Document:

EX-4.20

 Exhibit 4.20 

PATENT LICENSE AGREEMENT 
 THIS AGREEMENT
(“Agreement”) is between the Board of Regents (“Board”) of The University of Texas System (“System”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin,
Texas 78701, and Trinity Biotech, Incorporated, a Missouri corporation having a principal place of business located at1930 Business Center Drive, Saint Louis, Missouri 63114, USA (“Trinity”). 

TABLE OF CONTENTS 
  

					
			RECITALS		PAGE 2
			
	1.		EFFECTIVE DATE		PAGE 2
			
	2.		DEFINITIONS		PAGE 2
			
	3.		WARRANTY, SUPERIOR RIGHTS AND REPRESENTATIONS		PAGE 4
			
	4.		LICENSE		PAGE 4
			
	5.		PAYMENTS AND REPORTS		PAGE 5
			
	6.		TERM AND TERMINATION		PAGE 8
			
	7.		INFRINGEMENT		PAGE 9
			
	8.		ASSIGNMENT		PAGE 10
			
	9.		PATENT MARKING		PAGE 10
			
	10.		INDEMNIFICATION		PAGE 10
			
	11.		USE OF BOARD AND UNIVERSITY NAME		PAGE 11
			
	12.		CONFIDENTIAL INFORMATION		PAGE 11
			
	13.		PATENTS AND INVENTIONS		PAGE 11
			
	14.		ALTERNATE DISPUTE RESOLUTION		PAGE 15
			
	15.		GENERAL		PAGE 15
		
	SIGNATURES		PAGE

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 1 of 15

 RECITALS 

A. Board owns certain Patent Rights and Technology Rights related to Licensed Subject Matter, which were developed at The
University of Texas Health Science Center at Houston (“University”), a component institution of System. 
 B. Board desires to
have the Licensed Subject Matter developed in the Licensed Field and used for the benefit of Trinity, the Inventor, Board, and the public as outlined in Board’s Intellectual Property Policy. 

C. Trinity desires to obtain a license from Board to practice Licensed Subject Matter. 

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the parties agree as follows: 

1. EFFECTIVE DATE 
 This
Agreement is effective as of April 18th, 2005 (“Effective Date”). 
 2. DEFINITIONS 

As used in this Agreement, the following terms have the meanings indicated: 

2.1 “Affiliate” means: 
  

	 	a.	any business entity at least 50% owned by Trinity, or 

  

	 	b.	any business entity that owns at least 50% of Trinity, or 

  

	 	c.	any business entity that is at least 50% owned by a business entity that owns at least 50% of Trinity, or 

  

	 	d.	any business entity in which Trinity has a controlling share. 

 2.2 “Actively Attempting to
Commercialize” means an effective, ongoing and active research, development, manufacturing, marketing or sales program as appropriate, directed toward obtaining regulatory approval, and/or production and/or Sales of Licensed
Products or Sales of a product incorporating Licensed Products or a part thereof, in any jurisdiction, and where Trinity has provided plans acceptable to University, in its sole discretion, to Commercialize
Licensed Subject Matter in Licensed Territory. 
 2.3 “Commercialize” means having Sales of Licensed Products, or
Sales of products incorporating Licensed Products or parts thereof. 
 2.4 “Inventor” means Dr. Steven J. Norris or
any person specifically under Dr. Norris’s direction in his capacity as a principal investigator at University. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 2 of 15

 2.5 “Licensed Field” means the use of Licensed Subject Matter to make, have made, use and
Sell a protein or antibody-based human diagnostic test for Lyme disease. 
 2.6 “Licensed Product” means any product or
Service comprised or derived from Licensed Subject Matter; or which utilizes Licensed Subject Matter in its development; or any products with which Licensed Subject Matter is combined, attached, packaged, retrofitted,
marketed, or Sold. 
 2.7 “Licensed Subject Matter” means protein and antibody based inventions covered by Patent Rights or
Technology Rights for use within Licensed Field. 
 2.8 “Licensed Territory” means worldwide 

2.9 “Net Sales” means the gross revenues received by Trinity or its Affiliates, as the case may be, from the Sale of
Licensed Products or performance of a Service with in the Licensed Territory, less: 
  

	 	a.	Sales and/or use taxes actually paid; 

  

	 	b.	Import and/or export duties actually paid; 

  

	 	c.	Non-reimbursed outbound transportation prepaid or allowed; and 

  

	 	d.	Amounts allowed or credited due to returns. 

 Such deductions shall only arise from
Trinity’s expenses incurred in Selling a Licensed Product within the Licensed Territory and shall not exceed the original billing or invoice amount. 

2.10 “Patent Rights” means Board’s rights in information or discoveries covered by the University’s patent(s) or
patent applications in the Licensed Territory, which are listed in Exhibit A, for: 
  

	 	a.	“VMP-Like Sequences of Pathogenic Borrelia”; and 

  

	 	b.	“VMP-Like Sequences of Pathogenic Borrelia Species and Strains”; and 

  

	 	c.	any patent(s) issuing from the foregoing applications; and 

  

	 	d.	any reissue, extension, revival or reexamination of the foregoing patent(s). 

 2.11 “Patent
Territory” means Austria, Belgium, Denmark, Finland, France, Germany, Netherlands, Spain, Sweden, Switzerland and The United States of America. 

2.12 “Sale, Sold or Sell” means the transfer or disposition of a Licensed Product for value to a party other than Trinity. 

2.13 “Service” means Trinity’s or its Affiliate’s performance of in-house testing using Licensed Subject
Matter. For calculating Net Sales, Service shall not include Trinity’s or its Affiliate’s use of Licensed Subject Matter to perform quality assurance testing for any Licensed Product. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 3 of 15

 2.14 “Technology Rights” means Board’s rights in technical information, know-how,
processes, procedures, compositions, devices, methods, formulas, protocols, techniques, trade secrets, drawings or data created by Inventor at UTHSC-H, before the Effective Date, relating to Patent Rights, which are not
covered by Patent Rights but which are necessary for practicing the invention covered by Patent Rights. 
 3. WARRANTY:
SUPERIOR-RIGHTS 
 3.1 Except for the rights, if any, of the Government of the United States, as set forth below, Board represents and
warrants its belief that (i) it is the owner of the entire right, title, and interest in and to Licensed Subject Matter, (ii) it has the right to grant licenses thereunder, and (iii) it has not knowingly granted licenses
thereunder to any other entity that would restrict rights granted to Trinity except as stated herein. 
 3.2 Trinity understands that the
Licensed Subject Matter may have been developed under a funding agreement with the Government of the United States of America and, if so, that the Government may have certain rights relative thereto. This Agreement is explicitly made
subject to the Government’s rights under any agreement and any applicable law or regulation. If there is a conflict between an agreement, applicable law or regulation and this Agreement, the terms of the Government agreement, applicable
law or regulation shall prevail. 
 3.3 Trinity understands and acknowledges that Board, by this Agreement, makes no representation as
to the operability or fitness for any use, safety, efficacy, ability to obtain regulatory approval, patentability, and/or breadth of the Licensed Subject Matter or Materials. Board, by this Agreement, also makes no
representation as to whether there are any patents now held, or which will be held, by others or by Board in the Licensed Field, nor does Board make any representation that the inventions contained in Patent Rights or
Materials do not infringe any other patents now held or that will be held by others or by Board. 
 3.4 Trinity, by execution hereof,
acknowledges, covenants and agrees that it has not been induced in any way by Board, System, University or its employees to enter into this Agreement, and further warrants and represents that (i) it has conducted
sufficient due diligence with respect to all items and issues pertaining to this Article 3 and all other matters pertaining to this Agreement; and (ii) Trinity has adequate knowledge and expertise, or has utilized knowledgeable
and expert consultants, to adequately conduct the due diligence, and agrees to accept all risks inherent herein. 
 4. LICENSE

 4.1 Board hereby grants to Trinity a royalty-bearing, non-exclusive license under
Licensed Subject Matter to manufacture, have manufactured, use, distribute, Sell, offer to Sell, import, lease, loan or otherwise Commercialize Licensed Products in
Trinity’s ordinary course of business, within the Licensed Territory for use within Licensed Field. This grant specifically excludes the right to (i) sublicense,
(ii) cross-license, and (iii) transfer any rights granted herein. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 4 of 15

 
This grant is subject to any rights held by the Government of the United States as set forth in Paragraph 3.2, the payment by Trinity to University of all consideration as provided
herein, and is further subject to the following rights retained by University and Board to: 
  

	 	a.	Publish the general scientific findings from research related to Licensed Subject Matter subject to the terms of Section 12, Confidential Information; and 

 

	 	b.	Use Licensed Subject Matter for research, teaching and other educationally-related purposes; and 

  

	 	c.	Grant other licenses to Licensed Subject Matter. 

 4.2 Trinity may extend the license granted
herein to any Affiliate provided that the Affiliate consents in writing to be bound by this Agreement to the same extent as Trinity. 

4.3 Trinity shall at all times use commercially reasonable efforts develop, manufacture or have others manufacture, seek and obtain any necessary
governmental approval, and actively promote, Sell and distribute Licensed Products in the Licensed Territory in only lawful ways and to the extent commercially reasonable. 

4.4 Trinity shall use commercially reasonable efforts to develop and market Licensed Products for Sale in the Licensed
Territory according to the timetables set-forth below. 
  

	 	a.	Within nine (9) months after the Effective Date, Trinity shall develop a Licensed Product; and 

  

	 	b.	Within twelve (12) months after the Effective Date, Trinity shall offer for Sale or Sell a Licensed Product. 

4.5 To assist Trinity’s development of Licensed Products, University, through its Inventor, shall provide to
Trinity the following (“Materials”): 
  

	 	a.	Five micrograms of its expression vector for Borrelia burgdorferi Vls protein (VlsE1-His); and 

  

	 	b.	Ten milligrams of its purified, recombinant Borrelia burgdorferi VlsE1-His protein. 

Such Materials shall be provided within 14 days after University’s receipt of Trinity’s payment
indicated in Paragraph 5.1.a. 
 5. PAYMENTS AND REPORTS 

5.1 In consideration of rights granted by Board to Trinity under this Agreement, Trinity will pay Board the following (all
dollar amounts are in United States Dollars): 
  

	 	a.	A non-refundable, non-creditable license documentation fee in the amount of seventy thousand dollars ($70,000). Such fee shall be due and payable within fourteen (14) days after the Effective Date.

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 5 of 15

	 	b.	An annual non-creditable license management fee in the amount of two thousand five hundred dollars ($2,500), due and payable on each anniversary of the Effective Date beginning on the first anniversary; and

  

	 	c.	A running royalty equal to four percent (4%) of Net Sales of a Licensed Product. 

  

	 	d.	A non-refundable, non-creditable amount of thirty thousand dollars ($30,000) upon: 

  

	 	(i)	achieving five million dollars ($5,000,000) of gross, aggregate income from Sales of all Licensed Products in the United States of America; and 

 

	 	(ii)	achieving five million dollars ($5,000,000) of gross, aggregate income from Sales of all Licensed Products in EPO member countries; and 

 

	 	(iii)	achieving ten million dollars ($10,000,000) of gross, aggregate income from Sales of all Licensed Products in the United States of America 

 

	 	(iv)	achieving ten million dollars ($10,000,000) of gross, aggregate income from Sales of all Licensed Products in EPO member countries 

(The parties agree that each payment under Sections 5.1(d) shall only be due and paid once during the Term of this
Agreement.) 
 5.2 Trinity shall pay University ten thousand dollars ($10,000) of University’s prior expenses incurred by
for filing, prosecuting, enforcing and maintaining Patent Rights in the Licensed Territory, through the Effective Date. Such amount shall be due and payable within thirty (30) days after this Agreement is executed by
Trinity. 
 5.3 For expenses incurred after the Effective Date and subject to Section 5.3(b): 

 

	 	a.	Trinity shall pay twenty percent (20%) of all future expenses incurred by University for filing, patent office prosecution, and maintaining Patent Rights in the Patent Territory
(“Expenses”), for so long as this Agreement remains in effect. Since this Agreement is non-exclusive, if the percent reimbursement for future Expenses made under all license agreements for Patent Rights
in the Patent Territory exceeds one hundred percent (100%), then during the period in which such percent reimbursements exceed one hundred percent (100%), the percentage due from Trinity shall be decreased proportionately so that the
percent reimbursement does not exceed 100%. University will invoice Trinity on a regular basis beginning with expenses incurred by University after the Effective Date. The invoiced amounts will be due and payable by
Trinity within thirty (30) days after receipt of invoice from University. 

  

	 	b.	If the amount owed by Trinity under Section 5.3(a) exceeds $10,000 during any year of this Agreement, then Trinity may elect to carry forward the amount in excess of $10,000 to the following
year. Subject to the foregoing, any amount carried forward hereunder shall be (i) added to the legal fees due during the following year and (ii) paid with the March 31 quarterly report, up to the $10,000 cap. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 6 of 15

 5.4 During the term of this Agreement and for three (3) years thereafter, Trinity agrees to
keep complete and accurate records of its and its Affiliate’s Sales and Net Sales of Licensed Products under the license granted in this Agreement in sufficient detail to enable the royalties payable hereunder to be
determined. Trinity agrees to permit Board or its representatives, at Board’s expense, to periodically examine its books, ledgers, and records during regular business hours for the purpose of and to the extent necessary to
verify any report required under this Agreement. If the amounts due to Board are determined to have been underpaid by five percent (5%) or greater, Trinity will pay the cost of the examination and accrued interest at the
prime rate, as published by the United States Federal Reserve Bank, New York, New York on the date quarterly due date for which the payment was due plus three percent (3%). 

5.5 Within thirty (30) days after March 31, June 30, September 30, and December 31, beginning immediately after the
Effective Date, Trinity shall deliver to Board a true and accurate written report, even if no payments are due Board, giving the particulars of the business conducted by Trinity and its Affiliate(s), during
the preceding three (3) calendar months under this Agreement as are pertinent to calculating payments hereunder. This report will include at least: 
  

	 	a.	The total quantities of Licensed Products produced; 

  

	 	b.	The total Sales separately listed by country; 

  

	 	c.	The calculation of royalties and amounts payable thereon; 

  

	 	d.	The total royalties computed and due Board; and, 

  

	 	e.	All other amounts due University herein. 

 Simultaneously with the
delivery of each report, Trinity shall pay to Board the amount, if any, due for the period of each report. 
 5.5 On or before each anniversary
of the Effective Date, irrespective of having a first Sale or offer for Sale, Trinity shall deliver to Board a written report summarizing Trinity’s efforts and accomplishments during the preceding year
in diligently commercializing Licensed Subject Matter in the Licensed Territory and Trinity’s commercialization plans for the upcoming year. 

5.6 All amounts payable herein by Trinity shall be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind.
When Licensed Product is Sold for monies other than United States dollars, the earned royalties first will be determined in the foreign currency in the country in which such Licensed Products were sold, and then converted into
equivalent United States funds. The exchange rate will be that rate established by the United States Federal Reserve Bank, New York, New York on the last day of the reporting period, and will be quoted in the continental terms method of quoting
exchange rates (local currency per United States dollar). All royalty payments which are not paid by Trinity by the thirty-first (31st) day after each quarterly payment date shall bear
interest at the Prime Rate of the United States Federal Reserve Bank, New York, New York plus three percent (3%). Such interest payments shall be calculated from the quarterly due dates until the payment is received by University.
University is a tax-exempt organization under the laws of the State of Texas and of the United States and shall be solely responsible for any taxes that may hereafter be levied upon the payments to Board. Payments shall be made by
check payable to The University of Texas Health Science Center at Houston, and mailed to University at the address set forth in Section 14.2, or made via electronic 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 7 of 15

 
funds transfer to: Bank Name: JP Morgan Chase Bank; Bank Account #:             ; ABA Routing
#:            ; Account Name: The University of Texas Health Science Center at Houston. In the event of a wire transfer, Trinity shall promptly notify University in writing of
such transfer. 
 5.7 No payments due or royalty rates owed under this Agreement will be reduced as a result of co-ownership of Licensed Subject
Matter by Board and another party, including, but not limited to, Trinity. 
 6. TERM AND TERMINATION 

6.1 The term of this Agreement is from the Effective Date to the full end of the term or terms for which Patent Rights have not expired,
unless otherwise terminated as provided herein. Notwithstanding the foregoing, if only Technology Rights are licensed and no Patent Rights are applicable, the term of this Agreement shall be for fifteen (15) years from the
Effective Date, after which Virotech shall have a non-exclusive, royalty free license to Technology Rights. 
 6.2 Any time after three
(3) years from the Effective Date, Board and University have the right to terminate this license in any national political jurisdiction in the Licensed Territory if Trinity, within ninety (90) days after
receiving written notice from University of intended termination, fails to provide written evidence, satisfactory to University, that Trinity or an Affiliate has Commercialized or is Actively Attempting to
Commercialize a licensed invention in such jurisdiction(s). 
 6.3 Subject to any rights that survive termination, this Agreement will earlier
terminate in its entirety: 
  

	 	a.	automatically if Trinity becomes bankrupt or insolvent and/or if the business of Trinity is placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Trinity or otherwise;
or 

  

	 	b.	upon thirty (30) days written notice from University if Trinity breaches or defaults on its obligation to make payments (if any are due) or reports, in accordance with the terms of Article 5
hereunder, unless, before the end of the thirty (30) day period, Trinity has cured the default or breach and so notifies Board, stating the manner of the cure; or 

 

	 	c.	upon sixty (60) days written notice from University if Trinity breaches or defaults on any other obligation under this Agreement, unless, before the end of the sixtieth (60) day period,
Trinity has cured the default or breach and so notifies Board, stating the manner of the cure; or 

  

	 	d.	upon sixty (60) days written notice from Trinity if University materially breaches or defaults on its other obligation under this Agreement, unless, before the end of the sixtieth (60) day
period, University has cured the default or breach and so notifies Trinity, stating the manner of the cure; or 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 8 of 15

	 	e.	at any time by mutual written agreement between Trinity, University and Board, upon one hundred eighty (180) days written notice to all parties and subject to any terms herein which survive
termination; or 

  

	 	f.	under the relevant provisions of Paragraphs 6.2 if invoked. 

 6.4 If Trinity is current in its payments
under Section 5 herein, then Trinity may terminate this Agreement by providing Board one hundred eighty (180) days written notice. Such termination shall become effective on the one-hundred eightieth (180th) day after Board receives such written notice. 
 6.5 If this Agreement is terminated
for any cause: 
  

	 	a.	nothing herein will be construed to release either party of any obligation matured prior to the effective date of the termination; and 

 

	 	b.	after the effective date of the termination, Trinity may Sell all Licensed Products and parts thereof it has on hand at the date of termination, if Trinity pays running royalties thereon and
any other amounts according to the terms of Article 5; and 

  

	 	c.	Trinity covenants and agrees to be bound by the provisions of Articles 10 (Indemnification), 11 (Use of Board and University Name), and 12 (Confidential Information) of this Agreement; and

  

	 	d.	all data, prototypes, derivatives of data, designs or Materials, and accompanying rights thereto, provided to Trinity by Inventors, will be returned to University at Trinity’s
expense. 

 7. INFRINGEMENT 

7.1 If Trinity is notified of any patent held by a third party that Trinity reasonably believes would be infringed by the continued Sale
of Licensed Products, or by the use of Licensed Products by its customers, or of the possible infringement by a third party of the Patent Rights granted hereunder, Trinity agrees to promptly notify Board of same in
writing. 
 7.2 Trinity, at its expense, may enforce any patent licensed hereunder against third party infringement within the Licensed Field
and Licensed Territory, and shall be entitled to retain recoveries from such enforcement. If legally required to do so, Board and University agree to be named parties in any litigation instituted by Trinity to enforce
Patent Rights. Trinity agrees to pay Board a royalty as set forth above on any monetary recovery (after deduction of Trinity’s third-party, documented, unrecovered reasonable legal expenses incurred exclusively from
such suit) if the monetary recovery is for damages based on sales of an infringing product or a reasonable royalty in lieu thereof. If Trinity does not file suit against a substantial infringer of a patent within six (6) months of
knowledge thereof, then Board and University, at their sole discretion and expense, may enforce any patent licensed hereunder on behalf of themselves and Trinity, with Board retaining all recoveries from such enforcement.

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 9 of 15

 7.3 In any infringement suit or dispute, the parties agree to cooperate fully with each other. At the request and
expense of the party bringing suit, the other party will permit access to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours. 

7.4 Trinity may request that Board join the prosecution of an infringer. If Board agrees, then Trinity and Board shall
jointly enforce against infringement by third parties and shall be entitled to retain any recovery from such enforcement. After deducting Trinity’s and Board’s third-party, documented, unrecovered reasonable legal expenses
incurred exclusively from such suit, any remaining recovery shall be divided equally. 
 8. ASSIGNMENT 

Except in connection with the sale of substantially all of Trinity’s assets to a third party, this Agreement may not be assigned by
Trinity without the prior written consent of Board, which will not be unreasonably withheld. 
 9. PATENT MARKING AND
MAINTENANCE 
 9.1 Trinity shall permanently and legibly mark all products and documentation manufactured or Sold by Trinity or
its Affiliates pursuant to this Agreement with a patent notice as may be permitted or required under Title 35, United States Code, or if such marking is not practicable, shall so mark the accompanying outer box or product insert for
Licensed Products accordingly. 
 9.2 Board shall use reasonable efforts to obtain and maintain Patent Rights in the Patent
Territory, including payment of maintenance fees and, where appropriate, preparing, filing, and prosecuting patent applications. 

10. INDEMNIFICATION 

Trinity agrees to hold harmless and indemnify Board, System, University, its Regents, officers, employees and agents from and
against any claims, demands, or causes of action whatsoever, or costs of suit or reasonable attorney’s fees, including without limitation those costs arising on account of any injury or death of persons or damage to property caused by, or
arising out of, or resulting from, the exercise or practice of the license granted hereunder by Trinity, its officers, Affiliates or their officers, employees, agents or representatives. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 10 of 15

 11. USE OF BOARD AND UNIVERSITY NAME 

Trinity may not use the name of University, System, or Board without express written consent. 

12. CONFIDENTIAL INFORMATION AND PUBLICATION 

12.1 Board and Trinity each agree that all information contained in documents marked “confidential” and forwarded to one by the other
(i) are to be received in strict confidence, (ii) used only for the purposes of this Agreement, and (iii) not disclosed by the recipient party, its agents or employees without the prior written consent of the other party,
except to the extent that the recipient party can establish competent written proof that such information: 
  

	 	a.	was in the public domain at the time of disclosure; 

  

	 	b.	later became part of the public domain through no act or omission of the recipient party, its employees, agents, successors or assigns; 

 

	 	c.	was lawfully disclosed to the recipient party by a third party having the right to disclose it; 

  

	 	d.	was already known by the recipient party at the time of disclosure; 

  

	 	e.	was independently developed by the recipient, as evidenced by written documentation; or 

  

	 	f.	is required by law or regulation to be disclosed. 

 12.2 Each party’s obligation of confidence hereunder
shall be fulfilled by using at least the same degree of care with the other party’s confidential information as it uses to protect its own confidential information. This obligation shall exist while this Agreement is in force and for a
period of three (3) years thereafter. 
 13. PATENTS AND INVENTIONS 

13.1 If after consultation with Trinity, both parties agree that a patent application should be filed for Licensed Subject Matter, Board
will prepare and file the appropriate patent applications, and Trinity will pay the cost, according to Section 5.1(g) above, of searching, preparing, filing, prosecuting and maintaining same. If Trinity notifies Board that
it does not intend to pay the costs of an application, or if Trinity does not respond or make an effort to agree with Board on the disposition of rights in the subject invention, then Board may file an application at its own
expense and Trinity will have no rights to such invention. 
 13.2 Board will provide Trinity a copy of any patent application for
which Trinity has paid the costs, according to Section 5.1(g) above, of searching, preparing and filing, as well as copies of any documents received or filed with the respective patent office during the prosecution thereof
(“Notice”). Should Trinity decline to support a particular patent application in a particular country, Trinity shall so notify the University in writing within thirty (30) days after receiving Notice
and Trinity shall thereafter have no further rights hereunder in that particular patent application in that particular country. 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 11 of 15

 14. ALTERNATE DISPUTE RESOLUTION 

Any dispute or controversy arising out of or relating to this Agreement, its construction or its actual or alleged breach may be decided by mediation.
If the mediation does not result in a resolution of such dispute or controversy, it may be decided by an appropriate method of alternate dispute resolution, including without limitation, arbitration, conducted in the city of Houston, Texas in
accordance with the Licensing Agreement Arbitration Rules of the American Arbitration Association. The arbitration panel will include members knowledgeable in the evaluation of protein and antibody-based technologies. Judgment upon the award
rendered may be entered in the highest court or forum having jurisdiction, state or federal. The provisions of this Article 14 will not apply to decisions on the validity of patent claims or to any dispute or controversy as to which any treaty or
law prohibits such arbitration. The decision of the arbitration must be sanctioned by a court of law having jurisdiction to be binding upon and enforceable by the parties. The use of any method of alternative dispute resolution will not be construed
by either party in a manner that would adversely affect the other party’s rights in court. Nothing in this section will prevent one party from resorting to judicial proceedings if good faith efforts to resolve a dispute have been unsuccessful
or if injunctive relief is necessary to prevent serious and irreparable harm to one party or third parties. 
 15. GENERAL 

15.1 This Agreement constitutes the entire and only agreement between the parties for Licensed Subject Matter and all other prior negotiations,
representations, agreements, and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by a written document signed by both parties. 

15.2 Any notice required by this Agreement shall be given by prepaid, first class, certified mail, return receipt requested, addressed to: 

The University of Texas Health Science Center at Houston 

Office of Technology Management 

7000 Fannin Street, Suite 720 

Houston, Texas 77030 
 FAX:
713.500.0331 
 PHONE: 713.500.3369 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 12 of 15

 with copy to: 

Board of Regents 
 The
University of Texas System 
 201 West 7th Street 

Austin, Texas 78701 
 ATTENTION:
Office of General Counsel 
 FAX: 512.499.4523 

or in the case of Trinity to: 

Trinity Biotech, Inc. 
 1930
Business Center Drive 
 St. Louis , Missouri 63114 USA 

ATTENTION: 
 FAX: 

PHONE: 
 or other addresses as may be given from
time to time under the terms of this notice provision. 
 15.3 Trinity shall comply with all applicable federal, state, and local laws and regulations
in connection with its activities pursuant to this Agreement. 
 15.4 This Agreement will be construed and enforced in accordance with the laws
of the United States of America and of the State of Texas. 
 15.5 Failure of Board to enforce a right under this Agreement will not act as a
waiver of that right or the ability to later assert that right relative to the particular situation involved. 
  

	15.6	Headings are included herein for convenience only and shall not be used to construe this Agreement. 

15.7 If any part of this Agreement is for any reason found to be unenforceable, all other parts nevertheless remain enforceable. 

(Remainder of Page Intentionally Blank) 

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 13 of 15

 IN WITNESS WHEREOF, parties hereto have caused their duly authorized representatives to execute this
Agreement. 
  

			
	Board of Regents of		Trinity Biotech, Inc.
	The University of Texas System		
		
	By: /s/ Kevin Dillon		By: /s/ Jim Walsh
	T. Kevin Dillon		(Typed Name)
	Executive Vice President for Finance and Business Affairs		(Typed Title)
	The University of Texas Health Science Center at Houston		
	Date: 4/12/05		
			Date: 4/18/05
		
	Approved as to Content:		
		
	By: /s/ Bruce D. Butler		
	Bruce D. Butler, Ph.D.		
	Assistant Vice President for Research and Technology		
	Date: 4/12/05		
		
	Read and Understood:		
		
	By: /s/ Steven Norris		
	Steven J. Norris, Ph.D.		
	Inventor		
	Date: 4/12/05		

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.		Page 14 of 15

 Exhibit A 
  

											
	 Patent Title
	  	 UTHSC-H
File Number
	  	 Type of Application
	  	 Filing Date
	  	 Serial Number
	  	 Issue Date / Number

						
	VMP Like Sequences of Pathogenic Borrelia	  	1996-0001	  	US Provisional	  	Feb 21, 1996	  	60/012,028	  	N.A.
						
		  	1996-0001	  	U.S. Nationalization of PCT Patent Application Number PCT/US97/02952	  	 -Feb 21, 1997
 -Jul 10, 2001
	  	09/125,619	  	 Aug 20, 2002
 6,437,116

						
		  	1996-0001	  	Continuation of U.S. Patent Number 6,437,116	  	May 10, 2002	  	10/143,024	  	 May 25, 2004
 6,740,744

						
		  	1996-0001	  	Continuation of U.S. Patent Number 6,437,116	  	Aug 16, 2002	  	10/222,566	  	April 13, 2004 6,719,983
						
		  	1996-0001	  	Continuation of U.S. Patent Number 6,437,116	  	May 24, 2004	  	10/852,555	  	Notice of allowance received
						
	VMP Like Sequences of Pathogenic Borrelia	  	1996-0001	  	PCT Conversion of US Provisional Application Number 60/012,028	  	Feb 21, 1997	  	PCT/US97/02952	  	N.A.
						
		  	1996-0001	  	EPO Nationalization of PCT Conversion of PCT Application Number PCT/US97/02952	  	Oct 26, 1998	  	 97,914,794.9
 EPO Publication Number:
EP894143
 Publication Date:
 Aug. 8, 1997
	  	Pending
						
	VMP-Like sequences of Pathogenic Borrelia Species and Strains	  	2003-0002	  	US Provisional	  	Dec 20, 2002	  	60/435,077	  	N.A.
						
		  	2003-0002	  	PCT Conversion of US Provisional Application Number 60/435,077	  	Dec. 22, 2003	  	 PCT/US03/47782
 PCT Publication Number:

WO04/058181
 Publication Date:

July 15, 2004
	  	Pending

  

					
	Patent License Agreement between the Board of Regents of The University of Texas System and Trinity Biotech, Inc.	 	Page 15 of 15EX-4.21

 Exhibit 4.21 

Execution Version 

PATENT LICENSE AGREEMENT 

This PATENT LICENSE AGREEMENT (the “Agreement”) is entered into as of August 3, 2006, by and between Inverness Medical
Innovations, Inc., a corporation organized and existing under the laws of Delaware (hereinafter called “Inverness”), and Trinity Biotech PLC, a corporation organized and existing under the laws of the Republic of Ireland
(hereinafter called “Trinity”). 
 Inverness and one of its affiliates and Trinity are parties to a Settlement Agreement
and Mutual Release dated as of the date set forth above (the “Settlement Agreement”) pursuant to which certain litigation was settled and, among other conditions, the parties agreed that Inverness would license or sub-license to Trinity
certain patents. Trinity desires to acquire a limited, nonexclusive license under those patents on the terms set forth herein. In consideration of the promises and mutual covenants herein contained and contained in the Settlement Agreement,
Inverness and Trinity agree as follows: 
 Section 1. Definitions. 

“Affiliate” shall mean shall mean any entity that controls, is controlled by, or is under common control with a party hereto.
For purposes of this definition, “control” shall mean (i) in the case of corporate entities, direct or indirect ownership of a majority of the stock or shares having the right to vote for the election of directors, and (ii) in
the case of non-corporate entities, direct or indirect ownership of a majority of the equity interest with the power to direct the management and policies of such non-corporate entities. 

“Charlton Field” shall mean sale through any channels for use by licensed professional health-care providers (including
hospitals, physicians acting as such and licensed professional health-care centers). 
 “Charlton Patents” shall mean the
following, to the extent Controlled by Inverness or its Affiliates: (i) U.S. Patent Nos. 5,714,389, 5,989,921, and 6,485,982; (ii) U.S. Patent Application No. 11/035,047; (iii) any continuations or divisionals of such patents and
patent applications, whether such continuations or divisionals are filed before or after the Effective Date; and (iv) any foreign counterparts of the patents and patent applications described in sub-paragraphs (i)-(iii) above. 

“Control” shall mean the ability of a party to grant a license or sublicense under any Patent Rights without violating the
terms of any agreement or other arrangement with any Third Party. 
 “Current Patents” shall mean the following, to the
extent owned or Controlled by Inverness or its Affiliates: (i) U.S. Patent Nos. 6,352,862; 6,534,320; 5,622,871; 5,656,503; 6,187,598; 4,956,302; 6,627,459; and 5,120,643; (ii) U.S. Patent Application Nos. 09/780,351; 10/990,946;
09/944,389; 10/328,402; 10/456,771, and 10/328,403; (iii) any continuations or divisionals of such patents and patent applications, whether such continuations or divisionals are filed before or after the Effective Date; and (iv) any
foreign counterparts of the patents and patent applications described in sub-paragraphs (i)-(iii) above. 

  
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“Effective Date” shall mean the date on which this Agreement is executed by the party which lasts executes this Agreement.

 “Existing Products” shall mean the Trinity products listed on Exhibit B, provided such products are manufactured
by Trinity or any Trinity Subsidiary. 
 “Future Patents” shall mean: (a) any continuation-in-part of the Current
Patents, and any foreign counterparts of any such continuation-in-part; (b) any continuation-in-part of the Charlton Patents and any foreign counterparts of such continuation-in-part, provided that the inclusion of this sub-paragraph
(b) in this definition of Future Patents shall not be construed to grant any license to Charlton Patents outside the Charlton Field; and (c) any other Patent Rights in respect of which Inverness acquires ownership or Control after the
Effective Date and that would be infringed by Trinity’s (including Trinity Subsidiaries) making, using, offering for sale, importing or selling Licensed Products. 

“Future Product” means any diagnostic product that is first commercially sold after the Effective Date: 

(a) the manufacture, use, sale or importation of which would, but for the licenses granted herein, infringe at least one claim of the Current
Patents or Charlton Patents; and 
 (b) that is manufactured by Trinity or any Trinity Subsidiary; and 

(c) that is “Developed or Substantially Developed” by Trinity or any Trinity Subsidiary, where “Developed or Substantially
Developed” means that all or substantially all of the technical product development man/hours required to take the product from conception to market were spent by employees or individuals engaged as contractors by Trinity or a Trinity
Subsidiary; 
 but excluding the following: 

(d) any diagnostic products for women’s healthcare applications, including without limitation pregnancy hormone (hCG) and ovulation (LH);

 (e) any cardiac tests, cardiovascular risk assessment tests or diagnostic product designed to test for cardiovascular disease other than
D-dimer test products; 
 (f) any product acquired by Trinity or any Trinity Subsidiary after the Effective Date (and the parties agree,
without limitation of the foregoing, that where a product had been sold to an arms-length purchaser in the United States of America or a member country of the European Union on or before being acquired by Trinity or such Trinity Subsidiary, such
product has been acquired, and not Developed or Substantially Developed by Trinity); and 
 (g) any product Developed or Substantially
Developed before the Effective Date by a Third Party that is acquired by Trinity or a Trinity Subsidiary, or that otherwise becomes a Trinity Subsidiary, after the Effective Date. 

  
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For the avoidance of doubt, the parties agree that the exclusion set forth in sub-paragraph (f) of this definition of Future Product is
not intended to limit the scope of sub-paragraph (c), but rather provides an example of a product that was not “Developed or Substantially Developed” by Trinity or a Trinity Subsidiary. 

“HIV Products” shall mean Licensed Products used to test for the presence of HIV. 

“Kang Patents” shall mean U.S. Patent Nos. 6,737,277, 6,541,277, 6,506,612, 6,027,943, 5,728,587, 5,559,041, and 5,252,496,
any continuations, continuations-in-part or divisionals of the foregoing patents, and any foreign equivalents of any of the foregoing. 

“LDC Countries” shall mean those countries set forth on Exhibit A attached hereto. 

“Licensed Product” shall mean (a) Existing Products; and (b) Future Products, but, with respect to Future Patents,
only to the extent set forth in Section 2.3. 
 “Net Sales” shall mean the amount invoiced by Trinity or Trinity
Subsidiaries on sales of the Licensed Products less: (a) customary trade, quantity or cash discounts actually allowed and taken; (b) amounts repaid or credited by reason of rejection or return of the Licensed Products and amounts paid by
reason of late delivery of Licensed Products; (c) commissions paid to brokers or government imposed rebates; and (d) to the extent separately stated on purchase orders, invoices or other documents of sale, taxes levied and/or other
governmental charges made as to production, sale, transportation, delivery or use of the Licensed Products. Notwithstanding the foregoing definition, if Licensed Products are transferred for less than fair market value (for example as part of a
“bundle” of products or as a “loss leader”), Net Sales attributable to such Licensed Products shall be no less than their fair market value, which shall be calculated based on the sales price of comparable Licensed Products sold
separately in the same market. 
 “Non-Retail Field” shall mean products sold through any distribution channels other than
the Retail Field. 
 “Patent Rights” shall mean (a) any patents, pending patent applications, any patents issuing
therefrom worldwide, and all provisional rights with respect to patent applications, (b) any substitutions, divisionals, patents of addition, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations,
extensions, supplementary protection certificates, term extensions (under applicable patent law or regulation or other law or regulation), and certificates of invention of any patents or patent applications described in clause (a); and (c) all
rights in any of the foregoing. 
 “Retail Field” shall mean products sold to consumers through retail distribution
channels for use by a consumer without the supervision of any health care professional. 
 “Third Party” shall mean any
person or entity other than Trinity and Trinity Subsidiaries, or Inverness and Inverness Affiliates. 
 “Third Party Mark”
shall mean any trademark, trade name or trade dress, all right, title and interest (including all goodwill) in which is wholly owned by any Third Party. 

“Trinity HIV Product” shall mean the FDA approved Trinity Unigold Lateral Flow HIV Test. 

  
 3 

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“Trinity Mark” shall mean any trademark, trade name or trade dress, all right, title and interest (including all goodwill) in
which is wholly owned by Trinity or any Trinity Subsidiary. 
 “Trinity Subsidiary” shall mean a corporation, company or
other entity: (a) more than fifty percent (50%) of whose outstanding shares or securities (representing the right to vote for the election of directors or other managing authority) are owned or controlled, directly or indirectly, by
Trinity, or a corporation, company or other entity that is subsequently formed by Trinity during the term of the Agreement, which corporation, company or other entity does not include assets from a Third Party, but such corporation, company or other
entity shall be deemed to be a Trinity Subsidiary only so long as such ownership or control exists; or (b) which does not have outstanding shares or securities, as may be the case in a partnership, joint venture or unincorporated association,
but more than fifty percent (50%) of whose ownership interest representing the right to make the decisions for such corporation, company or other entity is owned or controlled, directly or indirectly, by Trinity, or a corporation, company or
other entity that is subsequently formed by Trinity during the term of the Agreement, but such corporation, company or other entity shall be deemed to be a Trinity Subsidiary only so long as such ownership or control exists. 

Section 2. Lateral Flow Licenses. 

2.1 License to Lateral Flow Patents. Subject to the terms and conditions of this Agreement, Inverness grants to Trinity (including
Trinity Subsidiaries) a non-exclusive, non-transferable (except as set forth in Section 11 below), non-sublicensable, worldwide, royalty-bearing license, under the Current Patents and Future Patents to make, use, offer for sale, import and
sell: (a) Licensed Products sold by Trinity under a Trinity Mark (and no Third Party Mark) in the Non-Retail Field; (b) HIV Products sold by Trinity under a Trinity Mark (and no Third Party Mark) in the Retail or Non-Retail Field; and
(c) HIV Products sold by Trinity to any Third Party for re-sale in the Retail or Non-Retail Field by such Third Party under a Third Party Mark owned by such Third Party (“Re-Branded HIV Products”). 

2.2 License to Charlton Patents. Subject to the terms and conditions of this Agreement, Inverness grants to Trinity (including Trinity
Subsidiaries) a non-exclusive, non-transferable (except as set forth in Section 11 below), non-sublicensable, worldwide, royalty-bearing license, under the Charlton Patents to make, use, offer for sale, import and sell: (a) Licensed
Products sold by Trinity under a Trinity Mark (and no Third Party Mark) in the Charlton Field; (b) HIV Products sold by Trinity under a Trinity Mark (and no Third Party Mark) in the Charlton Field; and (c) HIV Products sold by Trinity to
any Third Party for re-sale by such Third Party as Re-Branded HIV Products in the Charlton Field. 
 2.3 Limitations on Licenses as to
Future Patents. The licenses granted in Sections 2.1 and 2.2 grant licenses to Future Patents: (a) for Existing Products; and (b) for Future Products, but only with respect to claims in the Future Patents that are infringed by the
making, using, selling or importing of any Existing Product. Otherwise, Inverness grants no right or license to any Future Patents under this Agreement, including without limitation any license to any Future Patent except as described in the
foregoing sentence. 

  
 4 

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2.4 Have Made Restrictions and Exception. The licenses granted in Sections 2.1 and 2.2 shall not permit Trinity to have Licensed
Products made by any Third Party, with the following exceptions: (a) at any time during the Term with respect to HIV Products sold by Trinity for final sale in any country that is a member of the Economic Community of West African States as at
the Effective Date, Trinity may have any part of the manufacturing process from the uncut nitrocellulose sheet stage onwards conducted by a contract manufacturer located in Nigeria; and (b) after the third anniversary of the Effective Date,
Trinity may subcontract the manufacture of any HIV Products to any contract manufacturer. Trinity shall execute a written sublicense with any contract manufacturer which shall be subject to Trinity’s rights and obligations under the terms of
this Agreement, and shall provide a copy of the sublicense agreement to Inverness within 30 days’ after execution. Trinity shall ensure that any such sublicense agreement contains terms that are at least as protective of the Current Patents,
Charlton Patents and Future Patents as the terms set forth herein, and contains no terms that would be in violation of the license grant set forth in this Agreement, and, with respect to such sublicense agreement, shall cause any contract
manufacturer to assume and perform all of the covenants and obligations of Trinity to Inverness contained in this Agreement, to the extent applicable to such contract manufacturer’s exercise of its sublicense rights. Upon termination of this
Agreement as provided herein, any sublicense agreement shall thereupon automatically terminate, and Trinity shall cause any sublicense agreements to provide for such termination. Except as set forth above or in Section 11, Trinity shall
otherwise have no right to sublicense, transfer or assign any right or license granted by Section 2.1 or 2.2, and any purported sublicense, transfer or assignment shall be void. 

2.5 Use of Distributors. The restrictions in Section 2.1, 2.2 and 2.4 on transfer and sub-licensing of license rights shall not
prohibit Trinity or Trinity Subsidiaries from distributing Licensed Products under a Trinity Mark through any distributor that is granted only the right to offer for sale and sell Licensed Products under such Trinity Mark where such products and
their packaging are not modified by the distributor from the form in which the products and packaging are shipped by Trinity or the Trinity Subsidiary, nor shall such restrictions prevent third parties that purchase HIV Products from Trinity
(including Trinity Subsidiaries) for re-sale as Re- Branded HIV Products from selling such Re-Branded HIV Products through distributors selling such Re-Branded HIV Products under the same packaging and Third Party Mark (any such distributor a
“Distributor”). Inverness acknowledges that Distributors include distributors that sell Licensed Products on commission as well as distributors that purchase Licensed Products from Trinity (including Trinity Subsidiaries) for resale for
the distributor’s own account. 
 2.6 Section 365(n). The licenses granted under this Section 2 shall be treated as
licenses of rights to “intellectual property” (as defined in Section 101(56) of Title 11 of the United States Code, as amended (the “Bankruptcy Code”)) for purposes of Section 365(n) of the Bankruptcy Code. The parties
agree that Trinity may elect to retain and may fully exercise all of its rights and elections under the Bankruptcy Code provided that it abides by the terms of this Agreement. 

  
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2.7 Marking. To the extent commercially feasible and consistent with prevailing business practices, Trinity and Trinity Subsidiaries
shall mark all Licensed Products in accordance with applicable patent-marking laws of the jurisdiction in which such Licensed Products are manufactured, used or sold. 

2.8 Kang Patents. Trinity acknowledges that this Agreement does not and shall not grant any right or license to the Kang Patents. 

2.9 Reservation of Rights. Except as expressly set forth herein, this Agreement does not grant to Trinity or Trinity Subsidiaries any
right, title, interest, ownership or license, by implication, estoppel or otherwise, to any Patent Rights owned or Controlled by Inverness. Inverness retains the unqualified right to exploit the Current Patents, Charlton Patents and any Future
Patents, and to develop, make, have made, use, sell, have sold, lease, or import Licensed Products. 
 Section 3. Not Used.

 Section 4. Royalties and Payment. 

4.1 Royalties Payable. Trinity (and/or Trinity Subsidiaries) shall pay royalties to Inverness in respect of Net Sales invoiced after the
Effective Date as follows: 
 (i) With respect to Net Sales in LDC Countries, 1% of Net Sales invoiced on or before December 31, 2008,
and 2% of Net Sales invoiced thereafter; 
 (ii) With respect to Net Sales of HIV Products in the Retail Field worldwide but excluding
LDC Countries, $2.00 per unit of Licensed Product (with each unit being a single diagnostic test) or 10% of Net Sales for such unit, whichever is greater; and 

(iii) With respect to all other Net Sales, 5% of Net Sales invoiced on or before December 31, 2008, and 8.5% of Net Sales invoiced
thereafter. 
 4.2 Royalty Increase on Change of Control. In the event of any Change of Control (as defined in Section 11), the
royalties payable pursuant to Section 4.1(iii) above shall increase to 10% of Net Sales, whether such Net Sales are invoiced before or after December 31, 2008. 

4.3 Royalty Conditions. The above royalties shall be payable on a Licensed Product-by-Licensed Product basis. The royalty term for each
Licensed Product shall continue until the date when the last to expire of the Current Patents, Charlton Patents or Future Patents (if any) covering such Licensed Product expires. In the event that more than one Current Patent, Charlton Patent or
Future Patent (if any) is applicable to any Licensed Product subject to royalties under this Section 4, then only one royalty shall be paid to Inverness in respect of such Licensed Product. Furthermore, in no event shall more than one royalty
be due hereunder with respect to any Licensed Product. 
 4.4 Interest. Trinity (and/or Trinity Subsidiaries) shall be liable for
interest on any overdue royalty payment commencing on the date such royalty payment becomes due, at an annual rate which is the greater of eight percent (8%) and one percentage point higher than the

  
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prime interest rate as quoted by the head office of Citibank, N.A., New York, at the close of banking on such date, or on the first business day thereafter if
such date falls on a non-business day. If such interest rate exceeds the maximum legal rate in the jurisdiction where a claim therefor is being asserted, the interest rate shall be reduced to such maximum legal rate. 

4.5 Underpayments. In the event an audit under the provisions of Section 5.6 identifies an underpayment of royalties by Trinity,
Trinity shall pay an amount equal to such underpayment within sixty days of Inverness’s written request following such audit. Such amounts shall be subject to interest under the provisions of Section 4.4. 

Section 5. Royalty Accruals, Records, Reports and Other Information. 

5.1 Royalty Accrual. Royalties shall accrue when a Licensed Product is first sold or otherwise transferred for value by Trinity or a
Trinity Subsidiary to a Third Party (including, except as otherwise agreed in writing by Inverness, sold or otherwise transferred to Inverness or any Inverness Affiliate). 

5.2 Currency Conversion. Trinity shall pay all royalties and other payments due hereunder in United States dollars. All royalties for an
accounting period in respect of Net Sales billed and received in other currencies shall be converted into United States dollars at the exchange rate for bank transfers from such currency to United States dollars as quoted by the head office of
Citibank, N.A., New York, at the close of banking on the last day of such accounting period (or the first business day thereafter if such last day shall be a non-business day). 

5.3 Quarterly Report and Payment. Within thirty (30) days after the end of each calendar quarter during the Term, Trinity shall
furnish to Inverness a written report containing the information specified in Section 5.4 and shall pay to Inverness all royalties accrued hereunder for such calendar quarter. 

5.4 Content of Reports. Trinity’s written reports shall be certified by an officer of Trinity and shall contain for each type of
Licensed Product upon which a royalty has accrued (i) a description of said Licensed Product, (ii) the quantity of such Licensed Product sold or otherwise transferred during the accounting period, (iii) the price at which the Licensed
Product was sold, (iv) the region (LDC Country or other than LDC Country) in which it was sold, (v) Net Sales attributable to each of the Licensed Products during such accounting period and (vi) the calculation of royalties and the
total royalties due Inverness. In the event no royalties are due, Trinity’s report shall so state. 
 5.5 Verification of Licensed
Products. For the purpose of determining whether products offered for sale or otherwise marketed by Trinity (including Trinity Subsidiaries) and not identified by Trinity as Licensed Products in the reports delivered pursuant to Section 5.4
should be considered Licensed Products, Trinity shall, within thirty (30) days of a written request by Inverness for confirmation that any such product is not a Licensed Product (such request to include the basis on which Inverness believes the
product is a Licensed Product), provide to an independent outside patent attorney selected by Inverness and reasonably acceptable to Trinity, which patent attorney shall at Trinity’s request enter into a confidentiality agreement reasonably

  
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acceptable to Trinity as a condition precedent to receiving such materials containing terms consistent with the provisions of Section 9, evidence that
the product does not in fact infringe any Current Patent, Charlton Patent or any Future Patent. Such patent attorney shall only disclose his/her conclusions regarding whether the products that are the subject of Inverness’s request should be
characterized as Licensed Products, including the basis for such conclusion, but shall not disclose the materials provided by Trinity without Trinity’s prior written consent, except to the extent that the disclosure is necessary to provide the
basis for the conclusion regarding infringement. Such patent attorney shall simultaneously provide Trinity and Inverness with a copy of any such conclusions. 

5.6 Records and Audit. Trinity (including Trinity Subsidiaries) shall establish and maintain complete and accurate records in sufficient
detail to permit the determination of Licensed Products subject to this Agreement, the royalties due Inverness, and the accuracy of the information in Trinity’s written reports. 

(a) Such records shall include, but not be limited to, detailed records supporting the information provided under Section 5.4 which, if
applicable, shall be kept in accordance with generally accepted accounting principles (“GAAP”). 
 (b) Such records shall be kept
for two years following the reporting period to which they pertain. 
 (c) Upon Inverness’s written request for an audit, Trinity will
permit an independent certified public accounting firm of recognized standing, selected by Inverness and reasonably acceptable to Trinity, together with a limited number of such independent legal and technical support personnel as Inverness deems
necessary which personnel are reasonably acceptable to Trinity, to examine, during ordinary business hours, records, materials, and manufacturing processes of Trinity for the purpose of verifying the accuracy of the royalty reports and payments by
Trinity. The audit shall be limited to pertinent books and records for any calendar year ending not more than twenty-four (24) months prior to the date of such request. Such audit right shall not be exercised more than once in any calendar
year. The accounting firm and legal and technical firm employees shall sign confidentiality agreements reasonably acceptable to Trinity as a condition precedent to their audit, which shall contain terms consistent with the provisions of
Section 9. Trinity may designate competitively sensitive information which such auditor may not disclose to Inverness; provided, however, that such designation shall not encompass the auditor’s conclusions. The accounting
firm shall disclose to Inverness only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. 

(d) Such requested audit shall be restricted to an audit of those records, materials, and manufacturing processes reasonably related to
Licensed Products, Current Patents, Charlton Patents and Future Patents (if any). Accordingly, such records and materials shall include the records specified in this Section 5.6 and other general financial information to the extent necessary to
provide a cross-check for the amount of royalties reported. Such financial information shall include, but not be limited to, records on the total revenue derived from Licensed Products for the accounting period with documentation supporting the
non-payment of royalty on that portion of the total revenue which Trinity claims should not be included in Net Sales, records of sales of products that were bundled with Licensed Products, and records pertaining to Licensed Products that were
transferred for below fair market value. 

  
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(e) Trinity shall provide its full cooperation in such audit. 

(f) Inverness shall pay the cost of such audit. However, in the event that the audit reveals underpayment of five percent (5%) or more of
the royalties which should have been paid for the accounting periods being audited, then Trinity shall pay for the cost of such audit. 

Section 6. Option To Distribute. 

6.1 Grant of Option. Trinity hereby grants Inverness the option to serve as the exclusive distributor of the Trinity HIV Product in the
Retail Field in the United States, subject to the parties’ negotiation of a mutually acceptable distribution agreement (the “Option”). Inverness shall exercise the Option by delivering to Trinity written notice of its intention to
exercise the Option during the period beginning on the Effective Date and ending on the six-month anniversary of the Effective Date (the “Option Period”), after which such Option shall expire. In the event that Inverness exercises the
Option within the Option Period, Trinity shall use its best efforts to negotiate in good faith with Inverness the terms of a mutually acceptable distribution agreement. Trinity shall negotiate with Inverness for not less than three (3) months
after exercise of the Option (unless the parties conclude an agreement within that period). During the Option Period and such negotiation period, Trinity shall not appoint any Third Party to distribute the Trinity HIV Product in the United States.
If the parties are unable to reach mutually agreeable terms within the three month period, the parties hereby agree to submit the matter to a third party mediator, and to work with such mediator in good faith to arrive at a resolution for a period
of up to 30 days from appointment of the mediator. 
 6.2 Inverness Credit. If Inverness exercises the Option and the parties enter
into an agreement within 9 months after the Effective Date pursuant to which (a) Trinity appoints Inverness as the exclusive distributor of the Trinity HIV Product in the Retail Field in the United States (that is, neither Trinity nor any
Trinity Subsidiary nor any Third Party may distribute the Trinity HIV Product in the Retail Field in the United States); and (b) Inverness agrees not to distribute or sell any other HIV diagnostic tests in the Retail Field in the United States
during the term of such agreement, then Trinity agrees that Inverness may withhold and retain 20% of the amounts otherwise due to Trinity in each payment period under such distribution agreement, until Inverness has withheld and retained a total of
$1 million in such payments. 
 Section 7. Term of Agreement; Termination. 

7.1 Term. The term of this Agreement shall be from the Effective Date hereof until the last to expire of the Current Patents, Charlton
Patents or Future Patents, unless it is sooner terminated in accordance with this Section 7 (the “Term”). 
 7.2
Termination for Trinity Convenience. Trinity may terminate this Agreement at any time on written notice to Inverness. Such termination shall be effective on the date such notice is mailed. 

  
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7.3 Termination for Breach. If either party shall breach any material provision of this Agreement, and such failure has not been cured
within sixty (60) days after written notice from the non-breaching party specifying the nature of such failure, the non-breaching party shall have the right to terminate this Agreement on written notice to the breaching party. 

7.4 Termination on Insolvency. If any party enters any involuntary bankruptcy, insolvency, receivership, dissolution, or similar
proceeding which continues for thirty (30) days from filing, or any voluntary bankruptcy, insolvency, receivership, dissolution, liquidation, or similar proceeding, or otherwise fails to be able to pay its debts as and when they fall due, the
other party may terminate this Agreement on written notice to such party. 
 7.5 Termination for Patent Challenge. If Trinity or any
Trinity Subsidiary shall challenge the validity of any of the Current Patents, Charlton Patents or Future Patents before any court or governmental agency, then this Agreement and the licenses granted herein shall terminate immediately without
notice. 
 7.6 Effect of Termination. No termination of this Agreement shall relieve either party of any obligation or liability
accrued hereunder prior to such termination (including unpaid royalties), or rescind or give rise to any right to rescind anything done by Trinity or any payments made or other consideration given to Inverness hereunder prior to the time such
termination becomes effective, and such termination shall not affect in any manner any rights of either party arising under this Agreement prior to such termination. The provisions of Sections 5 (with respect to sales made through the effective date
of termination), 7.6, 8, 9, 10, 11 and 12.3-12.8 shall survive any termination or expiration of this Agreement in accordance with their respective terms. 

Section 8. Warranty, Disclaimers, Indemnification, Insurance and Limitation of Liability. 

8.1 Mutual Representations and Warranties: Each Party represents and warrants that: 

(a) it has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 

(b) this Agreement constitutes a valid and binding agreement, enforceable against it in accordance with its terms; and 

(c) the execution, delivery and performance of this Agreement does not violate any law, statute, ordinance, rule or regulation, or any
judgment, injunction, order, writ or decree of any court, arbitrator, or governmental entity by which such Party or any of its assets or properties may be bound, and does not conflict with or result in the breach or termination of any license,
permit, approval, consent, franchise, lease, contract, or other instrument or agreement by which such party is bound. 

  
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8.2 Inverness Warranty. Inverness represents and warrants that: 

(a) it has the full right and power to grant the licenses set forth in Section 2 and Section 3, and that there are no outstanding
agreements, assignments, or encumbrances inconsistent with the provisions of such licenses or with any other provisions of this Agreement; 

(b) as at the Effective Date, the Current Patents and Charlton Patents include all Patent Rights owned or Controlled by Inverness or Inverness
Affiliates that are used in, useful or necessary for the manufacture, use, sale or importation of Licensed Products, and Inverness and Inverness Affiliates have not taken any action to exclude from the Current Patents or Charlton Patents any such
Patent Rights; and 
 (c) to the best of the Inverness’s knowledge, all Patent Rights licensed hereunder are valid and enforceable, and
all patents, if any, issuing on any of the pending patent applications of the Patent Rights will be valid and enforceable. 
 8.3
Disclaimer. Inverness does not represent or warrant that the Current Patents or Charlton Patents are applicable to any particular Licensed Product. Inverness also makes no other representations or warranties, express or implied, and hereby
disclaims the implied warranties of merchantability, fitness for a particular purpose or non-infringement of third party rights. Inverness disclaims and Trinity assumes any liability in respect of any infringement of patents or other rights of Third
Parties due to Trinity’s operation under the license herein granted. Without limiting the disclaimer, Inverness specifically disclaims any representation, warranty or implication that the licenses granted hereby are sufficient for Trinity to
make, use, lease, import, sell and otherwise transfer Licensed Products. 
 8.4 Indemnification. Trinity shall indemnify, defend, and
hold harmless Inverness and its Affiliates and their directors, officers, employees and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss, or expense (including reasonable
attorneys’ fees and expenses of litigation) incurred by or imposed upon any of the Indemnitees by any Third Party in connection with any claims, suits, actions, demands or judgments arising out of any theory of liability (including without
limitation actions in the form of tort, warranty, or strict liability and regardless of whether such action has any factual basis) concerning any product, process, or service that is made, used, or sold pursuant to the exercise by Trinity (including
Trinity Subsidiaries) of any right or license granted under this Agreement. To receive the benefit of indemnification the Indemnitees must (i) provide Trinity with prompt written notice within twenty (20) days of any claim, suit, action,
demand, or judgment for which indemnification is sought under this Agreement; (ii) cooperate fully with Trinity in such defense; and (iii) permit Trinity to conduct and control such defense and the disposition of such claim, suit, or
action (including all decisions relative to litigation, appeal, and settlement). Trinity agrees, at its own expense, to provide attorneys reasonably acceptable to Inverness to defend against any such claim. In the event that Inverness has rejected
Trinity’s choices of counsel three (3) consecutive times, then Trinity, in its sole decision, shall select counsel acceptable to Trinity. Notwithstanding the provision of Section 8.4(iii), any Indemnitee shall have the right to retain
its own counsel, at the expense of Trinity, if representation of such Indemnitee by the counsel retained by Trinity would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other party represented
by such counsel. Trinity agrees to keep Inverness informed of the progress in the defense and disposition of such claim and to consult with Inverness with regard to any proposed settlement. Trinity shall

  
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have no obligation to indemnify any Indemnitee in connection with any settlement made without Trinity’s written consent. The foregoing indemnification
obligations shall not apply to the extent that a court of competent jurisdiction determines that applicable losses arose as a result of any Indemnitee’s negligence or intentional misconduct. 

8.5 Insurance. Trinity shall maintain insurance or self-insurance that is reasonably adequate to fulfill any potential obligation to the
Indemnitees, but in any event not less than one million dollars ($1,000,000) for injuries to any one person arising out of a single occurrence and two million dollars ($2,000,000) for injuries to all persons arising out of a single occurrence.
Trinity shall provide Inverness, upon request, with written evidence of such insurance or self- insurance. Trinity shall continue to maintain such insurance or self-insurance after the expiration or termination of this Agreement during any period in
which Trinity continues to make, use, or sell a product that was a Licensed Product under this Agreement, and thereafter for a period of five (5) years. 

8.6 Limitation of Liability. EXCEPT FOR BREACHES OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER AND FOR VIOLATIONS OF ANOTHER PARTY’S
INTELLECTUAL PROPERTY RIGHTS AND FOR DAMAGES CAUSED BY A PARTY’S GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, IN NO EVENT SHALL A PARTY BE LIABLE TO ANY OTHER PARTY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION,
DAMAGES RESULTING FROM LOSS OF USE, PROFITS, BUSINESS OR GOODWILL, WHETHER OR NOT THE PARTY ALLEGEDLY CAUSING THE DAMAGE HAS BEEN ADVISED OF THE POSSIBILITY THEREOF. THIS SECTION 8.6 SHALL NOT BE CONSTRUED TO LIMIT TRINITY’S INDEMNIFICATION
OBLIGATIONS UNDER SECTION 8.4 HEREOF. 
 Section 9. Confidentiality. 

9.1 Definition. In this Agreement, “Confidential Information” means any material non-public information disclosed by one party
(“Disclosing Party”) to the other (“Recipient”), including without limitation any trade secrets, any written information marked “confidential”, any technical or product information, any information relating to the
business strategies or plans of such party, and, with respect to Trinity, any information which Inverness obtains from Trinity’s fulfillment of its obligation under Sections 5.3, 5.5 or 5.6. 

9.2 Obligations. The Recipient shall: (a) not disclose the Disclosing Party’s Confidential Information to third parties;
(b) not use the Disclosing Party’s Confidential Information for any purpose other than for the purposes permitted under this Agreement, provided that the Recipient retains the right to use such information in a court of law, in
arbitration, or in other similar proceedings to establish its rights under this Agreement; and (c) limit access to the Disclosing Party’s Confidential Information to those of its personnel for whom such access is reasonably necessary for
the purposes permitted under this Agreement. The above mentioned limitations shall not apply to Confidential Information which (i) was in the possession of the Recipient prior to disclosure hereunder; (ii) was in the public domain at the
time of disclosure or later became part of the public domain without breach of the confidentiality obligations herein contained; (iii) was disclosed by a Third Party without breach of any 

  
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obligation of confidentiality owed to the Disclosing Party; (iv) is the subject of a subpoena or other validly issued administrative or judicial process
requesting disclosure of such Confidential Information; provided, that the Recipient provides prompt notice to the Disclosing Party and permits the Disclosing Party to contest or narrow such request for disclosure, and thereafter complies
with such subpoena or other process; or (v) was independently developed by the Recipient without reference to the Disclosing Party’s Confidential Information. 

Section 10. Patent Prosecution and Enforcement. 

10.1 Prosecution. Inverness and its Third Party licensors shall retain all right, in their absolute discretion, to control the
prosecution (or failure to prosecute) all Patent Rights included within the Current Patents, Charlton Patents and Future Patents. Neither party nor any of its Affiliates (including Inverness Subsidiaries) shall be required hereunder to file any
patent application, or to secure any patent or patent rights, or to maintain any patent in force, or to provide copies of patent applications to the other party or its Affiliates, or to disclose any inventions described or claimed in such patent
applications. 
 10.2 Enforcement. Trinity shall promptly inform Inverness if and when it becomes aware of any Third Party
infringement of any of the Current Patents, Charlton Patents or any Future Patents. Inverness shall not have any obligation hereunder to institute any action or suit against third parties for infringement of any such Patent Rights or to defend any
action or suit brought by a Third Party which challenges or concerns the validity of any such Patent Rights. In addition, Trinity shall not have any right to institute any action or suit against third parties for infringement of any of the Current
Patents, Charlton Patents or any Future Patents. 
 Section 11. Assignment. 

Trinity (including Trinity Subsidiaries) shall not assign, transfer or grant any right under any of the Current Patents, Charlton Patents or
Future Patents whether by agreement, operation of law (as in the case, by way of example, of a Change of Control as hereinafter defined; it being understood that the result of a Change of Control shall be determined in accordance with the following
sentence), or otherwise. If, after the Effective Date (a) Trinity is acquired by any Third Party, whether by stock acquisition, merger, consolidation or otherwise (including whether or not Trinity survives as a separate corporation or legal
entity as a result of such acquisition), (b) Trinity enters into a transaction in which the outstanding voting stock of Trinity is converted into cash, securities, or other property, or (c) any person, entity or group (within the meaning
of Section 13(d) or 14(d) of the Securities Exchange Act of 1934, as amended) acquires the majority of the voting power of the voting stock of Trinity, or (d) Trinity sells all or substantially all of the assets of Trinity (any of the
foregoing a “Change of Control”), then with automatic effect on occurrence of such Change of Control (the “Change of Control Event”) and without any action required of Inverness, the licenses granted in Sections 2.1 and 2.2 of this Agreement shall thenceforth be limited to Licensed Products which, at the time that Trinity first
entered into discussions with a Third Party leading to such Change of Control Event: (i) have been commercially released (that is, have been sold by Trinity or Trinity Subsidiaries as finished products to Third Parties in arms’ length
transactions); or (ii) have already been substantially developed, by employees employed by, or individuals engaged as subcontractors by, Trinity or a Trinity Subsidiary. 

  
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Section 12. Miscellaneous. 

12.1 Communications and Notices. Payment shall be made by electronic funds transfer. Payments shall be deemed to be made on the date of
electronic funds transfer. Any notice or other communication required or permitted to be made or given to either party hereto pursuant to this Agreement shall be sent to such party by facsimile (such notice to be effective when sent, if confirmed by
registered airmail or registered or certified mail) or by registered airmail (except that registered or certified mail may be used where delivery is in the same country as mailing) (such mailed notice to be effective on the date which is three
(3) business days after the date of mailing), postage prepaid, addressed to it at its address set forth below, or to such other address as it shall designate by written notice given to the other party. The addresses are as follows: 

For electronic funds transfers of payments: 

To an Inverness account notified in writing to Trinity. 

For mailing to Inverness: 

Inverness Medical Innovations, Inc. 

Attention: Office of the General Counsel 

51 Sawyer Road 
 Waltham MA 02453

 USA 
 For facsimile
transmission to Inverness: 
 Inverness Medical Innovations, Inc. 

Attention: Office of the General Counsel 

Facsimile: (781) 647 3939 

For mailing to Trinity: 
 Trinity
Biotech plc 
 Attention: Chief Financial Officer 

Southern Cross Road 
 Bray, Co.
Wicklow, 
 Ireland 
 Facsimile:
+353 1 2769883 
 12.2 No Publicity. Nothing contained in this Agreement shall be construed as conferring any right to use in
advertising, publicity, or other promotional activities any name, trade name, trademark or other designation of either party hereto (including any contraction, abbreviation or simulation of any of the foregoing). Each party hereto agrees not to use
or refer to this Agreement or any provision thereof in any promotional activity, without the express written approval of the other party. 

  
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12.3 Amendments; Entire Agreement. This Agreement will not be binding upon the parties until it has been signed herein below by or on
behalf of each party, in which event it shall be effective as of the Effective Date. No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed. This Agreement and any schedules or exhibits
hereto or thereto, together with the related Settlement Agreement, embody the entire understanding of the parties with respect to the subject matter hereof and merge all prior discussions between them, and neither of the parties shall be bound by
any conditions, definitions, warranties, understandings or representations with respect to the subject matter hereof other than as expressly provided herein. In the event of any conflict or contradiction between the terms of this Agreement and the
Settlement Agreement, this Agreement shall control. 
 12.4 Compliance with Laws. Trinity shall comply with all local, state, federal,
and international laws and regulations relating to the development, manufacture, use, and sale of Licensed Products. Trinity expressly agrees to comply with the following: (i) Trinity shall obtain all necessary approvals from U.S. regulatory
authorities and any similar governmental authorities of any foreign jurisdiction in which Trinity intends to make, use, or sell Licensed Products; and (ii) Trinity shall comply with all United States laws and regulations controlling the export
of commodities and technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit, or require a license for, the export of
certain types of commodities and technical data to specified countries. Trinity hereby gives written assurance that it will comply with all United States export control laws and regulations, that it bears sole responsibility for any violation of
such laws and regulations by itself or any Trinity Subsidiary, and that it will indemnify, defend, and hold Inverness harmless (in accordance with Article 8.4) for the consequences of any such violation. 

12.5 Headings. The heading of the several Sections are inserted for convenience of reference only and are not intended to be a part of
or to affect the meaning or interpretation of this Agreement. 
 12.6 Severability. If any Section of this Agreement is found by
competent authority to be invalid, illegal or unenforceable in any respect for any reason, the validity, legality and enforceability of any such Section in every other respect and the remainder of this Agreement shall continue in effect. 

12.7 Disclosure of Agreement. The parties and each of their respective counsel, and other agents, agree that the negotiations concerning
and the terms of this Agreement, including the Agreement, shall be strictly confidential, and shall not be released or disclosed by any party or their counsel in any way to any person, entity, or form of media (including but not limited to
written/published media, television, radio or electronic media), unless required by law or by an order of a court of competent jurisdiction. In the event that either party is served with a request or order requiring disclosure of the terms of this
Agreement, it shall provide the other party with prompt notice thereof, provided however that the terms of the Agreement may be disclosed 

  
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without notice on a confidential basis to an attorney, auditor, insurance agent or carrier, or other person having a legitimate business need to know such
information; provided that the disclosing party ensures that such persons shall be subject to obligations to use such information solely for such purposes. 

12.8 Governing Law; Venue. This Agreement shall be construed, and the legal relations between the parties hereto shall be determined, in
accordance with the law of the Commonwealth of Massachusetts, United States of America, without reference to its conflicts of law principles. Any claim arising under this Agreement and any action to enforce the terms of this Agreement may be brought
only in a state or federal court sitting in Massachusetts and the parties consent to jurisdiction over them by state and federal courts sitting in Massachusetts, and waive any objection to Massachusetts as a convenient forum or venue for any action
arising under this Agreement. Before either party may initiate litigation, the chief executive officers of the respective parties shall meet and confer in good faith in an effort to resolve any claims or disputes arising under this Agreement. 

[Remainder of page left intentionally blank] 

  
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly signed as of the date first above written. 

 

									
							Inverness Medical Innovations, Inc.
					
	Witness		  
				By		  

							Title		  

				
							Trinity Biotech PLC
					
	Witness		(ILLEGIBLE)				By		 (ILLEGIBLE)

							Title		CFO

  
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EXHIBIT A 
 LESS DEVELOPED
COUNTRIES 
  

			
	 Afghanistan
 Algeria

Angola
 Bangladesh

Belize
 Benin

Bhutan
 Botswana

Burkina Faso
 Burundi

Cameroon
 Cape Verde

Central Africa Rep.
 Chad

Comoros
 Congo

Cote d’Ivoire
 Cuba

Djibouti
 Dominica

Egypt
 Equatorial Guinea

Eritrea
 Ethiopia

Fiji
 Gabon

Gambia
 Ghana

Guatemala
 Guinea

Guinea-Bissau
 Guyana

Haiti
 Honduras

Iran-Islamic Rep. of
 Iraq

Jordan
 Kenya

Kiribati
 Laos

Lebanon
 Lesotho

Liberia
 Libya

Madagascar
		 Malawi
 Maldives

Mali
 Mauritania

Mauritius
 Micronesia

Mongolia
 Morocco

Mozambique
 Myanmar

Namibia
 Nepal

Nicaragua
 Niger

Nigeria
 North Korea

Pakistan
 Papua New Guinea

Philippines
 Rwanda

Samoa
 Sao Tome & Principe

Senegal
 Seychelles

Sierra Leone
 Solomon Islands

Somalia
 Sudan

Suriname
 Swaziland

Syrian Arab Rep.
 Tanzania

Timor
 Togo

Tonga
 Tunisia

Tuvalu
 Uganda

Vanuatu
 Vietnam

West Bank and Gaza
 Yemen

Zaire
 Zambia

Zimbabwe

  
 18

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