HomeMy WebLinkAboutContract 46729 a
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HeartSine- .. LLq.�
Inventor.Innovator.Lifesaver.
Supply Agreement with an effective date of" 05/07/2015 "between HeartSine Technologies Inc.
("HeartSine")of 121 Friends Lane,Suite 400, Newtown, PA 18940 and The City of Fort Worth located
at 1000 Throckmorton,Fort Worth,TX 76012("the city").
HeartSine wishes to conclude and Out of Hospital clinical study using products and services supplied by
HeartSine to City.
HeartSine with supply to the City:
Item Quantity
1. Samaritan PAD 350P 130 units
2. Adult Pad-Pak 130 units
3. Pediatric Pedi-Pak 110 units
4. USB Data transfer cable 10 units
HeartSine will provide these units free of charge to the City under the following conditions:
1. The City agreed to supply anonymized patient Saver EVO event data as per the case report form
as detailed in the HeartSine H611-001-001 protocol for the duration of the study.
2. HeartSine will replenish a Pad-Pak or Pedi-Pak free of charge for the duration of the
study.At the conclusion of the 2 year study,upon mutual written agreement by both
parties,the no-charge PadPak replenishment may be extended by both parties on annual
basis.
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3. In the event of a device malfunction Heartsine will replace any device that is broken,
C-) damaged,and/or nonfunctional due to an accidental incident. HeartSine will issue
M replacement devices as per HeartSine's standard customer return procedure.
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0 4. In accordance with the provisions of the Federal Food, Drug,and Cosmetic Act(the
"Act"),as amended, HeartSine's samaritan PAD and certain associated accessories have
Z been defined as"tracked devices" requiring traceability to the end user.
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C= The City shall maintain accurate records in order to supply HeartSine with any and all
information necessary including name,address, phone number or email,for HeartSine to
comply with its obligations under the Act and in particular Section 519(e)as outlined in the Code
of Federal Regulations Title 21 Part 821.The City Records shall include:
a. Lot, batch or serial number of each product
b. The address of each product
c. The location of each product
d. The date the product was provided to the City
e. The name,address and telephone number of the physician prescribing the product, if
applicable. QFMC o
SIM SECRETAIRY
F`�. WORTH
TX
U.S./Americas 121 Friends Lane.Suite 400,Newtown,PA i894o - P:+1215 960 ., - R+1215 860 8192
AirportEurope/ROW 203 00
QHeartSine-
Inventor.Innovator.Lifesaver.
5. Upon completion of the study, both parties shall agree to an extension or otherwise as mutually
agreed.
6. Termination:either party may have the right to terminate this agreement with 90 day written
notice to the other party.
Signed
For HeartSine Technologies Inc.
Name: Stephen Garrett
Signature:
Date: 05/07/2""015
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For Fort Worth Fire Department 0 �YY
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Name: Au j 0C
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Signature:
Maty J. ei, cityls&Teulry
Date: L-S
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OFFICIAL RECORD
CITY SECRETARY
FT. WORTH, TX