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HomeMy WebLinkAboutContract 53687 C7Y SECRETARY 4 ACT NO. 53L 9:7 t ns V�,o Research Agreement This Research Agreement (including the Schedules attached hereto, this "Agreement") is made and entered into as of 2/28/2020 by and between The City of Forth Worth ("Laboratory") and IDEXX Laboratories, Inc. ("Sponsor"). BACKGROUND The research program contemplated by this Agreement is of mutual interest and benefit to Laboratory and to Sponsor. TERMS 1. SCOPE OF WORK. Laboratory shall exercise its best efforts to carry out the research for the research program (the "Study") in accordance with the referenced protocol set forth in Schedule 1 (the "Protocol"). Changes in the Protocol may be made only through prior written agreement between Sponsor and Laboratory, 2. PRINCIPAL INVESTIGATOR Laboratory shall appoint David Nelson as principal investigator for the Study ("Principal Investigator") who will be responsible for the direction of the Study in accordance with the Protocol, applicable Laboratory policies, generally accepted standards of good clinical practice, all applicable local, state and federal laws and regulations governing the performance of clinical investigations. If, for any reason, David Nelson is unwilling or unable to continue to serve as Principal Investigator and a successor acceptable to both Laboratory and Sponsor is not available, this Agreement may be terminated as provided in Section 13. 3. EFFECTIVE PERIOD The effective period of this Agreement will be from the date of execution of this Agreement until May 31, 2020 unless otherwise terminated in accordance with Section 13. The effective period may be extended by the mutual written consent of the parties hereto, as provided in Section 15. 4. RECORDKEEPING A. Laboratory and Principal Investigator shall prepare and maintain records, reports and data as provided in the Protocol and in accordance with all applicable local, state and federal laws and regulations. OFFICIAL RECORD CITY SECRETARY I FT WORTH,TX B. Laboratory shall cooperate with any regulatory authority with appropriate jurisdiction and allow them reasonable access to relevant study records and data. C. Laboratory shall cooperate with Sponsor in matting records, reports and data developed under this Agreement available to Sponsor upon reasonable notice during Laboratory' normal business hours. Sponsor may utilize all data and results for any reasonable purpose, including regulatory submissions. D, Laboratory shall retain Study records for the period of time required by applicable law and regulations. S. CONFIDENTIAL INFORMATION The terms of the Confidential Disclosure Agreement between the parties, dated February 3, 2020, shall apply to the disclosure of confidential information between the parties under this Agreement. G_ PUBLICATIONS Principal Investigator and Laboratory shall not publish or present the results and data of the Study. Sponsor shall take the lead on any publication. 7. PATENTS AND INVENTIONS A. The entire right, tittle and interest in and to any invention or discovery that is confirmed through performance of the Study that relates to an existing or Sponsor-proposed product or service of Sponsor shall be the property of Sponsor ("Sponsor Inventions"). Other than for Sponsor Inventions, it is recognized and understood that the existing inventions and technologies of Sponsor and Laboratory are their separate property, respectively, and are not affected by this Agreement and neither party shall have any claims to or rights in such existing inventions and technologies of the other party. Laboratory agrees to enter into appropriate agreements with all persons involved in the Study to insure the foregoing. B. Title to any inventions or discoveries arising from the Study, whether conceived and reduced to practice by Sponsor employees, Laboratory employees or jointly by Laboratory employees and Sponsor employees, shall be owned by Sponsor. 8. USE OF LABORATORY OR SPONSOR'S NAME(ADVERTISING) 7 Laboratory and Principal Investigator, on the one hand, and Sponsor, on the other hand, will obtain prior written permission from each other before using the name, symbols and/or marks of the other in any form of publicity in connection with the Study or this Agreement. This shall not include legally required disclosure by Laboratory, Sponsor or Principal Investigator that identifies the existence of this Agreement. Further, Sponsor's use of the name, symbols and/or marks of Laboratory, or names of Laboratory' employees, in connection with the Study or this Agreement shall be limited to identification of Laboratory as the Study site and the Study staff as participants in the Study. 9. NOTICE Any notice shall be sent to the following addresses. Notice shall be effective on the date of receipt. If to Laboratory, to: David Nelson, Ph.D. Water Quality Manager City of Fort Worth Water and Wastewater Central Laboratory 2600 SE Loop 820 Fort Worth, TX 76140 Office: 817.392.5902 Fax: 817.392.5920 Email: David.Nelson@FortWorthTexas.gov If to Sponsor, to: IDEXX Laboratories, Inc. One IDEXX Drive Westbrook, ME 04092 Attention: Dan Broder Email: Daniel-Broder@idexx.com Phone: (207) 556-2119 Phone: (207) 556-2091 10. INDEMNIFICATION A. Subject to the other provisions of this Sections 11, Sponsor agrees to indemnify, defend and hold harmless Laboratory, its trustees, officers, agents and employees and Principal Investigator from any and all liabilities for personal injury or property damage arising out of or connected with performance of the Study. I B. The obligation of indemnification under this Section 11 shall not apply to the extent that liabilities (1) are caused by a failure of Laboratory and/or Principal Investigator to use materials in accordance with the Protocol or other written instructions of Sponsor or the negligence or willful misconduct of Principal Investigator or any employee of Laboratory or (ii) relate to the obligations that Laboratory assumes under Sections 12(B) and (D). C. Laboratory must promptly notify Sponsor of any claim or suit against any party to be indemnified hereunder, must allow Sponsor to have full control of any disposition or settlement of such claim or suit, and must fully cooperate with Sponsor regarding such disposition or settlement. D. Sponsor shall not dispose or settle any claim admitting liability on the part of Laboratory without Laboratory' prior consent. EQUIPMENT A. Sponsor shall provide Laboratory with the equipment listed on Schedule 2 (the "Equipment and Materials Provided") until expiration or termination of this Agreement. During such period, Laboratory may use the Equipment solely for the Study and not for any other purposes, commercial or otherwise, and shall use the Equipment in accordance with the applicable documentation provided by Sponsor. B_ Sponsor shall install and remove the Equipment at no cost to Laboratory. Sponsor shall also provide all support and maintenance for the Equipment at no cost to Laboratory; provided that Laboratory shall reimburse Sponsor for the cost of repairing any damage or alternation to the Equipment caused by Laboratory or any of its trustees, officers, agents or employees. C. Title to the Equipment is and shall remain in Sponsor at all times. Laboratory shall keep and use the Equipment only at its address shown above and not remove the Equipment from that address or alter it in any way. Laboratory shall not take any actions inconsistent with Sponsor's title to and ownership of the Equipment. Laboratory shall not permit any security interest or other lien or encumbrance to attach to the Equipment, and shall notify Sponsor immediately if one does. Laboratory shall indemnify Sponsor against any and all liabilities, including reasonable attorneys' fees, if any security interest or other lien or encumbrance attached to the Equipment. Laboratory shall dispose of any unused test devices upon completion of the study. D. Laboratory agrees that Sponsor makes no representations regarding the accuracy of the Equipment or Laboratory' use or operation of the Equipment. The Equipment is being delivered "AS IS"WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT 4 LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY OF TITLE OR INFRINGEMENT. WITHOUT LIMITING THE FOREGOING, SPONSOR DOES NOT WARRANT THAT THE OPERATION OF THE EQUIPMENT WILL BE UNINTERRUPTED, ERROR FREE OR WILL APPEAR AS DESCRIBED IN THE DOCUMENTATION. 12. TERMINATION A. This Agreement may be terminated by Sponsor for any reason upon 30 days prior written notice. B. This Agreement may be terminated by either party if the other party breaches any term or condition of this Agreement and does not remedy such breach within 30 days of notice from the non-breaching party. C. This Agreement may be terminated upon 30 days prior written notice by either party if a successor Principal Investigator is not available pursuant to Section 2. D. Upon the effective date of expiration or termination, there shall be an accounting conducted by Laboratory. Within 30 days after receipt of the final accounting for the Study, Sponsor will make payment to Laboratory for all services rendered and monies expended by Laboratory until the date of termination not yet paid for by Sponsor. 13. APPLICABLE LAW: This Agreement shall be governed by the laws of the State of Maine, U.S.A., without regard to its principles of conflict of law. 14. AMENDMENT This Agreement may only be extended, renewed or otherwise amended by the mutual written consent of the parties hereto. This Agreement represents the entire understanding of the parties with respect to the subject matter hereof. The invalidity or u n enforceability of any term or provision of this Agreement shall not affect the validity or enforceability of any other term or provision hereof. Neither this Agreement nor the rights or obligations hereunder shall be assignable or otherwise transferred or subcontracted without the other party's prior consent. 15. SUBCONTRACTOR In the performances of all services hereunder, Laboratory shall be deemed to be and shall be an independent contractor and, as such, shall not be entitled to any benefits applicable to employees of Sponsor. 16. FORCE MAJEURE Neither party shall be liable for any failure to perform as required by this Agreement to the extent such failure to perform is due to circumstances reasonably beyond such party's control, including, without limitation, labor disturbances or labor disputes of any kind, accident, failure of any governmental approval required for full performance, civil disorders or commotions, acts of aggression, acts of God, energy or other conservation measures imposed by law or regulation, explosions, failure of utilities, mechanical breakdowns, material shortages, disease, or other such occurrence. 17. COUNTERPARTS This Agreement may be executed by the parties on any number of separate counterparts, and all such counterparts so executed shall constitute one agreement binding on all parties thereto notwithstanding that all such parties are not signatories to the same counterpart. (signature page follows) 6 IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above. Sponsor: IDEXX LABORATORIES, INC. Signature: -fit 3 Name: Dan Broder, PhD Title: Research scientist,Trial Coordinator PRINCIPAL INVESTIGATOR I understand that I may be under strict obligations of confidentiality under the terms and conditions of the Study and this Agreement. I will abide by such terms and conditions along with all other terms and conditions that apply to me in this Agreement. I understand that I may be personally responsible for breaches of confidentiality for Information provided to me under the Study or this Agreement, if any. Acknowledged and Agreed: Laboratory: City of Fort Worth Water and Wastewater Central Laboratory Signature: Name: David Nelson Title: Water Quality Manager 7 CSC No. ACarm AND AGREED, CITY OF FORT WORTH CONTRACT COMPLIANCE MANAGER: By signing I acknowledge that I am the person responsible for the monitoring and administration of this contract,including By: _ ensuring all performance and reporting Name: Dana Burg'hAoff requirements. Title: Assistant C Man it) By: APPROVAL RECOMMENDED: Name:David Nelson Title: Water Quality Manager APPROVED AS TO FORM AND r By: e//.( LEGAL=: Name: Chris I-larder,PE Title: Water Director ATTEST: By: — Name. Christa R.Lopez-Rc ds Title: Senior Assistant City Attorney By: '' t CONTRACT AUTHORIZATION: Name: ry ay r P &C: NA Title: City Secretary ate Approved: C.3 1 1295 Certification No.: IIaUXLaboratorlas, Inc. By: s-- 3NZ020 Name: aniel Broder, Title: Research Scientist,Trial Coordinator OFFMAL RECORD C17Y SECRETARY Fri. WORTH,TX 1DEXX Research Agreement Page 1 of I SCHEDULEI PROTOCOL BETA TRIAL COMPARISON OF EASY DISC 112A WITH SM9215, R2A AGAR OBJECTIVE To compare IDEXX EasyDisc R2A with SM9215' using Reasoner's 2A agar (R2A). The water samples to be tested include any samples normally evaluated by R2A by a participating laboratory. This study aims to collect 50-75 positive data pairs from each participating laboratory, although more samples may be run if available. It is anticipated that at least three and up to five (5) laboratories will participate in the trial, Participating laboratories will generate usable data points derived from a range of sample sites, In the context of this study, sample sites can be interpreted as geographically distinct locations or samples taken from the same location at least two days apart(3). SCOPE EasyDisc R2A is presented in a unique petri plate format with growth reagent embedded to the plate inner surface, and is designed to test 1 milliliter of water sample. It utilizes IDEXX's formulation to detect a range of heterotrophic bacteria comparable to those detected by the method SM9215 R2A. As with R2A, EasyDisc R2A is incubated at 20-28°C°C for 5-7 days. When heterotrophs are present in a water sample, on EasyDisc R2A they grow into colonies on the surface of the media and may produce a blue/purple, or cleartwhite color. Enumeration is achieved by counting the total number of all colonies, regardless of color. OVERVIEW OF PROTOCOL The aim of the protocol is to utilize water samples naturally contaminated with heterotrophic bacteria to compare the sensitivity and performance Characteristics of EasyDisc R2A to SM9215 R2A. Samples that are found to be highly contaminated may be analyzed following appropriate dilutions. usable data points are defined as those which are not too numerous to count (TNTC) by either method or zero by both methods. NOTE. In the context of 5M 9215,only samples where colony counts 30-300 for at least one method should be considered in the final evaluation. If no plate contains 30 to 300 colonies, and one or more plates have >300 colonies. use the plate(s)whose count is nearest 300 colonies. Compute the count as above and report as estimated Cf=U/ml. NOTE Information regarding samples is to be recorded, information will include (but is not limited to) structure/building, source, water type (hot/cold), sample temperature. This information is to be tracked in the"EasyDisc R2A worksheet.xls". Where possible, water samples should be collected in bottles containing appropriate neutralizing agent as required. After thorough mixing, 9 ml aliquots or suitable dilutions/volumes R should be analysed according to EasyDisc R2A and SM9125. Samples will be incubated for the required amount of time prior to enumeration. PROTOCOL Tracking and categorization of water samples In the EasyDisc R2A trials bench worksheet enter information about each water sample tested. Provide as much detail as is available. Water samples for split sample analysis 1. Hold water samples at ambient temperature for at least 1 hour. 2. Immediately prior to use, agitate the water samples or dilutions thoroughly for at least 5 seconds. Sample analysis using EasyDisc R2A 1. Remove the white lid from an EasyDisc R2A plate and set on a flat surface. 2. Pipet 1.0 ml of sample to the plate and Immediately swirl the water sample to coat the surface of the plate with the sample. Reattach the white lid and press down gently to secure. o EasyDisc requires 1.0 ml of sample for complete hydration and functionality. Therefore, if volumes of 41.0 ml are going to be evaluated, prepare a suitable dilution in an appropriate sterile, diluent (peptone water, Butterfield's Buffer, or deionized water) and use 1 ml of the diluted sample for inoculation. 3. Leave inoculated plate flat on the benchtop undisturbed for 20-30 minutes. 4. Incubate the plate at 20-28°C for 5-7 days with the white lid side up to improve stack stability. o Samples should be incubated in the same conditions/temperature as those prepared on the same day using SM9215 o Please note the incubation temperature used in column Q of the worksheet o Please note the incubation time used in column R of the worksheet 5. Examine the plates as soon as they are removed from the incubators (if incubators are used). o Samples prepared on the same day using SM9215 should be removed and analyzed at the same time. 6. Following incubation, inspect the plates with the white lid side down. 7. Reject any plate with confluent growth in which colonies cannot be resolved or with growth counts that exceed 300 CFU. 8. Count the number colonies, regardless of color. o Nearly all colonies will appear blue/purple, but some may produce natural pigments with other colonies. All colonies should be summed for the final result. 9. Enter number of colonies into column L. 10. Enter the dilution factor, into column N. If no dilutions were performed, enter 1.The worksheet will automatically calculate the CFU/ml of the starting sample. 0 Sample analysis according to SM9215, R2A R2A media preparation 1. Add the ingredients, or the complete dehydrated medium,to 1 L of sterile, deionized water and dissolve by heating. Adjust the pH if necessary so that after sterilization it will be (7.2* 0.2) at 25°C. o R2A agar recipe ■ Casein acid hydrolysate 0.5 g Dextrose 0.5 g ■ Dipotassium phosphate 0.3 g ■ Magnesium sulfate 0.024 g ■ Proteose peptone 0.5 g ■ Sodium pyruvate 0.3 g ■ Starch, soluble 0.5 g ■ Yeast extract 0.5 g ■ Agar 15.09 2. Sterilize in the autoclave at (121 t 3)°C for(15+ 1) minutes. Pour-plate method, SM921513: 1. For use, melt the medium, allow to cool and maintain it at 45 t VC using a water bath. 2. Place 1 ml of the test sample into a sterile, empty Petri dish, add 15-20 ml of the molten medium to each, and mix carefully by gentle rotation. Allow the medium to set. o If volumes < 1.0 ml must be analyzed, in order to eliminate the volume added to the test as a statistical variable, prepare a suitable dilution in an appropriate sterile, diluent (peptone water, Butterfiield's Buffer, or deionized water) and use 1 ml of the diluted sample for inoculation. Spread plate method, SM9215C 1_ Spread 0.1 - 0.5 ml of the sample onto pre-prepared R2A agar and allow the agar to absorb the sample completely. Membrane filtration method, SM9215D 1-. Filter sample through a 0,45 um pore.size filter and overlay filter onto pre-prepared R2A medium using sterile forceps. Take care to ensure no bubbles are trapped between the filter and the agar surface. o If volumes < 1,Oml must be analyzed, to eliminate the volume added to the test as a statistical variable, prepare a suitable dilution In an appropriate sterile, diluent (peptone water, Butterfield's Buffer, or deionized water) and use 1 ml of the diluted sample for inoculation. All SM9215 plates 1. Invert the plates and incubate 20-28°C for 5-7 days. o Samples should be incubated in the same conditions/temperature as those prepared on the same day using SM9215 in o Please note the incubation temperature used in column Q of the worksheet o Please note the incubation time used in column R of the worksheet 2. Examine the plates as soon as they are removed from the Incubators; if this is not possible, store them at 5 t 3°C and examine them within 48 h. 3. Reject any plate with confluent growth in which colonies cannot be resolved or with growth counts that exceed the method-specific TNTC upper limit. 4. Enter number of colonies into column M in the worksheet. 5. Enter the dilution factor, into column N. If no dilutions were performed, enter 1. The worksheet will automatically calculate the CFU/ml of the starting sample. Communication of results Results will be communicated by email and discussed by telephone conference call on a weekly schedule starting 2 weeks after the trial start date. Prior to conference calls please transmit the data in the electronic worksheet provided to Dan-Broder(&dexx.com for preliminary analysis in preparation for discussions. A conference call number and/or web conference link will be provided. Analytical Quality Control Laboratories must undertake analytical quality control (AQC)for analyses by both EasyDisc and SM 9215 that is acceptable under the requirements of ISO/1EC 17025:20173 Quality control strain(s) as recommended in ISO 11133:201401-11 Reference source net found. will be supplied by IDEXX, to be used in conjunction with the laboratory's own QC cultures (Annex A). Results of AQC testing should be included in either the Excel results file provided or in a separate Excel file. 1. One of the following quality control procedures is recommended for each lot of EasyDisc: A. IDEXX-QC HPCfrVC: E. faecalls(ATCC 194331 WDCM 00009) i. Follow procedure outlined at idexx.com https://www.idexx.com/en/water/water-products-servicesfidexx-oc/with the following protocol differences: 1. Resuspend the colored disc in 10 mL of sterile, nonbuffered, oxidant- free water. 2. Use 1 mL of resuspension for inoculation onto EasyDisc. B. Fill three sterile vessels with 100 ml of sterile non-buffered oxidant-free water and inoculate with a sterile loop of any QC strains listed in Annex A. 2. Follow"Sample analysis using EasyDisc° procedure.Steps 1-7. 3. Negative Control/Blank test should not contain any colonies. 11 Assistance Please contact Dan Broder(Dan-Broder@idexx.com)with any issues. Dan Broder IDEXX Laboratories 1 IDEXX Drive Westbrook, Maine 04092 USA Tel: 00+1+(207)556-2119 Annex A Quality Control Strains The following strains may be used during the trials as positive quality control strains as per ISO- 11133:20144. If alternate QC strains are preferred please contact Dan Broder to confirm. Positive Controls: ATCC I WDCM Escherichia coil ATCC 11775/WDCM 00090 Enterococcus faecaliis ATCC 29212/WDCM 00009 Pseudomonas aeruginosa ATCC 10145 Annex B References 1. 9215 Heterotrophic Plate Count(2017). Standard Methods For the Examination of Water and Wastewater, 23rd. 2. A new medium for the enumeration and subculture of bacteria from potable water. Reasoner DJ, Geldreich EE.Appl Environ Microbiol. 1985 Jan;49(1):1-7. 3. ISO/iEC 17025.2017. General requirements for the competence of testing and calibration laboratories. 4. ISO 11133:2014, Microbiology of food, animal feed and water—Preparation, production, storage and performance testing of culture media SCHEDULE2 EQUIPMENT AND MATERIALS PROVIDED • EasyDisc R2A tests (n=150, additional tests available upon request) • IDEXX-QC HPClTVC, Cat# UN3373-WQC-HPC o Contains E. faecalis • IDEXX-QC Pseudomonas Cat# UN3373-WQC-PSE 17 o Contains Pseudomonas aeruginosa, Escherichia coli, and Pseudomones fluorescens EQUIPMENT AND MATERIALS PROVIDED BY PRINCIPAL INVESTIGATOR • Materials to run SM9215 method 0 An n n r n n n n r n n n n n n n n n n n v c d YY U N N N N N N N N N N N N N N N N N N N C u 4 pp pp�7�� Epp QY pp py QQ pp ,�,Q N N 'i N N n( Do O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O E v�i $ rpm p (n Q O W G Op pp p{ as pp y� pyp� ei �v-11 U ,y pmp p� ��yy ryry�� Q Q N d rl N N N eNi ri rt N N 'r'I N �Q-1 �Q-1 WRRR Ne� p� '1 N Ill gq 9 9 � uQiu4i ,9ivYiuiviv9iu4iuYiJ� v� viJ� JiJ� J� v� J� J� vi A A A A c 'aJ J J J J J J J J J J J J J J J J J J N G G C C G G G G G C G G C G G C C C G G N N '1p0 M 10 1S A19 yN_ W � V rya g f f f f f f f � f f f f e f f f f f E s m n Q "c n A c o N 2 � N m a . m m m m m m m m m m m to m m m m m m m co ,�n $ m to m 14 8 �+ `fz N` pM�� e~i epp~i�� pp�-��I a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 O O N e'1 M '1 ri rl ri Nm-1 e�i ei H H ,m-I rl r1 N ti ri ei a V c c u a a u 0 0 O O b 0 0 0 Q ry q a a 0 0 LL0 LL0 LL0 tt0 L0 L0 L0 L0 u� L V V d N Z V N a E OA M.0 .0 L .G L L L I C a 01 O1 Rl Q O r n L � rl •i ei •1 ei rl �-1 rl N N N N N N N NI V W G ~ N N rl '1 •i •i ei e-1 rl eq ei •i e9 •i ei •i �Y t� r1 I LA t a aaaaaa .nr� asa.npaaaaaa a N p q� ei N Kf Q v1 �O n a0 V� a~-1 d rQl cam/ ti ti ti ei N N N fmV N N N N t�V N (0�1 t~/t m m t�l o�i M on oO01 m V Q v Q Q Q v v Q v01 N saldwex3