Exhibit 4.19
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT-NONEXCLUSIVE
COVER PAGE
Patent License Number: A198-11
Serial Number(s) of Licensed Patent(s):
US Patent 8,148,057, entitled, “Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, issued 4/3/2012, claiming priority to US Provisional Patent Application No. 60/693,120, filed 6/21/2005, inventor, Arnold Castro.
US Patent Application Serial No. 13/421,681, entitled, “Methods, Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, filed 3/15/2012, claiming priority to US Provisional Patent Application No. 60/693,120, filed 6/21/2005, inventors, Arnold Castro and Robert George.
PCT Patent Application Serial No. PCT/US06/024117 entitled, “Methods, Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, filed 6/20/2006, and related foreign applications, inventors, Arnold Castro and Robert George.
[CDC Ref. No 1-010-05].
Licensee: | Trinity Biotech Manufacturing Limited | |
IDA Business Park | ||
Southern Cross Road | ||
Bray | ||
Co. Wicklow | ||
Ireland |
CRADA Number (if applicable): NCHHSTP-C1D11426-00
Additional Remarks: This royalty rate is for use in Trinity’s dual Trep/Non-Trep Syphilis rapid test. The treponemal (total antibody) + non-treponemal assay essentially is a combination screen and confirmation test. In accordance with fair government practices, this technology is being licensed at the same rates as previous licenses.
Public Benefit (s): Development of a point of care test that can quickly detect both treponomal and nontreponomal antigens.
This Patent License Agreement, hereinafter referred to as the “Agreement,” consists of this Cover Page, an attachedAgreement, a Signature Page, Appendix A (List of Patent(s) 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 (Example Royalty Report). The Parties to thisAgreement 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 (“HHS”); and |
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
PHSandLicenseeagree as follows:
1. | BACKGROUND |
1.01 | In the course of conducting biomedical and behavioral research,PHS investigators made inventions that may have commercial applicability. |
1.02 | By assignment of rights fromPHS employees and other inventors,HHS, 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 inventionsHHS also owns any tangible embodiments of these inventions actually reduced to practice byPHS. |
1.03 | The Secretary of HHS has delegated toPHS the authority to enter into thisAgreementfor the licensing of rights to these inventions under 35 U.S.C. §§200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. §3710(a), and the regulations governing the licensing of Government-owned inventions, 37 C.F.R. Part 404. |
1.04 | PHS desires 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. |
2.02 | “Commercial Development Plan” means the written commercialization plan attached as Appendix F. |
2.03 | “First Commercial Sale” means the initial transfer by or on behalf ofLicenseeofLicensed Productsor the initial practice of aLicensed Processby or on behalf ofLicenseein exchange for cash or some equivalent to which value can be assigned for the purpose of determiningNet Sales. |
2.04 | “Government” means the Government of the United States of America. |
2.05 | “Licensed Fields of Use” means the field(s) of use identified in Appendix B. |
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; |
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; and iv) any reissues, reexaminations, and patent term extensions; |
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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 applications and patents to a) and b) above, including those listed in Appendix A. |
Licensed Patent Rightsshallnot 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, inthecourse of being practiced would, in the absence of thisAgreement,infringe one or more claims of theLicensed 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, offer to sell, sale, or importation would, in the absence of thisAgreement,infringe one or more claims of theLicensed Patent Rightsthat have notbeenheld invalid or unenforceablebyan 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 ofLicensed Productsor practice ofLicensedProcessesby or on behalf ofLicensee,and from leasing, renting, or otherwise makingLicensed 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 byLicensee,and on its payroll, or for the cost of collections. |
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 orGovernment regulations available to the public on reasonable terms. |
3. | GRANT OF RIGHTS |
3.01 | PHShereby grants andLicenseeaccepts, subject to the terms and conditions of thisAgreement,a nonexclusive license under theLicensed Patent Rightsin theLicensed Territoryto make and have made, to use and have used, and to sell and have sold, to offer to sell, and to import anyLicensed Productsin theLicensed Fields of Useand to practice and have practiced anyLicensed Processesin theLicensed Fields of Use. |
3.02 | ThisAgreementconfers no license or rights by implication, estoppel, or otherwise under any patent applications or patents ofPHSother thanLicensed Patent Rightsregardless of whether such patents are dominant or subordinate toLicensed Patent Rights. |
4. | SUBLICENSING |
4.01 | Licensee has no right to sublicense. |
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5. | STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS |
5.01 | Prior to theFirst Commercial Sale, Licenseeagrees to providePHSreasonable quantities ofLicensed Productsor materials made through theLicensed ProcessesforPHSresearch use. |
5.02 | Licensee agrees that productsusedorsoldin the United States embodyingLicensed Productsor produced through use ofLicensed Processesshall be manufactured substantially in the United States, unless a written waiver is obtained in advance fromPHS. |
6. | ROYALTIES AND REIMBURSEMENT |
6.01 | Licenseeagrees to pay toPHSa noncreditable, nonrefundable license issue royalty as set forth in AppendixCwithin thirty(30) days from the date that thisAgreementbecomes effective. |
6.02 | Licenseeagrees to pay toPHS a nonrefundable minimum annual royalty as set forth in AppendixC.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 thisAgreementmay be prorated according to the fraction of the calendar year remaining between the effective date of thisAgreementand the next subsequent January1. |
6.03 | Licenseeagrees to payPHSearned royalties as set forth in AppendixC. |
6.04 | Licensee agrees to payPHS benchmark royalties as set forth in AppendixCand Appendix E. |
6.05 | A patent or patent application licensed under thisAgreementshall cease to fall within theLicensedPatent Rightsfor the purpose of computing the earned royalty and 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. |
6.06 | No multiple royalties shall be payable because anyLicensed ProductsorLicensed Processesare covered by more than one of theLicensed Patent Rights. |
6.07 | On sales ofLicensedProductsbyLicensee to affiliated parties or on sales made in other than an arm’s-length transaction, the value of theNet 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 theLicensed Patent Rightsincurred byPHSprior to the effective date of thisAgreement, Licenseeshall pay toPHS,as an additional royalty, within sixty (60) days ofPHS’ssubmission of a statement, and request for payment toLicensee,an amount equivalent to such patent expenses previously incurred byPHS. |
6.09 | With regard to expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within theLicensed Patent Rightsincurred byPHSon or after the effective date of thisAgreement, PHS,at its sole option, may requireLicensee: |
1. | to payPHS on an annual basis, within sixty (60) days ofPHS’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 |
2. | to pay such expenses directly to the law firm employed byPHSto handle such functions. However, in such event,PHSand notLicenseeshall be the clientofsuch lawfirm. |
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6.10 | Licenseemay elect to surrender its rights in any country of theLicensed Territoryunder anyLicensed Patent Rightsupon ninety (90) days written notice toPHSand owe no payment obligation under Paragraph 6.09 for patent-related expenses incurred in that countryafterthe effective dateofsuch written notice. |
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 theLicensed Patent Rights. |
7.02 | Pursuant to statute 15 U.S.C. §3710c(a)(l)(A)(i),PHS may use royalty payments as calculated in Appendix C, in whole or in part, to pay some or all of the patent costs of theLicensed Patent Rights. |
8. | RECORD KEEPING |
8.01 | Licenseeagrees to keep accurate and correct records ofLicensed Productsmade, used, sold, or imported andLicensed Processespracticed under thisAgreementappropriate to determine the amount of royalties duePHS.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 ofPHSby an accountant or other designated auditor selected byPHSfor the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose toPHSinformation relating to the accuracy of reports and payments made under thisAgreement.If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, thenLicenseeshall reimbursePHSfor the cost of the inspection at the timeLicenseepays the unreported royalties, including any late charges as required by Paragraph 9.08 of thisAgreement.All payments required under this Paragraph shall be due within thirty (30) days of the datePHSprovidesLicenseenotice of the payment due. |
8.02 | Licenseeagrees to conduct an audit of sales and royalties conducted by an independent auditor at least every two (2) years if annual sales of theLicensed ProductorLicensed Processesare over two (2) million dollars. The audit shall address, at a minimum, the amount of gross sales by or on behalf ofLicenseeduring the audit period, terms of the license as to percentage or fixed royalty to be remitted to theGovernment,the amount of royalty funds owed to theGovernmentunder thisAgreement,and whether the royalty amount owed has been paid to theGovernmentand is reflected in the records of theLicensee.The audit shall also indicate thePHSlicense number, product, and time period being audited. A report certified by the auditor shall be submitted promptly by the auditor directly toPHSon completion.Licenseeshall pay for the entire cost of the audit. |
9. | REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS |
9.01 | Prior to signing thisAgreement, Licenseehas provided toPHStheCommercial Development Planat Appendix F, under whichLicenseeintendstobring the subject matter of theLicensed Patent Rightsto the point ofPractical Application.ThisCommercial Development Planis hereby incorporated by reference into thisAgreement.Based on this plan, performanceBenchmarksare determined as specified in Appendix E. |
9.02 | Licenseeshall provide written annual reports on its product development progress or efforts to commercialize under theCommercial Development Planfor each of theLicensed Fields of Usewithin sixty (60) days after December 31 of each calendar year. These progress reports shall include, but not be limitedto:progress on research and development, status of applications for regulatory approvals, manufacturing, marketing, importing, and sales during the preceding calendar year, as well |
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as plans for the present calendar year.PHSalso encourages these reports to include information on any ofLicensee’spublic service activities that relate to theLicensed Patent Rights.If reported progress differs from that projected in theCommercial Development PlanandBenchmarks, Licenseeshall explain the reasons for such differences. In any such annual report,Licenseemay propose amendments to theCommercial Development Plan,acceptance of which byPHSmay not be denied unreasonably.Licenseeagrees to provide any additional information reasonably required byPHSto evaluateLicensee’sperformance underthis Agreement. Licenseemay amend theBenchmarksat any time upon written consent byPHS. PHSshall not unreasonably withhold approval of any request ofLicenseeto extend the time periods of this schedule if such request is supported by a reasonable showing byLicenseeof diligence initsperformance under theCommercial Development Planand toward bringing theLicensed Productsto the point of practical application as defined in 37 CFR 404.3(d).Licenseeshall amend theCommercial Development PlanandBenchmarksat the request ofPHSto address anyLicensed Fields of Usenot specifically addressed in the plan originally submitted. |
9.03 | Licenseeshall report toPHSthe dates for achievingBenchmarksspecified in Appendix C and/or Appendix E and theFirst Commercial Salein each country in theLicensed Territorywithin thirty (30) days of such occurrence. |
9.04 | Licenseeshall submit toPHSwithin 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 theLicensed Productssold orLicensed Processespracticed by or on behalf ofLicenseein each country within theLicensed Territory,theNet Sales,and the amountofroyalty accordingly due. With each such royalty report,Licenseeshall submit paymentofthe earned royalties due.Ifno earned royalties are due toPHSfor any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officerof Licenseeand shall include a detailed listing of all deductions made under Paragraph 2.10 to determineNet Salesmade under Article 6 to determine royalties due. |
9.05 | Royalties due under Article 6 shall be paid inU.S.dollars. For conversion of foreign currency toU.S.dollars, the conversion rate shall be the New York foreign exchange rate quoted inThe 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 “CDC/Technology Transfer” and shall reference the licensing agreement number assigned by the Centers for Disease Control and Prevention (CDC). All such payments shall be sent to the following address: CDC, Financial Management Office, P.O. Box 15580, Atlanta, GA 30333 or by wire transfer. To ensure timely and accurate payment processing, please be sure to include the invoice number (if applicable), tax ID number, and/or a copy of the invoice with your payment. Also, please send a copy/confirmation of such payment to the following address: CDC, Technology Transfer Office, 4770 Buford Highway NE, MailStop K-79, Atlanta, GA 30341. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely byLicensee.The royalty report required by Paragraph 9.04 of thisAgreementshall accompany each such payment and a copy of such report shall also be mailed toPHSat its address for notices indicated on the Signature Page of thisAgreement. |
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. |
9.07 | Additional royalties may be assessed byPHSon any payment that is more than ninety (90) days overdue at the rate of one percent (1%) per month. This one percent (1%) per month rate may be applied retroactively from the original due date until the date of receipt byPHSof the overdue payment and additional royalties. The payment of additional royalties shall not preventPHSfrom 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” byLicenseeshall, to the extent permitted by law, be treated byPHS as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of such records by thePHS under the Freedom of Information Act, 5 U.S.C. § 552 shall be subject to the predisclosure notification requirements of 45 CFR § 5.65(d). |
10. | PERFORMANCE |
10.01 | Licensee shall use its reasonable best efforts to bring the License Products and Licensed Processes to Practical Application. “Reasonable best efforts” for the purposes of this provision shall include adherence to theCommercial Development Planat Appendix F and performance of theBenchmarksat Appendix E. |
10.02 | Upon theFirst Commercial Sale,until the expiration of thisAgreement, Licenseeshall use its reasonable best efforts tomake Licensed ProductsandLicensed Processesreasonably accessible to the United States public. |
11. | INFRINGEMENT AND PATENT ENFORCEMENT |
11.01 | PHS andLicenseeagree to notify each other promptly of each infringement or possible infringement of theLicensed Patent Rights,as well as any facts which may affect the validity, scope, or enforceability of theLicensed Patent Rightsof which either Party becomes aware. |
11.02 | In the event that a declaratory judgment action alleging invalidity of any of theLicensed Patent Rightsshall be brought againstPHS,PHS agrees to notifyLicenseethat an action alleging invalidity has been brought.PHS does not represent that it will commence legal action to defend against a declaratory action alleging invalidity.Licenseeshall take no action to compel theGovernmenteither to initiate or to join in any such declaratory judgment action. Should theGovernmentbe made a party to any such suit by motion or any other action ofLicensee, Licenseeshall reimburse theGovernmentfor any costs, expenses, or fees which theGovernmentincurs as a result of such motion or other action. UponLicensee’spayment of all costs incurred by theGovernmentas a result ofLicensee’sjoinder motion or other action, these actions byLicenseewill not be considered a default in the performance of any material obligation under thisAgreement. |
12. | NEGATION OF WARRANTIES AND INDEMNIFICATION |
12.01 | PHS offers no warranties other than those specified in Article 1. |
12.02 | PHS does not warrant the validity of theLicensed Patent Rightsand makes no representations whatsoever with regard to the scope of theLicensed Patent Rights,or that theLicensed 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 THELICENSED PATENT RIGHTSOR TANGIBLE MATERIALS RELATED THERETO. |
12.04 | PHS does not represent that it will commence legal actions against third parties infringing theLicensed Patent Rights. |
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12.05 | Licensee shall indemnify and holdPHS, 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 ofLicensee,directors, employees, or third parties of anyLicensed Patent Rights,or b) the design, manufacture, distribution, or use of anyLicensed Products, Licensed Processesor materials byLicensee,or other products or processes developed in connection with or arising out of theLicensed Patent Rights. Licenseeagrees to maintain a liability insurance program consistent with sound business practice. |
13. | TERM, TERMINATION, AND MODIFICATION OF RIGHTS |
13.01 | ThisAgreement is effective when signed by all parties and shall extend to the expiration of the last to expire of theLicensed Patent Rightsunless sooner terminated as provided in this Article 13. |
13.02 | In the event thatLicensee is in default in the performance of any material obligations under thisAgreement,including but not limited to the obligations listed in Paragraph 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of such default,PHS may terminate thisAgreementby written notice, and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. |
13.03 | In the event thatLicenseebecomes 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 notifyPHS in writing. Furthermore,PHS shall have the right to terminate thisAgreementimmediately uponLicensee’s receipt of written notice. |
13.04 | Licensee shall have a unilateral right to terminate thisAgreementand/or any licenses in any country by givingPHS sixty (60) days written notice to that effect. |
13.05 | PHS shall specifically have the right to terminate or modify, at its option, thisAgreement,ifPHSdetermines that theLicensee:1)is not executing theCommercial Development Plansubmitted with its request foralicense and theLicenseecannot otherwise demonstrate toPHS’ssatisfaction that theLicenseehas taken, or can be expected to take withinareasonable time, effective steps to achieve practical application of theLicensed ProductsorLicensed Processes;2)has not achieved theBenchmarksas may be modified under Paragraph9.02; 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 acovenantor agreement contained in the license;5)is not keepingLicensed ProductsorLicensed 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 Paragraph5.02unless 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 byLicenseeunder Paragraph9.02.Prior to invoking this right,PHSshall give written notice toLicenseeprovidingLicenseespecific notice of, and a ninety(90) day opportunity to respond to,PHS’sconcerns as to the previous items1)to 7). IfLicenseefails to alleviatePHS’sconcerns as to the previous items1)to 7) or fails to initiate corrective action toPHS’ssatisfaction,PHSmay terminate thisAgreement. |
13.06 | PHS reserves the right according to 35 U.S.C. § 209(d)(3) to terminate or modify thisAgreementif 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 byLicensee. |
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13.07 | Within thirty (30) days of receipt of written notice ofPHS’s unilateral decision to modify or terminate thisAgreement, Licenseemay, consistent with the provisions of 37 CFR 404.11, appeal the decision by written submission to the designatedPHSofficial. The decision of the designatedPHSofficial shall be the final agency decision.Licenseemay thereafter exercise any and all administrative or judicial remedies that may be available. |
13.08 | Within ninety (90) days of termination of thisAgreementunder this Article 13, a final report shall be submitted byLicensee. Any royalty payments, including those incurred but not yet paid (e.g., full minimum annual royalty), and those related to patent expense, due toPHSshall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under thisAgreement,upon termination or expiration of thisAgreement, Licenseeshall return allLicensed Productsor materials included within theLicensed Patent RightstoPHSor providePHSwith certification of the destruction thereof. |
14. | GENERAL PROVISIONS |
14.01 | Neither Party may waive or release any of its rights or interests in thisAgreementexcept in writing. The failure of theGovernmentto assert a right hereunder or to insist upon compliance with any term or condition of thisAgreementshall not constitute a waiver of that right by theGovernmentor excuse a similar subsequent failure to perform any such term or condition byLicensee. |
14.02 | ThisAgreementconstitutes the entire agreement between the Parties relating to the subject matter of theLicensed Patent Rights,and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by thisAgreement. |
14.03 | The provisions of thisAgreementare severable, and in the event that any provision of thisAgreementshall 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 thisAgreement. |
14.04 | If either Party desires a modification to thisAgreement,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 thisAgreementor their designees. |
14.05 | The construction, validity, performance, and effect of thisAgreementshall be governed by Federal law as applied by the Federal courts in the District of Columbia. |
14.06 | All notices required or permitted by thisAgreementshall be given by prepaid, first class, registered or certified mail 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. |
14.07 | ThisAgreementshall not be assigned byLicenseeexcept a) with the prior written consent ofPHS,such consent not to be withheld unreasonably; or b) as part of a sale or transfer of substantially the entire business ofLicenseerelating to operations which concern this Agreement.Licenseeshall notifyPHSwithin ten (10) days of any assignment of this Agreement byLicensee,and Licensee shall payPHS,as an additional royalty, one percent (1%) of the fair market value of any consideration received for any assignment of this Agreement within thirty(30) days of such assignment. |
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14.08 | Licenseeagrees in its use of anyPHS-supplied materials to comply with all applicable statutes, regulations, and guidelines, includingPHS andHHS regulations 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 notifyingPHS, in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification toPHS of 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 byLicenseethat 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 theLicensed Productsor their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent Pending” status. AllLicensed Productsmanufactured in, shipped to, or sold in other countries shall be marked in such a manner as to preservePHSpatent rights in such countries. |
14.11 | By entering into thisAgreement, PHSdoes not directly or indirectly endorse any product or service provided, or to be provided, byLicenseewhether directly or indirectly related to thisAgreement. Licenseeshall not state or imply that thisAgreementis an endorsement by theGovernment, PHS,any otherGovernmentorganizational unit, or anyGovernmentemployee. Additionally,Licenseeshall not use the names of NIH, CDC,PHS,or HHS or theGovernmentor their employees in any advertising, promotional, or sales literature without the prior written consent ofPHS. |
14.12 | The Parties agree to attempt to settle amicably any controversy or claim arising under thisAgreementor a breach of thisAgreement,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 designatedPHSofficial, 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 thisAgreementshall survive termination of thisAgreement. |
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PHS PATENT LICENSE AGREEMENT-NONEXCLUSIVE
SIGNATURE PAGE
ForPHS: | ||
/s/ David Holmes | May 22, 2012 | |
Signature of Authorized PHS Official | Date | |
David Holmes, Ph.D. Director, Division of Laboratory Policy and Practice Centers for Disease Control and Prevention |
Mailing Address for Notices: | Technology Transfer Office Centers for Disease Control and Prevention 4770 Buford Highway Mailstop K-79 Atlanta, Georgia 30341 USA |
ForLicensee(Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements ofLicenseemade or referred to in this document are truthful and accurate.):
by | ||||
/s/ Pat Vaughan | 14th May 2012 | |||
Signature of Authorized Official | Date | |||
Pat Vaughan, Ph.D. VP of R&D |
Official and Mailing Address for Notices: | Trinity Biotech Manufacturing Limited | |
IDA Business Park | ||
Southern Cross Road | ||
Bray | ||
Co. Wicklow | ||
Ireland |
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are 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):
US Patent 8,148,057, entitled, “Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, issued 4/3/2012, claiming priority to US Provisional Patent Application No. 60/693,120, filed 6/21/2005, inventor, Arnold Castro.
US Patent Application Serial No. 13/421,681, entitled, “Methods, Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, filed 3/15/2012, claiming priority to US Provisional Patent Application No. 60/693,120, filed 6/21/2005, inventors, Arnold Castro and Robert George.
PCT Patent Application Serial No. PCT/US06/024117 entitled, “Methods, Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies”, filed 6/20/2006, and related foreign applications, inventors, Arnold Castro and Robert George. |CDC Ref. No. 1-010-05|.
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APPENDIX B—Licensed Field(s) of Use and Territory
Licensed Field(s) of Use:
Forin vitro diagnostic use inLicensee’sdual Trep/Non-Trep Syphilis rapid test.
Licensed Territory:
In all countries where claims of theLicensed Patent Rightsexist.
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APPENDIX C—Royalties
Royalties:
Licenseeagrees to pay to PHS a noncreditable, nonrefundable license issue royalty in the amount of five thousand ($5,000) dollars.
Licenseeagrees to pay toPHSa nonrefundable minimum annual royalty of Five Thousand ($5,000) dollars; the first such payment will be dueJanuary 1, 2013.
Licenseeagrees to payPHSearned royalties onNet Salesby or on behalf ofLicensee of five percent (5%).
Royalty will be reduced to two and a half percent (2.5%) ofNet SalesonLicensed Productssold in countries classified as low-income and lower-middle-income economies by the World Bank (www.worldbank.org). Classification will be reassessed at the beginning of each calendar year.
Licenseeshall be entitled to a one-half percent (0.5%) credit against the earned royalty rate for each percent (1%) of royaltyLicenseemust pay to third party licensors for the manufacture and saleof Licensed Products.Said reduction, however, shall not reduce the royalty rate for Net Sales ofLicensed Productsto below two and one-half percent (2.5%) in high-income and middle-income economies and the royalty will not be reduced below one and a quarter percent (1.25%) in low-income and lower-middle-income economies.
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APPENDIX D—Modifications
PHSandLicenseeagree to the following modifications to the Articles and Paragraphs of thisAgreement:
6.08 Deleted.
6.09 Deleted.
6.10 Deleted.
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APPENDIX E—Benchmarks and Performance
Licenseeagrees to the followingBenchmarksfor its performance under thisAgreementand, within thirty (30) days of achieving aBenchmark,shall notifyPHSthat theBenchmarkhas been achieved.
None.
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APPENDIX F—Commercial Development Plan
Licenseeshall expend reasonable efforts and resources to carry out the development and marketing plan submitted withLicensee’sapplication for a license and to bring theLicensed Patent Rightsto the point of practical application as defined in Title 37 of the Code of Federal Regulations, Section 404.3(d).Licenseeshall offerLicensed Productsfor sale within eighteen (18) months of the Effective Date of thisAgreementunless this period is extended by mutual agreement of the parties.PHSshall not unreasonably withhold approval of any request byLicenseeto extend this period if such request is supported by evidence of reasonable efforts byLicenseeto bring theLicensed Patent Rightsto practical application, including any reasonable and diligent application for regulatory approvals required by anyGovernmentagency.
The research involves development of a visually read, qualitative immunochromatographic test for detecting both Treponemal and non-Treponemal antibodies on the same device. With this configuration the assay will simultaneously screen for the presence of anti-cardiolipin antibodies and confirm the results by the detection of antibodies toT. pallidum. The test results could be obtained in 15 to 20 minutes in point of care settings and patients can be counseled as to whether they have active infection that would require treatment.
The design of the rapid lateral flow test device will be used with whole blood or serum/plasma samples.
This assay will be unique in its ability to simultaneously test for both non-Treponemal and Treponemal antibodies. If successful, this test will provide testing opportunities where current test methods could not be performed. It will allow patients to be advised of infection status and to be treated in a single visit to a clinic.
Proposed components:
Configuration: | Lateral Flow device. | |
Control line: | Possibly anti-Human 1g or other blood marker | |
Trep line: | R17 proteins or equivalent. | |
Non-Trep: | Modified cardiolipin molecule | |
Cardiolipin/Lecithin/Cholesterol | ||
Time: | 15 - 20 minutes for POC. | |
Sample: | Whole blood, serum/plasma 5 -20 ul for POC |
Methods:
First phase: Development of non-Treponemal test.
The first phase of research is focusing on the development of the assay for the reagin or non-Treponemal antibodies.
Traditionally, non-Treponemal assays detect antibodies reactive to cardiolipin present in a mixture containing cholesterol and lecithin (VDRL antigen). This antigen is not easily bound to nitrocellulose membranes devices and it is disrupted and released from the membrane by detergents frequently used as blocking agents. In the cardiolipin molecular structure there are no other reactive groups that can readily link cardiolipin to proteins, latex particles, or to nitrocelullose. The long fatty acid ester groups in cardiolipin imparts a high degree of hydrophobicity to the molecule and makes it difficult to bind cardiolipin to polar surfaces such as nitrocellulose or ELISA plates.
1. | The first objective of this research is to investigate methods to attach the micelle produced when an alcoholic preparation of cardiolipin, lecithin and cholesterol is diluted 1:10 in buffered saline. The micelle is (CDC method) enabling it to bind to nitrocellulose CDC is initiating a patent application for a proprietary method of modifying the VDRL antigen.“Methods, Immunoassays and Devices for Detection of Anti-Lipoidal Antibodies” U.S. Patent Application No. 11/993,213. – Training by CDC complete and development ongoing at Trinity Biotech |
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2. | CDC will instruct Trinity in the preparation of the micelle antigen using the CDC invention“Composition and Methods for Detecting Syphilis Using Synthetic Antigens. U.S. Patent Application No. 10/009,698. - Training by CDC complete and development ongoing at Trinity Biotech |
3. | Investigate the modified antigen for its ability to detect all stages of syphilis infections with a high degree of sensitivity and specificity. |
4. | Work is currently underway at Trinity Biotech (since 2011) to apply the nitrocellulose bound cardiolipin and latex bound cardiolipin into a lateral flow assay to detect non-treponemal antibodies. Prototypes were generated in Q1 2012 and further refinement continues into Q2 and Q3 2012. |
Second phase: Development of Treponemal test.
Concurrently, and independent of the CDC technology, the second phase of research is focusing on the development of a sensitive and specific assay for Treponemal antibodies. There is substantial published data available which is related to the attachment of antigens of protein in nature to nitrocellulose. This assay is based onT. pallidumrecombinant antigens, Tp17 and possibly Tp47. Prototypes have been developed Q1 2012 and are soon to enter verification and validation Q2 2012.
Third phase:
Third phase: | Combining the Treponemal and non-Treponemal antigens on the same device for the dual POC test. This work is due to start in Q3 2012 and continue for approximately 6 months. |
Fourth phase:
Fourth phase: | Conduct medium scale test studies using stored sera from CDC serum bank with both documented and non-documented cases of syphilis in Q4 2012. |
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APPENDIX G – EXAMPLE ROYALTY REPORT
Required royalty report information includes:
• | CDC TTO license reference number (A198-11) |
• | Reporting period |
• | Catalog number and units sold of each Licensed Product (Please separate items by country) |
• | Gross Sales per catalog number per country |
• | Total Gross Sales (Summarized by country) |
• | Itemized deductions from Gross Sales |
• | Earned Royalty Rate and associated calculations |
• | Gross Earned Royalty |
• | Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made |
• | Net Earned Royalty due |
** In addition, a sample product and/or product packaging is to be sent on the first report and each time the product packaging is re-designed. **
Example:
A198-11: Trinity Biotech Manufacturing Limited: Reporting Period: January 2012 through December 2012
Country | Product Name | Catalog/Item # | Units Sold | Item Price (US$) | Gross Sales (US$) | |||||
Australia | A | 123ABC | 250 | 100.00 | 62,500 | |||||
Australia | A | 456DEF | 32 | 75.00 | 16,500 | |||||
Australia | A | 789GHI | 25 | 50.00 | 15,625 | |||||
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TOTAL | 307 | 94,625 | ||||||||
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Country | Product Name | Catalog/Item # | Units Sold | Item Price (US$) | Gross Sales (US$) | |||||
USA | B | 010JKL | 0 | 79.00 | 0 | |||||
TOTAL | 0 | 0 | ||||||||
Country | Product Name | Catalog/Item # | Units Sold | Item Price (US$) | Gross Sales (US$) | |||||
United Kingdom | C | 011MNO | 57 | 80.00 | 57,125 | |||||
United Kingdom | C | 012PQR | 12 | 25.00 | 1,500 | |||||
TOTAL | 62 | 58,625 |
Grand Total Gross Sales | 153,250 | |||
Less Deductions: | ||||
Freight | 3,000 | |||
Returns | 7,000 | |||
Total Net Sales: | 143,250 | |||
Royalty Rate | 8 | % | ||
Royalty Due | 11,460 | |||
Less Creditable Payments | 10,000 | |||
Net Royalty Due: | 1,460 |
Sample product packaging included?YorN
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