained by the transfer agent for the Common Stock, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earliest of (i) two (2) Trading Days after the delivery to the Company of the Notice of Exercise; provided that payment of the aggregate Exercise Price is received by the Company by such date, and (ii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise; provided that payment of the aggregate Exercise Price is received by the Company by such date (such date, the “Warrant Share Delivery Date”). Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the Warrant Shares, provided that payment of the aggregate Exercise Price is received within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date; provided that payment of the aggregate Exercise Price is received by the Company by such date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the third Trading Day after the Warrant Share Delivery Date) for each Trading Day after such Warrant Share Delivery Date until the earlier of such Warrant Shares being delivered or the Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Stock as in effect on the date of delivery of the Notice of Exercise.

ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(c)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.

v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

vi. Charges, Taxes and Expenses. The issuance and delivery of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

vii. Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

d) Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with (i) the Holder’s Affiliates, (ii) any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates, and (iii) and other Persons whose beneficial ownership of the shares of Common Stock would or could be aggregated with the Holder’s for the purposes of Section 13(d) of the Exchange Act (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of Warrant Shares issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of Warrant Shares which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(d), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(d) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination and shall have no liability for exercises of the Warrant that are not in compliance with the Beneficial Ownership Limitation, except to the extent the Holder relies on the number of outstanding shares of Common Stock that was provided by the Company. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, and the Company shall have no obligation to verify or confirm the accuracy of such determination and shall have no liability for exercises of the Warrant that are not in compliance with the Beneficial Ownership Limitation, except to the extent the Holder relies on the number of outstanding shares of Common Stock that was provided by the Company. For purposes of this Section 2(d), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company (including any public announcement on a securities exchange where the Company’s equity securities are listed) or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% (or, upon election by a Holder prior to the issuance of any Warrants, 9.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to the Warrant Shares issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(d), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of Warrant Shares upon exercise of this Warrant held by the Holder and the provisions of this Section 2(d) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61^st day after such notice is delivered to the Company. The provisions of this paragraph shall not be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(d) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant. If the Warrant is unexercisable as a result of the Holder’s Beneficial Ownership Limitation, no alternate consideration is owing to the Holder.

Section 3. Certain Adjustments.

a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any Warrant Shares issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification. Notwithstanding anything herein to the contrary, for so long as the Company’s CHESS Depositary Interests trade on the Australian Securities Exchange (the “ASX”), in the event of a reorganization of the Company’s capital the rights attaching to this Warrant, and the rights of the Holder, will be changed to the extent necessary to comply with the listing rules of the ASX (the “ASX Listing Rules”) applying to a reorganization of capital.

b) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution (provided, however, that, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

c) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person in which the Company is not the surviving entity (other than a reincorporation in a different state or jurisdiction), (ii) the Company or any Subsidiary, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of the assets of the Company and its Subsidiaries, taken together as a whole, in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of more than 50% of the aggregate voting power of all classes of equity of the Company, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Company’s Common Stock or any compulsory share exchange pursuant to which the Company’s Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, merger or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the aggregate voting power of all classes of equity of the Company (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(d) on the exercise of this Warrant), the number of securities of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(d) on the exercise of this Warrant). If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section 3(c) pursuant to written agreements in form and substance reasonably satisfactory to the Holder prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for, the term “Company” under this Warrant (so that from and after the date of such Fundamental Transaction, each and every provision of this Warrant referring to the “Company” shall refer instead to the Successor Entity) and may exercise every right and power of the Company and the Successor Entity shall assume all of the obligations of the Company under this Warrant with the same effect as if Successor, had been named as the Company herein.

d) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.

e) Notice to Holder.

i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by facsimile or email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

ii. Notice to Allow Exercise by Holder. If, while the Warrant is outstanding, (A) the Company declares a dividend (or any other distribution in whatever form) on the shares of Common Stock, (B) the Company declares a special nonrecurring cash dividend on or a redemption of the shares of Common Stock, (C) the Company authorizes the granting to all holders of the shares of Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company is required in connection with a Fundamental Transaction, or (E) the Company authorizes the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by facsimile or email to the Holder at its last facsimile number or email address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

f) Voluntary Adjustment by the Company. Subject to the rules and regulations of the Trading Market, the Company may at any time during the term of this Warrant reduce the then current Exercise Price to any amount and for any period of time deemed appropriate by the board of directors of the Company.

Section 4. Transfer of Warrant.

a) Transferability. Subject to compliance with any applicable securities laws, this Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date on which the Holder delivers an assignment form to the Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.

b) New Warrants. Subject to compliance with applicable securities laws, this Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

Section 5. Miscellaneous.

a) No Rights as Stockholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(c)(i), except as expressly set forth in Section 3. In no event shall the Company be required to net cash settle an exercise of this Warrant.

b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it, and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.

c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then, such action may be taken or such right may be exercised on the next succeeding Trading Day.

d) Authorized Shares.

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued shares of Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued and delivered as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued and delivered upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof that would require the application of the laws of any other jurisdiction. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, will have restrictions upon resale imposed by state and federal securities laws, and in such case, the Holder, by the acceptance hereof, represents and warrants that the Holder will acquire such Warrant Shares issuable upon such exercise for its own account and not with a view to or for distributing or reselling Warrant Shares or any part thereof in violation of the Securities Act or any applicable state securities law.

g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

h) Notices. Any and all notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at Anteris Technologies Global Corp., Toowong Tower, Level 3, Suite 302, 9 Sherwood Road, Toowong, QLD, Australia, Attention: Chief Financial Officer, or such other facsimile number, email address or address as the Company may specify for such purposes by notice to the Holders. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service addressed to each Holder in accordance with the notice provisions of the Subscription Agreement. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.

i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder or the beneficial owner of this Warrant, on the other hand.

m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

[Signature Page Follows]

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

	ANTERIS TECHNOLOGIES GLOBAL CORP.

	By:
	Name:
	Title:

NOTICE OF EXERCISE

TO: ANTERIS TECHNOLOGIES GLOBAL CORP.

(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2) Payment shall take the form of wire transfer in lawful money of the United States.

(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

The Warrant Shares shall be delivered to the following DWAC Account Number, if available, and otherwise registered in the below name and address in the DRS book entry system maintained by the transfer agent for the Common Stock:


[SIGNATURE OF HOLDER]

Name of Investing Entity:

Signature of Authorized Signatory of Investing Entity:

Name of Authorized Signatory:

Title of Authorized Signatory:

Date:

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to:

Name:
			(Please Print)
Address:
			(Please Print)
Phone Number:

Email Address:

Dated:

Holder’s Signature:

Holder’s Address:

Exhibit 4.3

Private and Confidential

[Name of Investor]

[Attention: [Insert]]

[Email]

URGENT

EMAIL CONFIRMATION REQUIRED BY [INSERT]

Dear Investor

Confirmation

1	Master ECM Terms

We refer to our earlier telephone conversation and confirm Your irrevocable agreement to acquire Your Allocation, upon the terms of this Confirmation and the Master ECM Terms (“Terms”) available on the AFMA website at https://afma.com.au/standards/standard-documentation.

You confirm (for the benefit of the Offeror, the Lead Manager and each of their respective Affiliates) that You have read and understood and agree to be bound by the Terms, including without limitation the Acknowledgements, Warranties, Undertakings and Foreign Jurisdiction Representations, as applied by and incorporated by reference into this Confirmation, any selling restrictions in the Information Materials and that You understand Your settlement obligations. You confirm that by acquiring Your Allocation, You will be deemed to have represented, warranted and agreed as to the matters covered by the provisions of the Terms that apply and are incorporated by reference into this Confirmation, and as to any additional representation, warranty, variation and agreement set out in this Confirmation.

Any capitalised term used but not defined in this Confirmation has the meaning given to it in the Terms.

2	Transaction Details

	Offeror (entity offering the Securities for issue or sale)	Anteris Technologies Global Corp ARBN 677 960 235 (“Offeror” or “Company”)
	Offer Structure	Non-underwritten institutional placement of Securities to eligible institutional investors and sophisticated investors of up to A$[insert] (“Offer”) The Company has received signed subscription agreements from eligible US investors to raise US$[insert], at an issue price of US$4.90 per share of common stock in the Company, with a free attaching warrant to acquire common stock at an exercise price of US$7.50 (“US Offer”, and together with the Offer, the “Global Offer”).

	Information Materials	As specified in paragraphs (a), (c), (d) and (g) in the definition of “Information Materials” in section 2.1 of the Terms, including without limitation the ASX announcement, the investor presentation and the cleansing notice that have been or will be lodged with the ASX in respect of the Global Offer, together with any amending, supplementary, further draft or replacement of those documents (“Information Materials”). These may be accessed at www.asx.com.au in addition to the Offer’s continuous disclosure announcements.

	Securities	New CHESS Depositary Interest in the Offeror (“CDIs”) Each new CDI will include one free attaching warrant to acquire a CDI, on the terms set out in Appendix 3 (“Warrants”).

	Price	A$7.50 per CDI

	Lead Manager	Evolution Capital Pty Ltd

	Settlement Date	[Insert time and date]

	Settlement Agent	Evolution Capital Pty Ltd

	Offering jurisdictions	Australia and [Insert]

	US Exemption(s)	Regulation S / Category 3

	Note: The offer and sale of the Securities have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state or other jurisdiction of the United States, and the Securities may not be offered, sold, pledged or otherwise transferred, directly or indirectly, in the United States without registration under the U.S. Securities Act (which You acknowledge none of the Issuer, the Offeror and the Lead Manager has any obligation to do or to procure) unless the Securities are offered, sold, pledged, transferred or otherwise disposed of in a transaction exempt from, or not subject to, the registration requirements of the U.S. Securities Act and the securities laws of any state or any other jurisdiction in the United States.

3	Your Allocation

You have been allocated the following Securities on and subject to the Terms:

Security	Price (per Security)	Number of Securities	Total Amount
CDIs	$[insert amount]	[insert number]	$[insert amount]
Warrants	N/A	[insert number]	N/A

4	Acknowledgements

The General Acknowledgements and the following Additional Acknowledgements apply:

(No disclosure document lodged with ASIC)

(On-Sale of Securities)

(Purpose of Offer)

5	Warranties

The General Warranties and the following Additional Warranties apply:

Nil

6	Undertakings

The General Undertakings and the following Additional Undertakings apply:

Nil

7	Foreign Jurisdiction Representations

The General Foreign Jurisdiction Representations apply, and the following Additional Foreign Jurisdiction Representations apply:

U.S. Offer – Section 4(a)(2) and Rule 506 of the U.S. Securities Act (offers and sales of Securities in the United States made only to “accredited investors” as defined in Rule 501 under U.S. Securities Act.

Non-U.S. Offer -- Regulatory S Offer – Category 2 – excluding Eligible U.S. Fund Manager (provided that any offer or sales of Securities made outside the United States must not be made to a U.S. Person as defined in Rule 801 under the U.S. Securities Act, or a person acting for the account or benefit of a U.S. Person).

The following additional representations apply:

References to “40 days” in the representation set forth in Section 2(4)(e), Section 2(4)(f) and Section 2(4)(g) of the Foreign Jurisdiction Representations shall be changed to “six months”.

Each distributor selling Securities to a distributor, a dealer (as defined in section 2(a)(12) of the U.S. Securities Act), or a person receiving a selling concession, fee or other remuneration, prior to the expiration of the six-month distribution compliance period, shall send a confirmation or other notice to the purchaser stating that the purchaser is subject to the same restrictions on offers and sales that apply to a distributor.

Variation

The following other terms apply:

The terms set out in Appendix 4 apply.

Timetable

The indicative Timetable for the Offer is set out in Appendix 1.

10	Confirmation of Allocation and Settlement Details

You must:

•

complete, sign and return by email or facsimile the attached Confirmation of Allocation by 4pm AEDT on 24 October 2025; and

•

provide Your Settlement Details (see below) by [time and date],

to the Lead Manager (to the attention of the person and to the relevant email address indicated in this Confirmation):

Evolution Capital Pty Ltd

Attention: [Insert]

Email: [Insert]

Any queries on the Offer may be directed to [insert name] of [insert] (Phone: [insert], Email: [insert])

Yours sincerely

[insert signatory]

Appendix 1 - Timetable

	Summary of Key Dates		Date/Time
	Trading halt		24 October 2025
	Return Confirmation of Allocation		4:00pm AEDT on 24 October 2025
	Announcement of Offer and trading halt lifted		24 October 2025
	Settlement of new CDIs		30 October 2025
	Allotment of new CDIs and Warrants Normal trading of new CDIs commences on ASX		7 November 2025 (or earlier, if determined by the Company)

The above timetable is indicative only and may change without notice to, or consultation with, You. All times are in Sydney, Australia time.

Appendix 2 – Confirmation of Allocation

PART 1 – DETAILS OF OFFER

	Entity	Anteris Technologies Global Corp ARBN 677 960 235
	Description of Offer	Non-underwritten institutional placement

PART 2 - DETAILS OF ALLOCATION:

Bidder Name	[Institution]
Contact Name	[Contact_Name]	Code	[Code]
Email	[Email]
	Number of Securities	Total Amount
CDIs	Alloc_Securities	A$Alloc_Value
Warrants	Alloc_Securities	N/A

PART 3 - SETTLEMENT DETAILS

	Trade Date		Settlement date		Price		Settlement Code		Settlement ISIN		Settlement SEDOL
	[Trade Date]		[Settlement Date]		A$[insert]/ CDI		[DVP Code]		[ISIN]

SETTLEMENT DATE: SETTLEMENT IS DELIVERY VERSUS PAYMENT ON [insert time and date]

In order for the Offeror to settle Your Securities on a delivery versus payment basis (“DvP”), please provide Your custodian details and Your various Allocation quantities (if applicable) either in the table below or via any electronic format or platform as agreed with the Lead Manager or by manual instructions via email to the Lead Manager at [insert email address] (Attn: [insert name]), in each case by no later than [insert time and date].]

You must also immediately instruct Your settling custodians to settle with [insert settlement agent] ([PID [INSERT NUMBER]]) on [insert date]] DvP with a Transaction basis of “I“ (IPO) and a stock code of "[insert settlement code]" quoting Bid Reference Number "[Code]”.

	ADDITIONAL INFORMATION
	Omgeo-CTM or IOS required? (Circle)	Yes	No	If Yes, which acronym / BIC?

Settlement Contact Details (Please provide details of Your settlement person’s name and contact numbers)

Australian Settlement Contact Name		Email address
		Phone No.

All settlement enquiries are to be directed to [insert name] of [insert] (Phone: [insert], Email: [insert])

PART 4 – DECLARATION

We confirm (for the benefit of the Offeror and the Lead Manager and each of their respective Affiliates):

•	our irrevocable agreement to acquire and pay the Price per Security for our Allocation on the Master ECM Terms available on the AFMA website at https://afma.com.au/standards/standard-documentation, as the Master ECM Terms are applied by and incorporated by reference into the Confirmation (“Terms”);

•

we have read and understood and agree to be bound by the Terms, including without limitation the Acknowledgments, Warranties, Undertakings, Variations and Foreign Jurisdiction Representations, as applied by and incorporated by reference into the Confirmation and any selling restrictions in the Information Materials; and

•	we understand our settlement obligations.

The Terms apply to this Confirmation of Allocation and any Settlement Details. Capitalised terms used but not defined in this document have the meaning given to them in the Terms.

We confirm (for the benefit of the Offeror and the Lead Manager and each of their respective Affiliates):

•	our agreement to the use of electronic signatures or other electronic records and acknowledge that an electronic signature or electronic record will have the same legal and binding effect as a physical or handwritten record of the same; and

•	our agreement to the use and digital storage of an electronic version of this document.

Appendix 3 – Terms of Warrants

1.	Definitions: In these terms of issue, the following defined terms have the following meanings:

ASX means ASX Limited, or the securities exchange operated by it, as the context requires.

Business Day means a ‘trading day’ (as defined in the ASX listing rules).

CDI means a CHESS Depositary Interest in Anteris Technologies Global Corp ARBN 677 960 235.

Exercise Notice means an exercise notice in the form enclosed with these terms.

Warrant means a warrant to acquire a CDI having the terms set out in this Appendix 3.

2.	Right to Security: Each Warrant gives the holder the right to be issued one CDI in accordance with these terms of issue.

3.	Exercise Price: The exercise price of each Warrant is A$11.50 (Exercise Price).

4.	Exercise Period: A Warrant may be exercised at any time commencing on the date which is six months after the date of issue of the Warrant until 5:00pm (AEST) on the date which is five years from the date of issue of the Warrant (Exercise Period).

5.	Method of Exercise: Warrants may be exercised by:

lodging with the Offeror during the Exercise Period a duly signed Exercise Notice, specifying the number of Warrants which are being exercised; and

payment of the Exercise Price by way of telegraphic transfer of cleared funds or a direct credit of cleared funds to the Offeror or any other method of providing the Exercise Price that is acceptable to the Offeror.

An Exercise Notice is only effective when the Offeror has received the full amount of the Exercise Price for the relevant Warrants being exercised in cleared funds.

6.	Issue of CDIs on exercise: Within 5 Business Days after receipt of full payment of the Exercise Price (and an Exercise Notice, if applicable), the Offeror will:

issue to the holder the number of CDIs specified or taken to be specified in the Exercise Notice;

cancel the certificate for the Warrants being exercised and update the register accordingly; and

if applicable, issue a new certificate for any unexercised Warrants.

Ranking: Except in relation to any restrictions on disposal of the CDIs by law or by agreement with the Offeror, all CDIs issued or transferred upon the exercise of Warrants will rank pari passu in all respects with other CDIs of the Offeror from the date of issue or transfer to the Holder, other than in respect of rights attaching to CDIs by reference to a record date prior to the date of their issue or transfer to the holder.

Transferability: Subject to compliance with all relevant laws, including U.S. securities laws, the Warrants may not be transferred at any time without the prior written consent of the Offeror. No transfer is effective until the Offeror processes the transfer, updates the register and issues a new certificate or confirmation to the new registered holder.

No Rights to Participate in New Issues: The holder has no right or entitlement, without exercising the Warrants, to participate in new issues of CDIs or other securities offered to the Offeror’s stockholders during the Exercise Period, whether by way of rights issue, bonus issue or other pro-rata offer of CDIs or other securities to stockholders.

10.

No Rights to Participate in Dividends: The holder has no right or entitlement to participate in any dividends of the Offeror until the CDI is issued to the holder on exercise of the Warrants and then only in respect of rights attaching to CDIs by reference to a record date on or after the date of their issue to the holder.

11.

Capital reconstruction: If there is a reorganisation of the issued capital of the Offeror while the Warrants are on issue, then, subject to the ASX listing rules, the number of CDIs to which a holder is entitled, or the Exercise Price (or both) will be proportionally adjusted to reflect the consolidation, sub-division, return of capital or other reorganisation. For so long as the Offeror is subject to the ASX listing rules, the rights of the holder under the terms of issue may be amended to the extent necessary to comply with the ASX listing rules (including ASX listing rule 6.22, or its replacement or successor) applying to a reorganisation of capital at the time of the reorganisation.

12.

No other rights: The Holder has no rights or entitlements in addition to those set out in clause 11 above to a change in the Exercise Price, or a change to the number of CDIs over which the Warrants can be exercised. Other than as set out in these terms of issue, the terms of the Warrants may only be amended by the Offeror with the consent of the holder and subject to applicable law, including the ASX listing rules and the Nasdaq listing rules.

13.	Quotation: The Warrants are unlisted and quotation of the Warrants will not be sought. The Offeror will immediately apply for quotation of the CDIs resulting from the exercise of Warrants on any applicable securities exchange on which such securities are quoted.

Form of Exercise Notice – Warrants

To: Anteris Technologies Global Corp (Company)

We, the undersigned, being the registered holder of the securities set out below, irrevocably exercise the following securities:

	Securities to be exercised		Securities to be received		Aggregate Exercise Price paid
	[insert] Warrants		[insert] CDIs		A$[insert]

We have enclosed receipt of payment of the full amount of the Exercise Price as set out above in full settlement of the Exercise Price for the securities hereby exercised.

Capitalised terms used in this notice but not otherwise defined herein have the meaning given in the confirmation letter governing the issuance of the securities dated [insert] October 2025.

Signed (for and on behalf of the registered holder set out below):

Name and title of authorised signatory:

Date:

Registered holder:

Address:

Appendix 4 – Additional terms

The Company agrees that, as promptly as reasonably practicable following allotment of the Securities, the Company will use its commercially reasonable efforts to file with the Securities and Exchange Commission (“Commission”) (at the Company’s sole cost and expense) a registration statement (the “Registration Statement”) registering the resale of the Registrable Securities (to the extent determinable at that time and capable of being so registered), and the Company shall use its commercially reasonable efforts to have the Registration Statement declared effective as soon as practicable after the filing thereof. The Company shall provide a draft of the Registration Statement to You (the “Subscriber”) for review at least two Business Days in advance of the date of filing the Registration Statement with the Commission (the “Filing Date”), and the Subscriber shall provide any comments on the Registration Statement to the Company no later than the day immediately preceding the Filing Date. Unless otherwise agreed to in writing by the Subscriber prior to the filing of the Registration Statement the Subscriber shall not be identified as a statutory underwriter in the Registration Statement; provided, that if the Commission requests that the Subscriber be identified as a statutory underwriter in the Registration Statement, the Subscriber will have the opportunity to withdraw from the Registration Statement upon its prompt written request to the Company. Notwithstanding the foregoing, if the Commission prevents the Company from including any or all of the Registrable Securities proposed to be registered under the Registration Statement due to limitations on the use of Rule 415 of the Securities Act of 1933, as amended (“Securities Act”) for the resale of the Registrable Securities by the applicable holders or otherwise, such Registration Statement shall register for resale such number of Registrable Securities which is equal to the maximum number of Registrable Securities as is permitted by the Commission. In such event, the number of Registrable Securities to be registered for each selling stockholder named in the Registration Statement shall be reduced pro rata among all such selling stockholders and as promptly as practicable after being permitted to register additional Registrable Securities under Rule 415 under the Securities Act, the Company shall amend the Registration Statement or file one or more new Registration Statement(s) (such amendment or new Registration Statement shall also be deemed to be “Registration Statement” hereunder) to register such additional Registrable Securities and cause such amendment or Registration Statement(s) to become effective as promptly as practicable after the filing thereof, but in any event no later than 30 calendar days after the filing of such Registration Statement (the “Additional Effectiveness Deadline”); provided, that the Additional Effectiveness Deadline shall be extended to 120 calendar days after the filing of such Registration Statement if such Registration Statement is reviewed by, and comments thereto are provided from, the Commission; provided, further, that the Company shall have such Registration Statement declared effective within ten Business Days after the date the Company is notified (orally or in writing, whichever is earlier) by the staff of the Commission that such Registration Statement will not be “reviewed” or will not be subject to further review; provided, further, that (i) if such day falls on a Saturday, Sunday or other day that the Commission is closed for business, the Additional Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business and (ii) if the Commission is closed for operations due to a government shutdown, the Effectiveness Date shall be extended by the same number of Business Days that the Commission remains closed for, provided that such extension shall not exceed 60 calendar days. Any failure by the Company to file a Registration Statement by the Effectiveness Deadline or Additional Effectiveness Deadline shall not otherwise relieve the Company of its obligations to file or effect a Registration Statement as set forth in Section 5. A “Business Day” shall be defined as a day other than Saturday, Sunday or other day on which commercial banks in New York, New York are authorized or required by law to close.

The Company agrees that, except for such times as the Company is permitted hereunder to suspend the use of the prospectus forming part of a Registration Statement, the Company will use its commercially reasonable efforts to cause such Registration Statement to remain effective with respect to the Subscriber, including to prepare and file any post-effective amendment to such Registration Statement or a supplement to the related prospectus such that the prospectus will not include any untrue statement or a material fact or omit to state any material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, until the earlier of (i) two years from the effective date of the Registration Statement, and (ii) the date on which all of the Registrable Securities shall have been sold and the Company shall use its commercially reasonable efforts to obtain the withdrawal of any order suspending the effectiveness of any Registration Statement as soon as reasonably practicable. For so long as the Registration Statement shall remain effective, the Company will use commercially reasonable efforts to file all reports, and provide all customary and reasonable cooperation, necessary to enable the Subscriber to resell the Registrable Securities pursuant to the Registration Statement, qualify the Registrable Securities for listing on the applicable stock exchange on which the Company’s shares of common stock are then listed, and update or amend the Registration Statement as necessary to include the Registrable Securities. The Company will use its commercially reasonable efforts to (i) for so long as the Subscriber holds the Registrable Securities, make and keep public information available (as those terms are understood and defined in Rule 144) and file with the Commission in a timely manner all reports and other documents required of the Company under the Securities Exchange Act of 1934, as amended (“Exchange Act”) and the General Rules and Regulations under the Exchange Act (“Exchange Act Rules”), so long as the Company remains subject to such requirements to enable Subscriber to resell the Registrable Securities pursuant to Rule 144, (ii) cause the removal of all restrictive legends from any Registrable Securities being sold under the Registration Statement or pursuant to Rule 144 at the time of sale of such Registrable Securities and, at the request of a Holder, cause the removal of all restrictive legends from any Registrable Securities held by such Holder that may be sold by such Holder without restriction under Rule 144, including without limitation, any volume and manner of sale restrictions, and (iii) cause its legal counsel to deliver the necessary legal opinions, if any, to the transfer agent in connection with the instruction under subclause (ii) upon the receipt of such supporting documentation, if any, as reasonably requested by such counsel. “Holder” shall mean the Subscriber or person to which the rights under this Appendix 4 shall have been assigned pursuant to the terms of this agreement. The Subscriber agrees to disclose its beneficial ownership, as determined in accordance with Rule 13d-3 of the Exchange Act, of the Registrable Securities to the Company (or its successor) upon reasonable request to assist the Company in making the determination described above.

The Company’s obligations to include the Registrable Securities in the Registration Statement are contingent upon the Subscriber furnishing in writing to the Company a completed selling stockholder questionnaire in customary form that contains such information regarding the Subscriber, the securities of the Company held by the Subscriber and the intended method of disposition of the Registrable Securities as shall be reasonably requested by the Company to effect the registration of the Registrable Securities, and the Subscriber shall execute such documents in connection with such registration as the Company may reasonably request that are customary of a selling stockholder in similar situations, including providing that the Company shall be entitled to postpone and suspend the effectiveness or use of the Registration Statement during any customary blackout or similar period or as permitted hereunder; provided, that the Company shall request such information from the Subscriber, including the selling stockholder questionnaire, at least five (5) Business Days prior to the anticipated filing date of the Registration Statement. For the avoidance of doubt, the Subscriber shall not in connection with the foregoing be required to execute any lock-up or similar agreement or otherwise be subject to any contractual restriction on the ability to transfer the Registrable Securities. In the case of the registration effected by the Company pursuant to this agreement, the Company shall, upon reasonable request, inform the Subscriber as to the status of such registration. The Subscriber shall not be entitled to use the Registration Statement for an underwritten offering of the Registrable Securities. Notwithstanding anything to the contrary contained herein, the Company may delay or postpone filing of such Registration Statement, and from time to time require the Subscriber not to sell under the Registration Statement or suspend the use or effectiveness of any such Registration Statement if it determines in good faith that in order for the registration statement to not contain a material misstatement or omission, an amendment thereto would be needed, or if such filing or use would reasonably be expected to materially affect a bona fide business or financing transaction of the Company or would reasonably be expected to require premature disclosure of information that would materially adversely affect the Company (each such circumstance, a “Suspension Event”); provided, that (x) the Company shall not so delay filing or so suspend the use of the Registration Statement for a period of more than 60 consecutive days or more than two times in any 360 day period and (y) the Company shall use commercially reasonable efforts to make such registration statement available for the sale by the Subscriber of such securities as soon as practicable thereafter.

Upon receipt of any written notice from the Company (which notice shall not contain any material non-public information regarding the Company and which notice shall not be subject to any duty of confidentiality) of the happening of (a) an issuance by the Commission of any stop order suspending the effectiveness of any Registration Statement or the initiation of any proceedings for such purpose, which notice shall be given no later than three (3) Business Days from the date of such event, (b) any Suspension Event during the period that the Registration Statement is effective, which notice shall be given no later than three (3) Business Days from the date of such Suspension Event, or (c) or if as a result of a Suspension Event the Registration Statement or related prospectus contains any untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made (in the case of the prospectus) not misleading, the Subscriber agrees that (1) it will immediately discontinue offers and sales of the Registrable Securities under the Registration Statement (excluding, for the avoidance of doubt, sales conducted pursuant to Rule 144) until the Subscriber receives copies of a supplemental or amended prospectus (which the Company agrees to promptly prepare) that corrects the misstatement(s) or omission(s) referred to above and receives notice that any post-effective amendment has become effective or unless otherwise notified by the Company that it may resume such offers and sales, and (2) it will maintain the confidentiality of any information included in such written notice delivered by the Company unless otherwise required by law, subpoena or regulatory request or requirement. If so directed by the Company, the Subscriber will deliver to the Company or, in the Subscriber’s sole discretion destroy, all copies of the prospectus covering the Registrable Securities in Subscriber’s possession; provided, however, that this obligation to deliver or destroy all copies of the prospectus covering the Registrable Securities shall not apply (x) to the extent the Subscriber is required to retain a copy of such prospectus (A) in order to comply with applicable legal, regulatory, self-regulatory or professional requirements or (B) in accordance with a bona fide pre-existing document retention policy or (y) to copies stored electronically on archival servers as a result of automatic data back-up.

For purposes of this Appendix 4, (i) “Registrable Securities” shall mean, as of any date of determination to the extent determinable, the common stock issuable upon conversion of the CDIs, common stock issuable upon conversion of the CDIs issuable upon exercise of the Warrants, and any other equity security issued or issuable with respect to the foregoing by way of share split, dividend, distribution, recapitalization, merger, exchange, or replacement, and (ii) the “Subscriber” shall include any person to which the rights under this Appendix 4 shall have been duly assigned pursuant to the terms of this agreement.

Notwithstanding the registration obligations set forth herein, if the Commission informs the Company that the resale of all of the Registrable Securities as a secondary offering cannot, as a result of the application of Rule 415, be registered on a single registration statement, the Company agrees to promptly inform each of the holders of the Registrable Securities thereof and use its reasonable efforts to file amendments to the Registration Statement as required by the Commission, covering the maximum number of the Registrable Securities permitted to be registered by the Commission. In addition, notwithstanding any other provision of this agreement, if the Commission or any SEC Guidance sets forth a limitation on the number of the Registrable Securities permitted to be registered on the Registration Statement, the number of the Registrable Securities to be registered on such Registration Statement will be reduced pro rata among all such selling stockholders whose securities are included in such Registration Statement. In the event of a cutback hereunder, the Company shall give the applicable holder of the Registrable Securities at least five (5) Business Days prior written notice along with the calculations as to such holder’s allotment. In the event the Company amends the Registration Statement in accordance with the foregoing, the Company will use its reasonable efforts to file with the Commission, as promptly as allowed by the Commission or SEC Guidance provided to the Company, one or more registration statements to register the resale of those Common Shares that were not otherwise registered. “SEC Guidance” means (a) any publicly-available written or oral guidance of the Commission staff, or any comments, requirements or requests of the Commission staff and (b) the Securities Act and the rules and regulations promulgated thereunder.

The Company shall indemnify and hold harmless the Subscriber (to the extent a seller under the Registration Statement), the officers, directors, members, managers, partners, agents and employees of the Subscriber, each person who controls the Subscriber (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, members, managers, partners, agents and employees of each such controlling person, to the fullest extent permitted by applicable law, from and against any and all losses, claims, damages, liabilities, costs (including, without limitation, reasonable attorneys’ fees) and expenses (collectively, “Losses”) that arise out of or are based upon any untrue or alleged untrue statement of a material fact contained in the Registration Statement, any prospectus included in the Registration Statement or any form of prospectus or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein (in the case of any prospectus or form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading, except to the extent that untrue statements, alleged untrue statements, omissions or alleged omissions are based upon information regarding the Subscriber furnished in writing to the Company by or on behalf of the Subscriber expressly for use therein or the Subscriber has omitted a material fact from such information, provided that the Company has given notice of such event to the Subscriber in accordance with the terms of this agreement. The Company shall notify the Subscriber promptly of the institution, threat or assertion of any proceeding arising from or in connection with the transactions contemplated by this Appendix 4 of which the Company is aware. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of an indemnified party and shall survive the transfer of the Securities by the Subscriber. Notwithstanding the forgoing, the Company’s indemnification obligations shall not apply to amounts paid in settlement of any Losses or action if such settlement is effected without the prior written consent of the Company (which consent shall not be unreasonably withheld or delayed).

The Subscriber shall indemnify and hold harmless the Company, its directors, officers, agents and employees, each person who controls the Company (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, agents or employees of such controlling persons, to the fullest extent permitted by applicable law, from and against all Losses arising out of or based upon any untrue statement of a material fact contained in any Registration Statement, any prospectus included in the Registration Statement, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any prospectus, or any form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading to the extent, but only to the extent, that such untrue statements or omissions are based upon information regarding the Subscriber furnished in writing to the Company by or on behalf of the Subscriber expressly for use therein or the Subscriber has omitted a material fact from such information, and that the Subscriber has received notice from the Company of such event in accordance with the terms of this agreement. In no event shall the liability of the Subscriber be greater in amount than the dollar amount of the net proceeds received by the Subscriber upon the sale of the Securities giving rise to such indemnification obligation. Notwithstanding the forgoing, the Subscriber indemnification obligations shall not apply to amounts paid in settlement of any Losses or action if such settlement is effected without the prior written consent of the Subscriber (which consent shall not be unreasonably withheld or delayed).

Any person or entity entitled to indemnification herein shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification (provided that the failure to give prompt notice shall not impair any person’s or entity’s right to indemnification hereunder to the extent such failure has not prejudiced the indemnifying party) and (ii) unless in such indemnified party’s reasonable judgment a conflict of interest between such indemnified and indemnifying parties may exist with respect to such claim, permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party. If such defense is assumed, the indemnifying party shall not be subject to any liability for any settlement made by the indemnified party without its consent (but such consent shall not be unreasonably withheld, conditioned or delayed). An indemnifying party who is not entitled to, or elects not to, assume the defense of a claim shall not be obligated to pay the fees and expenses of more than one counsel for all parties indemnified by such indemnifying party with respect to such claim, unless in the reasonable judgment of any indemnified party a conflict of interest may exist between such indemnified party and any other of such indemnified parties with respect to such claim. No indemnifying party shall, without the consent of the indemnified party, consent to the entry of any judgment or enter into any settlement which (i) cannot be settled in all respects by the payment of money (and such money is so paid by the indemnifying party pursuant to the terms of such settlement), (ii) includes a statement or admission of fault and culpability on the part of such indemnified party, or (iii) does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect to such claim or litigation.

10.

The indemnification provided for under this agreement shall remain in full force and effect regardless of any investigation made by or on behalf of the indemnified party or any officer, director or controlling person or entity of such indemnified party and shall survive the transfer of Securities purchased pursuant to this agreement.

11.

If the indemnification provided under Appendix 4 from the indemnifying party is unavailable or insufficient to hold harmless an indemnified party in respect of any losses, claims, damages, liabilities and expenses referred to herein, then the indemnifying party, in lieu of indemnifying the indemnified party, shall contribute to the amount paid or payable by the indemnified party as a result of such losses, claims, damages, liabilities and expenses in such proportion as is appropriate to reflect the relative fault of the indemnifying party and the indemnified party, as well as any other relevant equitable considerations; provided, however, that the liability of the Subscriber shall be limited to the net proceeds received by such the Subscriber from the sale of Securities giving rise to such indemnification obligation. The relative fault of the indemnifying party and indemnified party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact, was made by (or not made by, in the case of an omission), or relates to information supplied by (or not supplied by, in the case of an omission), or on behalf of such indemnifying party or indemnified party, and the indemnifying party’s and indemnified party’s relative intent, knowledge, access to information and opportunity to correct or prevent such action. The amount paid or payable by a party as a result of the losses or other liabilities referred to above shall be deemed to include, subject to the limitations set forth in this Appendix 4, any legal or other fees, charges or expenses reasonably incurred by such party in connection with any investigation or proceeding. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution pursuant to this paragraph 11 from any person or entity who was not guilty of such fraudulent misrepresentation. Notwithstanding anything to the contrary herein, in no event will any party be liable for consequential, special, exemplary or punitive damages in connection with this agreement or the transactions contemplated hereby.

FIRST AMENDED AND RESTATED MASTER SERVICES AGREEMENT

This First Amended and Restated Master Services Agreement (the “Agreement”) is effective as of July 31, 2025 (“Amendment Effective Date”) by and between Anteris Technologies Corporation, a Minnesota corporation, having its principal place of business at 860 Blue Gentian Road, Suite 340, Eagan, MN 55121 (“Anteris”) and Switchback Medical, LLC, a Minnesota limited liability company having its principal place of business at 7625 Boone Avenue North, Brooklyn Park, MN 55428 (“Switchback” and collectively with Anteris, the “Parties”, and each a “Party”).

WHEREAS, Anteris is a structural heart company that develops and manufactures cardiovascular solutions, primarily based on its ADAPT® Tissue;

WHEREAS, Anteris is developing medical devices for the treatment of cardiovascular valve disease, including transcatheter aortic valve replacement (“TAVR”) devices for the treatment of aortic stenosis and other aortic conditions, and has developed the balloon expandable DurAVR^TM THV valve (“Valve”);

WHEREAS, Switchback and Anteris are parties to that Master Services Agreement (the “Original Agreement”) with an effective date of June 1, 2021 (the “Original Effective Date”);

WHEREAS, under the Original Agreement, Switchback and Anteris collaborated to develop a transcatheter delivery system that can deploy the Valve according to requirements from Anteris (“Product”);

WHEREAS, Anteris continues to desire to retain Switchback for various Development Services (as defined hereunder) and to manufacture the Products and Switchback is willing to perform such services.

NOW, THEREFORE, in consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

DEFINITIONS. Capitalized terms used in this Agreement have the respective meanings assigned to them in this Agreement. Additionally, the following terms, when used herein, shall have the following meanings:

1.1

“ADAPT® Tissue” means any animal tissue treated by Anteris’s proprietary ADAPT® tissue treatment process.

1.2

“Affiliate” means a Person that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, the Person specified. The term “control” (including the terms “controlled by” and “under common control with”) as used with respect to Affiliate means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, direct or indirect ownership of at least a majority of the equity interests, or otherwise.

1.3

“Anteris Components” means the Valve and any other components used in the Manufacture of the Products or with the Products

1.4

“Anteris Intellectual Property” has the meaning set forth in Section 6.1.

1.5

“Applicable Law” means the United States Federal Food, Drug and Cosmetics Act, and any regulations and guidance promulgated thereunder, as amended from time-to-time, and all other laws, regulations, rules and guidance of any Governmental Authority pertaining to the development, manufacture, extrusion, packaging, labeling, storage, marketing, sale, distribution or intended use of a Product, in each case, as amended or replaced from time-to-time.

1.6

“Clinical Use Products” means Products intended for human use in one or more clinical trials, including First-in-Human (“FIH”) trials, early feasibility studies (“EFS”), pivotal trials, and post trial continued access, in any geography prior to Commercial Approval, even if not ultimately used in such clinical trials in Anteris’s sole discretion.

1.7

“Commercial Approval” means, for each jurisdiction,approval of the Products for commercial sale by the relevant Government Authority.

1.8

“Commercial Use Products” means Products for commercial sale in such jurisdictions where Anteris has received Commercial Approval.

1.9

“Contingency Plan” has the meaning set forth in Section 2.1.8.

1.10

“Developed Intellectual Property” has the meaning set forth in Section 6.3.

1.11

“Development Products” means Products for benchtop and animal testing, including prototypes.

1.12

“Documentation” means all written technical reports, testing reports, operator and user manuals, Records, training materials, guides, listings, specifications, module flow, systems flow, process flow, problem log, process documents, standard operating procedures, regulatory documents, design documents, enhancement requests and other material which relate to the development of the Products or are otherwise necessary or useful in connection with the Products.

1.13

“EFS Trial” means an FDA Early Feasibility Study clinical trial for the Product.

1.14

“Expenditures” means those direct costs and expenses of materials, supplies and equipment incurred by Switchback Medical in carrying out the development of the Products.

1.15

“Failure to Supply” means Switchback’s failure to deliver any Products following a Purchase Order from Anteris that is with such Purchase Order going unfilled for a period of fourteen (14) days after the Product Delivery Date specified on the Purchase Order without changes to the Specification or other cause by Anteris.

1.16

“FDA” means the United States Food and Drug Administration.

1.17

“Force Majeure” means acts or circumstances beyond the reasonable control of the Party including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, invasion or hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest, national emergency, revolution, insurrection, epidemic or pandemic, lock-outs, strikes or other labor disputes (whether or not relating to either Party’s workforce), or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials, materials or telecommunication breakdown or power outage that may cause or result in a Party’s failure to perform its obligations under this Agreement.

1.18

“Governmental Authority” means any nation, territory or government (or union thereof), foreign, domestic or multinational, any state, local or other political subdivision thereof, and any bureau, court, tribunal, board, commission, department, agency or other entity, including the FDA and ISO, in each case, exercising executive, legislative, judicial, regulatory or administrative functions of government, and all other entities exercising regulatory authority over medical products or devices.

1.19

“Intellectual Property” means all rights, priorities and privileges relating to intellectual property, whether arising under United States, multinational or foreign laws or otherwise, including copyrights, copyright licenses, patents, patent licenses, trademarks, trademark licenses, trade secrets and know-how, whether registered or unregistered, including the right to make applications, and all rights to sue at law or in equity for any infringement, misappropriation or other impairment thereof, including the right to receive all proceeds and damages therefrom.

1.20

“Inspection Period” has the meaning set forth in Section 2.5.4.

1.21

“ISO” means the International Organization for Standardization.

1.22

“Labor Cost” means the cost of Switchback personnel as described in Appendix B, which may be amended after completion of the EFS Trial.

1.23

“Manufacture”, “Manufactured”, and “Manufacturing” means all steps, processes and activities necessary to produce Product(s), including without limitation, the design, manufacturing, processing, quality control testing, release and storage of Product(s) in accordance with the terms and conditions of this Agreement.

1.24

“Materials Cost” means Switchback’s materials, supplies and components as described in Appendix B, used in the Manufacture of the Products, which may be amended after completion of the EFS Trial.

1.25

“Person” means an individual, corporation, partnership, limited partnership, limited liability company, unincorporated association, trust, joint venture, union or other organization or entity, including a Governmental Authority.

1.26

“Personnel” means, with respect to Switchback or Anteris, as applicable, the employees, agents, contractors, consultants, representatives and advisers of either of them, respectively, or of any of their respective Affiliates.

1.27

“Product” has the meaning set forth in the preamble and includes all components.

1.28

“Product Prices” means the prices for the Clinical Use Products or Commercial Use Products as agreed upon by the Parties.

1.29

“Product Delivery Date” means the date requested by Anteris for Switchback to deliver Product to Anteris or to an Anteris Designee.

1.30

“Product Manufacturing IP” means all steps, methods, processes, procedures, protocols, testing, inventions, data, and know-how used to Manufacture the Product, including packaging and labeling for the Product. Product Manufacturing IP excludes the Supplier Background Intellectual Property.

1.31

“Purchase Order” has the meaning set forth in Section 2.1.1.

1.32

“Quality Requirements” means, with respect to the Products, the requirements set forth in this Agreement including Sections 2, 3, and 4.

1.33

“Records” has the meaning set forth in Section 3.6.

1.34

“Scrap Components” has the meaning set forth in Section 2.12.2 and excludes the Scrap Valves.

1.35

“Scrap Valves” has the meaning set forth in Section 2.12.1.

1.36

“Specifications” means all applicable specifications and protocols relative to the design, physical characteristics, function, performance, biocompatibility, manufacture, packaging and quality of the Products communicated by Anteris to Switchback including, without limitation, those specifications set forth in Appendix A, and future specification modifications based on Anteris’s needs over time.

1.37

“Supplier Background Intellectual Property” has the meaning set forth in Section 6.2.

1.38

“Switchback Facility” means the manufacturing facility where Switchback engineers, tests, Manufactures, assembles, packages, stores, distributes or otherwise handles the Products.

1.39

“Term” means the Initial Term, the First Renewal Term, and any Subsequent Renewal Term according to Section 8.

1.40

“Testing Services” means verification and validation testing.

1.41

“Transfer Initiation Notice” has the meaning set forth in Section 9.1.

1.42

“Valve” has the meaning set forth in the preamble.

2.1

Development Services

2.1.1

Switchback shall provide Anteris with engineering services, development services or Testing Services (“Development Services”) according to one or more purchase orders or statements of work to be issued by Anteris and accepted by Switchback (which acceptance shall not be unreasonably withheld (“Development Work Orders”).

2.1.2

Fees for the Development Services shall be determined on a “time and materials” basis. Anteris shall pay Switchback for hours worked (with evidence supporting such hours) by Switchback’s employees or contractors in performing the Development Services at the hourly rates mutually agreed between the Parties. Switchback will charge Anteris for any reasonable travel time cost and expense with prior written approval from Anteris with estimated expenses and upon providing cost and expense evidence to Anteris. In addition Anteris will reimburse Switchback for all expenses which are incurred by Switchback in connection with the development of the Products and Switchback’s performance under this Agreement; provided, however, that such expenses are agreed to in advance by Anteris.

2.1.3

Switchback shall collaborate with Anteris to develop the Product Manufacturing IP, including all processes, procedures, protocols, and know-how used to Manufacture the Products. As between Anteris and Switchback, the Product Manufacturing IP shall be owned by Anteris and the Product Manufacturing IP shall be deemed Developed Intellectual Property as defined in Section 6.3. Anteris grants Switchback a limited, exclusive, revocable, non-sublicensable, fully paid-up, royalty-free license to use the Product Manufacturing IP only to Manufacture the Development Products, Clinical Use Products, and Commercial Use Products during the Term.

2.1.4

Switchback shall provide the Development Services (a) in accordance with the terms and subject to the conditions set forth in the respective SOW and this Agreement; (b) using personnel of required skill, experience, and qualifications; (c) in a timely, workmanlike, and professional manner; and (d) in accordance with generally accepted industry standards. For the sake of clarity, nothing in this Agreement shall be construed to prevent Anteris from itself performing or from acquiring services from other providers that are similar.

2.1.5

Anteris shall own any right, title, and interest in and to the results of the Development Services provided for the Products or the Anteris Components, any report provided for Anteris regarding the results of the Testing Services provided for the Products or the Anteris Components, and any data generated by Switchback in connection with the Testing Services provided for Anteris. .

2.1.6

Additionally, upon request from Anteris, the Development Services provided by Switchback under this Agreement will further include, but will not be limited to: (a) conducting design, research and development activities with respect to the Products; (b) developing and manufacturing a functional prototype of each Product; and (c) any other actions necessary to make the Products commercially saleable by Anteris or its designee.

2.1.7

In the performance of the Development Services, Switchback agrees to provide all Documentation regarding the Development Services and Development Products.

2.1.8

Switchback and Anteris will designate mutually agreeable project managers with respect to the Development Services and Development Products and neither party will change such designated project managers without timely notification to the other party.

2.1.9

Anteris will be given access to the facilities and personnel of Switchback during normal business hours as reasonably requested by Anteris in order to permit representatives of Anteris to inspect the progress of the Development Services and Development Products.

2.1.10

Anteris and Switchback shall agree on a Development Schedule substantially of the form provided in Appendix A-1 and Switchback shall adhere to the timelines provided within the Development Schedule in the performance of the Services. If necessary, the parties shall update the Development Schedule as mutually agreed during the Term.

2.1.11

Manufacture of Development Products. Switchback shall Manufacture the Development Products as reasonably requested by Anteris from time to time in writing in one or more Development Work Orders. Switchback shall Manufacture, package and label the Development Products (a) in strict accordance with any applicable Specifications for the Development Products, (b) reasonably in accordance with the Quality Requirements, and (c) in strict accordance with all other terms and conditions of this Agreement. Development Products shall be manufactured only at the Switchback Facility unless Anteris, in its sole discretion, provides advance written approval of an alternative facility(ies) (such approval not to be unreasonably withheld). Switchback shall provide Anteris with access to the manufacturing processes and procedures used by Switchback to Manufacture, package and label the Development Products. Switchback shall charge Anteris for the Development Products on a time and materials basis (“Development Product Pricing”).

2.1.12

Switchback will, at its own expense furnish the facilities and research, engineering and other personnel reasonably necessary to carry out the services pursuant to this Section 2.1, unless otherwise agreed by the parties in writing.

2.2 Manufacture of Products for Clinical Use.

2.2.1

Switchback shall Manufacture Clinical Use Products according to one or more purchase orders issued by Anteris and accepted by Switchback (which acceptance shall not be unreasonably withheld) (“Clinical Use Purchase Orders”).

2.2.2

Product Prices for the Clinical Use Purchase Orders shall be determined according to agreed upon pricing per unit.

2.2.3

Prior to Switchback commencing Manufacture under Section 2.2.1, Anteris shall approve final Specifications for the Clinical Use Products in writing, and Switchback shall not make any changes to the Clinical Use Products, their Specifications, design, materials, production processes or production testing or otherwise to the Manufacture of the Clinical Use Products without Anteris’s prior written consent and shall comply with the Quality Requirements when making any such changes. Switchback shall submit change orders to Anteris for Anteris’s review and approval prior to implementing any changes.

Upon request, if any, from Anteris, Switchback shall establish an appropriate and reasonable contingency Manufacturing plan (the “Contingency Plan”) acceptable to Anteris that details the steps to be taken to prevent any disruption in the supply of the Clinical Use Products in order to ensure Anteris’s continued supply of the Clinical Use Products.

ii.

Upon request, if any, from Anteris, Switchback shall establish a plan for preventing cross-contamination of the Products with other products manufactured or supplied by Switchback (the “Cross-Contamination Plan”) reasonably acceptable to Anteris that details the steps to be taken to prevent any contamination of the Products that may affect the quality, safety, or suitability of the Anteris Components or the Products at the Switchback Facility.

iii.

Once final Specifications are approved by Anteris, design documentation shall be submitted to Anteris and managed through Anteris’s quality management system and/or product management system.

2.2.4

Switchback shall Manufacture, package and label the Clinical Use Products under any accepted Purchase Order in strict accordance with any applicable Specifications and the Quality Requirements, as well as the terms and conditions of this Agreement.

2.2.5

Switchback shall validate the Manufacture of the Products according to validation processes, procedures and criteria accepted by Anteris to the extent necessary for the Clinical Use Products to be used for their intended purpose.

2.2.6

Products shall be manufactured only at the Switchback Facility unless Anteris, in its sole discretion, provides advance written approval of an alternative facility(ies) (such approval not to be unreasonably withheld).

2.2.7

Switchback agrees to provide all Documentation regarding the Manufacture or the Clinical Use Products, including any certificate of conformance requested by Anteris.

2.3

Manufacture of Products following Commercial Approval. [Reserved.]

2.4

Invoicing & Payment

2.4.1

For Development Services and Development Products, Switchback will submit to Anteris bi-weekly detailed invoices for fees and Expenditures incurred during that 2 week period setting forth the amount of fees and the nature and amount of the Expenditures which Switchback actually incurred during that month. Such invoices are due and payable by Anteris within thirty (30) days of receipt. In the event Anteris fails to pay Switchback within thirty (30) days of receipt of such invoices, Switchback reserves the right to discontinue any services provided under this Agreement until such invoice is paid in full by Anteris. In the event Anteris fails to pay Switchback Medical within ninety (90) days of receipt of such invoices, Switchback reserves the right to terminate this Agreement.

2.4.2

For Clinical Use Products or Commercial Use Products, Switchback shall issue an invoice to Anteris at shipment of the Clinical Use Products or Commercial Use Products referencing the relevant Clinical Use Purchase Order or Commercial Use Purchase Order with each invoice being due and payable within thirty (30) days of receipt by Anteris of said invoice from Switchback, unless otherwise mutually agreed upon in writing by the Parties.

2.4.3

The books and records of Switchback will be maintained in such manner and in such detail as may be required by Anteris in order to permit it to verify the fees and expenses indicated on the invoices which are received from Switchback.

2.5

Forecasting and Orders

2.5.1

Forecasting Process.

Anteris will provide Switchback a binding annual purchase forecast for Clinical Use Products, followed by a rolling non-binding build forecast for such Clinical Use Products, based on a set timeschedule or project milestone basis. The forecast is to aid Switchback in long range staff and material planning.

2.5.2

Order Process.

(i)

Clinical Use Products. During the Term, Anteris shall place binding Clinical Use Purchase Orders for Products at least ten (10) weeks in advance of the date it wishes to have Switchback deliver Product (“Product Delivery Date”). Product Prices for Clinical Use Products are provided on Appendix B. Amendments to the Specifications may impact the Product Prices, which will be reviewed at the time of any requested amendment to the Specifications. Switchback shall provide evidence for the potential pricing change and share that with Anteris prior to its acceptance of the new product prices (which acceptance can be reasonably withheld).

(ii)

Commercial Use Products. Reserved.

(iii)

Orders under this Section 2.5.2 will identify the quantities, sizes and types of Clinical Use Products or Commercial Use Products being ordered, the delivery address and the Product Delivery Date. Anteris may submit orders under this Section 2.5.2 via mail, fax or email. Orders submitted under this Section 2.5.2 will be deemed accepted upon receipt unless Switchback rejects an order within five (5) days of receipt. If Switchback is unable to deliver the Clinical Use Products or Commercial Use Products on the Product Delivery Date, Switchback shall provide Anteris with written notice of the delivery date within five (5) days of receipt of the relevant purchase order.

2.5.3

Expedited Orders. In the event that Anteris requests an order of Clinical Use Products or Commercial Use Products on an expedited basis (“Expedited Order”), Switchback will use its best efforts to fill the Expedited Order. If the Expedited Order is likely to result in disruption to Switchback’s other business in order to meet the Product Delivery Date for the Expedited Order, Switchback may in good faith provide an adjusted price quote (“Expedited Price Quote”) for the Clinical Use Products or Commercial Use Products on the Expedited Order based proportionally on the disruption caused by the Expedited Order. Anteris has the right to accept or reject the Expedited Price Quote, and Anteris also has the right to request information about the basis for the Expedited Price Quote in an effort to mitigate any such disruption. For such Expedited Orders, with consent by Anteris, Switchback may either (i) request Anteris to deliver the Anteris Components by express delivery necessary to fulfill the Expedited Order or (ii) may use Anteris Components previously delivered to Switchback for another open Purchase Order and Anteris will replenish Switchback’s supply of Anteris Components to fulfill any other open Purchase Orders.

2.5.4

Termination of Purchase Orders. Anteris may terminate any Purchase Order at any time for (i) any Product affected by any regulatory recall, (ii) a failure of Switchback to meet the Quality Requirements in any previous Purchase Order, (iii) for any affected Product if, as a result of an event of Force Majeure, as provided in Section 10.14. Except as set for herein, Anteris may not cancel, in whole or in part, any Purchase Order for Product for any reason, but may, in its discretion, delay any such order for up to thirty (30) days upon written notice to Switchback.

2.6

Changes to Specifications. If Anteris desires to modify the Specifications, it must provide Switchback with written notice at least ten (10) days prior to Anteris submitting a Purchase Order for Products conforming to the modified Specifications. The Parties agree and acknowledge that, during the Term of this Agreement, Anteris may make reasonable modifications to the Specifications as a result of Product testing, to conform with requirements from a Government Authority, and changes of scale for animal testing.

2.7.1

Shipping Terms. Unless otherwise specified in an applicable order, delivery of Products will be DDP (as per Incoterms 2010). Title and risk of loss with respect to all Products shall remain with Switchback until delivered.

2.7.2

Shipment. Switchback shall ship Products according to Anteris’s instructions and to Anteris’s designated shipping address using carriers selected by Anteris and at Anteris’s cost. Switchback will pack all Products ordered hereunder in a manner validated for shipment, consistent with the Specifications, and reasonably sufficient to withstand the effects of shipping and handling.

2.7.3

Timely Delivery/Delays. Switchback shall deliver Products on the delivery dates and to the locations specified in the Purchase Orders. Switchback shall promptly notify Anteris of any actual or prospective delay in delivery and Switchback shall obtain Anteris’s approval prior to making any partial deliveries of less than 80% of any size of Products on the respective Purchase Order. If the delivery of Products is delayed through no fault of Anteris and without a Force Majeure event, in addition to its other rights and remedies under this Agreement , Anteris may (i) cancel or reschedule the order in whole or in part without liability or (ii) require Switchback to deliver Products by means of commercially reasonable transport identified by Anteris, at Switchback’s cost. Products shall not be delivered more than fourteen (14) days prior to the stated delivery date without Anteris’s prior written consent. Without limiting any of Anteris’s rights herein, a Failure to Supply shall be a breach of this Agreement.

2.7.4

Inspection. Anteris shall have ten (10) Business Days after delivery to inspect the delivered Products and to accept or reject delivered Products (“Inspection Period”) using inspection methods previously agreed upon by Switchback and Anteris. Anteris shall only reject Products that are not in conformance with the Specifications or the Quality Requirements. If Anteris has not provided Switchback with written notice of rejected Products by the end of the Inspection Period, Switchback will deem the delivery to be accepted. Anteris is responsible for all handling of all Products after delivery, including during the Inspection Period. For any rejected Products, Anteris shall provide reasons for the rejection, and Anteris and Switchback shall work together in good faith to replace rejected Products as needed.

2.7.5

Third Party Fabricators. If requested in writing by Anteris, Switchback will drop ship Product to third party fabricators identified by Anteris. Delivery of the Products to the third party fabricators, service providers, or other vendors shall be treated the same as if it were delivered to Anteris directly. Switchback is not liable or otherwise responsible for any changes to the Product, or its quality, caused by the use or manipulation of the Product by any such third party fabricator.

2.8

Subcontractors.

2.8.1

Switchback may use qualified and reputable subcontractors to assist Switchback in providing the Services in this Section 2 with Anteris’s written consent. Switchback shall obtain Anteris’s written consent, which may be given or withheld in Anteris’s sole discretion, prior to entering into agreements with or otherwise engaging any Person, including all subcontractors and Affiliates of Switchback other than Switchback’s employees, to provide any of the Services in this Section 2 (each such approved subcontractor or other third party, a “Permitted Subcontractor”).

2.8.2

Anteris’s approval shall not relieve Switchback of its obligations under this Agreement, and Switchback shall remain fully responsible for the acts and omissions of each such Permitted Subcontractor and its employees and for their compliance with all of the terms and conditions of this Agreement.

2.8.3

Nothing contained in this Agreement shall create any contractual relationship between Anteris and any Permitted Subcontractor.

2.8.4

If Anteris provides its consent for Switchback to engage the Permitted Subcontractor, the Permitted Contractor must be under a written agreement which (i) obligates the subcontractor to comply with all relevant terms and conditions of this Agreement as though it were Switchback including all confidentiality obligations, (ii) names Anteris as a third party beneficiary with the right to enforce the rights of Switchback under such subcontract agreement, and (iii) authorizes Switchback to disclose the terms of the subcontract agreement to Anteris. Switchback shall provide Anteris with a copy of a subcontract agreement promptly after Anteris’s request.

2.9

Supplier Management.

2.9.1

Supplier Performance. For Products Manufactured during the Initial Term, Switchback shall select suppliers currently approved by Anteris, where possible, and any additional unapproved suppliers shall be identified as conditional until they can be qualified. All such unapproved suppliers shall have appropriate certifications where possible according to Switchback’s quality management system. For any Products Manufactured during the First Renewal Term and any Subsequent Renewal Term, Switchback shall work with Anteris to define and review Switchback’s approved supplier list for the Clinical Use Products or Commercial Use Products and the associated risk with such suppliers . Switchback will manage and be responsible for its approved supplier list with input from Anteris on definitions of risk severity and associated status of such suppliers. For any approved supplier on the list, Anteris may request an audit of any supplier upon reasonable request, provided that Anteris acknowledges that Switchback shall only be required to provide commercially reasonable efforts in facilitating Anteris’ supplier audit request. Switchback shall provide Anteris with a copy of its supplier performance management procedure upon reasonable request by Anteris.

2.9.2

Sole Source Risk Management. Upon Anteris’ reasonably request, Switchback will use commercially reasonable efforts to engage multiple suppliers or sources for high risk components used in the Clinical Use Products or Commercial Use Products through continuous risk evaluation with Anteris having the ability to provide input to the process and receive information regarding the process.

2.9.3

Switchback will use commercially reasonable efforts to ensure a reliable supply of a quantity and quality of raw materials sufficient to meet Switchback’s obligations under this Agreement, which may, in Switchback’s discretion, include long-term purchasing agreements with one or more suppliers or individual or blanket purchase orders with one or more suppliers.

2.10

No Reverse Engineering. Other than as expressly instructed by Anteris in writing, Switchback agrees not to analyze for composition, internal elements, structure or reverse engineer or transfer to any third party for analysis or reverse engineering the Valve or the ADAPT® Tissue.

2.11

Equipment. To assist Switchback in the performance of the Services, Anteris may provide Switchback with equipment purchased by Anteris (“Anteris Owned Equipment”) to be used at a Switchback Facility. For the duration of the Term, the Anteris Owned Equipment shall be owned exclusively by Anteris or its designee, unless subject to a separate asset purchase agreement between the Parties. The Anteris Owned Equipment shall be used solely in the provision of Services for Anteris or Anteris’s designee and for no other third party. Switchback shall return all Anteris Owned Equipment in good condition upon expiration or termination of this Agreement for any reason or for no reason, but in any event no later than thirty (30) days following expiration or termination. For as long as Switchback uses the Anteris Owned Equipment, Switchback is responsible for all maintenance and calibration (including associated costs) in connection with Switchback’s quality management system, and expenses for such maintenance and calibration will be charged back to Anteris.

2.12

Anteris Components. Anteris may supply Switchback with Anteris Components only for use by Switchback to Manufacture the Products, and Switchback shall not use the Anteris Components for any other purpose. Anteris shall supply the Anteris Components at no charge to Switchback and Anteris shall pay all costs associated with delivering the Anteris Components to Switchback. Anteris shall deliver, or have delivered, sufficient quantities of the Anteris Components to Switchback such that for each Purchase Order, Switchback has sufficient quantities on hand within three (3) weeks of the Product Delivery Date for the respective Purchase Order. Switchback must store any Valves supplied to Switchback in strict accordance with all applicable requirements communicated to Switchback by Anteris.

2.12.1

Any Valves provided to Switchback but not utilized by Switchback (“Scrap Valves”) under this Section 2 shall be returned to Anteris

2.12.2

Other than the Scrap Valves, any other Anteris Components, besides the Valves, that are provided to Switchback but not be able to be utilized in the performance of the services (“Scrap Components”) may be returned to Anteris or destroyed by Switchback at the sole discretion of Anteris.

2.12.3

Any non-conforming Clinical Use Products (“Scrap Products”) not delivered to Anteris may be used, in Anteris’s sole discretion, as Development Products at no additional cost to Anteris. Such Scrap Products shall not be used for any human use.

2.12.4

Scrap Products shall be delivered to Anteris for non-clinical use or destruction at Anteris’s discretion.

3.1

General. All Products supplied under this Agreement will be manufactured in accordance with:

(a) all applicable standards of the International Organization for Standardization (ISO) and applicable ISO-certified processes; (b) FDA Current Good Manufacturing Practice (cGMP) and other applicable FDA quality guidelines; and (c) all other quality standards and quality assurance plans referenced in the Specifications. Switchback shall use commercially reasonable efforts to ensure that entities that supply raw materials used by Switchback in the production of the Products are bound to the same provisions.

3.2

Performance. Switchback shall resolve promptly any Product quality issues that arise during the Term of this Agreement. These efforts shall be tracked in a quality management system (“QMS”) such as corrective action and preventive action framework that is compliant with industry standards including, but not limited to, FDA Current Good Manufacturing Practice regulations. Upon written demand by Anteris, such efforts may include making appropriate Switchback personnel available (at Switchback’s expense) in person or through video conferencing at the facilities where such Product quality or performance issues are identified or require remediation.

3.3

Control and Inspection. Switchback will provide for Anteris’s approval of a Quality Control Plan and Outgoing Lot Inspection Test Plan. Switchback will monitor production per the Quality Control Plan and complete inspection of each lot of shipment per the Outgoing Lot Inspection Test Plan as well as perform any other tests or inspections required by the Specifications to ensure conformance. Switchback will include a certificate of conformance for each lot based on conformance to Outgoing Lot Inspection Test Plan. Anteris retains the right to perform incoming lot inspection.

3.4

Process Monitoring. Upon request from Anteris in writing, Switchback will monitor and control the Manufacturing process using applicable industry standard tools, which may include in-process inspection and/or statistical process control. At a minimum, Switchback shall monitor or inspect critical dimensions or critical performance criteria as directed by Anteris in writing. Switchback will identify and document key Manufacturing process steps that affect Product performance. Anteris will aid Switchback in such identification as it relates to Product performance. Switchback will (a) identify and document critical inputs to the key Manufacturing process steps and critical variables of the key Manufacturing process steps, and (b) define process monitoring, control strategies, and tools to ensure that Manufacturing processes operate within control limits and Manufacturing yields are satisfactory. These key and critical parameters will be documented in the Quality Control Plan to be used in the Switchback production monitoring and control. In the event any of the Manufacturing process steps are out of control or Manufacturing yields decline considerably, Switchback will take appropriate corrective and preventive actions to rectify the situation and maintain documentation of the actions taken.

3.5

Non-Conforming Product. Anteris will have the right to reject any Product that does not meet all applicable Specifications based on testing or inspection methods mutually agreed upon by Switchback and Anteris. Any such rejection based on nonconformity with the Specifications shall be accomplished by written notice (specifying the basis for rejection) from Anteris to Switchback promptly after identification. In the event that any Product does not meet applicable Specifications and Anteris has notified Switchback and Switchback agrees that the Product does not meet applicable Specifications, Switchback will replace such Product free of charge and Switchback shall cover expenses (including freight and customs clearance, if any) incurred by Anteris in connection with (a) shipment of replacement Product to the same location and (b) shipment of the nonconforming Product back to Switchback (if so requested by Switchback). In the event of a rejection of defective Product, Switchback will ship replacement Product as soon as practical but in any event within 60 (sixty) days of its receipt of a proper rejection notice from Anteris.

3.6

Records Retention. Switchback shall be responsible for setting up and maintaining Product traceability and maintaining all records related to the provision of the Products this Agreement in accordance with the FDA or other applicable Government Authority’s archival guidelines or as otherwise required in writing by Anteris (the “Records”). Upon Anteris’s request, Switchback shall promptly provide Anteris with copies of Records. Records shall be available at reasonable times for inspection, examination and copying by or on behalf of Anteris, or for inspection by third parties, including Regulatory Authorities, for so long as any of them are in Switchback’s possession. Switchback shall not transfer, deliver or otherwise provide to any third parties original Records without Anteris’s prior written consent. Traceability and quality records will be maintained throughout the life of the Product (which shall be determined by Anteris). Traceability requirements include, but are not limited to the following:

3.6.1

All Products are traced by lot at a minimum.

3.6.2

Raw material traceability to original material Manufacturing lot.

3.7

Quality Audits. Upon reasonable notice and within normal business hours, Anteris and any third party consultant designated by Anteris shall have reasonable access to observe and inspect the Switchback Facility and procedures with respect to the Products, including all quality and other controls related to the Products and all analytical and Manufacturing documentation related to the Products no more than twice per year, except as such additional access as may be required to resolve any delivery, quality, inspection, regulatory, performance or related issues. In addition, Anteris shall have the right to conduct at least one periodic audit each Agreement year. Periodic audits shall be scheduled with Switchback’s compliance representative. Switchback shall not unreasonably reject proposed audit schedules. If Anteris wishes to undertake more than one periodic audit in an Agreement year, Anteris shall provide written explanation to Switchback of reason for the additional periodic audit and the proposed schedule for the audit, and Switchback shall not unreasonably reject the request. Anteris and Switchback shall mutually agree upon responsibilities and ownership of any such audit.

3.8

Complaint Process. Upon Anteris’s reasonable request, Switchback will perform analysis, inspection, or similar investigative services or provide a device history record (“DHR”) as a result of a customer complaint, Switchback must complete such services or provide the DHR within thirty (30) days of the request from Anteris.

REGULATORY COMPLIANCE

4.1

Regulatory Approvals; Cooperation. Switchback agrees to comply with all required regulatory requirements for the Manufacture of the Products. Switchback agrees to use its commercially reasonable efforts to cooperate with Anteris in connection with seeking and obtaining any and all regulatory approvals for the Products. Without limiting the generality of the foregoing, from and after the Original Effective Date, upon request by Anteris, Switchback shall reasonably support Anteris’s regulatory filings regarding the Products, provided that Anteris shall compensate Switchback for its out-of-pocket expenses incurred in providing such assistance.

4.2

Regulatory Audits and Inspections.

4.2.1

Switchback Facility. Switchback shall promptly notify Anteris when a Government Authority inspection of its facilities (or an inspection by third parties in accordance with Government Authority regulations) is expected and/or underway relevant to the Products or the Manufacture of the Products, and shall promptly provide Anteris with copies of all applicable regulatory correspondence with any Government Authority relevant to the Products or the Manufacture of the Products. With respect to inspections relating to the Products, Switchback will secure Anteris’s written agreement prior to making any commitment to a regulatory agency regarding the Products. Anteris shall be provided with draft responses to regulatory observations that involve the Products and its manufacture prior to submission to the regulatory authorities and Switchback shall permit Anteris's input into responses and corrective actions. Anteris shall retain the final authority and responsibility for the content of the responses to the Government Authority.

4.2.2

Anteris Facility. If Anteris is hosting a regulatory audit or inspection, Switchback shall provide reasonable support and promptly produce documents as soon as possible and no later than twenty-four (24) hours from any request from Anteris. Anteris will make reasonable efforts to ensure that Switchback is promptly notified of any regulatory audit or inspection of Anteris where this assistance may be needed.

4.3

Compliance History. Switchback shall provide Anteris with a review of Switchback’s regulatory compliance history, which shall include, but not be limited to: (i) any reports and/or records from Government Authority inspections conducted within the last five (5) years and any related correspondence between Switchback and any Government Authority; (ii) any warning letters and related correspondence between Switchback and any Government Authority within the last five (5) years; (iii) all reports and/or findings from any third party audits, and related correspondence between Switchback and the third party auditor, within the last five (5) years, and (iv) notice of any regulatory matters relating to Switchback’s other buyers directly or indirectly due to Switchback’s Manufacturing responsibilities.

4.4

Import/Export Compliance. Switchback and Anteris shall work together to ensure compliance with the applicable Regulations regarding the shipping, transfer, import and export of all Products. For purposes of this paragraph, Products includes product-associated technology and technical data and the documents related to that technology and data. “Regulations” as used in this paragraph means all laws, treaties, governmental orders and regulations of the countries from which Products are exported and to which Products are imported including, rules regarding classification, marking, packaging, payments of tariffs and duties, embargoes, and restricted transactions.

4.5

Change in Manufacturing Process. Switchback shall notify Anteris in writing of any proposed changes in the Products, Manufacturing process or any other change which affects fit, form, or function or the safety or effectiveness of the supply process, including any changes that affect: (a) a government submission made by or on behalf of Switchback or Anteris (i.e., any change to a technical file or international product master file), (b) master batch records or written quality plans for production or written quality procedures respecting same, or (c) any changes outside the validated level or procedure, in Manufacturing procedures, component part or raw materials vendors, Manufacturing sites or batch sizes. Upon such notice, Anteris shall evaluate and communicate to Switchback its approval or disapproval of such change within fourteen (14) days after the date of its receipt of notice. Only upon notice of written approval from Anteris and after Switchback has demonstrated to Anteris’s satisfaction that all change and validation processes have been successfully completed in compliance with any regulations or applicable legal requirements may Switchback incorporate such change into the Manufacturing process.

4.6

Right to Audit/Product Safety. Switchback shall ensure that Anteris and any regulatory authorities may, during regular business hours and upon reasonable advance written notice, (a) examine and inspect any Switchback Facility or, the facilities of any subcontractor or Switchback used by it in the development, sourcing or manufacture of Products, and (b) inspect all data, documentation and work product relating to the activities performed by it or any subcontractor. This right to inspect all data, documentation and work product relating to the Product may be exercised at any time during the Term of this Agreement upon reasonable notice or such longer period as shall be required by applicable law. Switchback shall promptly provide Anteris with the results of any audit by a Government Authority relating to the Products. Switchback shall provide to Anteris, upon Anteris’s request, copies of Safety Data Sheets (“SDSs”) and any other information and documentation related to product safety, including physical, chemical, and biological characteristics of the Products. At reasonable times and upon reasonable notice, Anteris shall have the right to audit Switchback’s established procedures and processes, including documentation, to accommodate the direct handling of health emergencies, product ingredient inquiries, and distribution of SDSs related to the Products.

4.7

Environmental Compliance. Switchback shall comply with the following terms and conditions for all Products provided to Anteris:

4.7.1

Materials Disclosures. Switchback shall provide full disclosure of all materials used in the Products (“Materials Disclosure”) to Anteris. Further, Switchback shall comply with all Environmental Regulations applicable to the Products. For the purposes of this section, “Environmental Regulations” shall include any and all laws, regulations, directives, ordinances, orders and decrees of any kind, adopted or implemented in any country, state, region or jurisdiction, which govern, regulate or restrict: (i) the use of hazardous substances; (ii) biological or other hazardous waste; (iii) packaging and packaging waste; and (iv) the registration, evaluation, authorization and restriction of chemicals. Switchback shall provide Anteris with assistance and sufficient documentation, as reasonably determined by Anteris, to enable Anteris to verify the materials used in the Products and that Products are in full compliance with Environmental Regulations.

4.7.2

Environmental Regulations. Switchback represents and warrants that, as of the Original Effective Date, the Products are in full compliance with all applicable Environmental Regulations. In addition, at any time upon request from Anteris, Switchback shall provide Anteris with a report on the status of the Products’ ongoing compliance with Environmental Regulations. Any such report shall include Switchback’s representation and warranty that, as of the date of the report, the Products are in full compliance with all applicable Environmental Regulations, as from time to time in force.

4.7.3

Changes Impacting Environmental Safety. During the Term of this Agreement, in accordance with applicable Quality Requirements, Switchback shall promptly notify Anteris of any changes in the Products’ design, technical specification, composition, components, substances or materials, or any changes in a component, substance or material, that may have an impact on the ongoing compliance of the Products with Environmental Regulations. Switchback will not change the appearance, text and all other aspects of the package labeling without having first obtained Anteris’s prior written approval.

4.7.4

Accuracy of Information. Switchback certifies that it gathered the information required by this Agreement and that all information submitted to Anteris in connection with this Agreement is accurate. Switchback acknowledges that Anteris will rely on this certification in determining the compliance of its products. Anteris acknowledges that Switchback may have relied on information provided by others, and that Switchback may not have independently verified such information. However, in situations where Switchback has not independently verified information provided by others, Switchback agrees that, at a minimum, its Permitted Subcontractors have provided certifications regarding their contributions to the Products, and those certifications are at least as comprehensive as the certification provided by Switchback.

CONFIDENTIALITY AND PUBLICITY

5.1

Confidential Information: Each Party agrees it shall not disclose or use the other Party’s Confidential Information except for the purpose of this Agreement. The receiving Party will safeguard the disclosing Party’s Confidential Information against unauthorized disclosure using the same degree of care as it uses for its own Confidential Information of like importance, but no less than reasonable care. Any disclosure of the disclosing Party’s Confidential Information to the receiving Party’s employees or consultants will be preceded by disclosure and acknowledgement of the Party’s obligations of confidentiality hereunder. The receiving Party is responsible for any disclosure of the disclosing Party’s Confidential Information by the receiving Party’s employees or consultants. “Confidential Information” means non-public information relating to a Party’s business, research and development, Intellectual Property, business plans and other financial or marketing information and other Manufacturing and regulatory information whether provided orally or in writing. For the avoidance of doubt, Confidential Information of Anteris includes (i) the Specifications and (ii) any Results of any testing services performed by Switchback.

5.2

Exclusions. Confidential Information does not include information that:

(i)

is known to the receiving Party without confidentiality obligations prior to receipt thereof, as demonstrated by reliable evidence;

(ii)

is disclosed to the receiving Party, without restriction or following expiration of a restriction and without a breach of such third party’s confidentiality obligations by a third party;

(iii) is or becomes public knowledge, by publication or otherwise, through no fault of the receiving Party; or

(iv)

is independently developed by the receiving Party, without using Confidential Information of disclosing Party, as demonstrated by reliable evidence.

5.3

Ownership. Except as otherwise expressly provided in this Agreement, all Confidential Information remains the property of the disclosing Party.

5.4

Copies; Return or Destruction of Materials. Neither Party will copy or duplicate any materials containing Confidential Information except as necessary to comply with Law, perform its obligations, or exercise its rights under this Agreement. The Parties will return or certify in writing the destruction of all materials containing Confidential Information that have been provided by the other Party, including all copies, upon demand by the disclosing Party. The receiving Party will treat any materials containing Confidential Information of the disclosing Party that are not destroyed or returned to the disclosing Party in accordance with this Section 5. A Party may elect to keep a single copy of Confidential Information for evidentiary purposes, to comply with Law and such Party’s quality and regulatory requirements. The confidentiality obligations regarding this copy of Confidential Information shall survive termination of this Agreement in perpetuity.

5.5

Required Disclosure. In the event that, on the advice of legal counsel, the receiving Party is compelled by Law to disclose the disclosing Party’s Confidential Information, the receiving Party will, to the extent reasonably possible, notify the disclosing Party in advance of such disclosure about the need for, any such disclosure so that the disclosing Party may seek a protective order or other remedy, if such remedy is reasonable under the circumstances. The receiving Party will take reasonable action to ensure protection of the disclosed Confidential Information to the extent allowable by Law.

5.6

Publicity. Neither Party may make any public announcement about or advertise the existence of this Agreement or divulge its terms and conditions to third parties other than as required by any Government Authority or to attorneys and financial consultants that are under a duty of confidentiality without the prior written consent of the other Party.

5.7

Term of Obligations. Except as otherwise provided under this Section 5, each Party’s obligations under this Section remain in effect during the Term of this Agreement seven (7) additional years after the expiration or termination of this Agreement, except that Confidential Information that contains trade secrets shall be maintained in confidence indefinitely by the receiving Party until such trade secret is made public through no action or omission of the receiving Party.

INTELLECTUAL PROPERTY RIGHTS

6.1

Anteris Intellectual Property. Switchback acknowledges that Anteris or its Affiliates own all right, title, and interest throughout the world in and to all Intellectual Property relating to the Products including, without limitation, the development, manufacture, use and sale of (i) the Products; (ii) the Anteris Valve; (iii) the Anteris Frame; (iv) any delivery system for the Products, and (v) the ADAPT® treated tissue (“Anteris Intellectual Property”).

6.2

Supplier Background Intellectual Property. Switchback shall retain any and all of its right, title and interest throughout the world in and to any trade secrets, concepts, ideas, know-how, procedures, processes, methodologies and other Intellectual Property provided by or used by Switchback in connection with performing the Services, in each case (i) developed or acquired by Switchback prior to commencement of the Services, (ii) independently of this Agreement or its provision of any services for Anteris or its Affiliates or (iii) general knowledge acquired by Switchback in connection with performing the Services and not specific to the Products(“Supplier Background Intellectual Property”). If any of the Supplier Background Intellectual Property is required for Anteris to use, manufacture, or sell the Products, Switchback hereby grants to Anteris and its Affiliates a limited, perpetual, irrevocable, worldwide, non-exclusive, fully-paid, royalty-free right and license to use such Supplier Background Intellectual Property to the extent incorporated in, combined with or other wise necessary for the manufacture, sale, or use of the Products. Nothing in this Agreement shall be deemed a transfer of any of Switchback’s rights in the Supplier Background Intellectual Property to Anteris or its Affiliates.

6.3

Developed Intellectual Property. Anteris shall own all right, title and interest in and to all Intellectual Property developed under this Agreement as of the Original Effective Date and during the Term or arising from the performance of the services under this Agreement (“Developed Intellectual Property”). The Developed Intellectual Property shall not include any of the Supplier Background Intellectual Property. Switchback hereby irrevocably assigns to Anteris, in each case without additional consideration, all right, title and interest throughout the world in and to the Developed Intellectual Property. Upon Anteris’s request and at Anteris’s expense, Switchback shall promptly take such further actions, including execution and delivery of all appropriate instruments of conveyance, as may be necessary to assist Anteris to prosecute, register, perfect or record its rights in or to the Developed Intellectual Property.

6.4

License to Manufacture the Products. Anteris grants to Switchback a limited, non-exclusive, non-transferable, revocable license under such Anteris Intellectual Property required to Manufacture the Products, such license expressly limited to the right to produce and have produced the Products for supply to Anteris during the Term of this Agreement. Any such Anteris Intellectual Property will remain the property of Anteris and will be subject to the Confidentiality Section of this Agreement. Without limiting the generality of the foregoing, the Parties agree that the Specifications, as existing as of the Original Effective Date of this Agreement or as modified, constitute Anteris Intellectual Property. In no case will Switchback use any such Anteris Intellectual Property for the benefit of any third party other than under this Agreement. No other license under any Anteris Intellectual Property is granted, and none is to be implied.

6.5

Third Party Licenses. Switchback shall comply with and maintain in full force and effect all license agreements with third parties pursuant to which Switchback is licensed to use the Intellectual Property of third parties that is used or employed for Switchback to perform its obligations under this Agreement. Switchback shall promptly notify Anteris in writing of any allegation that Switchback is in breach of any such license agreement. Anteris may, but is not obligated to, cure any such alleged breach and recover the cost of such cure from Switchback, including without limitation, by set-off against amounts Anteris owes Switchback hereunder.

WARRANTIES AND REPRESENTATIONS

7.1

Ability to Perform. Switchback represents and warrants that it (i) has the required skill, experience, and qualifications to Manufacture the Products; (ii) will Manufacture the Products in a timely, workmanlike, and professional manner in accordance with generally recognized industry standards and in compliance with all Applicable Laws; and (iii) is able to comply, and will comply, with all of the Quality Requirements.

7.2

Compliance Covenants and Representations. Switchback represents and warrants to Anteris that:

(i) the Products delivered to Anteris are not adulterated or misbranded within the meaning of the United States Food, Drug, and Cosmetic Act, (ii) all Products delivered to Anteris have been manufactured in accordance with a quality system that is consistent with the applicable Quality Requirements; and (iii) the Manufacture, sale and delivery of Products does not violate any, and the Products conform to all applicable law, including without limitation, the regulations of any Government Authority. Switchback shall promptly notify Anteris in writing if Switchback becomes aware that Products or any applicable Quality Requirements may not comply with Law.

7.3

Product Warranty. Switchback represents and warrants that each of the Products delivered under this Agreement (i) fully complies and will comply with all applicable Specifications and applicable Quality Requirements, and (ii) is and will be free from defects in materials and workmanship and shall be manufactured and provided in accordance and conformity with the Specifications and in compliance with this Agreement and the Quality Requirements. Switchback shall inform Anteris in writing no more than two (2) days after Switchback learns of any actual or potential problems relating to the performance of any Products or any similar product manufactured by Switchback for a third party.

7.4

Government Watch List. Switchback represents and warrants that neither Switchback nor any Switchback personnel who will perform services under this Agreement, is included in or listed: (i) on the List of Excluded Individuals/Entities maintained by the HHS Office of Inspector General pursuant to 42 U.S.C. Sections 1320a-7, 13955ccc, 1320c-5 and regulations promulgated thereunder, which, as of the Original Effective Date, can be searched at the internet website of http://exclusions.oig.hhs.gov/ (“OIG List”); (ii) on the Excluded Parties List System maintained by the United States General Services Administration which, as of the Original Effective Date, can be searched at the internet website of http://epls.arnet.gov (the “GSA List”); or (iii) as a Specially Designated National or Blocked Person on the U.S Treasury’s Office of Foreign Assets Control list of Specially Designated Nationals and Blocked Persons which, as of the Original Effective Date, is located at the internet web site of http://www.ustreas.gov/offices/enforcement/ofac/sdn/ (the “SDN List”). Switchback will promptly inform Anteris if it or its personnel should come to be included on the OIG List, the GSA List or SDN List.

7.5

Compliance with Agreement. Switchback represents and warrants that all of its employees, agents, contractors and consultants whose services may be used to fulfill the obligations under this Agreement are or will be informed of the terms of this Agreement to the extent necessary to comply with its terms, and that all such persons are sufficiently obligated to Switchback, by contract or otherwise, to fully comply with all provisions of this Agreement.

7.6

Conflicts. Switchback represents and warrants to Anteris that the execution of this Agreement or any Purchase Order or Development Work Order placed hereunder and Switchback's performance thereunder is within its duly authorized powers and does not conflict with any other contract or obligation of Switchback. Switchback represents that all other business relationships, employment relationships and development obligations of Switchback will not present a conflict with the obligations to Anteris set forth herein, are not likely to entail or involve the disclosure of Anteris Confidential Information, and will not impede or interfere with the performance of Switchback’s obligations under this Agreement. If at any time the nature of Switchback’s work for Anteris or other business relationships, employment relationships or development obligations should change and make a potential conflict likely, Switchback agrees to notify Anteris that a potential conflict exists, and to disclose to Anteris the nature of the potential conflict.

7.7

Disclaimer. OTHER THAN THE EXPRESS WARRANTIES IN THIS AGREEMENT, SWITCHBACK MAKES NO OTHER WARRANTY AND HEREBY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED.

7.8

Indemnification.

7.8.1

Indemnification by Switchback. Switchback shall defend, indemnify, and hold harmless Anteris and Anteris’s Affiliates, officers, managers, directors, governors, employees, agents, successors, and permitted assigns (each, an “Anteris Indemnitee”) from and against all losses, damages, liabilities, deficiencies, actions, judgments, interest, awards, penalties, fines, costs, or expenses of whatever kind, including reasonable attorneys’ fees and the cost of enforcing any right to indemnification hereunder and the cost of pursuing any insurance providers (“Losses”), arising out of or resulting from any third-party claim, suit, action, or proceeding (each, an “Action”) arising out of or resulting from:

(i)

any breach of any representation, warranty, or obligations of Switchback or its Affiliates under this Agreement;

(ii)

any Manufacturing defect or non-conformity with respect to the Products to the extent arising from Switchback’s performance of services under this Agreement, except where such Manufacturing defect or non-conformity applies solely to the Anteris Components and the Anteris Components are stored, handled and used by Switchback according to the Specifications;

(iii)

violation of any Applicable Law by Switchback or its Affiliates in connection with Switchbacks performance of its obligations under this Agreement;

(iv)

bodily injury, death of any person, or damage to real or tangible, personal property resulting from the willful, fraudulent, or grossly negligent acts or omissions of Switchback or its personnel; or

(v)

the release, discharge, storage or disposal by Switchback or at Switchback’s direction or by its Affiliates of any material or substance, including, without limitation, any hazardous material or substance related to this Agreement.

7.8.2

Indemnification by Anteris. Anteris shall defend, indemnify, and hold harmless Switchback and Switchback’s Affiliates, officers, managers, directors, governors, employees, agents, successors, and permitted assigns (each, a “Switchback Indemnitee”) from and against all Losses arising out of or resulting from any Action arising out of or resulting from:

(i)

Anteris’s material breach of any representation, warranty, or obligation of Anteris in this Agreement;

(ii)

any Manufacturing defect or non-conformity respecting the Anteris Components to the extent the Anteris Components is stored, handled, and used by Switchback according to the Specifications;

(iii)

the Products’ infringement upon a third party’s Intellectual Property right;

(iv)

violation of any Applicable Law by Anteris or its Affiliates in connection with Anteris’s obligations under this Agreement; or

(v)

bodily injury, death of any person, or damage to real or tangible, personal property resulting from the grossly negligent or willful acts or omissions of Anteris.

7.8.3

The party seeking indemnification hereunder shall promptly notify the indemnifying party in writing of any Action and cooperate with the indemnifying party at the indemnifying party’s sole cost and expense. The indemnifying party shall immediately take control of the defense and investigation of such Action and shall employ counsel of its choice to handle and defend the same, at the indemnifying party’s sole cost and expense. The indemnified party’s failure to perform any obligations under this Section 7.7 shall not relieve the indemnifying party of its obligations under this Section 7.7 except to the extent that the indemnifying party can demonstrate that it has been materially prejudiced as a result of such failure. The indemnified party may participate in and observe the proceedings at its own cost and expense.

7.8.4

Notwithstanding anything to the contrary in this Agreement, the indemnifying party is not obligated to indemnify, hold harmless, or defend the indemnified party against any claim (whether direct or indirect) to the extent such claim or corresponding losses arise out of or result from, in whole or in part, the indemnified party’s: (i) gross negligence or more culpable act or omission (including recklessness or willful misconduct); or (ii) bad faith failure to materially comply with any of its material obligations set forth in this Agreement.

7.9

Limitation of Remedies. Except for their obligations to make payment and obligations under Sections 2, 3, 5, 6, 7.1, 7.2, 7.7, 7.8 and any other section that specifically refers to this Limitation of Remedies Section, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR TO ANY THIRD PARTY FOR ANY LOSS OF USE, REVENUE, OR PROFIT, OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, OR PUNITIVE DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER OR NOT THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.

7.10

Insurance. At all times during the term of this Agreement as defined in Section 8 and for a period of three (3) years thereafter, each Party (or an Affiliate of such Party) shall procure and maintain, at its sole cost and expense, insurance with the following minimum coverage and limits: (a) commercial general liability insurance on an occurrence basis with minimum combined single limit coverage of $1,000,000 per occurrence and $2,000,000 in the annual aggregate; (b) product liability of $2,000,000 per occurrence covering all Products. Upon a Party’s request, the other Party shall provide the requesting Party with a certificate of insurance evidencing the insurance coverage specified in this Agreement.

TERM AND TERMINATION

8.1

Term. This Agreement is effective as of the Original Effective Date until May 12, 2025 (the “Initial Term”), is renewed for a further term until March 31, 2028 (the “First Renewal Term”), and shall automatically be extended on the same terms and conditions for one (1) year increments (each, a “Subsequent Renewal Term”), unless either Party gives written notice of non-renewal at least 180 days prior to the end of the then-current renewal term.

8.2.1

Either Party may terminate this Agreement in the event that (i) the other Party breaches any material provision of this Agreement and such breach remains uncured for thirty (30) days following the receipt by the defaulting Party of notice of such breach, or (ii) upon notice if the other Party becomes insolvent, is adjudicated bankrupt, voluntarily or involuntarily files a petition for bankruptcy, makes an assignment for the benefit of creditors, seeks any other similar relief under any bankruptcy law or related statutes or otherwise becomes financially incapable of performing its obligations in accordance with the terms of this Agreement.

8.2.2

Anteris may terminate this Agreement for any reason or no reason upon sixty (60) days’ written notice to Switchback.

8.2.3

Other than as provided under Section 8.2.1 and Section 8.2.2, neither Party may terminate this Agreement for any reason prior to the expiration of the Initial Term.

8.3

After the Initial Term, Anteris may terminate this Agreement upon thirty (30) days’ written notice to Switchback, if the Technology Transfer under Section 9 has been completed.

8.4

Effect of Expiration or Termination:

8.4.1

Agreement. The Parties acknowledge and agree that the termination or expiration of any individual order shall not in itself terminate this Agreement or have any effect on the rights and obligations of third parties or any other purchase order placed hereunder. If this Agreement expires or is terminated under Section 8, no further Purchase Orders or SOWs may be entered into by the Parties under this Agreement.

8.4.2

Orders. Upon termination or expiration of this Agreement, all then outstanding accepted orders thereunder for Products shall survive. If Anteris seeks to terminate any open Purchase Order at termination or expiration, Anteris shall be liable for all Products that are in the process of Manufacture as of the end of the Term (“Work in Process”) and shall reimburse Switchback for its Material Cost and Labor Cost associated with such Work in Process. Switchback shall deliver the Work in Process to Anteris, unless otherwise notified by Anteris.

8.4.3

Return to Anteris. Switchback shall promptly return all applicable Anteris property, return or securely destroy the records in Switchback’s possession as directed by Anteris, and execute such documents and take other action as reasonably requested by Anteris in connection therewith. For the avoidance of doubt, Switchback shall return all Products, all Work in Process, all Anteris Components (including all Anteris Frames and Anteris Valves), all Scrap Components (including all Scrap Valves), all Anteris Owned Equipment, and any materials provided to Switchback for the performance of any feasibility assessment, testing services, or any other services under Section 2.1. Switchback agrees to cease using the Confidential Information of Anteris for any purpose and return to Anteris all documentation relating to the Confidential Information and to destroy all other copies of such documentation;

8.4.4

Transfer of Material Information of Switchback to Anteris. In the event of the termination or expiration of this Agreement for any reason, Switchback will transfer all Records to Anteris and would provide Anteris with reasonable access to Switchback personnel and to such Manufacturing processes, procedures and know-how related to the Products as reasonably required to enable Anteris to continue to source or to internally manufacture the Products. If for any reason a Transfer Initiation Notice has not been issued under Section 9 as of termination or expiration of this Agreement (including any termination as a result of any breach by Anteris of this Agreement), termination or expiration of this Agreement shall effectively initiate transfer of Manufacturing of the Products to Anteris or its designee and Switchback shall perform all obligations under Section 9 as required to transfer Manufacturing of the Products to Anteris or its designee. Switchback will also furnish to Anteris reasonably detailed information as to the status of all efforts pertaining to the development of the Products within five (5) business days of termination or expiration of this Agreement.

8.4.5

Termination of Agreement Following Change of Control. Any failure to assign or otherwise transfer this Agreement to a Party’s successor in interest following a Change of Control as set forth in Section 10.2 shall be deemed a breach of this Agreement by the Party.

8.4.6

Rights in Bankruptcy. Any rights and licenses granted by Switchback to Anteris in this Agreement are, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. Anteris shall retain all of its rights, elections, and protections under the U.S. Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding against Switchback under the U.S. Bankruptcy Code, all rights, licenses, and privileges granted to Anteris under this Agreement shall continue subject to the terms and conditions hereof and Anteris’s rights under Section 365(n). Further, in the event of the commencement of a bankruptcy proceeding against Switchback, Anteris shall be entitled to a complete duplicate of, or complete access to, as appropriate, all such intellectual property licensed under this Agreement, which if not already in Anteris’s possession, shall be promptly delivered to Anteris, unless Switchback elects to and does in fact continue to perform its obligations under this Agreement.

8.5

Survival. All provisions which are continuing in nature, including, but not limited to, Sections 3, 5, 6, 7, 8, 9, and 10 will survive termination of this Agreement.

8.6

Non-Compete. During the Term and for one (1) year thereafter, Switchback will not alone, or in any capacity with another firm: (a) directly or indirectly participate in or support in any capacity (e.g., as an advisor, principal, agent, partner, officer, director, shareholder, employee or otherwise) the manufacture, invention, development, sale, solicitation of sale, marketing, testing, research or other business aspect of any actual or projected product, product line or service designed, developed, manufactured, marketed or sold which duplicates the Product as defined herein;(b) disrupt, damage, impair, or interfere with the business of Anteris as it relates directly to the Product, whether by way of interfering with or disrupting Anteris’s relationship with employees, customers, agents, representatives or vendors; or (c) employ or attempt to employ any of Anteris’s then employees on behalf of any other entity, whether or not such entity competes with Anteris; provided, however, this section does not prohibit Switchback from employing any such person who contacts Switchback on his or her own initiative and without any direct or indirect solicitation by Switchback or who responds to an advertisement not specifically targeted to Anteris’s employees.

TRANSFER OF MANUFACTURING TO ANTERIS

9.1

Anteris, at its sole discretion, shall provide notice to Switchback in writing of its intention to transfer Manufacturing of the Products to Anteris or to its designee (“Transfer Initiation Notice”). Except in the case of a breach of this Agreement by Switchback, Anteris shall not provide a Transfer Initiation Notice during the Initial Term.

9.2

Switchback shall provide Anteris with all Records, access to those personnel with know-how to Manufacture the Products, and any Product Manufacturing IP.

9.3

In addition to any license provided under Section 6 of this Agreement, Switchback hereby grants Anteris or its designee a limited, perpetual, irrevocable, worldwide, non-exclusive, sub-licensable, fully-paid, royalty-free right and license to use (i) the Product Manufacturing IP, to the extent Switchback has any rights to the Product Manufacturing IP and (ii) the Supplier Background Intellectual Property, as defined in Section 6.2, to the extent required to Manufacture the Products.


	ANTERIS TECHNOLOGIES CORPORATION

	By:	/s/ David St. Denis
	Name: David St. Denis
	Title: President

	SWITCHBACK MEDICAL LLC

	By:	/s/ Brady Hatcher
	Name: Brady Hatcher
	Title: Chief Executive Officer


Date:	November 12, 2025	By:	/s/ Wayne Paterson
			Wayne Paterson
			Chief Executive Officer
			(Principal Executive Officer)


By:	/s/ Wayne Paterson
	Wayne Paterson
	Chief Executive Officer (Principal Executive Officer)
	November 12, 2025

By:	/s/ Matthew McDonnell
	Matthew McDonnell
	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
	November 12, 2025

Number of

Allocated

Securities

A/C Name / Code

Australian

Custodian Details

CHESS PID#