Exhibit 4.22

CONFIDENTIAL

1999 DEC-8 P
3:20

PUBLIC HEALTH SERVICE

PATENT LICENSE AGREEMENT-NONEXCLUSIVE

COVER PAGE

For PHS internal use only:

Patent License Number: L-165-99/0

Serial Number(s) of Licensed Patent(s) and/or Patent Application(s): 06/602,945; 06/602946; 06/643,729; 06/785,638; 07/117,937

Licensee: Trinity Biotech Plc

Cooperative Research and Development Agreement (CRADA) Number (if applicable): N/A

Additional Remarks: Trinity Biotech currently manufactures all of its HIV test kits in Ireland. It is currently Trinity Biotechs
intention to continue manufacturing HIV test kits for worldwide distribution from its Irish manufacturing site. However, any new plant, built by Trinity Biotech, for production of HIV test kits for sale in the United States, must be built in the
United States, as stated in the U.S. Manufacturing Waiver dated November 3, 1999, a copy of which is included in Appendix G.

Public
Benefit(s): N/A

This Patent License Agreement, hereinafter referred to as the Agreement, consists of this Cover Page, an attached
Agreement, a Signature Page, Appendix A (List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E (Benchmarks), Appendix F (Commercial
Development Plan) and Appendix G (U.S. Manufacturing Waiver). The Parties to this Agreement are:



| | 1) | The National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), or the Food and Drug Administration (FDA), hereinafter singly or collectively referred
to as PHS, agencies of the United States Public Health Service within the Department of Health and Human Services (DHHS); and
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| | 2) | The person, corporation, or institution identified above and/or on the Signature Page, having offices at the address indicated on the Signature Page, hereinafter referred to as Licensee.
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PHS PATENT LICENSE AGREEMENT-NONEXCLUSIVE

PHSand Licenseeagree as follows:



|1. | BACKGROUND
|-- | ----------



| | 1.01 | In the course of conducting biomedical and behavioral research, PHSinvestigators made inventions that may have commercial applicability.
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| | 1.02 | By assignment of rights from PHSemployees and other inventors, DHHS,on behalf of the United States Government, owns intellectual property rights claimed in any United States and/or foreign patent
applications or patents corresponding to the assigned inventions. DHHSalso owns any tangible embodiments of these inventions actually reduced to practice by PHS.
| | ---- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 1.03 | The Secretary of DHHShas delegated to PHSthe authority to enter into this Agreementfor the licensing of rights to these inventions.
| | ---- | -----------------------------------------------------------------------------------------------------------------------------------



| | 1.04 | PHSdesires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit.
| | ---- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 1.05 | Licenseedesires to acquire commercialization rights to certain of these inventions in order to develop processes, methods, and/or marketable products for public use and benefit.
| | ---- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



|2. | DEFINITIONS
|-- | -----------



| | 2.01 | Benchmarksmean the performance milestones that are set forth in Appendix E.
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| | 2.02 | Commercial Development Planmeans the written commercialization plan attached as Appendix F.
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| | 2.03 | First Commercial Salemeans the initial transfer by or on behalf of Licenseeor its sublicensees of Licensed Productsor the initial practice of a Licensed Processby or on behalf
of Licenseeor its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales.
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| | 2.04 | Governmentmeans the Government of the United States of America.
| | ---- | -----------------------------------------------------------------



| | 2.05 | Licensed Fields of Usemeans the fields of use identified in Appendix B.
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| | 2.06 | Licensed Patent Rights shall mean:
| | ---- | ------------------------------------



| | a) | Patent applications (including provisional patent applications and PCT patent applications) and/or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such
applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;
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| | b) | to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: i) continuations-in-part of a) above; ii) all divisions and continuations of these
continuations-in-part; iii) all patents issuing from such continuations-in-part, divisions, and continuations; iv) priority patent application(s) of a) above; and v) any reissues, reexaminations, and extensions of all such patents;
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| | c) | to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: all counterpart foreign and U.S. patent applications and patents to a) and b) above, including
those listed in Appendix A.
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Licensed Patent Rightsshall not include b) or c) above to the extent that they
contain one or more claims directed to new matter which is not the subject matter disclosed in a) above.



| | 2.07 | Licensed Process(es) means processes which, in the course of being practiced would, in the absence of this Agreement,infringe one or more claims of the Licensed Patent Rightsthat have
not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
| | ---- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2.08 | Licensed Product(s) means tangible materials which, in the course of manufacture, use, sale, or importation would, in the absence of this Agreement,infringe one or more claims of the
Licensed Patent Rightsthat have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
| | ---- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2.09 | Licensed Territory means the geographical area identified in Appendix B.
| | ---- | --------------------------------------------------------------------------



| | 2.10 | Net Sales means the total gross receipts for sales of Licensed Productsor practice of Licensed Processesby or on behalf of Licenseeor its sublicensees, and from leasing,
renting, or otherwise making Licensed Productsavailable to others without sale or other dispositions, whether invoiced or not, less returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the
transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they be with independent sales
agencies or regularly employed by Licensee,or sublicensees, and on its payroll, or for the cost of collections.
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| | 2.11 | Practical Application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case,
under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Governmentregulations available to the public on reasonable terms.
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|3. | GRANT OF RIGHTS
|-- | ---------------



| | 3.01 | PHShereby grants and Licenseeaccepts, subject to the terms and conditions of this Agreement,a nonexclusive license under the Licensed Patent Rightsin the Licensed Territoryto make
and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Productsin the Licensed Fields of Useand to practice and have practiced any Licensed Processesin the Licensed Fields
of Use.
| | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 3.02 | This Agreementconfers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of PHSother than Licensed Patent Rightsregardless of whether such
patents are dominant or subordinate to Licensed Patent Rights.
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|4. | SUBLICENSING
|-- | ------------



| | 4.01 | Licensee has no right to sublicense.
| | ---- | ------------------------------------



|5. | STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
|-- | -------------------------------------------------------------



| | 5.01 | Prior to the First Commercial Sale, Licenseeagrees to provide PHSreasonable quantities of Licensed Productsor materials made through the Licensed Processesfor PHSresearch use.
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| | 5.02 | Licenseeagrees that products used or sold in the United States embodying Licensed Productsor produced through use of Licensed Processesshall be manufactured substantially in the United States,
unless a written waiver is obtained in advance from PHS.
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|6. | ROYALTIES AND REIMBURSEMENT
|-- | ---------------------------



| | 6.01 | Licenseeagrees to pay to PHSa noncreditable, nonrefundable license issue royalty as set forth in Appendix C within thirty (30) days from the date that this Agreementbecomes effective.
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| | 6.02 | Licenseeagrees to pay to PHS a nonrefundable minimum annual royalty as set forth in Appendix C. The minimum annual royalty is due and payable on January 1 of each calendar year and may be credited
against any earned royalties due for sales made in that year. The minimum annual royalty due for the first calendar year of this Agreementmay be prorated according to the fraction of the calendar year remaining between the effective date of
this Agreementand the next subsequent January 1.
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| | 6.03 | Licenseeagrees to pay PHSearned royalties as set forth in Appendix C.
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| | 6.04 | Licenseeagrees to pay PHSbenchmark royalties as set forth in Appendix C.
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| | 6.05 | A patent or patent application licensed under this Agreementshall cease to fall within the Licensed Patent Rightsfor the purpose of computing earned royalty payments in any given country on the earliest
of the dates that a) the application has been abandoned and not continued, b) the patent expires or irrevocably lapses, or c) the claim has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent
jurisdiction or administrative agency.
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| | 6.06 | No multiple royalties shall be payable because any Licensed Productsor Licensed Processesare covered by more than one of the Licensed Patent Rights.
| | ---- | ----------------------------------------------------------------------------------------------------------------------------------------------------



| | 6.07 | On sales of Licensed Productsby Licenseeto sublicensees or on sales made in other than an arms-length transaction, the value of the Net Salesattributed under this Article 6 to such a
transaction shall be that which would have been received in an arms-length transaction, based on sales of like quantity and quality products on or about the time of such transaction.
| | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 6.08 | With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rightsincurred by PHS prior to the
effective date of this Agreement, Licenseeshall pay to PHS, as an additional royalty, within sixty (60) days of PHSs submission of a statement and request for payment to Licensee,an amount equivalent
to such patent expenses previously incurred by PHS.
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| | 6.09 | With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rightsincurred by PHSon or after
the effective date of this Agreement, PHS,at its sole option, may require Licensee:
| | ---- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(a) to pay PHS on
an annual basis, within sixty (60) days of PHSs submission of a statement and request for payment, a royalty amount equivalent to all such patent expenses incurred during the previous calendar year(s); or

(b) to pay such expenses directly to the law firm employed by PHS to handle such functions. However, in such event, PHS and not
Licenseeshall be the client of such law firm.

Under exceptional circumstances, Licenseemay be given the right to assume
responsibility for the preparation, filing, prosecution, or maintenance of any patent application or patent included with the Licensed Patent Rights.In that event, Licenseeshall directly pay the attorneys or agents engaged to
prepare, file, prosecute, or maintain such patent applications or patents and shall provide to PHS copies of each invoice associated with such services as well as documentation that such invoices have been paid.



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| | 6.10 | Licenseemay elect to surrender its rights in any country of the Licensed Territoryunder any Licensed Patent Rightsupon sixty (60) days written notice to PHSand owe no payment
obligation under Article 6.09 for patent-related expenses incurred in that country after the effective date of such written notice.
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|7. | PATENT FILING, PROSECUTION, AND MAINTENANCE
|-- | -------------------------------------------



| | 7.01 | PHSagrees to take responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights.
| | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



|8. | RECORD KEEPING
|-- | --------------



| | 8.01 | Licenseeagrees to keep accurate and correct records of Licensed Productsmade, used, sold, or imported and Licensed Processespracticed under this Agreementappropriate to determine the
amount of royalties due PHS.Such records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours for inspection at the expense of PHSby an accountant
or other designated auditor selected by PHSfor the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHSinformation relating to the accuracy of reports and payments made under
this Agreement.If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Licenseeshall reimburse PHSfor the cost of the inspection at the time
Licenseepays the unreported royalties, including any late charges as required by Paragraph 9.07 of this Agreement.All payments required under this Paragraph shall be due within thirty (30) days of the date PHSprovides
Licenseenotice of the payment due.
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| | 8.02 | Licenseeagrees to have an audit of sales and royalties conducted by an independent auditor at least every two (2) years if annual sales of the Licensed Productor Licensed Processesare over
two (2) million dollars. The audit shall address, at a minimum, the amount of gross sales by or on behalf of Licenseeduring the audit period, terms of the license as to percentage or fixed royalty to be remitted to the Government,the amount of royalty funds owed to the Governmentunder this Agreement,and whether the royalty amount owed has been paid to the Governmentand is reflected in the records of the Licensee.The audit shall also
indicate the PHSlicense number, product, and the time period being audited. A report certified by the auditor shall be submitted promptly by the auditor directly to PHSon completion. Licenseeshall pay for the entire cost of
the audit.
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|9. | REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
|-- | ----------------------------------------------------



| | 9.01 | Prior to signing this Agreement, Licenseehas provided to PHSthe Commercial Development Planat Appendix F, under which Licenseeintends to bring the subject matter of the Licensed Patent
Rightsto the point of Practical Application.This Commercial Development Planis hereby incorporated by reference into this Agreement.Based on this plan, performance Benchmarksare determined as specified in
Appendix E.
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| | 9.02 | Licenseeshall provide written annual reports on its product development progress or efforts to commercialize under the Commercial
Development Planfor each of the Licensed Fields of Usewithin sixty (60) days after December 31 of each calendar year. These progress reports shall include, but not be limited to: progress on research and development, status of
applications for regulatory approvals, manufacturing, marketing, importing, and sales during the preceding calendar year, as well as plans for the present calendar year. PHSalso encourages these reports to include information on any of
Licenseespublic service activities that relate to the Licensed Patent Rights. If reported progress differs from that projected in the Commercial Development Planand Benchmarks, Licenseeshall explain the reasons
for such differences. In any such annual report, Licenseemay propose amendments to the Commercial Development Plan,acceptance of which by PHSmay not be denied unreasonably. Licenseeagrees to
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| | provide any additional information reasonably required by PHSto evaluate Licenseesperformance under this Agreement. Licenseemay amend the Benchmarksat any
time upon written consent by PHS. PHSshall not unreasonably withhold approval of any request of Licenseeto extend the time periods of this schedule if such request is supported by a reasonable showing by Licenseeof diligence
in its performance under the Commercial Development Planand toward bringing the Licensed Productsto the point of Practical Application.
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 9.03 | Licenseeshall report to PHSthe dates for achieving Benchmarksspecified in Appendix E and the First Commercial Salein each country in the Licensed Territorywithin thirty
(30) days of such occurrences.
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| | 9.04 | Licenseeshall submit to PHSwithin sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half-year period the amount
of the Licensed Productssold or Licensed Processespracticed by or on behalf of Licenseein each country within the Licensed Territory,the Net Sales,and the amount of royalty accordingly due. With each such
royalty report, Licenseeshall submit payment of the earned royalties due. If no earned royalties are due to PHSfor any reporting period, the written report shall so state. The royalty report shall be certified as correct by an
authorized officer of Licenseeand shall include a detailed listing of all deductions made under Paragraph 2.10 to determine Net Salesmade under Article 6 to determine royalties due.
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| | 9.05 | Royalties due under Article 6 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wall Street Journal
on the day that the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to NIH/Patent Licensing. All such payments shall be sent to the following address: NIH, P.O. Box
360120, Pittsburgh, PA 15251-6120. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Licensee.The royalty report required by Paragraph 9.04 of this
Agreementshall accompany each such payment, and a copy of such report shall also be mailed to PHSat its address for notices indicated on the Signature Page of this Agreement.
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| | 9.06 | Licenseeshall be solely responsible for determining if any tax on royalty income is owed outside the United States and shall pay any such tax and be responsible for all filings with appropriate agencies of
foreign governments.
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| | 9.07 | Interest and penalties may be assessed by PHSon any overdue payments in accordance with the Federal Debt Collection Act. The payment of such late charges shall not prevent PHSfrom exercising any other
rights it may have as a consequence of the lateness of any payment.
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| | 9.08 | All plans and reports required by this Article 9 and marked confidential by Licenseeshall, to the extent permitted by law, be treated by PHSas commercial and financial information obtained
from a person and as privileged and confidential, and any proposed disclosure of such records by the PHS under the Freedom of Information Act (FOIA), 5 U.S.C. 552 shall be subject to the predisclosure notification requirements of 45 CFR
5.65(d).
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|10. | PERFORMANCE
|--- | -----------



| | 10.01 | Licenseeshall use its reasonable best efforts to bring the Licensed Productsand Licensed Processesto Practical Application.Reasonable best efforts for the purposes of this
provision shall include adherence to the Commercial Development Planat Appendix F and performance of the Benchmarksat Appendix E.
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 10.02 | Upon the First Commercial Sale,until the expiration of this Agreement, Licenseeshall use its reasonable best efforts to make Licensed Productsand Licensed Processes reasonably accessible
to the United States public.
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|11. | INFRINGEMENT AND PATENT ENFORCEMENT
|--- | -----------------------------------



| | 11.01 | PHSand Licenseeagree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights,as well as any facts which may affect the validity, scope, or
enforceability of the Licensed Patent Rightsof which either Party becomes aware.
| | ----- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 11.02 | In the event that a declaratory judgment action alleging invalidity of any of the Licensed Patent Rightsshall be brought against PHS, PHSagrees to notify Licenseethat an action alleging
invalidity has been brought. PHSdoes not represent that it will commence legal action to defend against a declaratory action alleging invalidity. Licenseeshall take no action to compel the Governmenteither to initiate or to
join in any such declaratory judgment action. Should the Governmentbe made a party to any such suit by motion or any other action of Licensee, Licenseeshall reimburse the Governmentfor any costs, expenses, or fees which the
Governmentincurs as a result of such motion or other action. Upon Licenseespayment of all costs incurred by the Governmentas a result of Licenseesjoinder motion or other action, these actions by
Licenseewill not be considered a default in the performance of any material obligation under this Agreement.
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|12. | NEGATION OF WARRANTIES AND INDEMNIFICATION
|--- | ------------------------------------------



| | 12.01 | PHSoffers no warranties other than those specified in Article 1.
| | ----- | ----------------------------------------------------------------



| | 12.02 | PHSdoes not warrant the validity of the Licensed Patent Rightsand makes no representations whatsoever with regard to the scope of the Licensed Patent Rights,or that the Licensed Patent Rightsmay be exploited without infringing other patents or other intellectual property rights of third parties.
| | ----- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 12.03 | PHSMAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTSOR TANGIBLE MATERIALS RELATED
THERETO.
| | ----- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 12.04 | PHSdoes not represent that it will commence legal actions against third parties infringing the Licensed Patent Rights.
| | ----- | ----------------------------------------------------------------------------------------------------------------------



| | 12.05 | Licenseeshall indemnify and hold PHS,its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited
to death, personal injury, illness, or property damage in connection with or arising out of: a) the use by or on behalf of Licensee,its directors, employees, or third parties of any Licensed Patent Rights;or b) the design,
manufacture, distribution, or use of any Licensed Products, Licensed Processesor materials by Licensee,or other products or processes developed in connection with or arising out of the Licensed Patent Rights. Licenseeagrees
to maintain a liability insurance program consistent with sound business practice.
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|13. | TERM, TERMINATION, AND MODIFICATION OF RIGHTS
|--- | ---------------------------------------------



| | 13.01 | This Agreementis effective when signed by all parties and shall extend to the expiration of the last to expire of the Licensed Patent Rightsunless sooner terminated as provided in this Article 13.
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| | 13.02 | In the event that Licenseeis in default in the performance of any material obligations under this Agreement,including but not limited to the obligations listed in Article 13.05, and if the default has
not been remedied within ninety (90) days after the date of notice in writing of such default, PHSmay terminate this Agreementby written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt
Collection Act.
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| | 13.03 | In the event that Licenseebecomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third partys
intention to file an involuntary petition in bankruptcy, Licenseeshall immediately notify PHSin writing. Furthermore, PHSshall have the right to terminate this Agreementimmediately upon Licenseesreceipt
of written notice.
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| | 13.04 | Licenseeshall have a unilateral right to terminate this Agreementin any country or territory by giving PHSsixty (60) days written notice to that effect.
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| | 13.05 | PHSshall specifically have the right to terminate or modify, at its option, this Agreement,if PHSdetermines that the Licensee:1) is not executing the Commercial Development Plansubmitted with its request for a license and the Licenseecannot otherwise demonstrate to PHSssatisfaction that the Licenseehas taken, or can be expected to take within a reasonable time, effective steps to achieve
Practical Applicationof the Licensed Productsor Licensed Processes;2) has not achieved the Benchmarksas may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a
material fact in the license application or in any report required by the license Agreement;4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Productsor Licensed
Processesreasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph
5.02 unless waived. In making this determination, PHSwill take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by
Licenseeunder Paragraph 9.02. Prior to invoking this right, PHSshall give written notice to Licenseeproviding Licenseespecific notice of, and a ninety (90) day opportunity to respond to, PHSsconcerns as to the previous items 1) to 7). If Licenseefails to alleviate PHSsconcerns as to the previous items 1) to 7) or fails to initiate corrective action to PHSssatisfaction, PHSmay terminate
this Agreement.
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| | 13.06 | PHSreserves the right according to 35 U.S.C. 209(f)(4) to terminate or modify this Agreementif it is determined that such action is necessary to meet requirements for public use specified by
federal regulations issued after the date of the license and such requirements are not reasonably satisfied by Licensee.
| | ----- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 13.07 | Within thirty (30) days of receipt of written notice of PHSs unilateral decision to modify or terminate this Agreement, Licenseemay, consistent with the provisions of 37 CFR 404.11, appeal the
decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licenseemay thereafter exercise any and all administrative or judicial remedies that
may be available.
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| | 13.08 | Within ninety (90) days of expiration or termination of this Agreementunder this Article 13, a final report shall be submitted by Licensee.Any royalty payments, including those incurred but not yet
paid (such as the full minimum annual royalty), and those related to patent expense, due to PHSshall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement,upon termination or expiration of this Agreement, Licenseeshall return all Licensed Productsor other materials included within the Licensed Patent Rightsto PHSor provide PHSwith certification of the
destruction thereof.
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|14. | GENERAL PROVISIONS
|--- | ------------------



| | 14.01 | Neither Party may waive or release any of its rights or interests in this Agreementexcept in writing. The failure of the Governmentto assert a right hereunder or to insist upon compliance with any term
or condition of this Agreementshall not constitute a waiver of that right by the Governmentor excuse a similar subsequent failure to perform any such term or condition by Licensee.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.02 | This Agreementconstitutes the entire agreement between the Parties relating to the subject matter of the Licensed Patent Rights,and all prior negotiations, representations, agreements, and understandings
are merged into, extinguished by, and completely expressed by this Agreement.
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| | 14.03 | The provisions of this Agreementare severable, and in the event that any provision of this Agreementshall be determined to be invalid or unenforceable under any controlling body of law, such
determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.04 | If either Party desires a modification to this Agreement,the Parties shall, upon reasonable notice of the proposed modification by the Party desiring the change, confer in good faith to determine the
desirability of such modification. No modification will be effective until a written amendment is signed by the signatories to this Agreementor their designees.
| | ----- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.05 | The construction, validity, performance, and effect of this Agreementshall be governed by Federal law as applied by the Federal courts in the District of Columbia.
| | ----- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.06 | All notices required or permitted by this Agreementshall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly
addressed to the other Party at the address designated on the following Signature Page, or to such other address as may be designated in writing by such other Party. Notices shall be considered timely if such notices are received on or before the
established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt
from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.
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| | 14.07 | This Agreementshall not be assigned by Licenseeexcept: a) with the prior written consent of PHS,such consent not to be withheld unreasonably; or b) as part of a sale or transfer of
substantially the entire business of Licenseerelating to operations which concern this Agreement.Licenseeshall notify PHSwithin ten (10) days of any assignment of this Agreementby Licensee,and Licenseeshall pay PHS,as an additional royalty, one percent (1%) of the fair market value of any consideration received for any assignment of this Agreementwithin thirty (30) days of such assignment.
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.08 | Licenseeagrees in its use of any PHS-supplied materials to comply with all applicable statutes, regulations, and guidelines, including PHSand DHHSregulations and guidelines. Licenseeagrees not to use the materials for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. Licenseeagrees not to use the materials for research involving human
subjects or clinical trials outside of the United States without notifying PHS,in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification
to PHSof research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of such research or trials.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.09 | Licenseeacknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of
technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of such items may require a license from the cognizant Agency of the U.S. Governmentor written assurances by Licenseethat it shall not export such items to certain foreign countries without prior approval of such agency. PHSneither represents that a license is or is not required or that, if required, it shall be issued.
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.10 | Licenseeagrees to mark the Licensed Productsor their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate Patent Pending status. All
Licensed Productsmanufactured in, shipped to, or sold in other countries shall be marked in such a manner as to preserve PHSpatent rights in such countries.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



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| | 14.11 | By entering into this Agreement,PHSdoes not directly or indirectly endorse any product or service provided, or to be provided, by Licenseewhether directly or indirectly related to this
Agreement.Licenseeshall not state or imply that this Agreementis an endorsement by the Government, PHS,any other Governmentorganizational unit, or any Governmentemployee. Additionally,
Licenseeshall not use the names of NIH, CDC, PHS,or DHHSor the Governmentor their employees in any advertising, promotional, or sales literature without the prior written consent of PHS.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.12 | The Parties agree to attempt to settle amicably any controversy or claim arising under this Agreementor a breach of this Agreement,except for appeals of modifications or termination decisions
provided for in Article 13. Licenseeagrees first to appeal any such unsettled claims or controversies to the designated PHSofficial, or designee, whose decision shall be considered the final agency decision. Thereafter, Licenseemay exercise any administrative or judicial remedies that may be available.
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.13 | Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the
acquisition and use of rights pursuant to 37 CFR Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant.
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 14.14 | Paragraphs 8.01, 9.06-9.08, 12.01-12.05, 13.07, 13.08, and 14.12 of this Agreementshall survive termination of this Agreement.
| | ----- | ------------------------------------------------------------------------------------------------------------------------------

SIGNATURES BEGIN ON NEXT PAGE



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PHS PATENT LICENSE AGREEMENTNONEXCLUSIVE

SIGNATURE PAGE



|                                                                                                                                      |  |         
|------------------------------------------------------------------------------------------------------------------------------------- |  | --------
|For PHS:                                                                                                                              |  |         
|                                                                                                                                      | 
|/s/ Jack Spiegel                                                                                                                      |  | 12/17/99
|Jack Spiegel, Ph.D.                                                                                                                   |  | Date    
|Director, Division of Technology Development and Transfer
Office of Technology Transfer National Institutes of
Health                 |  |         
|                                                                                                                                      | 
|Mailing Address for Notices:                                                                                                          |  |         
|                                                                                                                                      | 
|Office of Technology Transfer National
Institutes of Health 6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A. |  |         

For Licensee(Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any
statements of Licenseemade or referred to in this document are truthful and accurate.):



|                                 |  |        
|-------------------------------- |  | -------
|by: /s/ Jim Walsh                |  | 3/12/99
|Signature of Authorized Official |  | Date   
|                                 | 
|/s/ Jim
Walsh                    |  |        
|Printed Name                     |  |        
|                                 | 
|DIRECTOR
COO                     |  |        
|Title                            |  |        

Official and Mailing Address for Notices:

Dr. James Walsh

Chief Operating Officer

Trinity Biotech Plc

IDA Business Park

Southern Cross Rd.

Bray

Co. Wicklow

Ireland

Phone: 353-1-2769800

Fax: 353-1-2769888

Any false or misleading statements made, presented, or submitted to the Government,including any relevant omissions, under this Agreementand
during the course of negotiation of this Agreementare subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. 3801-3812 (civil liability) and 18 U.S.C. 1001 (criminal liability including fine(s)
and/or imprisonment).



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APPENDIX APatent(s) or Patent Application(s)

Patent(s) or Patent Application(s):

USPA
SN 06/602,945, filed April 23, 1984, (USPN 4,520,113, issued May 28, 1985) Serological Detection of Antibodies to HTLV-III in Sera of Patients with AIDS and Pre-AIDS Conditions

USPA SN 06/602,946, filed April 23, 1984, (USPN 4,647,773, issued March 3, 1987) Method of Continuous Production of Retrovirus
(HTLV-III) from Patients with AIDS and Pre-AIDS

USPA SN 06/643,729, filed August 24, 1984, (USPN 4,652,599, issued
March 24, 1987) Method of Continuous Production of Retrovirus (HTLV-III) from Patients with AIDS and Pre-AIDS Using Permissive Cells

USPA SN 06/785,638, filed October 8, 1985, (USPN 4,708,818, issued November 24, 1987) Human Immunodeficiency Viruses Associated
with Acquired Immune Deficiency Syndrome (AIDS), A Diagnostic Method for AIDS and Pre-AIDS and a Kit Therefor

USPA SN 07/117,937,
filed November 5, 1987, (USPN 5,135,684, issued August 4, 1992) Human Immunodeficiency Viruses Associated with Acquired Immune Deficiency Syndrome (AIDS), A Diagnostic Method for AIDS and Pre-AIDS and a Kit Therefor



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APPENDIX BLicensed Fields of Use and Territory

Licensed Fields of Use:

Development, manufacture and
sales of immunodiagnostic products for detection of HIV-1 antibodies.

Licensed Territory:

Worldwide



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APPENDIX CRoyalties

Royalties:

Licenseeagrees to pay to PHSa
noncreditable, nonrefundable license issue royalty in the amount of Ten Thousand Dollars ($10,000). Half of this amount shall be due on December 31, 1999. The other half shall be due on December 31, 2000.

Licenseeagrees to pay to PHSa nonrefundable minimum annual royalty in the amount of Ten Thousand Dollars ($10,000).

Licenseeagrees to pay PHSearned royalties on Net Salesby or on behalf of Licenseeas follows:

Six Percent (6%) of Net Sales of all Licensed Products made or sold in the Licensed Territory.

Licenseeagrees to pay PHSbenchmark royalties as follows:

None.

Licenseeagrees to pay PHSTwenty Eight
Thousand Five Hundred Thirty Dollars ($28,530) for Earned Royalties on sales of Licensed Productsbetween January 1, 1992 and December 31, 1998 as calculated below using an earned royalty rate of 6%. Half of this amount shall be due
upon signing of this Agreement.The other half shall be due on December 31, 1999.



|      |  |           |         |  |                 |  |         |              |  |  |        | 
|----- |  | --------- | ------- |  | --------------- |  | ------- | ------------ |  |  | ------ | 
|Year  |  | Net sales |         |  | Net HIV-1 sales |  |         | Royalty @ 6% | 
|1992  |  |           | 0       |  |                 |  | 0       |              |  |  | 0      | 
|1993  |  |           | 20,000  |  |                 |  | 10,000  |              |  |  | 600    | 
|1994  |  |           | 88,000  |  |                 |  | 44,000  |              |  |  | 2,640  | 
|1995  |  |           | 210,000 |  |                 |  | 105,000 |              |  |  | 6,300  | 
|1996  |  |           | 90,000  |  |                 |  | 45,000  |              |  |  | 2,700  | 
|1997  |  |           | 188,000 |  |                 |  | 94,000  |              |  |  | 5,640  | 
|1998  |  |           | 355,000 |  |                 |  | 177,500 |              |  |  | 10,650 | 
|      |  |           |         |  |                 |  |         |              |  |  |        | 
|Total |  |           | 951,000 |  |                 |  | 475,500 |              |  |  | 28,530 | 



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APPENDIX DModifications

PHSand Licenseeagree to the following modifications to the Articles and Paragraphs of this Agreement:

(New)



| | 2.12 | Combined Productmeans a product that contains a Licensed Productalong with at least one other active component or ingredient not covered by the Licensed Patent Rights.
| | ---- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

(New)



| | 2.13 | If the Licenseesells a Combined Product,the Net Salesfor purposes of earned royalty determination under Article 6 shall be the market price of the Licensed Productcontent of the
Combined Productwhen sold separately. If the Licensed Productis not sold separately, then Net Salesupon which a royalty is paid shall be the greater of (a) the market price at which the Licensed Productreasonably
could be sold as a separate item, or (b) Net Salesof the Combined Productmultiplied by a factor 1/x where x is the number of active components or ingredients contained in the Combined Productup to a maximum of x=3.
| | ---- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 5.01 | Deleted in its entirety.
| | ---- | ------------------------

(Amended)



| | 6.01 | Licenseeagrees to pay to PHSa noncreditable, nonrefundable license issue royalty as set forth in Appendix C within thirty (30) days from the date that this Agreement becomes
effective according to the payment schedule in Appendix C.
| | ---- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Amended)



| | 6.02 | Licenseeagrees to pay to PHSa nonrefundable minimum annual royalty as set forth in Appendix C beginning January 1, 2000. The minimum annual royalty is due and payable, half on
June 30, the other half on December 31 on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year. The minimum annual royalty due for the first calendar year of
this Agreementmay be prorated according to the fraction of the calendar year remaining between the effective date of this Agreementand the next subsequent January 1.
| | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 6.08 | Deleted in its entirety.
| | ---- | ------------------------



| | 6.09 | Deleted in its entirety.
| | ---- | ------------------------



| | 6.10 | Deleted in its entirety.
| | ---- | ------------------------



| | 8.02 | Deleted in its entirety.
| | ---- | ------------------------

(Amended)



| | 9.03 | Licenseeshall report to PHSthe dates for achieving Benchmarks specified in Appendix E and the First Commercial Salein each country in the Licensed Territorywithin
thirty (30) days of such occurrences.
| | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Amended)



| | 13.01 | This Agreementis effective as of January 1, 1992, when signed by all parties and shall extend to the expiration of the last to expire of the Licensed Patent Rightsunless
sooner terminated as provided in this Article 13.
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



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APPENDIX EBenchmarks and Performance

Licenseeagrees to the following Benchmarksfor its performance under this Agreementand, within thirty (30) days of achieving a
Benchmark,shall notify PHSthat the Benchmarkhas been achieved.

None.



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APPENDIX FCommercial Development Plan

The Commercial Development Planshall be as described in LicenseesApplication for License to Public Health Service Inventions.



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APPENDIX GU.S. Manufacturing Waiver



|     |  |                                       |  |  |                                                                                                          |                                                    
|---- |  | ------------------------------------- |  |  | -------------------------------------------------------------------------------------------------------- | ---------------------------------------------------
|LOGO |  | DEPARTMENT OF HEALTH & HUMAN SERVICES |  |  |                                                                                                          | Public Health Service
National Institutes of Health
|     |  |                                       |  |  | Office of Technology Transfer National
Institutes of Health 6011 Executive Boulevard Rockville, MD
20852

November 3, 1999

Dr. James Walsh

COO

Trinity Biotech Plc

IDA Business Park

Southern Cross Rd.

Bray, Co. Wicklow

Ireland



|SUBJECT: | Trinity Biotech Plc Request for a Waiver of the U.S. Manufacturing Requirement for Production of HIV Test KitsOTT Ref. No. L-165-99/0
|-------- | --------------------------------------------------------------------------------------------------------------------------------------

Dear Dr. Walsh:

I am pleased to inform you that the NIH
Office of Technology Transfer (OTT) has granted Trinity Biotech Plcs request for a waiver of the U.S. manufacturing requirement for the production of HIV test kits. Based on a review of information supplied by your company, OTT concluded that
it will not be commercially feasible for Trinity to produce its rapid HIV test kits in the United States. A condition of this waiver is that any new plant built by Trinity, for production of HIV test kits for sale in the United States, must be built
in the United States.

We look forward to completing the nonexclusive license agreement associated with this waiver request. Thank you for your interest
in NIH technology.



|                                                         
|---------------------------------------------------------
|Sincerely,                                               
|                                                         
|/s/ Jack Spiegel                                         
|Jack Spiegel, Ph.D.                                      
|Director, Division of Technology Development and Transfer

cc:

Kathleen Sybert, NCI



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