SEC Form F-3 filed by Trinity Biotech plc
Republic of Ireland
(State or other jurisdiction of incorporation or organization) |
Not Applicable
(I.R.S. Employer Identification No.) |
Steven J. Glusband, Esq.
Mary Brown, Esq.
Carter Ledyard & Milburn LLP
28 Liberty Street
New York, New York 10005
(212) 732-3200
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David Fitzgibbon, Esq.
David Jones, Esq.
Matheson LLP
70 Sir John Rogerson's Quay
Dublin 2 Ireland
+353 1 232 2000
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14
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the development of future products;
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the potential attributes and benefit of our products and their competitive position;
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our ability to successfully commercialize, or enter into strategic relationships with third parties to commercialize, our products;
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our estimates regarding expenses, future revenues, capital requirements and our need for additional financing;
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statements of our plans and objectives;
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our ability to acquire or in-license new product candidates;
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potential strategic relationships;
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the duration of our patent portfolio; and
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statements regarding the capabilities of our business operations;
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statements of expected future economic performance;
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statements regarding competition in our market; and
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assumptions underlying statements regarding us or our business.
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our substantial indebtedness, which could impair our flexibility and access to capital and adversely affect our financial position;
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our ability to generate or raise sufficient funds to repay our debt as it becomes due and to continue as a going concern;
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our continued listing on the Nasdaq Global Select Market:
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pandemics or other public health emergencies, including ongoing effects of the COVID-19 pandemic;
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the occurrence of hostilities and political instability, including hostilities between Russia and Ukraine and between Hamas and Israel, and resulting volatility and other effects on global economic conditions;
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changes in customer demand;
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our ability to successfully develop and commercialize new products, including our new biosensor related products, including our continuous glucose monitoring (“CGM”) product;
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recalls of our products or liability claims in connection with our products and services and the cost and reputational harm associated with such recalls or claims and with any voluntary corrective actions or regulatory agency
enforcement actions;
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delays or failures in our clinical trials and failure to maintain regulatory approvals and clearances to manufacture, market and distribute our products;
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interruptions in production at our principal manufacturing facilities, our third-party manufacturing facilities or our suppliers;
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the extent to which we are successful in gaining new long-term relationships with customers or retaining existing ones;
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developments and changes in laws and regulations, including increased regulation of our industry through legislative action and revised rules and standards;
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security breaches, cybersecurity attacks and other significant disruptions;
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natural events such as severe weather, fires, floods and earthquakes or man-made or other disruptions of our business and facilities;
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strategic actions, including acquisitions and dispositions and our success in integrating acquired businesses; and
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our ability to obtain and protect rights to the intellectual property necessary for the conduct of our business and the potential costs of enforcing or defending those rights.
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ADSs offered by the
selling shareholder
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650,000 ADSs (each ADS represents 20 A Ordinary Shares, par value $0.0109 per share). The offered ADSs are evidenced by ADRs.
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A Ordinary Shares outstanding as of November 14, 2024
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357,005,182 A Ordinary Shares (which excludes 48,696,672 A Ordinary Shares issuable upon the exercise of options at exercise prices that range from US$0.12-US$1.29 per share, 21,200,000
A Ordinary Shares represented by ADSs issuable upon the exercise of outstanding warrants, and 24,691,358 A Ordinary Shares represented by ADSs issuable upon conversion of the $20 million convertible note (the “MiCo Convertible Note”)
held by MiCo IDV Holdings, LLC (“MiCo”), with an ADS conversion price of $16.20 per ADS).
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Use of proceeds
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We will not receive any proceeds from the sale of the ‘ADSs offered hereby.
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Nasdaq symbol
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“TRIB”
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Risk Factors
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Prospective investors should carefully consider the Risk Factors beginning on Page 5 and under similar headings in the other documents that are incorporated by reference into this
prospectus for a discussion of certain factors that should be considered before buying the ADSs offered hereby.
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Difficulties in integrating the operations, systems, technologies, products, and personnel of the acquired businesses or enterprises;
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Diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations resulting from acquisitions;
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Integrating financial forecasting and controls, procedures and reporting cycles;
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Potential difficulties in completing projects associated with in-process research and development;
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Difficulties in entering markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions;
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Insufficient revenue to offset increased expenses associated with acquisitions; and
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The potential loss of key employees, customers, distributors, vendors and other business partners of the companies we acquire following and continuing after announcement of acquisition plans.
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Reducing complexity and cost by consolidating our main manufacturing operations into a considerably smaller number of sites and also moving to an outsourced model for a significant amount of our less complex manufacturing activities;
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Reducing the cost of goods of many of our products by changing suppliers and negotiating new deals with existing suppliers:
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Continued market acceptance of our new TrinScreen™ HIV rapid point-of-care test; and
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Simplifying our internal operations and optimizing our business support function locations.
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As of September 30, 2024
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Actual
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As Adjusted
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Equity (1):
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A Ordinary Shares, par value $0.0109 per share
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$
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2,377.00
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$
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2,422.55
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Share Premium
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$
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57,519.00
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$
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64,371.87
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Treasury shares
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$
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(24,922.00
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)
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$
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24,922.00
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)
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Reserves
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$
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984.00
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$
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984.00
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Accumulated deficit
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$
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(62,300.00
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)
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$
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(63,197.91
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)
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Total shareholders’ equity
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$
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(26,342.00
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)
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$
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(20,342.08
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)
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(1) |
The number of A Ordinary Shares issued and outstanding excludes: 48,696,672 A Ordinary Shares issuable upon exercise of stock options outstanding as of September 30, 2024 at exercise prices that range from US$0.12-US$1.29 per share;
21,200,000 A Ordinary Shares represented by ADSs issuable upon the exercise of outstanding warrants; 24,691,358 A Ordinary Shares represented by ADSs issuable upon conversion of the MiCo Convertible Note.
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Selling Shareholder
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Ordinary Shares Beneficially
Owned Prior to Offering/ Percentage of Class |
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Ordinary Shares
Being Offered
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Ordinary Shares Beneficially Owned Upon Completion of Offering /
Percentage of Class |
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Craig-Hallum(1)
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3.6% (2)
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13,000,000 A Ordinary Shares (represented by 650,000 million ADSs)
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-- %(3)
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(1) |
Craig-Hallum’s address is 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55420.
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(2) |
The A Ordinary Shares represented by the 650,000 ADSs offered hereby.
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(3) |
Assuming all ADSs representing A Ordinary Shares being registered for resale hereunder are sold.
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;
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purchases by a broker-dealer as principal and resale by the broker-dealer for its own account;
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an exchange distribution in accordance with the rules of the applicable exchange;
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privately negotiated transactions;
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short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the Commission;
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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through agreements between broker-dealers and the selling shareholder to sell a specified number of such shares at a stipulated price per share;
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a combination of any such methods of sale; and
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any other method permitted by applicable law.
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Commission registration fee
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$
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157.73
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EDGAR and printing fees
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$
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1,000
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Legal fees and expenses
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$
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10,000
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Accounting fees and expenses
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$
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5,500
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Miscellaneous
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$
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2,000
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Total
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$
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18,657.73
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●
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Our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, as filed with the
Commission on April 30, 2024, and Amendment No. 1 thereto on Form 20-F/A, as filed with the Commission on July 12, 2024;
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●
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Our Reports on Form 6-K furnished to the Commission on April 30, 2024, May 16, 2024, May
28, 2024, July 11, 2024, July 12, 2024, August
7, 2024, August 7, 2024, August 20, 2024, August
21, 2024, August 29, 2024, September 5, 2024 (with materials relating to the Company’s annual general meeting), September 23, 2024, September
25, 2024, September 30, 2024, October 2, 2024, October 25, 2024 (with respect to each of the EpiCapture Acquisition and the Novus Investment),
November 7, 2024 and November 15,
2024; and
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●
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The description of our ADSs contained in our Form 20-F for the fiscal year ended December 31,
2023 filed with the Commission April 30, 2024.
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(1) |
to file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
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(i) |
to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933 (the “Securities Act”);
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(ii) |
to reflect in the prospectus any facts or events arising after the effective date of this Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental
change in the information set forth in this Registration Statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than a 20% change in the maximum aggregate offering price set forth in the ‘‘Calculation of Registration Fee’’ table in the effective registration statement; and
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(iii) |
to include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in this Registration Statement;
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(2) |
that, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
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(3) |
to remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
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(4) |
to file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and
information otherwise required by Section 10(a)(3) of the Securities Act of 1933 need not be furnished, provided, that the registrant includes in the prospectus, by means of a post-effective
amendment, financial statements required pursuant to this paragraph (4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements.
Notwithstanding the foregoing, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Securities Act of 1933 or Rule 3-19 of Regulation S-X if such financial
statements and information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in
this Form F-3.
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(5) |
that, for the purpose of determining any liability under the Securities Act to any purchaser:
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(i) |
each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be a part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
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(ii) |
each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of
providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or
the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed
to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement
that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
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(6) |
that, for the purpose of determining liability of a registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
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(i) |
any preliminary prospectus or prospectus of the undersigned registrant to the offering required to be filed pursuant to Rule 424;
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(ii) |
any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by an undersigned registrant;
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(iii) |
the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
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(iv) |
any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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(b) |
The registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where
applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this Registration Statement shall be deemed to be a new registration statement
relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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(c) |
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions referred to in Item 8, or otherwise, the
registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
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TRINITY BIOTECH PLC
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By:
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/s/ John Gillard
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John Gillard
Chief Executive Officer
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Signature
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Title
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/s/ John Gillard
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Chief Executive Officer (Principal Executive Officer), Company Secretary and Director
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John Gillard
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/s/ Louise Tallon
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Chief Financial Officer (Principal Accounting Officer)
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Louise Tallon
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/s/ James Walsh
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Director
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James Walsh
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/s/ Ronan O’Caoimh
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Director
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Ronan O’Caoimh
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/s/ Thomas Lindsay
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Director
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Thomas Lindsay
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/s/ Andrew Omidvar
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Director
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Andrew Omidvar
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By:
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/s/ Donald J. Puglisi
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Name:
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Donald J. Puglisi
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Title:
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Managing Director
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Exhibit No.
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Description of Exhibit
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